Summary:
Title I: Animal Drug User Fee Amendments - Animal Drug User Fee Amendments of 2013 - (Sec. 103) Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect animal drug user fees, specifically new animal drug application or supplemental animal drug application fees, animal drug product fees, animal drug establishment fees, and animal drug sponsor fees.

Revises the due date for annual user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year.

Establishes the amount of revenue such fees can generate. Specifies percentages of the total revenue that shall be derived from each type of user fee.

Requires the Secretary of Health and Human Services (HHS) to adjust the total revenue amounts for FY2015 and subsequent fiscal years for inflation.

Authorizes the Secretary to accept payment of user fees prior to their due date.

Requires the total fees collected for FY2016-FY2018 to be increased by the cumulative amount, if any, by which the amount of user fees collected and appropriated for prior fiscal year falls below the cumulative amount of fees authorized.

(Sec. 104) Extends requirements for the FDA to report to Congress on achieving goals related to animal drug development and review processes and implementation of authority to collect animal drug user fees.

(Sec. 107) Terminates the authority to collect user fees October 1, 2018.

Title II: Animal Generic Drug User Fee Amendments - Animal Generic Drug User Fee Amendments of 2013 - (Sec. 202) Extends for FY2014-FY2018 the authority of the FDA to collect generic animal drug user fees, specifically abbreviated application fees for generic new animal drugs, generic new animal drug product fees, and generic new animal drug sponsor fees.

Subjects generic animal drug applications to a fee 50% of the amount of the normal fee if the application is for an animal drug which contains more than one active ingredient, or the labeling of the drug prescribes, recommends, or suggests use of the drug in combination with one or more other animal drugs, and the active ingredients or drugs intended for use in the combination have previously been separately approved.

Revises the due date for annual generic animal drug user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year.

Establishes the total amount of revenue each type of generic user fee shall generate.

Authorizes the Secretary to accept payment of user fees prior to their due date.

(Sec. 203) Extends requirements for the FDA to report to Congress on achieving goals related to the generic animal drug development and review process and the implementation of the authority to collect generic animal drug fees.

(Sec. 206) Terminates the authority to collect generic animal drug user fees October 1, 2018.

title animal drug user fee amendments animal drug user fee amendments sec amends cosmetic act extend fy2014 fy2018 authority food_and_drug_administration fda collect animal drug user fees specifically new animal drug application supplemental animal drug application fees animal drug product fees animal drug establishment fees animal drug sponsor fees revises date annual user fees later january year business day enactment appropriations act providing collection obligation fees fiscal year establishes revenue fees generate specifies percentages total revenue shall derived type user fee requires secretary health_and_human_services hhs adjust total revenue amounts fy2015 subsequent fiscal years inflation authorizes secretary accept payment user fees prior date requires total fees collected fy2016 fy2018 increased cumulative user fees collected appropriated prior fiscal year falls cumulative fees authorized sec extends requirements fda report congress achieving goals related animal drug development review processes implementation authority collect animal drug user fees sec terminates authority collect user fees october title animal generic drug user fee amendments animal generic drug user fee amendments sec extends fy2014 fy2018 authority fda collect generic animal drug user fees specifically abbreviated application fees generic new animal drugs generic new animal drug product fees generic new animal drug sponsor fees subjects generic animal drug applications fee normal fee application animal drug contains active ingredient labeling drug prescribes recommends suggests use drug combination animal drugs active ingredients drugs intended use combination previously separately approved revises date annual generic animal drug user fees later january year business day enactment appropriations act providing collection obligation fees fiscal year establishes total revenue type generic user fee shall generate authorizes secretary accept payment user fees prior date sec extends requirements fda report congress achieving goals related generic animal drug development review process implementation authority collect generic animal drug fees sec terminates authority collect generic animal drug user fees october


Summary:
Medicare Drug Savings Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to require drug manufacturers to pay the Secretary of Health and Human Services (HHS) drug rebates for rebate eligible (low-income) individuals. Excludes from Medicare coverage as a part D drug any drug or biological manufactured by a manufacturer that has not entered into and have in effect a rebate agreement with the Secretary.

Requires a rebate agreement to require a drug or biological manufacturer to provide to the Secretary a rebate, determined according to a specified formula, for each rebate period ending after December 31, 2011, for any covered Medicare part D drug dispensed after that date to any rebate eligible individual for which payment was made by a prescription drug plan (PDP) sponsor or MedicareAdvantage (MA) organization for such period.

Specifies a formula for determination of Medicaid rebate amounts for such drugs or biologicals.

Amends SSA title XIX (Medicaid) to exclude any amounts paid under a rebate agreement from the determination of best price and average manufacturer price under the Medicaid program.

medicare_drug_savings_act amends voluntary prescription drug benefit program title xviii medicare social security act ssa require drug manufacturers pay secretary health_and_human_services hhs drug rebates rebate eligible low income individuals excludes medicare coverage drug drug biological manufactured manufacturer entered effect rebate agreement secretary requires rebate agreement require drug biological manufacturer provide secretary rebate determined according specified formula rebate period ending december covered medicare drug dispensed date rebate eligible individual payment prescription drug plan pdp sponsor medicareadvantage organization period specifies formula determination medicaid rebate amounts drugs biologicals amends ssa title xix medicaid exclude amounts paid rebate agreement determination best price average manufacturer price medicaid program


Summary:
Medicare DMEPOS Market Pricing Program Act of 2013 - Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act (SSA) to establish a market pricing program for durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) as a replacement for the competitive acquisition program, which is terminated as of December 31, 2013. Terminates contracts awarded before enactment of this Act on July 1, 2013.

Prescribes requirements for transitional payments for items and services, including payments for diabetic supplies and off-the-shelf orthotics, in areas designated for rounds 1 and 2 of the erstwhile phase-in of the competitive acquistion program, as well as during the initial two-year period of the market pricing program.

Directs the Secretary to: (1) conduct market-priced auctions in eligible auction areas throughout the United States for the furnishing of market priced items and services, (2) establish an auction design through a specified process and meeting certain requirements, and (3) ensure that the first auction will be conducted for all eligible auction areas not later than 14 months after contracting with an auction expert.

Directs the Secretary to: (1) select a combination of two categories of items and services for each auction, (2) establish a lead product for each product category, (3) establish for each market priced item and service a clearing price equal to the highest cost bid that will meet capacity targets in the market area, (4) award a contract to any entity in an auction's eligible market area whose bid is at or below the clearing price, and (5) monitor the performance of suppliers that are awarded a contract to ensure their compliance with certain requirements. Requires the Secretary, through the Office of the Assistant Secretary for Planning and Evaluation, to contract with an auction expert and a market monitor to assist in the design, development, implementation, and functioning of the auction. Requires the market monitor, on an ongoing basis, also to monitor suppliers and the effects of the market pricing program.

Rescinds unobligated balances of all discretionary appropriations for each fiscal year (except those for accounts, programs, projects and activities operated by the Department of Defense [DOD] or the Department of Veterans Affairs [VA]) in an amount necessary to make this Act budget neutral for such fiscal year.

amends supplementary_medical_insurance title xviii medicare social security act ssa establish market pricing program durable medical equipment dme prosthetics orthotics supplies dmepos replacement competitive acquisition program terminated december terminates contracts awarded enactment act july prescribes requirements transitional payments items services including payments diabetic supplies shelf orthotics areas designated rounds phase competitive program initial year period market pricing program directs secretary conduct market priced auctions eligible auction areas united_states furnishing market priced items services establish auction design specified process meeting certain requirements ensure auction conducted eligible auction areas later months contracting auction expert directs secretary select combination categories items services auction establish lead product product category establish market priced item service clearing price equal highest cost bid meet capacity targets market area award contract entity auction eligible market area bid clearing price monitor performance suppliers awarded contract ensure compliance certain requirements requires secretary office assistant secretary contract auction expert market monitor assist design development implementation functioning auction requires market monitor ongoing basis monitor suppliers effects market pricing program rescinds unobligated balances discretionary appropriations fiscal year accounts programs projects activities operated department_of_defense dod department_of_veterans_affairs necessary act budget neutral fiscal year


Summary:
Safeguarding America's Pharmaceuticals Act of 2013 - (Sec. 2) Amends the Federal Food, Drug, and Cosmetic Act to establish requirements to facilitate the tracing of drug products through the pharmaceutical supply distribution chain.

Requires the Secretary of Health and Human Services (HHS) to establish standards for the exchange of transaction information.

Requires the Secretary to establish processes to: (1) provide waivers of requirements for undue economic hardship or emergency medical reasons; (2) provide waivers of requirements relating to product identifiers for prescription drug products packaged without sufficient space to bear the information; and (3) determine other prescription drug products or transactions that should be exempt from the requirements of this Act.

Establishes requirements for drug manufacturers, wholesalers, dispensers, and repackagers to ensure that all prior transaction information is provided at each transfer of ownership. Requires such entities to maintain such transaction information for three years. Sets forth exceptions, including for dispensing to a patient and returns.

Requires a manufacturer, wholesale distributor, dispenser, repackager, in the event of a recall or for the purpose of investigating a suspect prescription drug product or an illegitimate prescription drug product, to provide within two business days the applicable transaction documentation upon request by the Secretary or other appropriate federal or state official.

Requires a manufacturer or repackager to affix or imprint a prescription drug product identifier on each package and homogenous case of a prescription drug product.

Requires a manufacturer, wholesale distributor, dispenser, repackager, or third party logistics provider to ensure that each of its trading partners is authorized.

Requires a manufacturer, wholesale distributor, dispenser, repackager, and third party logistics provider to implement systems to: (1) investigate suspected illegitimate prescription drug products or, for a third party logistics provider, notify the owner of a need for such an investigation, and (2) handle illegitimate prescription drug products, including through quarantine, disposal, and appropriate notice to the Secretary and, as necessary, trading partners.

Requires manufacturers, wholesale distributors, repackagers to verify returned products before further distribution.

(Sec. 3) Requires the Secretary to establish projects and hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain.

Directs the Comptroller General (GAO) to examine implementation of the requirements established under this Act in order to inform regulations promulgated to enhance distribution supply chain safety and security.

Directs the Secretary to contract with a private, independent consulting firm with relevant expertise to conduct a technology and software study on the feasibility of dispensers that have 25 or fewer full-time employees conducting interoperable, electronic tracing of prescription drug products at the package level. Requires the Secretary to issue additional proposed regulations in 2027 to prevent a suspect, illegitimate or counterfeit product, or a product otherwise unfit for distribution from entering into or being further distributed in the supply chain.

(Sec. 4) Requires the Secretary to establish standards for the licensing of wholesale distributors and third party logistics providers. Requires third party logistics providers to be licensed by the state from which the drug is distributed or by the Secretary.

(Sec. 6) Applies specified criminal and civil penalties to violations of standards prescribed under this Act, including a certain enhanced penalty for knowing unlicensed activities, and failure to bear a prescription drug product identifier required by this Act.

 (Sec. 7) Preempts state and local requirements related to tracing drugs through the distribution system, and licensure of wholesale distributors or third party logistics provider licensure.

(Sec. 8) Allows certain prescription drug labeling to be provided solely by electronic means.

safeguarding_america pharmaceuticals act sec amends cosmetic act establish requirements facilitate tracing drug products pharmaceutical supply distribution chain requires secretary health_and_human_services hhs establish standards exchange transaction information requires secretary establish processes provide waivers requirements undue economic hardship emergency medical reasons provide waivers requirements relating product identifiers prescription drug products packaged sufficient space bear information determine prescription drug products transactions exempt requirements act establishes requirements drug manufacturers wholesalers dispensers ensure prior transaction information provided transfer ownership requires entities maintain transaction information years sets forth exceptions including dispensing patient returns requires manufacturer wholesale distributor dispenser repackager event recall purpose investigating suspect prescription drug product illegitimate prescription drug product provide business days applicable transaction documentation request secretary appropriate federal state official requires manufacturer repackager affix prescription drug product identifier package case prescription drug product requires manufacturer wholesale distributor dispenser repackager party logistics provider ensure trading partners authorized requires manufacturer wholesale distributor dispenser repackager party logistics provider implement systems investigate suspected illegitimate prescription drug products party logistics provider notify owner need investigation handle illegitimate prescription drug products including quarantine disposal appropriate notice secretary necessary trading partners requires manufacturers wholesale distributors verify returned products distribution sec requires secretary establish projects hold public meetings enhance safety security pharmaceutical distribution supply chain directs comptroller general gao examine implementation requirements established act order inform regulations promulgated enhance distribution supply chain safety security directs secretary contract private independent consulting firm relevant expertise conduct technology software study feasibility dispensers fewer time employees conducting interoperable electronic tracing prescription drug products package level requires secretary issue additional proposed regulations prevent suspect illegitimate counterfeit product product unfit distribution entering distributed supply chain sec requires secretary establish standards licensing wholesale distributors party logistics providers requires party logistics providers licensed state drug distributed secretary sec applies specified criminal civil penalties violations standards prescribed act including certain enhanced penalty knowing unlicensed activities failure bear prescription drug product identifier required act sec preempts state local requirements related tracing drugs distribution system licensure wholesale distributors party logistics provider licensure sec allows certain prescription drug labeling provided solely electronic means


Summary:
Drug Testing Integrity Act of 2013 - Makes it unlawful to knowingly manufacture, market, sell, ship, or otherwise provide to another individual any product with the intent to assist such individual to use such product to defraud a drug test.

Treats a violation of this Act as an unfair or deceptive act or practice under the Federal Trade Commission Act.

drug testing integrity act makes unlawful knowingly manufacture market sell ship provide individual product intent assist individual use product defraud drug test treats violation act unfair deceptive act practice federal_trade_commission_act


Summary: Gray Market Drug Reform and Transparency Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) make it a prohibited act and a misbranding for a wholesale distributor of prescription drugs to purchase or receive a prescription drug from a pharmacy or a pharmacist, (2) require annual reporting by wholesale distributors of prescription drugs, (3) require the Secretary of Health and Human Services (HHS) to establish and maintain a national database of information reported by wholesale distributors of prescription drugs and to require such database to include information on actions taken by states against wholesale distributors (e.g., disciplinary actions and license revocations), (4) require the Secretary to assess and collect fees from wholesale distributors of prescription drugs, and (5) require wholesale distributors of prescription drugs to provide to recipients of a prescription drug in shortage the sales price for such drug at the time of its sale and at the time of any prior sale of such drug when it was in shortage.

transparency_act amends cosmetic act prohibited act misbranding wholesale distributor prescription drugs purchase receive prescription drug pharmacy pharmacist require annual reporting wholesale distributors prescription drugs require secretary health_and_human_services hhs establish maintain national database information reported wholesale distributors prescription drugs require database include information actions taken states wholesale distributors disciplinary actions license revocations require secretary assess collect fees wholesale distributors prescription drugs require wholesale distributors prescription drugs provide recipients prescription drug shortage sales price drug time sale time prior sale drug shortage


Summary: Gluten in Medicine Disclosure Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to deem to be misbranded any drug intended for human use that contains an ingredient (other than a polyol) that constitutes or is derived from a grain or starch-containing ingredient and whose label fails to include a parenthetical statement identifying the source of the ingredient so constituted or derived.

medicine disclosure act amends cosmetic act deem misbranded drug intended human use contains ingredient constitutes derived grain starch containing ingredient label fails include statement identifying source ingredient constituted derived


Summary:
Patient Choice Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug.

Defines the term “adequately safe” to mean that: (1) for at least one population, the risk of death or morbidity caused directly by an adverse effect of the drug is unlikely to be greater than the combined direct and secondary risks of death or morbidity of the disease and existing therapies; or (2) the drug has had a valid marketing authorization for at least four years in specified countries and data adequate for the approval of such marketing authorization has been submitted to the Secretary.

Prohibits the Secretary from imposing any requirements for safety studies or data in addition to, or different than, the requirements for studies to establish safety for purposes of Phase 1 (initial introduction of an investigational new drug into humans) or Phase 2 (controlled clinical studies to evaluate the effectiveness of the drug for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug).

Applies the provisional approval only to the indication for the drug: (1) which is related to the treatment of the condition with respect to which the drug was designated as a fast track product, and (2) for which the drug is demonstrated to be adequately safety.

Prescribes requirements for termination of provisional approval, withdrawal of such approval, and application of market exclusivity to fast-track approval products.

patient choice act amends cosmetic act authorize provisional approval fast track products determined secretary health_and_human_services hhs adequately safe treats provisional approval manner approval drug provisional approval subject requirements related informed consent continued pursuit safety efficacy data purposes gaining approval drug defines term adequately safe mean population risk death morbidity caused directly adverse effect drug unlikely greater combined direct secondary risks death morbidity disease existing therapies drug valid marketing authorization years specified countries data adequate approval marketing authorization submitted secretary prohibits secretary imposing requirements safety studies data addition different requirements studies establish safety purposes phase initial introduction investigational new drug humans phase controlled clinical studies evaluate effectiveness drug particular indication patients disease condition study determine common short term effects risks associated drug applies provisional approval indication drug related treatment condition respect drug designated fast track product drug demonstrated adequately safety prescribes requirements termination provisional approval withdrawal approval application market exclusivity fast track approval products


Summary: Cardiac Arrest Survival Act of 2013 - Amends the Public Health Service Act to expand immunity from civil liability related to automated external defibrillator devices (AEDs), including by giving immunity to: (1) a person who owns, occupies, or manages the premises from which an AED is taken or at which an AED is used or attempted to be used on a victim of a perceived medical emergency; and (2) the owner-acquirer of an AED for any harm resulting from the use or attempted use of such device, unless the harm was proximately caused by the failure of the owner-acquirer to properly maintain the device according to the guidelines of the device manufacturer. Applies immunity regardless of whether: (1) the AED is marked with cautionary signage or registered with any government; or (2) the person who used or attempted to use the AED complied with such signage, had received training on such use, or was assisted or supervised by any other person, including a licensed physician.

cardiac arrest survival act amends public_health_service_act expand immunity civil liability related automated external devices aeds including giving immunity person owns occupies manages premises aed taken aed attempted victim perceived medical emergency owner aed harm resulting use attempted use device harm proximately caused failure owner properly maintain device according guidelines device manufacturer applies immunity regardless aed marked cautionary signage registered government person attempted use aed complied signage received training use assisted supervised person including licensed physician


Summary:
Human Cloning Prohibition Act of 2012 - Amends the federal criminal code to prohibit any public or private person or entity, in or affecting interstate commerce, from: (1) performing or attempting to perform human cloning; (2) participating in an attempt to perform human cloning; or (3) shipping, receiving, or importing the product of human cloning for any purpose. Sets forth criminal and civil penalties for violations.

Provides that nothing in this Act shall restrict areas of scientific research not specifically prohibited by this Act, including research in the use of nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans.

human cloning prohibition act amends federal criminal code prohibit public private person entity affecting interstate commerce performing attempting perform human cloning participating attempt perform human cloning shipping receiving importing product human cloning purpose sets forth criminal civil penalties violations provides act shall restrict areas scientific research specifically prohibited act including research use nuclear transfer cloning techniques produce dna cells human tissues organs plants animals humans


Summary:
Verifying Authority and Legality In Drug Compounding Act of 2013 or VALID Compounding Act - Amends the Federal Food, Drug, and Cosmetic Act with respect to the regulation of compounding drugs.

Requires the Secretary of Health and Human Services (HHS) to develop and maintain a list of bulk substances from which drug products may be compounded that specifies any limitation on compounding of the substance and the particular medical need that is met by placing such substance on the list. Requires the Secretary to receive and consider petitions from any person identifying a substance that should be added to or removed from the list. Sets forth requirements for such petitions. Requires the Secretary also to develop and maintain a list of drug products that should not be compounded.

 Allows a pharmacy to compound drugs which are not for an identified individual patient based on the receipt of a prescription order if the pharmacy registers with the Secretary and agrees to comply with any condition of operation or limitation of activity the Secretary specifies. Sets forth information that must be included in any such registration.

Authorizes the compounding of a drug that is a copy of a commercially available drug product if: (1) the drug is on the drug shortage list with notice given to the Secretary by the pharmacy, or (2) the drug product is necessary to protect public health and well-being. Requires the pharmacy to demonstrate to the Secretary that controls will be used that are comparable to elements required for safe use for a drug subject to a risk evaluation and mitigation strategy.

Requires the Secretary to establish standards, processes, and procedures for high-risk sterile compounding.

Establishes requirements related to inspections, labeling, and adverse event reporting for compounded drugs.

Requires the Secretary to assess an annual establishment fee from compounding pharmacies and a reinspection fee for any pharmacy subject to a reinspection in a fiscal year. Sets forth a methodology for setting such fees and requires reduced fees for small businesses (pharmacies with $1 million or less in annual sales).

States that the requirements of this Act do not preempt any non-federal requirement that is in addition to, and compatible with, such requirements.

valid compounding act amends federal food drug cosmetic act respect regulation compounding drugs requires secretary health_and_human_services hhs develop maintain list bulk substances drug products compounded specifies limitation compounding substance particular medical need met placing substance list requires secretary receive consider petitions person identifying substance added removed list sets forth requirements petitions requires secretary develop maintain list drug products compounded allows pharmacy compound drugs identified individual patient based receipt prescription order pharmacy registers secretary agrees comply condition operation limitation activity secretary specifies sets forth information included registration authorizes compounding drug copy commercially available drug product drug drug shortage list notice given secretary pharmacy drug product necessary protect public health requires pharmacy demonstrate secretary controls comparable elements required safe use drug subject risk evaluation mitigation strategy requires secretary establish standards processes procedures high risk sterile compounding establishes requirements related inspections labeling adverse event reporting compounded drugs requires secretary assess annual establishment fee compounding pharmacies reinspection fee pharmacy subject reinspection fiscal year sets forth methodology setting fees requires reduced fees small businesses pharmacies million annual sales states requirements act preempt non federal requirement addition compatible requirements


Summary:
Clinical Trial Cancer Mission 2020 Act - Revises clinical trial registry data bank provisions of the Public Health Service Act to: (1) include a device or drug clinical trial whether or not it results in a positive or negative outcome, and (2) subject clinical trials funded by the Department of Defense (DOD) to requirements to certify information submissions to the Director of the National Institutes of Health (NIH).

Restricts funding for a grantee and makes the grantee liable to the United States for repayment of any grant amount provided, if the grantee has not submitted clinical trial information within the 30-day correction period for noncompliance.

act revises clinical trial registry data bank provisions public_health_service_act include device drug clinical trial results positive negative outcome subject clinical trials funded department_of_defense dod requirements certify information submissions director national_institutes_of_health nih restricts funding grantee makes grantee liable united_states repayment grant provided grantee submitted clinical trial information day correction period noncompliance


Summary: Infant Formula Protection Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to deem an infant formula, including an infant formula powder, to be adulterated if its use-by date has passed.

amends cosmetic act deem infant formula including infant formula powder adulterated use date passed


Summary:
Preserving Access to Orphan Drugs Act of 2013 - Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions (orphan drug) from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.

Makes this Act effective as if included in PPACA.

preserving access orphan drugs act amends patient protection affordable care act ppaca exclude drug biological product approved licensed food_and_drug_administration fda marketing solely rare diseases conditions orphan drug annual fee manufacturers importers branded prescription drug sales exceeding million makes act effective included ppaca


Summary:
Health Care Innovation and Marketplace Technologies Act of 2013 - Amends the Internal Revenue Code to allow a medical care provider to deduct from gross income the amount paid or incurred for qualified health information technology placed in service during the taxable year.

Amends the Small Business Act to authorize the Administrator of the Small Business Administration (SBA) to guarantee up to 90% of the amount of a loan, up to specified loan amounts, to a small business health professional to be used for the acquisition and installation of health information technology for the professional's medical practice.

Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS), acting through the National Coordinator for Health Information Technology, to award grants for the development of an effective product, process, or structure that enhances the use, particularly by patients, of health information technology.

Requires the Secretary, acting through the National Coordinator, to award prizes for development in areas of health information technology that are not adequately addressed by certified electronic health records (EHR) technologies and the use of such technologies.

Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Wireless Health Technology.

Requires the Health Information Technology Research Center to provide support for mobile health software application technology.

Authorizes the National Coordinator to award grants for training health care workers in health information technology.

health care innovation marketplace technologies act amends internal revenue code allow medical care provider deduct gross income paid incurred qualified health information technology placed service taxable year amends small business act authorize administrator small_business_administration sba guarantee loan specified loan amounts small business health professional acquisition installation health information technology professional medical practice amends public_health_service_act require secretary health_and_human_services hhs acting award grants development effective product process structure enhances use particularly patients health information technology requires secretary acting award prizes development areas health information technology adequately addressed certified electronic health records ehr technologies use technologies amends cosmetic act establish requires provide support mobile health software application technology authorizes national coordinator award grants training health care workers health information technology


Summary:
Combination Drug Development Incentive Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to the five-year bar on a new drug application (or abbreviated drug application) by anyone that has not obtained a right of reference or use from the original and approved drug approval applicant by or for whom investigations under the original, subsequently approved application were conducted.

Applies this five-year bar, and the requirement of a grant of a right of reference or use, with respect to an approved drug application (or abbreviated drug application) if: (1) the application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, (2) the application is for a drug which contains a combination of active ingredients (combination drug), and (3) no such combination of active ingredients has been approved in any other application.

amends cosmetic act respect year bar new drug application abbreviated drug application obtained right reference use original approved drug approval applicant investigations original subsequently approved application conducted applies year bar requirement grant right reference use respect approved drug application abbreviated drug application application contains reports new clinical investigations studies essential approval application conducted sponsored applicant application drug contains combination active ingredients combination drug combination active ingredients approved application


Summary:
Medical Testing Availability Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to labeling in the shipment or delivery of an in vitro diagnostic product for an investigation exempt from compliance with a performance standard or the requirement of premarket approval.

Declares that such a product whose labeling states "For Research Use Only. Not for use in diagnostic procedures." may not be deemed misbranded on the basis that its manufacturer or distributor: (1) sells the product to an end user who uses the product in a manner inconsistent with such statement, or (2) engages in business communications regarding the product with an end user.

Defines "business communications": (1) as oral, written, or electronic contact between a manufacturer or distributor of such a product and an end user regarding the product's functioning; and (2) includes any such contact consisting of technical support, customer service, assistance with the installation of such product, communication relating to ensuring the performance of the product, and other similar contacts.

medical testing availability act amends cosmetic act respect labeling shipment delivery vitro diagnostic product investigation exempt compliance performance standard requirement premarket approval declares product labeling states research use use diagnostic procedures deemed misbranded basis manufacturer distributor sells product end user uses product manner inconsistent statement engages business communications product end user defines business communications oral written electronic contact manufacturer distributor product end user product functioning includes contact consisting technical support customer service assistance installation product communication relating ensuring performance product similar contacts


Summary:
Supporting Access to Formulated and Effective Compounded Drugs Act of 2013 or S.A.F.E. Compounded Drugs Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounded drugs.

Eliminates authority for compounding pharmacies to compound any drug product that is a copy of a commercially available drug. Prohibits such pharmacies from compounding: (1) any drug product appearing on a list of active ingredients and dosage forms that the Secretary of Health and Human Services (HHS) determines should not be compounded, or (2) in violation of promulgated minimum standards for the safe production of compounded drug products.

Establishes notification requirements before a patient is prescribed, dispensed, or administered a compounded drug, which must include providing the patient a document concerning the availability, safety, and production of such drugs.

 Requires a drug product compounded under the FFDCA to be clearly labeled as a “non-FDA approved compounded drug product.” Authorizes the Secretary of Health and Human Services (HHS) to establish different labeling requirements for compounded drugs.

Requires the Secretary to establish a process for pharmacies to register as compounding pharmacies. Exempts pharmacies that employ fewer than 20 full-time employees and perform traditional compounding of drug products for use in a single state.

Requires the Secretary to: (1) establish a database of information on compounding pharmacies licensed in more than one state for oversight purposes, (2) establish minimum standards for the safe production of compounded drugs as well as for which drugs must meet those standards, and (3) conduct regional training for state agencies that regulate compounding pharmacies.

 Directs the Secretary to establish advisory committees on labeling of compounded drugs and on the database under this Act. Requires the Secretary to convene an Advisory Committee on Pharmacy Compounding as appropriate to consider issues related to the safety and availability of compounded drugs.

Directs the Comptroller General (GAO) to review: (1) the extent to which federal health care programs ensure that compounded drug products they pay for are compounded in FFDCA-compliant facilities, (2) whether the reimbursement rates for such products under these federal programs are appropriate, and (3) whether these programs encourage the use of compounded drug products in place of otherwise available lawfully marketed drug products.

Prescribes criminal penalties for violations of prohibitions concerning compounded drug products that are committed: (1) knowingly and intentionally to defraud or mislead, or (2) with conscious or reckless disregard of a risk of death or serious bodily injury.

compounded drugs act amends cosmetic act ffdca respect regulation compounded drugs eliminates authority compounding pharmacies compound drug product copy commercially available drug prohibits pharmacies compounding drug product appearing list active ingredients dosage forms secretary health_and_human_services hhs determines compounded violation promulgated minimum standards safe production compounded drug products establishes notification requirements patient prescribed dispensed administered compounded drug include providing patient document concerning availability safety production drugs requires drug product compounded ffdca clearly labeled non fda approved compounded drug product authorizes secretary health_and_human_services hhs establish different labeling requirements compounded drugs requires secretary establish process pharmacies register compounding pharmacies exempts pharmacies employ fewer time employees perform traditional compounding drug products use single state requires secretary establish database information compounding pharmacies licensed state oversight purposes establish minimum standards safe production compounded drugs drugs meet standards conduct regional training state agencies regulate compounding pharmacies directs secretary establish advisory committees labeling compounded drugs database act requires secretary convene appropriate consider issues related safety availability compounded drugs directs comptroller general gao review extent federal health care programs ensure compounded drug products pay compounded ffdca compliant facilities reimbursement rates products federal programs appropriate programs encourage use compounded drug products place available lawfully marketed drug products prescribes criminal penalties violations prohibitions concerning compounded drug products committed knowingly intentionally defraud mislead conscious reckless disregard risk death bodily injury


Summary:
Compounding Clarity Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise requirements for the regulation of compounding drugs.

Revises the exemption of compounded drugs from certain new drug, labeling, and biological product requirements. Adds an exemption for drug products compounded by a licensed pharmacist or a licensed physician, pursuant to a non-patient-specific purchase order, which: (1) will be administered by a health care practitioner within a physician's office, a hospital, or another health care setting; and (2) meet other specified criteria.

Revises requirements for exempted bulk drug substances.

Prohibits the sale of a drug product by an entity other than the pharmacy or physician that compounded it.

Directs the Secretary of Health and Human Services (HHS) to develop a system for receiving and reviewing submissions from state boards of pharmacy: (1) describing actions taken against compounding pharmacies, or (2) expressing concerns that a compounding pharmacy may be acting in violation of one or more requirements of this section. Requires the Secretary to review such submissions and determine whether the pharmacy involved may be in violation of one or more compounding requirements.

Authorizes the Secretary to inspect a pharmacy's records to determine whether the pharmacy is in violation of one or more FFDCA requirements.

Exempts from certain new drug, labeling, and biological product requirements a drug product compounded for human use by a licensed pharmacist in a registered outsourcing facility if specified conditions, including labeling requirements, are met.

 Establishes annual registration requirements for any outsourcing facility. Requires a facility to report to the Secretary biannually on what drugs are compounded in it and to submit adverse event reports. Subjects such facilities to a risk-based inspection schedule.

Requires the Secretary to: (1) publish a list of drugs presenting demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug, taking into account the risk and benefits to patients; and (2) convene an advisory committee on compounding before creating the list.

Requires the Secretary to assess an annual establishment fee on each outsourcing facility and a reinspection fee, as necessary.

Prohibits the intentional falsification of a required prescription, a purchase order, or patient name for a compounded drug.

Prohibits the intentional failure of an outsourcing facility to register.

compounding clarity act amends cosmetic act ffdca revise requirements regulation compounding drugs revises exemption compounded drugs certain new drug labeling biological product requirements adds exemption drug products compounded licensed pharmacist licensed physician pursuant non patient specific purchase order administered health care practitioner physician office hospital health care setting meet specified criteria revises requirements exempted bulk drug substances prohibits sale drug product entity pharmacy physician compounded directs secretary health_and_human_services hhs develop system receiving reviewing submissions state boards pharmacy describing actions taken compounding pharmacies expressing concerns compounding pharmacy acting violation requirements section requires secretary review submissions determine pharmacy involved violation compounding requirements authorizes secretary inspect pharmacy records determine pharmacy violation ffdca requirements exempts certain new drug labeling biological product requirements drug product compounded human use licensed pharmacist registered outsourcing facility specified conditions including labeling requirements met establishes annual registration requirements outsourcing facility requires facility report secretary biannually drugs compounded submit adverse event reports subjects facilities risk based inspection schedule requires secretary publish list drugs presenting demonstrable difficulties compounding reasonably likely lead adverse effect safety effectiveness drug taking account risk benefits patients convene advisory committee compounding creating list requires secretary assess annual establishment fee outsourcing facility reinspection fee necessary prohibits intentional falsification required prescription purchase order patient compounded drug prohibits intentional failure outsourcing facility register


Summary:
Medicare Orthotics and Prosthetics Improvement Act of 2013 - Amends title XVIII (Medicare) of the Social Security Act, for application of quality standards for certain accredited suppliers of prosthetic devices, orthotics, and certain prosthetics, to require the Secretary of Health and Human Services (HHS) to designate and approve an independent accreditation organization with respect to such suppliers only if that organization is the American Board for Certification in Orthotics and Prosthetics, Inc. or the Board for Orthotist/ Prosthetist Certification (or a program with essentially equivalent accreditation and approval standards). Exempts from such standards any suppliers who: (1) are physicians, occupational therapists, or physical therapists licensed or otherwise regulated by the state in which they practice; and (2) receive Medicare payments. Applies to custom-fitted orthotics the special payment rules for certain prosthetics and custom-fabricated orthotics. Exempts from such rules off-the-shelf orthotics included in a competitive acquisition program.

Modifies the Medicare payment rules for orthotics and prosthetics to account for supplier qualifications and complexity of care.

Directs the Secretary to report to Congress on: (1) HHS steps taken to ensure that the state licensure and accreditation requirements are enforced, and (2) the effects of requirements of this Act on the occurrence of Medicare fraud and abuse with respect to orthotics and prosthetics.

Requires the Secretary, acting through the Chief Actuary of the Centers for Medicare and Medicaid Services, to submit to Congress a projection on the effect on cumulative federal spending under Medicare part B (Supplementary Medical Insurance) for 2014-2018 that will result from implementation of this Act. Requires the Secretary, if the Chief Actuary projects that implementation of this Act will not result in a cumulative spending reduction of at least $250 million for 2014-2018, to issue an interim final regulation to strengthen the licensure, accreditation, and quality standards applicable to orthotics and prosthetics suppliers in order to produce such a cumulative reduction by the end of 2018. Exempts from such regulation any qualified physical therapist or qualified occupational therapist.

medicare_orthotics prosthetics improvement act amends title xviii medicare social security act application quality standards certain accredited suppliers prosthetic devices orthotics certain prosthetics require secretary health_and_human_services hhs designate approve independent accreditation organization respect suppliers organization program essentially equivalent accreditation approval standards exempts standards suppliers physicians occupational therapists physical therapists licensed regulated state practice receive medicare payments applies custom fitted orthotics special payment rules certain prosthetics custom fabricated orthotics exempts rules shelf orthotics included competitive acquisition program modifies medicare payment rules orthotics prosthetics account supplier qualifications complexity care directs secretary report congress hhs steps taken ensure state licensure accreditation requirements enforced effects requirements act occurrence medicare fraud abuse respect orthotics prosthetics requires secretary acting chief actuary centers medicare medicaid_services submit congress projection effect cumulative federal spending medicare supplementary_medical_insurance result implementation act requires secretary chief actuary projects implementation act result cumulative spending reduction million issue interim final regulation strengthen licensure accreditation quality standards applicable orthotics prosthetics suppliers order produce cumulative reduction end exempts regulation qualified physical therapist qualified occupational therapist


Summary:
(This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

Drug Quality and Security Act - Title I: Drug Compounding - Compounding Quality Act - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. Exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements.

 Establishes annual registration requirement for any outsourcing facility. Requires a facility to report biannually to the Secretary of Health and Human Services (HHS) on what drugs are compounded in the facility and to submit adverse event reports. Subjects such facilities to a risk-based inspection schedule.

Requires the Secretary to: (1) publish a list of drugs presenting demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug, taking into account the risk and benefits to patients; and (2) convene an advisory committee on compounding before creating the list.

Requires the Secretary to assess an annual establishment fee on each outsourcing facility and a reinspection fee, as necessary.

(Sec. 103) Prohibits the resale of a compounded drug labeled “not for resale,” or the intentional falsification of a prescription for a compounded drug. Deems a compounded drug to be misbranded if its advertising or promotion is false or misleading in any particular.

(Sec. 105) Requires the Secretary to receive submissions from state boards of pharmacy: (1) describing any disciplinary actions taken against compounding pharmacies or any recall of a compounded drug, and (2) expressing concerns that a compounding pharmacy may be violating the FFDCA.

(Sec. 106) Revises compounding pharmacy requirements to repeal prohibitions on advertising and promotion of compounded drugs by compounding pharmacies and repeal the requirement that prescriptions filled by a compounding pharmacy be unsolicited.

(Sec. 107) Requires the Comptroller General (GAO) to report on pharmacy compounding and the adequacy of state and federal efforts to assure the safety of compounded drugs.

Title II: Drug Supply Chain Security - Drug Supply Chain Security Act - (Sec. 202) Establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain.

Requires the Secretary to establish standards for the exchange of transaction documentation, which shall include transaction information, transaction history, and transaction statements.

Requires the Secretary to establish processes to: (1) provide waivers of requirements, including for undue economic hardship or emergency medical reasons; (2) provide exceptions to requirements relating to product identifiers if a product is packaged without sufficient space to bear the information; and (3) determine other products or transactions that should be exempt from the requirements of this Act.

Establishes requirements for drug manufacturers, wholesalers, dispensers, and repackagers to ensure that all prior transaction information is provided at each transfer of ownership.

Requires a manufacturer, wholesale distributor, dispenser, and repackager, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, to provide within a reasonable time the applicable transaction documentation upon request by the Secretary or other appropriate federal or state official.

Requires a manufacturer or repackager to affix or imprint a product identifier on each package and homogenous case intended to be introduced in a transaction into commerce. Excepts from this requirement with respect to unique device identifiers any products required to have a standardized numerical identifier.

Requires a manufacturer, wholesale distributor, dispenser, or repackager to ensure that each of its trading partners is authorized.

Requires a manufacturer, wholesale distributor, dispenser, and repackager to implement systems to: (1) investigate suspect products; and (2) handle illegitimate products, including through quarantine, disposal, and appropriate notice to the Secretary and, as necessary, trading partners.

Requires manufacturers, wholesale distributors, and repackagers to verify returned products before further distribution.

(Sec. 203) Prescribes additional requirements related to the tracing of products at the package level (enhanced drug distribution security) which shall go into effect ten years after enactment of this Act.

Authorizes a dispenser to enter into a written agreement with a third party, including an authorized wholesale distributor, that requires the third party to maintain confidentially any information and statements required to be maintained. Requires the Secretary to provide for alternative methods of compliance with such additional drug distribution security requirements.

Directs the Secretary to contract with a private, independent consulting firm with expertise to conduct a technology and software assessment that looks at the feasibility of dispensers with 25 or fewer full-time employees conducting interoperable, electronic tracing of products at the package level.

Requires the Secretary to: (1) establish one or more pilot projects and hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain, (2) issue a final guidance document that outlines and makes recommendations with respect to the system attributes necessary to enable secure tracing at the package level, and (3) identify and make recommendations with respect to the standards necessary for adoption in order to support the secure interoperable electronic data exchange among the pharmaceutical distribution supply chain that comply with a form and format developed by a widely recognized international standards development organization.

(Sec. 204) Requires the Secretary to establish standards for the licensing of wholesale distributors and third party logistics providers.

(Sec. 205) Preempts state and local requirements related to tracing drugs through the distribution system, and licensure of wholesale distributors and third party logistics providers.

(Sec. 206) Subjects violations of this Act to specified criminal and civil penalties.

Deems misbranded any drug failing to bear its required product identifier.

measure amended introduced summary expanded action occurred measure drug quality security act title drug compounding compounding quality act sec amends cosmetic act ffdca respect regulation compounding drugs exempts compounded drugs new drug requirements labeling requirements track trace requirements drug compounded direct supervision licensed pharmacist registered outsourcing facility meets applicable requirements establishes annual registration requirement outsourcing facility requires facility report biannually secretary health_and_human_services hhs drugs compounded facility submit adverse event reports subjects facilities risk based inspection schedule requires secretary publish list drugs presenting demonstrable difficulties compounding reasonably likely lead adverse effect safety effectiveness drug taking account risk benefits patients convene advisory committee compounding creating list requires secretary assess annual establishment fee outsourcing facility reinspection fee necessary sec prohibits resale compounded drug labeled resale intentional falsification prescription compounded drug deems compounded drug misbranded advertising promotion false misleading particular sec requires secretary receive submissions state boards pharmacy describing disciplinary actions taken compounding pharmacies recall compounded drug expressing concerns compounding pharmacy violating ffdca sec revises compounding pharmacy requirements repeal prohibitions advertising promotion compounded drugs compounding pharmacies repeal requirement prescriptions filled compounding pharmacy unsolicited sec requires comptroller general gao report pharmacy compounding adequacy state federal efforts assure safety compounded drugs title drug supply chain security drug supply chain security act sec establishes requirements facilitate tracing prescription drug products pharmaceutical supply distribution chain requires secretary establish standards exchange transaction documentation shall include transaction information transaction history transaction statements requires secretary establish processes provide waivers requirements including undue economic hardship emergency medical reasons provide exceptions requirements relating product identifiers product packaged sufficient space bear information determine products transactions exempt requirements act establishes requirements drug manufacturers wholesalers dispensers ensure prior transaction information provided transfer ownership requires manufacturer wholesale distributor dispenser repackager event recall purpose investigating suspect product illegitimate product provide reasonable time applicable transaction documentation request secretary appropriate federal state official requires manufacturer repackager affix product identifier package case intended introduced transaction commerce excepts requirement respect unique device identifiers products required standardized numerical identifier requires manufacturer wholesale distributor dispenser repackager ensure trading partners authorized requires manufacturer wholesale distributor dispenser repackager implement systems investigate suspect products handle illegitimate products including quarantine disposal appropriate notice secretary necessary trading partners requires manufacturers wholesale distributors verify returned products distribution sec prescribes additional requirements related tracing products package level enhanced drug distribution security shall effect years enactment act authorizes dispenser enter written agreement party including authorized wholesale distributor requires party maintain confidentially information statements required maintained requires secretary provide alternative methods compliance additional drug distribution security requirements directs secretary contract private independent consulting firm expertise conduct technology software assessment feasibility dispensers fewer time employees conducting interoperable electronic tracing products package level requires secretary establish pilot projects hold public meetings enhance safety security pharmaceutical distribution supply chain issue final guidance document outlines makes recommendations respect system attributes necessary enable secure tracing package level identify recommendations respect standards necessary adoption order support secure interoperable electronic data exchange pharmaceutical distribution supply chain comply form format developed widely recognized international standards development organization sec requires secretary establish standards licensing wholesale distributors party logistics providers sec preempts state local requirements related tracing drugs distribution system licensure wholesale distributors party logistics providers sec subjects violations act specified criminal civil penalties deems misbranded drug failing bear required product identifier


Summary:
Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 or the SOFTWARE Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to apply it to medical software to the same extent and in the same manner as it applies to devices. Defines "medical software" as software that is intended to be marketed:

 to directly change the structure or any function of the body of man or other animals; or for use by consumers and makes recommendations for clinical action that includes the use of a drug, device, or procedure to cure or treat a disease or other condition without requiring the involvement of a health care provider and which, if followed, would change the structure or any function of the body of man or other animals. Excludes from such definition software whose primary purpose is integral to the functioning of a drug or device and is not a component of a device. Excludes clinical software and health software (defined as follows) from FDCA regulation.

Defines "clinical software" as software that: (1) captures, analyzes, changes, or presents patient or population clinical data or information and may recommend courses of clinical action, but does not directly change the structure or any function of the body of man or other animals; and (2) is intended for use only by a health care provider in a health care setting.

Defines "health software" as software that is not medical software or clinical software and that: (1) captures, analyzes, changes, or presents patient or population clinical data or information or supports administrative or operational aspects of health care and is not used in the direct delivery of care; or (2) has as its primary purpose to act as a platform for a secondary software, to run or act as a mechanism for connectivity, or to store data.

Expresses the sense of Congress concerning the value of clinical software and health software to health care quality and efficacy and the need for legislation that establishes a risk-based regulatory framework that reduces regulatory burdens, promotes patient safety, and fosters innovation.

Excludes medical software, clinical software, and health software from the FDCA definition of "device."

sensible oversight technology advances regulatory efficiency act software act amends cosmetic act fdca apply medical software extent manner applies devices defines medical software software intended marketed directly change structure function body man animals use consumers makes recommendations clinical action includes use drug device procedure cure treat disease condition requiring involvement health care provider followed change structure function body man animals excludes definition software primary purpose integral functioning drug device component device excludes clinical software health software defined follows fdca regulation defines clinical software software captures analyzes changes presents patient population clinical data information recommend courses clinical action directly change structure function body man animals intended use health care provider health care setting defines health software software medical software clinical software captures analyzes changes presents patient population clinical data information supports administrative operational aspects health care direct delivery care primary purpose act platform secondary software run act mechanism connectivity store data expresses sense congress concerning value clinical software health software health care quality efficacy need legislation establishes risk based regulatory framework reduces regulatory burdens promotes patient safety fosters innovation excludes medical software clinical software health software fdca definition device


Summary:
Small Manufacturer Protection Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to grant the owner of a human generic drug facility a waiver from, or reduction of, one or more human generic drug fees if the Secretary finds that the assessment of the fee would present a significant barrier to market entry because of the owner's limited resources or other circumstances.

Requires an owner seeking such fee waiver or reduction to submit a written request no later than 180 days after the fee is due.

Prohibits the Secretary, in determining whether to grant such waiver or reduction, from considering anything other than the circumstances and assets of the owner and any affiliate of the owner.

Makes these provisions applicable to fees authorized to be assessed and collected for FY2014-FY2017.

small manufacturer protection act amends cosmetic act direct secretary health_and_human_services hhs grant owner human generic drug facility waiver reduction human generic drug fees secretary finds assessment fee present significant barrier market entry owner limited resources circumstances requires owner seeking fee waiver reduction submit written request later days fee prohibits secretary determining grant waiver reduction considering circumstances assets owner affiliate owner makes provisions applicable fees authorized assessed collected fy2014 fy2017


Summary:
Protecting Consumer Access to Generic Drugs Act of 2013 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period, or (2) the waiver of a patent infringement claim for damages.

Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers.

Amends the Federal Food, Drug, and Cosmetic Act to deem an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.

protecting consumer access generic drugs act prohibits unfair deceptive act practice unfair method competition affecting interstate commerce person party agreement resolving settling patent infringement claim abbreviated new drug generic application filer receives value filer agrees research develop manufacture market sell generic drug excludes resolution settlement includes right market generic drug expiration patent exclusivity period waiver patent infringement claim damages authorizes federal_trade_commission ftc exempt agreements furtherance market competition benefit consumers amends cosmetic act deem applicant forfeited market exclusivity applicant enters agreement violates act amends medicare_prescription_drug improvement modernization act revise reporting requirements related agreements generic drug applicant brand drug company include description subject matter agreements parties certification materials filed represent complete final exclusive agreement parties


Summary:
Servicemembers and Veterans Prescription Drug Safety Act of 2013 - Directs the Secretary of Defense (Secretary) and the Attorney General (AG) to jointly carry out a program under which a member of the Armed Forces (member), an individual receiving or entitled to military retired or retainer pay, a dependent-beneficiary of a member, or any person lawfully entitled to dispose of the property of any of such individuals may deliver a personal-use controlled substance (the prescription medication of a deceased individual) for disposal at a facility to be specified by the Secretary and the AG. Requires the Secretary and AG, in implementing the program, to develop appropriate guidelines and procedures to prevent the diversion, misuse, theft, or loss of such delivered substances.

Directs the Secretary and the AG to jointly carry out a program under which a veteran, a veteran's spouse or dependent, a person in receipt of medical services at a Department of Veterans Affairs (VA) facility, or any person lawfully entitled to dispose of the property of any of such individuals may deliver such a controlled substance for disposal at a specified facility, subject to the same guidelines and procedures with respect to such delivered substances.

servicemembers directs secretary defense secretary attorney general jointly carry program member armed_forces member individual receiving entitled military retired retainer pay dependent beneficiary member person lawfully entitled dispose property individuals deliver personal use controlled substance prescription medication deceased individual disposal facility specified secretary requires secretary implementing program develop appropriate guidelines procedures prevent diversion misuse theft loss delivered substances directs secretary jointly carry program veteran veteran spouse dependent person receipt medical services department_of_veterans_affairs facility person lawfully entitled dispose property individuals deliver controlled substance disposal specified facility subject guidelines procedures respect delivered substances


Summary:
Personal Drug Importation Fairness Act of 2013 - Allows a drug to be imported into the United States, and re-imported into the United States by a person other than the drug's manufacturer, if the drug: (1) has the same active ingredients, route of administration, and strength as a prescription drug approved under provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) regarding adulterated drugs; (2) may be lawfully marketed in, and is imported or reimported from, a qualified country; (3) is dispensed by a licensed pharmacist; (4) is shipped directly to, or is imported by, the ultimate consumer from the qualified country; (5) is shipped or imported in quantities that do not exceed a 90-day supply; and (6) is accompanied by a copy of a valid prescription.

Defines: (1) "drug" for purposes of this Act as excluding any controlled substance; and (2) "qualified country" to mean any of specified countries (Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, a member-state of the European Union, or a country in the European Economic Area) that is determined by the Commissioner of Food and Drugs (FDA) to have standards for ensuring drug safety and effectiveness that are at least as protective as U.S. standards.

allows drug imported united_states imported united_states person drug manufacturer drug active ingredients route administration strength prescription drug approved provisions cosmetic act ffdca adulterated drugs lawfully marketed imported qualified country dispensed licensed pharmacist shipped directly imported ultimate consumer qualified country shipped imported quantities exceed day supply accompanied copy valid prescription defines drug purposes act excluding controlled substance qualified country mean specified countries australia canada israel japan new_zealand south_africa member state european_union country determined commissioner food drugs fda standards ensuring drug safety effectiveness protective standards


Summary:
Antibiotic Development to Advance Patient Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to authorize the Secretary of Health and Human Services (HHS) to approve the use of an antibacterial or antifungal drug that is intended for treatment of a serious or life-threatening disease or condition to treat a limited population of patients for which there is an unmet medical need.

Requires the labeling of such drugs to prominently include in the prescribing information the statement that the drug is indicated for use in a limited and specific population of patients.

Amends the Public Health Service Act to authorize the Secretary to license those antibacterial or antifungal drugs as biological products.

Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) monitor the use of antibacterial and antifungal drugs, (2) monitor changes in bacterial and fungal resistance to drugs, and (3) make the information derived from such monitoring available to the public.

Amends the FFDCA to direct the Secretary: (1) to identify upon approval, and subsequently update, susceptibility test interpretive criteria for antibacterial drugs by relying upon preclinical and clinical data, Bayesian and pharmacometric statistical methodologies, and such other confirmatory evidence the Secretary deems necessary; (2) on a quarterly basis, to evaluate new or updated criteria published by a nationally or internationally recognized standard development organization; and (3) to publish on the Food and Drug Administration's (FDA's) website a notice adopting, declining to adopt, or partially adopting such new or updated criteria.

amends cosmetic act ffdca authorize secretary health_and_human_services hhs approve use antibacterial antifungal drug intended treatment life threatening disease condition treat limited population patients unmet medical need requires labeling drugs prominently include prescribing information statement drug indicated use limited specific population patients amends public_health_service_act authorize secretary license antibacterial antifungal drugs biological products requires secretary acting director centers_for_disease_control_and_prevention cdc monitor use antibacterial antifungal drugs monitor changes bacterial resistance drugs information derived monitoring available public amends ffdca direct secretary identify approval subsequently update susceptibility test interpretive criteria antibacterial drugs relying preclinical clinical data statistical methodologies evidence secretary deems necessary quarterly basis evaluate new updated criteria published nationally internationally recognized standard development organization publish food_and_drug_administration fda website notice adopting declining adopt partially adopting new updated criteria


Summary: Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to revise the Medicare durable medical equipment face-to-face encounter documentation requirement.

amends supplementary_medical_insurance title xviii medicare social security act revise medicare durable medical equipment face face encounter documentation requirement


Summary:
Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 or DISARM Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to: (1) recognize the costs of new antimicrobial drugs under the Medicare payment system for the inpatient services of subsection (d) hospitals, (2) provide for additional payment with respect to discharges involving such drugs, (3) publish in the Federal Register a list of the new antimicrobial drugs, and (4) further reduce each of the average standardized payment amounts in a specified manner to maintain budget neutrality in a fiscal year beginning with FY2015.

(Generally, a subsection [d] hospital is an acute care hospital, particularly one that receives payments under Medicare's inpatient prospective payment system [IPPS] when providing covered inpatient services to eligible beneficiaries.)

Directs the Comptroller General (GAO) to study the barriers that prevent the development of new antimicrobial drugs and develop recommendations for actions to be taken in order to overcome such barriers.

developing innovative strategy antimicrobial resistant microorganisms act amends title xviii medicare social security act direct secretary health_and_human_services hhs recognize costs new antimicrobial drugs medicare payment system inpatient services subsection hospitals provide additional payment respect discharges involving drugs publish federal_register list new antimicrobial drugs reduce average standardized payment amounts specified manner maintain budget neutrality fiscal year beginning fy2015 generally subsection hospital acute care hospital particularly receives payments medicare inpatient prospective payment system ipps providing covered inpatient services eligible beneficiaries directs comptroller general gao study barriers prevent development new antimicrobial drugs develop recommendations actions taken order overcome barriers


Summary: Amends title XVIII (Medicare) of the Social Security Act to cover pharmacist services.

amends title xviii medicare social security act cover pharmacist services


Summary: Act to Ban Zohydro - Ends the sale and distribution of pure hydrocodone bitartrate extended-release capsules (marketed as Zohydro ER) within 45 days by withdrawing approval for its new drug application. Prohibits the Commissioner of Food and Drugs (FDA) from approving any new drug application for the capsules unless they are formulated to prevent abuse.

act sale distribution hydrocodone extended release marketed days withdrawing approval new drug application prohibits commissioner food_and_drugs fda approving new drug application formulated prevent abuse


Summary:
Independent Innovator and Repurposing Act - Establishes procedures under which the term of an unexpired patent claiming a method of using a biological product shall be extended for five years from its original expiration date.

 Requires an application for such an extension to demonstrate that: (1) the patent was issued to an independent innovator, and (2) the owner of record is the independent innovator or a small business (with fewer than 500 employees and which is not affiliated with the holder of the marketing application approved under licensing requirements of the Public Health Service Act for the commercial marketing of such biological product) in which the independent innovator has an ownership interest.

Defines "independent innovator" as a person or entity that obtains a method of use patent for a biological product and is not, at the time of invention or patent filing, affiliated with the holder of an approved application for the commercial marketing of the product.

independent innovator procedures term unexpired patent claiming method biological product shall extended years original expiration date requires application extension demonstrate patent issued independent innovator owner record independent innovator small business fewer employees affiliated holder marketing application approved licensing requirements public_health_service_act commercial marketing biological product independent innovator ownership interest defines independent innovator person entity obtains method use patent biological product time invention patent filing affiliated holder approved application commercial marketing product


Summary:
Improving Regulatory Transparency for New Medical Therapies Act - Amends the Controlled Substances Act to require any proceedings for the issuance, amendment, or repeal of a rule of the Attorney General for the classification of a controlled substance that are initiated at the request of the Secretary of Health and Human Services (HHS) to control a drug or other substance not previously scheduled, where the Secretary has recommended the drug or other substance be placed in schedule II, III, IV, or V, to be commenced not later than 120 days after receipt of written recommendations from the Secretary. Requires the final rule to be issued not later than 60 days after the date on which both the public comment period has closed and the new drug is the subject of an approved new drug application, unless a hearing on the proposed rule is granted by the Attorney General.

Directs the Attorney General, for the purposes of registration to manufacture a controlled substance in schedule III, IV, or V for use only in a clinical trial, to register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, not later than 180 days after receiving an application and all information necessary to make a determination about whether the issuance of such registration is inconsistent with the public interest.

Directs the Attorney General, for the purposes of registration to manufacture a controlled substance in schedule I or II for use only in a clinical trial, to: (1) issue a notice of application not later than 90 days after receipt of an application and all necessary information to issue such notice; and (2) register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, within 180 days following the close of the comment period and receipt of all information necessary to make a determination about whether the issuance of such registration is consistent with the public interest and with U.S. obligations under international treaties in effect on May 1, 1971, unless a hearing on the application has been granted pursuant to a provision of the Controlled Substances Import and Export Act regarding emergency situations.

improving regulatory transparency new medical therapies act amends controlled substances act require proceedings issuance amendment repeal rule attorney general classification controlled substance initiated request secretary health_and_human_services hhs control drug substance previously scheduled secretary recommended drug substance placed schedule iii commenced later days receipt written recommendations secretary requires final rule issued later days date public comment period closed new drug subject approved new drug application hearing proposed rule granted attorney general directs attorney general purposes registration manufacture controlled substance schedule iii use clinical trial register applicant serve applicant order cause registration denied revoked suspended later days receiving application information necessary determination issuance registration inconsistent public interest directs attorney general purposes registration manufacture controlled substance schedule use clinical trial issue notice application later days receipt application necessary information issue notice register applicant serve applicant order cause registration denied revoked suspended days following close comment period receipt information necessary determination issuance registration consistent public interest obligations international treaties effect hearing application granted pursuant provision controlled_substances_import_and_export_act emergency situations


Summary:
Compassionate Freedom of Choice Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration (FDA) shall not implement or enforce any law to prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients.

Prohibits the FDA Commissioner from requiring the disclosure, collection, or reporting of certain information concerning such drugs or devices, except that the sponsor of a clinical trial may voluntarily disclose, collect, or report such information to the FDA.

Declares that, except in cases of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, or administers an investigational drug or device shall not be liable in any action under state or federal law for loss, damage, or injury arising out of, relating to, or resulting from: (1) the design, development, clinical testing and investigation, manufacturing, labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or use of such drugs or devices; or (2) their safety or effectiveness.

compassionate freedom choice act amends cosmetic act declare public_health_service act shall prevent restrict food_and_drug_administration fda shall implement enforce law prevent restrict manufacture importation distribution sale investigational drugs devices terminally ill patients prohibits fda commissioner requiring disclosure collection reporting certain information concerning drugs devices sponsor clinical trial voluntarily disclose collect report information fda declares cases gross negligence willful misconduct person manufactures imports distributes prescribes administers investigational drug device shall liable action state federal law loss damage injury arising relating resulting design development clinical testing investigation manufacturing labeling distribution sale purchase donation dispensing prescription administration use drugs devices safety effectiveness


Summary: Ensuring Seniors Access to Local Pharmacies Act of 2014 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to direct any prescription drug plan that has in its network one or more pharmacies located in a health professional shortage area, in a medically underserved area, or among a medically underserved population, and that provides a reduction in coinsurance or copayments for covered part D drugs, to extend to any pharmacy located in that area, or among that population, the option to be an in-network pharmacy under terms and conditions comparable to those the plan has agreed upon with other in-network pharmacies located in the area or among that population.

ensuring seniors access local pharmacies act amends voluntary prescription drug benefit program title xviii medicare social security act direct prescription drug plan network pharmacies located health professional shortage area medically underserved area medically underserved population provides reduction coinsurance copayments covered drugs extend pharmacy located area population option network pharmacy terms conditions comparable plan agreed network pharmacies located area population


Summary:
Research for All Act of 2014 - Directs the Food and Drug Administration (FDA) to review and develop policies to ensure that the design and size of clinical trials for products granted expedited approval to treat a serious or life-threatening disease or condition are sufficient to determine the safety and effectiveness of the products for men and women using subgroup analysis.

Amends the Federal Food, Drug, and Cosmetic Act to require FDA, at the request of the sponsor of a new drug, to facilitate the development and expedite its review if the drug is:

 intended to avoid serious adverse events or to treat a serious or life-threatening disease or condition, intended for safer or more effective treatment for either men or women than a currently available product approved to treat the general population or the other sex, and supported by results of clinical trials that include and separately examine outcomes for men and women. Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to determine when it is appropriate for projects of basic research involving cells, tissues, or animals to include both male and female cells, tissues, or animals. Requires, in such cases, disaggregation of results according to sex. Provides guidelines for ensuring that sex differences are examined and analyzed.

Authorizes the Secretary of Health and Human Services (HHS) to support the continued operation and expansion of Special Centers of Research on Sex Differences.

Requires the Comptroller General (GAO) to provide to Congress updated versions of the reports entitled “Women's Health: NIH Has Increased Its Efforts To Include Women in Research” and “Women's Health: Women Sufficiently Represented in New Drug Testing, But FDA Oversight Needs Improvement,” including in the reports examination of:

 the inclusion of women, female animals, and female-derived cells and tissues in federally funded research over the past decade; federal reporting and analysis of subgroup information and the translation of differences to the medical community and patients; the effect of inclusion rates in research on the quality of women’s health care; and current efforts within government agencies to encourage the sharing of research data on sex differences and mechanisms to improve such sharing.

research act directs food_and_drug_administration fda review develop policies ensure design size clinical trials products granted expedited approval treat life threatening disease condition sufficient determine safety effectiveness products men women subgroup analysis amends cosmetic act require fda request sponsor new drug facilitate development expedite review drug intended avoid adverse events treat life threatening disease condition intended safer effective treatment men women currently available product approved treat general population sex supported results clinical trials include separately examine outcomes men women amends public_health_service_act require director national_institutes_of_health nih determine appropriate projects basic research involving cells tissues animals include male female cells tissues animals requires cases results according sex provides guidelines ensuring sex differences examined analyzed authorizes secretary health_and_human_services hhs support continued operation expansion requires comptroller general gao provide congress updated versions reports entitled women health nih increased efforts include women research women health women sufficiently represented new drug testing fda oversight needs improvement including reports examination inclusion women female animals female derived cells tissues federally funded research past decade federal reporting analysis subgroup information translation differences medical community patients effect inclusion rates research quality women health care current efforts government agencies encourage sharing research data sex differences mechanisms improve sharing


Summary: Speeding Access to Already Approved Pharmaceuticals Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), under procedures for expedited approval of products to treat a serious or life-threatening disease or condition, to facilitate the development and expedite the review of new drugs or devices approved for marketing in the European Union.

access approved pharmaceuticals act amends cosmetic act require food_and_drug_administration fda procedures expedited approval products treat life threatening disease condition facilitate development expedite review new drugs devices approved marketing european_union


Summary: Medicare DMEPOS Competitive Bidding Improvement Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to require state licensure and a bid and surety bond of at least $50,000 for each area for bidding entities under the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program.

medicare dmepos competitive bidding improvement act amends title xviii medicare social security act require state licensure bid surety bond area bidding entities medicare durable medical equipment prosthetics orthotics supplies dmepos competitive acquisition program


Summary:
Everson Walls and Ron Springs Gift for Life Act of 2014 - Amends the Public Health Service Act to require the Administrator of the Health Resources and Services Administration to establish a National Organ and Tissue Donor Registry Resource Center.

Requires the Center to: (1) advance the development, expansion, and evaluation of state organ donor registries; (2) facilitate timely exchange of donor information between state registries; and (3) maintain a clearinghouse for information on registry best practices.

Directs the Secretary of Health and Human Services (HHS) to award grants to states in order to develop, expand, or maintain state organ donor registries and establish benchmarks for improvement in organ donation. Requires a state registry that receives a grant to be accessible to individual donors and the Center.

Eliminates civil liability for a person taking an individual's organs as long as the person verified the individual's consent with a state organ donor registry.

Requires the Comptroller General (GAO) to study the feasibility of establishing a database to track the health effects of living organ donation.

life act amends public_health_service_act require administrator health_resources_and_services_administration establish requires center advance development expansion evaluation state organ donor registries facilitate timely exchange donor information state registries maintain clearinghouse information registry best practices directs secretary health_and_human_services hhs award grants states order develop expand maintain state organ donor registries establish benchmarks improvement organ donation requires state registry receives grant accessible individual donors center eliminates civil liability person taking individual organs long person verified individual consent state organ donor registry requires comptroller general gao study feasibility establishing database track health effects living organ donation


Summary:
Living Donor Protection Act of 2014 - Prohibits discrimination based on a person's status as a living organ donor in the offering, issuance, cancellation, coverage, price, or any other condition of a life insurance policy, disability insurance policy, or long-term care insurance policy.

Revises the Family and Medical Leave Act of 1993 to specifically include living organ donation as a serious health condition that entitles a covered employee to leave under that Act.

Requires the Secretary of Health and Human Services (HHS) to update public service announcements, websites, and other media regarding live organ donation to educate the public on the benefits of live organ donation and access to insurance for living organ donors.

living donor protection act prohibits discrimination based person status living organ donor offering issuance cancellation coverage price condition life insurance policy disability insurance policy long term care insurance policy revises family medical leave act specifically include living organ donation health condition entitles covered employee leave act requires secretary health_and_human_services hhs update public service announcements websites media live organ donation educate public benefits live organ donation access insurance living organ donors