Summary: Medicaid Generic Drug Price Fairness Act - Amends title XIX (Medicaid) of the Social Security Act to extend to manufacturers of generic drugs the requirement that drug manufacturers in certain circumstances pay an additional rebate to state Medicaid programs.

fairness act amends title xix medicaid social security act extend manufacturers generic drugs requirement drug manufacturers certain circumstances pay additional rebate state medicaid programs


Summary:
Promise for Antibiotics and Therapeutics for Health Act or the PATH Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to establish a program to approve an antibacterial drug intended to treat a serious medical condition and address an unmet medical need within an identifiable limited population as a limited population antibacterial drug.

Requires the sponsor of a drug eligible for approval as a limited population antibacterial drug to demonstrate the safety and effectiveness of the drug for its intended use.

Requires an HHS determination of the safety and effectiveness of a limited population antibacterial drug to reflect the drug's benefit-risk profile in the intended limited population. Prohibits a lack of evidence of a favorable benefit-risk profile in a broader population from resulting in a denial of approval.

Directs HHS to require: (1) the labeling of a limited population antibacterial drug to indicate that the drug has been approved for use only in a limited population, and (2) submission of promotional materials related to the drug prior to dissemination.

Directs HHS to describe considerations for demonstrating the safety and effectiveness of limited population antibacterial drugs and how the limited population pathway can be expanded to other therapeutic areas.

Requires HHS to conduct postapproval monitoring programs to study how antibacterial drugs approved through the limited population pathway are used and to monitor changes in bacterial drug resistance.

Allows HHS to remove the labeling, marketing, and postapproval monitoring requirements of a limited population antibacterial drug if the drug is approved for broader use.

Allows the limited population pathway to be expanded to other drugs intended to treat serious illness beginning October 1, 2016.

promise antibiotics path act amends federal food drug cosmetic act require department_of_health_and_human_services hhs establish program approve antibacterial drug intended treat medical condition address unmet medical need identifiable limited population limited population antibacterial drug requires sponsor drug eligible approval limited population antibacterial drug demonstrate safety effectiveness drug intended use requires hhs determination safety effectiveness limited population antibacterial drug reflect drug benefit risk profile intended limited population prohibits lack evidence favorable benefit risk profile broader population resulting denial approval directs hhs require labeling limited population antibacterial drug indicate drug approved use limited population submission promotional materials related drug prior dissemination directs hhs describe considerations demonstrating safety effectiveness limited population antibacterial drugs limited population pathway expanded therapeutic areas requires hhs conduct monitoring programs study antibacterial drugs approved limited population pathway monitor changes bacterial drug resistance remove labeling marketing monitoring requirements limited population antibacterial drug drug approved broader use allows limited population pathway expanded drugs intended treat illness beginning october


Summary:
Protect Medical Innovation Act of 2015

(Sec. 2) This bill amends the Internal Revenue Code to repeal the excise tax on medical device manufacturers and importers.

This repeal applies to sales in calendar quarters beginning after the enactment of this Act.

(Sec. 3) Prohibits the budgetary effects of this Act from being entered on either PAYGO scorecard under the Statutory Pay-As-You-Go Act of 2010.

protect medical innovation act sec bill amends internal_revenue_code repeal excise tax medical device manufacturers importers repeal applies sales calendar quarters beginning enactment act sec prohibits budgetary effects act entered paygo scorecard statutory pay act


Summary:
Medicare DMEPOS Competitive Bidding Improvement Act of 2015

Amends title XVIII (Medicare) of the Social Security Act with respect to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program.

Prohibits an entity from submitting a bid for a competitive acquisition area, during calendar 2017-2019, unless it has obtained a bid surety bond of between $50,000 and $100,000 for each such area.

Requires the forfeit of any bid bond submitted for a competitive acquisition area if the bidding entity does not accept a contract offered for any product category when its composite bid was at or below the median composite bid rate for all bidding entities included in the calculation of the single payment amounts for the product category and the area. Requires the Secretary of Health and Human Services to collect on the forfeited bond.

Requires return of a bid bond within a specified 90-day period to a bidding entity that does not meet such bid forfeiture conditions.

Prohibits the Secretary from awarding a contract to any entity that does not meet state licensure requirements.

Directs the Government Accountability Office to study the effect of this bid surety bond requirement on the participation of small suppliers in the Medicare DMEPOS competitive acquisition program.

medicare dmepos competitive bidding improvement act amends title xviii medicare social security act respect medicare durable medical equipment prosthetics orthotics supplies dmepos competitive acquisition program prohibits entity submitting bid competitive acquisition area calendar obtained bid surety bond area requires forfeit bid bond submitted competitive acquisition area bidding entity accept contract offered product category composite bid median composite bid rate bidding entities included calculation single payment amounts product category area requires secretary health_and_human_services collect forfeited bond requires return bid bond specified day period bidding entity meet bid forfeiture conditions prohibits secretary awarding contract entity meet state licensure requirements directs government_accountability_office study effect bid surety bond requirement participation small suppliers medicare dmepos competitive acquisition program


Summary:
Medical Testing Availability Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit a product labeled for research use only from being deemed adulterated or misbranded on the basis that its manufacturer or distributor: (1) sells the product to an end user who uses the product for a purpose other than research, or (2) engages in business communications with an end user regarding the product.

medical testing availability act bill amends cosmetic act prohibit product labeled research use deemed adulterated misbranded basis manufacturer distributor sells product end user uses product purpose research engages business communications end user product


Summary:
Combination Drug Development Incentive Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to provide a five-year marketing exclusivity period to a new drug approved by the Food and Drug Administration that is a novel combination of active ingredients. The application for the combination drug must contain reports of new clinical investigations that are essential to approval and were conducted or sponsored by the applicant. Currently, a new drug that includes an active ingredient that has already been approved is provided a three-year marketing exclusivity period.

bill amends cosmetic act provide year marketing exclusivity period new drug approved food_and_drug_administration novel combination active ingredients application combination drug contain reports new clinical investigations essential approval conducted sponsored applicant currently new drug includes active ingredient approved provided year marketing exclusivity period


Summary:
Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2015 or the DISARM Act of 2015

 Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to: (1) recognize the costs of DISARM 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 DISARM antimicrobial drugs, and (4) make a proportional adjustment in standardized payment amounts to assure that the requirements of this Act do not result in aggregate payments greater or less than those that would otherwise be made for a fiscal year.

(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.)

Defines a "DISARM antimicrobial drug" as one approved or licensed by the Food and Drug Administration on or after January 1, 2015, which, among other things, is intended to treat an infection:

 caused by, or likely to be caused by, a qualifying pathogen; associated with high rates of mortality or significant patient morbidity; and for which there is an unmet medical need. Requires that the mechanism established by the Secretary to recognize the costs of new medical services and technologies that are not DISARM antimicrobial drugs under the Medicare payment system is applicable to new medical services or technology if the service or technology is not a DISARM antimicrobial drug.

Directs the Comptroller General to study the barriers that prevent the development of DISARM antimicrobial drugs and develop recommendations for actions to be taken in order to overcome those barriers.

developing innovative strategy antimicrobial resistant microorganisms act act amends title xviii medicare social security act direct secretary health_and_human_services recognize costs antimicrobial drugs medicare payment system inpatient services subsection hospitals provide additional payment respect discharges involving drugs publish federal_register list antimicrobial drugs proportional adjustment standardized payment amounts assure requirements act result aggregate payments greater fiscal year generally subsection hospital acute care hospital particularly receives payments medicare inpatient prospective payment system ipps providing covered inpatient services eligible beneficiaries defines antimicrobial drug approved licensed food_and_drug_administration january things intended treat infection caused likely caused qualifying pathogen associated high rates mortality significant patient morbidity unmet medical need requires mechanism established secretary recognize costs new medical services technologies antimicrobial drugs medicare payment system applicable new medical services technology service technology antimicrobial drug directs comptroller general study barriers prevent development antimicrobial drugs develop recommendations actions taken order overcome barriers


Summary:
First Responder Medical Device Tax Relief Act

Amends the Internal Revenue Code to exempt a qualified emergency medical device from the excise tax on medical devices. Defines "qualified emergency medical device" as a medical device furnished by first responders or ambulance services in providing out-of-hospital or pre-hospital care, or transport to a medical care facility, for individuals with illnesses, injuries, or other medical emergencies or in need of medical transport, extrication, or evacuation.

responder medical device tax relief act amends internal revenue code exempt qualified emergency medical device excise tax medical devices defines qualified emergency medical device medical device furnished responders ambulance services providing hospital pre hospital care transport medical care facility individuals illnesses injuries medical emergencies need medical transport evacuation


Summary:
Pharmacy and Medically Underserved Areas Enhancement Act

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

pharmacy medically underserved areas enhancement act amends title xviii medicare social security act cover pharmacist services


Summary:
Clinical Trial Cancer Mission 2020 Act

Amends the Public Health Service Act to revise clinical trial registry data bank provisions to specify that a device or drug clinical trial must be included in the clinical trial registry data bank regardless of whether it results in a positive or negative outcome.

Requires the responsible party of any clinical trials funded in whole or in part by the Department of Defense (DOD) to certify in all required grant or progress forms that the required submissions to the clinical trial registry data bank have been made. Requires DOD to verify that the clinical trial information has been submitted before releasing any remaining grant funds or funding future grants.

Makes a clinical trial grantee of the Department of Health and Human Services or DOD who fails to submit the required information to the data bank ineligible for the remaining grant funds or future funds. Makes the grantee liable for repayment of grant amounts already provided.

act amends public_health_service_act revise clinical trial registry data bank provisions specify device drug clinical trial included clinical trial registry data bank regardless results positive negative outcome requires responsible party clinical trials funded department_of_defense dod certify required grant progress forms required submissions clinical trial registry data bank requires dod verify clinical trial information submitted releasing remaining grant funds funding future grants makes clinical trial grantee department_of_health_and_human_services dod fails submit required information data bank ineligible remaining grant funds future funds makes grantee liable repayment grant amounts provided


Summary:
(This measure has not been amended since it was passed by the Senate on October 26, 2015. The summary of that version is repeated here.)

Improving Regulatory Transparency for New Medical Therapies Act

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs.

This bill amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately.

For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later.

(Sec. 3) Timelines are established for DOJ to either register an applicant to manufacture a controlled substance for a clinical trial or serve an order to show cause upon the applicant.

(Sec. 4) This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.

measure amended passed senate october summary version repeated improving regulatory transparency new medical therapies act sec bill amends cosmetic act public_health_service_act delay effective date approval drug biological product animal drug food_and_drug_administration fda recommends controls controlled substances act department_of_justice doj issues final interim rule drug delay applies conditional approval indexing animal drugs bill amends controlled substances act require doj issue final interim rule drug product recommended controls fda later days doj receives recommendation controls fda approves drug final interim rule effective immediately purposes submitting application extend patent drug product recommended controls considered approved permission commercial marketing use date fda approval date interim final rule issued whichever later sec timelines established doj register applicant manufacture controlled substance clinical trial serve order cause applicant sec bill amends controlled_substances_import_and_export_act allow exported controlled substances exported


Summary: Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to exclude from the average sales price in calculating Medicare payments for drugs and biologicals any customary prompt pay discounts from manufacturers to wholesalers.

amends supplementary_medical_insurance title xviii medicare social security act exclude average sales price calculating medicare payments drugs biologicals customary prompt pay discounts manufacturers wholesalers


Summary:
Protecting Access to Diabetes Supplies Act of 2015

 Amends title XVIII (Medicare) of the Social Security Act to revise the special competitive acquisition program rule applied to diabetic testing strips to require the volume for such types of products to be determined through the use of multiple sources of data that measure consumption and utilization of such strips among individuals in the United States.

Directs the Secretary of Health and Human Services to reject any bid submitted by an entity under the competitive acquisition program that does not demonstrate that it can furnish the types of strips included in its bid.

Requires an entity to furnish to an individual the brand of strips compatible with the individual's home blood glucose monitor.

Prohibits an entity from attempting to influence or incentivize an individual to switch the brand of glucose monitor or testing strips selected.

Prohibits an entity from communicating directly to such an individual until it has given the individual verbally standardized information about the individual's rights with respect to the entity.

Directs the Secretary to establish a process under which an individual furnished with diabetic testing strips under a competitive acquisition program may reject them by notifying the supplier and the Secretary. Permits the individual to obtain different strips from another supplier and have a new claim processed.

amends title xviii medicare social security act revise special competitive acquisition program rule applied diabetic testing strips require volume types products determined use multiple sources data measure consumption utilization strips individuals united_states directs secretary health_and_human_services reject bid submitted entity competitive acquisition program demonstrate furnish types strips included bid requires entity furnish individual brand strips compatible individual home blood glucose monitor prohibits entity attempting influence incentivize individual switch brand glucose monitor testing strips selected prohibits entity communicating directly individual given individual standardized information individual rights respect entity directs secretary establish process individual furnished diabetic testing strips competitive acquisition program reject notifying supplier secretary permits individual obtain different strips supplier new claim processed


Summary:
Compassionate Freedom of Choice Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act prevents or restricts, and the Food and Drug Administration (FDA) must not prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients.

The FDA is prohibited 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.

Except in cases of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, or administers an investigational drug or device is not liable under state or federal law for loss, damage, or injury from: (1) the development, testing, production, acquisition, or use of such drugs or devices; or (2) their safety or effectiveness.

compassionate freedom choice act bill amends cosmetic act declare public_health_service_act prevents restricts food_and_drug_administration fda prevent restrict manufacture importation distribution sale investigational drugs devices terminally ill patients fda prohibited requiring disclosure collection reporting certain information concerning drugs devices sponsor clinical trial voluntarily disclose collect report information fda cases gross negligence willful misconduct person manufactures imports distributes prescribes administers investigational drug device liable state federal law loss damage injury development testing production acquisition use drugs devices safety effectiveness


Summary:
Ensuring Seniors Access to Local Pharmacies Act of 2015

 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:
Andrea Sloan Compassionate Use Reform and Enhancement Act or the Andrea Sloan CURE Act

Amends the Federal Food, Drug, and Cosmetic Act to require the sponsor of an “investigational drug” (which is a drug that is designated as a breakthrough therapy, fast track product, infectious disease product, or drug for a rare disease or condition) to submit to the Food and Drug Administration (FDA) and make available to the public the sponsor's policy on requests for expanded access to the unapproved drug, including the minimum criteria for considering or approving requests and the time needed to make a decision.

Requires an investigational drug sponsor to explain a denied request for expanded access to the person who made the request.

Directs the Department of Health and Human Services to establish an Expanded Access Task Force. Requires the Task Force and the Government Accountability Office (GAO) to evaluate patient access to investigational drugs and make recommendations for improving access.

Directs the FDA to finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As,” taking into account reports from the Task Force and GAO.

compassionate use reform enhancement act sloan cure act amends federal food drug cosmetic act require sponsor investigational drug drug designated breakthrough therapy fast track product infectious disease product drug rare disease condition submit food_and_drug_administration fda available public sponsor policy requests expanded access unapproved drug including minimum criteria considering approving requests time needed decision requires investigational drug sponsor explain denied request expanded access person request directs_the_department_of_health_and_human_services establish requires task force government_accountability_office gao evaluate patient access investigational drugs recommendations improving access directs fda finalize draft guidance entitled expanded access investigational drugs treatment use taking account reports task_force gao


Summary:
Helping Effective Antibiotics Last Act of 2015 or the HEAL Act

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to approve an antibacterial drug or biological product that is intended to treat a serious or life-threatening condition only for treating a well-defined population of patients. To be approved, the antibacterial product must produce superior outcomes over available therapies in the well-defined patient population.

A product approved by this pathway must include in its prescribing information the population of patients expected to benefit from using the product and the method for identifying members of that population. The FDA must require each product to have a risk evaluation and mitigation strategy.

The Centers for Disease Control and Prevention must monitor changes to bacterial drug resistance and changes to patient outcomes caused by bacterial drug resistance.

Upon approval of antibacterial products, the FDA must identify susceptibility test interpretive criteria (the drug concentrations where a type of bacteria is categorized as susceptible, intermediate, or resistant) and update the criteria as needed based upon evidence of changes in patient outcomes.

To be eligible for an exclusivity period extension, a qualified infectious disease product must be demonstrated to produce superior outcomes over available therapies.

The FDA must issue guidance on the development of target product profiles for antibacterial drugs.

helping effective antibiotics act heal act bill amends cosmetic act allow food_and_drug_administration fda approve antibacterial drug biological product intended treat life threatening condition treating defined population patients approved antibacterial product produce superior outcomes available therapies defined patient population product approved pathway include prescribing information population patients expected benefit product method identifying members population fda require product risk evaluation mitigation strategy centers_for_disease_control_and_prevention monitor changes bacterial drug resistance changes patient outcomes caused bacterial drug resistance approval antibacterial products fda identify susceptibility test interpretive criteria drug concentrations type bacteria categorized susceptible intermediate resistant update criteria needed based evidence changes patient outcomes eligible exclusivity period extension qualified infectious disease product demonstrated produce superior outcomes available therapies fda issue guidance development target product profiles antibacterial drugs


Summary:
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an “orphan disease”).

Allows the FDA to revoke an extension if the application for the new indication contained an untrue material statement.

Requires the sponsor of a product receiving an extension to notify the FDA one year prior to discontinuing production for commercial reasons.

Requires the FDA to notify the public of products that receive this extension and patents related to those products.

Limits a product to one extension under this Act. Sets forth that extensions under this Act are in addition to other extensions.

Applies only to products approved after enactment of this Act for a new indication that is a rare disease or condition.

accelerating cures treatments act amends cosmetic act require food_and_drug_administration fda extend months exclusivity period approved drug biological product product additionally approved prevent diagnose treat new indication rare disease condition known orphan disease allows fda revoke extension application new indication contained untrue material statement requires sponsor product receiving extension notify fda year prior discontinuing production commercial reasons requires fda notify public products receive extension patents related products limits product extension act sets forth extensions act addition extensions applies products approved enactment act new indication rare disease condition


Summary:
Clinical Trials Modernization Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to allow sponsors of applications for new drugs, biological products, and medical devices to propose incorporation of alternative statistical methods, including adaptive trial design and Bayesian methods, into clinical trial protocols and marketing applications.

The FDA is required to issue guidance that establishes or clarifies standards for using alternative statistical methods in clinical trials.

The FDA must establish a process under which a post-approval study or clinical trial required by the FDA is periodically evaluated to determine whether the trial or study is no longer scientifically warranted or whether the design should be renegotiated because of changes in medical practice or the standard of care.

clinical trials modernization act bill amends cosmetic act require food_and_drug_administration fda allow sponsors applications new drugs biological products medical devices propose incorporation alternative statistical methods including adaptive trial design methods clinical trial protocols marketing applications fda required issue guidance establishes clarifies standards alternative statistical methods clinical trials fda establish process post approval study clinical trial required fda periodically evaluated determine trial study longer scientifically warranted design renegotiated changes medical practice standard care


Summary:
Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or the PATIENT Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to extend to five years the three-year marketing exclusivity period provided to certain new drugs that include an active ingredient that was already approved by the Food and Drug Administration.

A drug is provided this extended exclusivity period if it is approved for a new indication or use, or the drug has been reformulated or redesigned to:

 promote greater patient adherence to an approved treatment regime, reduce the public health risks associated with the drug, reduce side effects or adverse events, provide benefits to the health-care system, or provide other comparable patient benefits.

promoting access treatments patient act bill amends cosmetic act extend years year marketing exclusivity period provided certain new drugs include active ingredient approved food_and_drug_administration drug provided extended exclusivity period approved new indication use drug promote greater patient adherence approved treatment regime reduce public health risks associated drug reduce effects adverse events provide benefits health care system provide comparable patient benefits


Summary:
Patient Choice Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Department 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 of the drug is unlikely to be greater than the combined 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 one of the countries specified and data adequate for the approval of that marketing authorization has been submitted to HHS.

Prohibits HHS 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 which the drug was: (1) designated as a fast track product, and (2) demonstrated to be adequately safe.

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

patient choice act amends cosmetic act authorize provisional approval fast track products determined department_of_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 drug unlikely greater combined risks death morbidity disease existing therapies drug valid marketing authorization years countries specified data adequate approval marketing authorization submitted hhs 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 designated fast track product demonstrated adequately safe prescribes requirements termination provisional approval withdrawal provisional approval application market exclusivity fast track approval products


Summary:
Speeding Access to Already Approved Pharmaceuticals Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to facilitate the development and expedite the review of a new drug, biological product, or device that has been approved in the European Union.

access approved pharmaceuticals act bill amends cosmetic act require food_and_drug_administration facilitate development expedite review new drug biological product device approved european_union


Summary:
Medical Device Tax Elimination Act

This bill amends the Internal Revenue Code to repeal the excise tax on medical devices and offsets the cost of such repeal by: (1) eliminating the tax deduction for income attributable to oil, natural gas, or primary products thereof for major integrated oil companies (companies that have an average daily worldwide annual production of crude oil of at least 500,000 barrels and annual gross receipts in excess of $1 billion); (2) prohibiting the use of the last-in, first-out (LIFO) accounting method by major integrated oil companies; and (3) denying the foreign tax credit to major integrated oil companies that are dual taxpayers (companies that receive an economic benefit from a foreign country or a possession of the United States that does not impose a generally applicable income tax).

medical device tax elimination act bill amends internal_revenue_code repeal excise tax medical devices offsets cost repeal eliminating tax deduction income attributable oil natural gas primary products thereof major integrated oil companies companies average daily worldwide annual production crude oil barrels annual gross receipts excess billion prohibiting use lifo accounting method major integrated oil companies denying foreign tax credit major integrated oil companies dual taxpayers companies receive economic benefit foreign country possession united_states impose generally applicable income tax


Summary:
Preservation of Antibiotics for Medical Treatment Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require an applicant for approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to the nontherapeutic use of the drug.

Medically important antimicrobials are drugs intended for use in food-producing animals that contain: (1) specified antibiotics, or (2) certain drugs on the World Health Organization’s list of critically important antimicrobials.

 Two years after enactment of this Act, the Food and Drug Administration (FDA) must withdraw approval of a drug's nontherapeutic use in food-producing animals unless the FDA makes a determination that, based on the application holder's demonstration or an FDA risk analysis, there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to nontherapeutic use.

 The FDA must rescind an exemption for investigational use of, or approval of a new drug application for, a medically important antimicrobial for its nontherapeutic use in food-producing animals two years after the exemption is granted or the application for approval is submitted unless there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to nontherapeutic use.

A medically important antimicrobial cannot be administered (including through animal feed) to a food-producing animal for disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the animal.

preservation_of_antibiotics_for_medical_treatment_act bill amends cosmetic act require applicant approval new animal drug medically important antimicrobial demonstrate reasonable certainty harm human health antimicrobial resistance attributable nontherapeutic use drug medically important antimicrobials drugs intended use food producing animals contain specified antibiotics certain drugs world_health_organization list critically important antimicrobials years enactment act food_and_drug_administration fda withdraw approval drug nontherapeutic use food producing animals fda makes determination based application holder demonstration fda risk analysis reasonable certainty harm human health antimicrobial resistance attributable nontherapeutic use fda rescind exemption investigational use approval new drug application medically important antimicrobial nontherapeutic use food producing animals years exemption granted application approval submitted reasonable certainty harm human health antimicrobial resistance attributable nontherapeutic use medically important antimicrobial administered including animal feed food producing animal disease control significant risk disease infection present premises transmitted animal


Summary:
Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015

This bill requires the Government Accountability Office (GAO) to study whether generic versions of certain complex drugs or certain biological drugs face significantly different challenges in meeting the approval standards of the Food and Drug Administration (FDA) than generic versions of small-molecule drugs. (Complex drugs and biological drugs can be composed of large molecules that are more difficult to fully characterize than small molecules, so it can be more difficult to demonstrate that generic versions of these drugs are the same as the brand name versions.)

If the GAO determines that these generic drugs face significantly different challenges, then the GAO must also determine: (1) the evidence that should be required to demonstrate that one of these generic drugs is sufficiently similar to the brand name drug in safety, composition, and activity; (2) whether the Federal Food, Drug, and Cosmetic Act should be amended to address the approval of these generic drugs; and (3) whether the FDA should develop a policy document on the evidence that is necessary to obtain approval of these generic drugs.

bill requires government_accountability_office gao study generic versions certain complex drugs certain biological drugs face significantly different challenges meeting approval standards food_and_drug_administration fda generic versions small drugs complex drugs biological drugs composed large difficult fully characterize small difficult demonstrate generic versions drugs brand versions gao determines generic drugs face significantly different challenges gao determine evidence required demonstrate generic drugs sufficiently similar brand drug safety composition activity cosmetic act amended address approval generic drugs fda develop policy document evidence necessary obtain approval generic drugs


Summary:
Diagnostic Imaging Services Access Protection Act of 2015

This bill amends title XVIII (Medicare) of the Social Security Act to prohibit the Secretary of Health and Human Services from applying a multiple procedure payment reduction policy to the professional component of imaging services furnished: (1) after a specified date in the year this Act is enacted; or (2) in any subsequent year before the Secretary conducts and publishes, as part of the Medicare Physician Fee Schedule for a year, an analysis of the Resource-Based Relative Value Scale Data Manager information used to determine what, if any, efficiencies exist within the professional component of imaging services when two or more studies are performed on the same patient on the same day.

bill amends title xviii medicare social security act prohibit secretary health_and_human_services applying multiple procedure payment reduction policy professional component imaging services furnished specified date year act enacted subsequent year secretary conducts publishes medicare physician fee schedule year analysis manager information determine efficiencies exist professional component imaging services studies performed patient day


Summary:
Safe and Affordable Drugs from Canada Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy that:

 is dispensed by a pharmacist licensed in Canada; is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice in the United States; and has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved under the FFDCA. Sets forth exceptions, including for controlled substances and biological products.

 Establishes a certification process for approving Canadian pharmacies. Requires HHS to publish a list of approved Canadian pharmacies.

safe affordable drugs canada act amends cosmetic act ffdca require department_of_health_and_human_services hhs promulgate regulations days permitting individuals import prescription drug purchased approved canadian pharmacy dispensed pharmacist licensed canada purchased personal use quantities greater day supply filled valid prescription issued physician licensed practice united_states active ingredient ingredients route administration dosage form strength prescription drug approved ffdca sets forth exceptions including controlled substances biological products establishes certification process approving canadian pharmacies publish list approved canadian pharmacies


Summary: This bill amends title XVIII (Medicare) of the Social Security Act to direct the Department of Health and Human Services to provide for a pharmaceutical and technology ombudsman within the Centers for Medicare and Medicaid Services.

bill amends title xviii medicare social security act direct department_of_health_and_human_services provide pharmaceutical technology ombudsman medicaid_services


Summary:
This bill amends the Federal Food, Drug, and Cosmetic Act to replace the requirement that the Food and Drug Administration (FDA) prioritize review of breakthrough medical devices with a requirement that the FDA establish a program to provide priority review for breakthrough medical devices.

Prior to submitting an application for approval, a medical device sponsor may request that the FDA designate the medical device for priority review. The FDA must provide a summary of the basis for its determination regarding designation.

To expedite the development and review of designated medical devices, the FDA must:

 assign a team of staff for each device, adopt an efficient process for dispute resolution, provide for interactive communication with the device sponsor, expedite review of manufacturing and quality systems compliance, disclose to the sponsor in advance the topics of any consultation between the FDA and external experts or an advisory committee and provide the sponsor the opportunity to recommend external experts, assign staff to address questions by institutional review committees concerning investigational use of the device. The FDA may: (1) coordinate with the sponsor regarding early agreement on a data development plan; (2) take steps to ensure that the design of clinical trials is as efficient as practicable; (3) utilize timely postmarket data collection; and (4) agree to clinical protocols, subject to an FDA determination that changes are required to prevent an unreasonable risk to the public health or that a substantial scientific issue is essential to the safety or effectiveness of the device.

bill amends cosmetic act replace requirement food_and_drug_administration fda prioritize review breakthrough medical devices requirement fda establish program provide priority review breakthrough medical devices prior submitting application approval medical device sponsor request fda designate medical device priority review fda provide summary basis determination designation expedite development review designated medical devices fda assign team staff device adopt efficient process dispute resolution provide interactive communication device sponsor expedite review manufacturing quality systems compliance disclose sponsor advance topics consultation fda external experts advisory committee provide sponsor opportunity recommend external experts assign staff address questions institutional review committees concerning investigational use device fda coordinate sponsor early agreement data development plan steps ensure design clinical trials efficient practicable utilize timely postmarket data collection agree clinical protocols subject fda determination changes required prevent unreasonable risk public health substantial scientific issue essential safety effectiveness device


Summary:
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), not later than 120 days after enactment of the 21st Century Cures Act (H.R. 6, a bill introduced on May 19, 2015), to identify types of class I medical devices (devices that do not need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, a report is needed for a class I device only if the device is of substantial importance in preventing impairment of human health or if it presents a potential unreasonable risk of illness or injury.)

Not later than 180 days after enactment of the 21st Century Cures Act, the FDA must publish a list of types of class II medical devices (devices that need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, such a list must be published each time the FDA exempts a type of class II device from the reporting requirement.) The public comment period for such an exemption is extended to 60 days.

bill amends cosmetic act require food_and_drug_administration fda later days enactment 21st century cures act bill introduced identify types class medical devices devices need special controls assure safety effectiveness report longer needed prior marketing provide reasonable assurance safety effectiveness currently report needed class device device substantial importance preventing impairment human health presents potential unreasonable risk illness injury later days enactment 21st century fda publish list types class medical devices devices need special controls assure safety effectiveness report longer needed prior marketing provide reasonable assurance safety effectiveness currently list published time fda exempts type class device reporting requirement public comment period exemption extended days


Summary:
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals.

Within 18 months of enactment of this Act, the FDA must define “probable benefit” for these devices.

bill amends cosmetic act expand humanitarian device exemption authorize food_and_drug_administration fda exempt effectiveness requirements certain medical devices intended benefit fewer individuals currently fda exempt devices intended benefit fewer individuals months enactment act fda define probable benefit devices


Summary: This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to describe the responsibilities of each agency center charged with reviewing drugs, medical devices, or biological products when reviewing a product that is a combination of drug, medical device, or biological product.

bill amends cosmetic act require food_and_drug_administration describe responsibilities agency center charged reviewing drugs medical devices biological products reviewing product combination drug medical device biological product


Summary: Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to begin the process to develop and implement a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies.

amends title xviii medicare social security act direct secretary health_and_human_services begin process develop implement prior authorization process certain durable medical equipment prosthetics orthotics supplies


Summary: This bill requires the Food and Drug Administration to issue guidance that addresses using alternative statistical methods, including adaptive trial design and Bayesian methods, in clinical trials and in the development and review of drugs and biological products.

bill requires food_and_drug_administration issue guidance addresses alternative statistical methods including adaptive trial design methods clinical trials development review drugs biological products


Summary: This bill requires the Department of Health and Human Services to publish guidance that revises “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” and includes guidance on using comparable performance between types of users to demonstrate the accuracy of a medical device.

bill requires department_of_health_and_human_services publish guidance revises recommendations clinical laboratory improvement amendments waiver applications manufacturers vitro diagnostic devices includes guidance comparable performance types users demonstrate accuracy medical device


Summary: This bill authorizes the Commissioner of Food and Drugs to award grants to institutions of higher education and nonprofit organizations to study and recommend improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.

bill authorizes commissioner food drugs award grants institutions higher education nonprofit organizations study recommend improvements process continuous manufacturing drugs biological products similar innovative monitoring control techniques


Summary:
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to define "precision drug or biological product." (Precision medications are commonly understood to be treatments for those patients who are likely to respond to the medication based on a biomarker, which is a biological characteristic such as a genetic factor.)

The FDA must issue and periodically update guidance that addresses the development and use of biomarkers to identify the subset of patients that are likely to respond to a medication.

The FDA may rely upon data previously submitted for a different approved medication or indication to expedite the clinical development of a precision medication that has been designated for the treatment of a serious or rare condition.

bill amends cosmetic act require food_and_drug_administration fda define precision drug biological product precision medications commonly understood treatments patients likely respond medication based biological characteristic genetic factor fda issue periodically update guidance addresses development use biomarkers identify subset patients likely respond medication fda rely data previously submitted different approved medication indication expedite clinical development precision medication designated treatment rare condition


Summary:
Everson Walls and Ron Springs Gift for Life Act of 2015

This bill amends the Public Health Service Act to require the Health Resources and Services Administration to establish a National Organ and Tissue Donor Registry Resource Center.

The Center must: (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.

The Department of Health and Human Services must award grants to states in order to develop, expand, or maintain state organ donor registries and establish benchmarks for improvement in organ donation. A state registry that receives a grant must be accessible to individual donors and the Center.

A person taking an individual's organs is not civilly liable as long as the person verified the individual's consent with a state organ donor registry.

The Government Accountability Office must study the feasibility of establishing a database to track the health effects of living organ donation.

life act bill amends public_health_service_act require health_resources_and_services_administration establish center advance development expansion evaluation state organ donor registries facilitate timely exchange donor information state registries maintain clearinghouse information registry best practices department_of_health_and_human_services award grants states order develop expand maintain state organ donor registries establish benchmarks improvement organ donation state registry receives grant accessible individual donors center person taking individual organs civilly liable long person verified individual consent state organ donor registry government_accountability_office study feasibility establishing database track health effects living organ donation


Summary:
This bill amends the Federal Food, Drug, and Cosmetic Act to direct the Department of Health and Human Services (HHS) to review each regulation and guidance that applies to the dissemination by means of the Internet of information about medical products and to propose revisions to such regulations and guidance that:

 facilitate meaningful use of the Internet by product sponsors for dissemination of truthful, non-misleading information about medical products; recognize that such sponsors may use the Internet to disseminate, in character-limited applications, truthful, introductory information about medical products and to provide additional information about the safety and effectiveness of the medical products using information that is hyperlinked to such introductory information; and treat such hyperlinked information as if it appeared in such introductory information, for regulatory purposes. HHS is required, after providing notice and an opportunity for public comment, to: (1) publish final regulations and guidance addressing such matters within 18 months after publication of proposed regulations and guidance; and (2) review and update such regulations and guidance periodically.

bill amends cosmetic act direct department_of_health_and_human_services hhs review regulation guidance applies dissemination means internet information medical products propose revisions regulations guidance facilitate meaningful use internet product sponsors dissemination truthful non misleading information medical products recognize sponsors use internet disseminate character limited applications truthful introductory information medical products provide additional information safety effectiveness medical products information introductory information treat information appeared introductory information regulatory purposes hhs required providing notice opportunity public comment publish final regulations guidance addressing matters months publication proposed regulations guidance review update regulations guidance periodically


Summary:
Surrogate Endpoint Improvement and Utilization Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the sponsor of a drug that is eligible for accelerated approval to request that the Food and Drug Administration (FDA) agree to an accelerated approval development plan that includes a surrogate endpoint for the study of the drug and a magnitude of drug effect that is sufficient to claim the drug is effective. (Accelerated approval is an FDA process for approving a new drug for a serious medical condition at a point in the study of the drug that is reasonably likely to predict a clinical benefit instead of at a later point when a clinical benefit can be confirmed.)

The FDA may require the sponsor to modify or terminate an agreed upon plan if additional information indicates that the plan is no longer sufficient to demonstrate the safety and effectiveness of the drug or the drug is no longer eligible for accelerated approval.

bill amends cosmetic act allow sponsor drug eligible accelerated approval request food_and_drug_administration fda agree accelerated approval development plan includes surrogate endpoint study drug magnitude drug effect sufficient claim drug effective accelerated approval fda process approving new drug medical condition point study drug reasonably likely predict clinical benefit instead later point clinical benefit confirmed fda require sponsor modify terminate agreed plan additional information indicates plan longer sufficient demonstrate safety effectiveness drug drug longer eligible accelerated approval


Summary:
Medical Imaging Modernization Act of 2015

This bill amends title XVIII (Medicare) of the Social Security Act to make a special rule reducing by 20% the payment under the physician fee schedule and the hospital outpatient prospective payment system for the technical component of imaging services that are x-rays taken using film.

Imaging services that are x-rays taken using computed radiography technology shall have the technical component payment: (1) for services furnished from 2018 through 2022 reduced by 7%; and (2) for services furnished during 2023 or a subsequent year reduced by 10%.

Reduced expenditures attributable to incentives to transition to digital radiography under the physician fee schedule are exempt from budget-neutrality calculation.

The Department of Health and Human Services may not apply a multiple procedure payment reduction to the professional component of imaging services furnished before it publishes, as part of the Medicare Physician Fee Schedule Proposed Rule for a year, a empirical analysis of the Resource-Based Relative Value Scale (commonly known as the "RBRVS") Data Manager information used to determine what, if any, efficiencies exist within the professional component of imaging services when two or more studies are performed on the same patient on the same day.

These payment reductions under the hospital outpatient prospective payment system for the transition from traditional x-ray imaging to digital radiography shall apply without regard to budget neutrality.

medical imaging modernization act bill amends title xviii medicare social security act special rule reducing payment physician fee schedule hospital outpatient prospective payment system technical component imaging services rays taken film imaging services rays taken computed technology shall technical component payment services furnished reduced services furnished subsequent year reduced reduced expenditures attributable incentives transition digital physician fee schedule exempt budget neutrality calculation department_of_health_and_human_services apply multiple procedure payment reduction professional component imaging services furnished publishes medicare physician fee schedule proposed rule year empirical analysis commonly known data manager information determine efficiencies exist professional component imaging services studies performed patient day payment reductions hospital outpatient prospective payment system transition traditional ray imaging digital shall apply regard budget neutrality


Summary:
Accelerating Innovation in Medicine Act of 2015 or the AIM Act of 2015

 Amends title XVIII (Medicare) of the Social Security Act to direct the Department of Health and Human Services (HHS) to develop an accelerating innovation in medicine (AIM) list of medical devices for which, because of their inclusion on the list, insurance benefits and payments are prohibited under Medicare (either directly or on a capitated basis), with the result that no Medicare claim may be submitted and an individual who consents to receive such a device is responsible for paying for it and for any related services.

Directs the Secretary to post on a public HHS website or other publicly accessible media an updated list of the medical devices on the AIM list.

accelerating innovation medicine act aim act amends title xviii medicare social security act direct department_of_health_and_human_services hhs develop accelerating innovation medicine aim list medical devices inclusion list insurance benefits payments prohibited medicare directly capitated basis result medicare claim submitted individual consents receive device responsible paying related services directs secretary post public hhs website publicly accessible media updated list medical devices aim list


Summary:
Part D Beneficiary Appeals Fairness Act

 Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure.

States that in no case may the Secretary of Health and Human Services allow a PDP sponsor to make any formulary tier of the tiered cost-sharing structure (including a formulary tier used for very high cost or unique items) ineligible for lower-cost sharing through an exception.

beneficiary appeals fairness act amends voluntary prescription drug benefit program title xviii medicare social security act respect prescription drug plan pdp provides tiered cost sharing formulary including structure provides different payment coinsurance amounts drugs different tiers included formulary authorize medicare eligible individual enrolled plan request exception tiered cost sharing structure states case secretary health_and_human_services allow pdp sponsor formulary tier tiered cost sharing structure including formulary tier high cost unique items ineligible lower cost sharing exception


Summary:
Antibiotic Development to Advance Patient Treatment Act

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to agree with the sponsor of an applicable medication on a process for approving the medication for use in a limited population of patients. Applicable medications are antibacterial or antifungal drugs or biological products for the treatment of a serious infection. The FDA may rely on alternate study endpoints, limited data sets, and additional data, including preclinical evidence, in approving such a medication.

A medication approved for use in a limited population must be labeled accordingly.

The Public Health Service Act is amended to require the Department of Health and Human Services to monitor the use of antibacterial and antifungal medications and monitor antibacterial and antifungal resistance. (An individual infected by a strain of bacteria or fungi that is resistant to a medication cannot be treated with that medication. Resistance can develop naturally with the use of a medication.)

The FDA must identify and publish susceptibility test interpretive criteria for antimicrobial medications. (These criteria are used to characterize the resistance of microbes to antimicrobial medications. "Microbes" or "microorganisms" include bacteria, some fungi, and other organisms.)

Every six months, the FDA must evaluate any new or updated susceptibility test interpretive criteria established by a standard development organization and recognize new criteria or withdraw recognition of criteria, as appropriate.

The FDA may allow marketing of medical devices that use these criteria without premarket approval.

treatment act bill amends cosmetic act allow food_and_drug_administration fda agree sponsor applicable medication process approving medication use limited population patients applicable medications antibacterial antifungal drugs biological products treatment infection fda rely alternate study endpoints limited data sets additional data including preclinical evidence approving medication medication approved use limited population labeled accordingly public_health_service_act amended require department_of_health_and_human_services monitor use antibacterial antifungal medications monitor antibacterial antifungal resistance individual infected strain bacteria resistant medication treated medication resistance develop naturally use medication fda identify publish susceptibility test interpretive criteria antimicrobial medications criteria characterize resistance microbes antimicrobial medications microbes microorganisms include bacteria organisms months fda evaluate new updated susceptibility test interpretive criteria established standard development organization recognize new criteria withdraw recognition criteria appropriate fda allow marketing medical devices use criteria premarket approval


Summary:
Fair Access for Safe and Timely Generics Act of 2015 or the FAST Generics Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS).

Upon request, the license holder of a medication that is not subject to a REMS must provide a product developer with the medication for testing.

For a medication subject to a REMS, a product developer must have FDA authorization to obtain the medication before the license holder must provide it. The FDA may authorize a product developer to conduct testing and clinical trials with the medication.

A wholesaler or specialty distributor who receives a request from a product developer for a medication for testing may not disclose to the license holder the identity of the product developer. The FDA may prohibit or limit transfer of a medication to a product developer if the transfer poses an imminent hazard to public health.

License holders are not liable for claims arising from a product developer testing the medication.

The FDA may waive the requirement that a drug use a single, shared system of elements to assure safe use with a comparable approved drug if the product developer is unable to finalize terms for a shared system with the license holder of the approved drug.

fast bill amends cosmetic act prohibit license holder food_and_drug_administration drug biological product restricting availability medication testing product developer seeking develop drug generic drug biosimilar including restricting availability risk evaluation mitigation strategy request license holder medication subject provide product developer medication testing medication subject product developer fda authorization obtain medication license holder provide fda authorize product developer conduct testing clinical trials medication wholesaler specialty distributor receives request product developer medication testing disclose license holder identity product developer fda prohibit limit transfer medication product developer transfer poses imminent hazard public health license holders liable claims arising product developer testing medication fda waive requirement drug use single shared system elements assure safe use comparable approved drug product developer unable finalize terms shared system license holder approved drug


Summary:
Right to Try Act of 2015

Bars the federal government from prohibiting or restricting the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that is: (1) intended to treat a patient who has been diagnosed with a terminal illness; and (2) authorized by, and in accordance with, state law.

Defines an "experimental drug, biological product, or device" as one that: (1) has successfully completed a phase 1 clinical investigation; (2) remains under investigation in a clinical trial approved by the Food and Drug Administration; and (3) is not approved, licensed, or cleared for commercial distribution under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act.

right try act bars federal government prohibiting restricting production manufacture distribution prescribing dispensing possession use experimental drug biological product device intended treat patient diagnosed terminal illness authorized accordance state law defines experimental drug biological product device successfully completed phase clinical investigation remains investigation clinical trial approved food_and_drug_administration approved licensed cleared commercial distribution cosmetic act public_health_service_act


Summary:
Veterans Access to Orthotic and Prosthetic Care Act

This bill directs the Department of Veterans Affairs (VA) to ensure that: (1) each VA prosthetist and orthotist and each VA employee who provides prosthetic or orthotic services meets all current certification and licensing requirements, and (2) each VA orthotic or prosthetic facility and laboratory that provides prosthetic and orthotic services is certified by one of the nationally recognized accrediting bodies.

prosthetic care act bill directs department_of_veterans_affairs ensure employee provides prosthetic orthotic services meets current certification licensing requirements orthotic prosthetic facility laboratory provides prosthetic orthotic services certified nationally recognized accrediting bodies


Summary:
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015

This bill amends the Internal Revenue Code to allow tax credits for 50% of the clinical testing expenses for: (1) infectious disease products that are intended to treat a serious or life-threatening infection, including one caused by an antibacterial or antifungal resistant pathogen or a qualifying pathogen listed by the Department of Health and Human Services as having the potential to pose a serious threat to public health; and (2) in-vitro diagnostic devices that identify in less than four hours the presence, concentration, or characteristics of a serious or life-threatening infection.

diagnostic innovation act bill amends internal_revenue_code allow tax credits clinical testing expenses infectious disease products intended treat life threatening infection including caused antibacterial antifungal resistant pathogen qualifying pathogen listed department_of_health_and_human_services having potential pose threat public health vitro diagnostic devices identify hours presence concentration characteristics life threatening infection


Summary:
Orphan Drug Fairness Act

This bill amends the Patient Protection and Affordable Care Act (PPACA) to exclude sales of any drug or biological product approved by the Food and Drug Administration solely for rare diseases or conditions (orphan drug) from the calculation of the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.

This Act is effective as if included in PPACA.

fairness act bill amends patient_protection affordable care act ppaca exclude sales drug biological product approved food_and_drug_administration solely rare diseases conditions orphan drug calculation annual fee manufacturers importers branded prescription drug sales exceeding million act effective included ppaca


Summary:
Gluten in Medicine Disclosure Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of 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 does not include a parenthetical statement identifying the source of that ingredient.

medicine disclosure act bill amends cosmetic act prohibit sale drug intended human use contains ingredient constitutes derived grain starch containing ingredient label include statement identifying source ingredient


Summary:
Preserving Access to Orphan Drugs Act of 2015

This bill amends the Patient Protection and Affordable Care Act to expand the definition of orphan drug for purposes of the annual fee paid by brand name prescription drug manufacturers and importers to include medications for rare conditions that were, prior to 2011, approved or in clinical trials. (Drug manufacturers and importers pay an annual fee based on their sales of brand name prescription drugs, excluding sales of orphan drugs.) Currently, only medications for rare conditions for which a tax credit for clinical trials was allowed are considered orphan drugs.

This Act applies to fees paid after 2014.

preserving access orphan drugs act bill amends patient_protection affordable care act expand definition orphan drug purposes annual fee paid brand prescription drug manufacturers importers include medications rare conditions prior approved clinical trials drug manufacturers importers pay annual fee based sales brand prescription drugs excluding sales orphan drugs currently medications rare conditions tax credit clinical trials allowed considered orphan drugs act applies fees paid


Summary:
Strategy To Oppose Predatory Organ Trafficking Act or the STOP Organ Trafficking Act

 (Sec. 3) This bill expresses the sense of Congress that:

 kidnapping or coercion of individuals to extract their organs for profit contradicts the standards for ethical behavior upon which the United States has based its laws; illegal harvesting of organs from children is a violation of the chid's human rights and a breach of international medical ethical standards; illegal harvesting and trafficking of human organs violates the Universal Declaration of Human Rights; and establishing efficient national organ donation systems with strong enforcement mechanisms is the most effective way to combat trafficking of persons for the removal of their organs. (Sec. 4) It shall be U.S. policy to: (1) combat trafficking of persons for the removal of their organs, (2) promote the establishment of voluntary organ donation systems with effective enforcement mechanisms, and (3) promote the dignity and security of human life.

(Sec. 5) The Passport Act of 1926 is amended to authorize the Department of State to refuse to issue a passport to, and revoke a previously issued passport from, a person convicted of trafficking in human organs who used a passport or otherwise crossed an international border in committing such offense.

(Sec. 6) The Trafficking Victims Protection Act of 2000 is amended to define "trafficking of persons for the removal of their organs" as the recruitment, transportation, transfer, harboring, or receipt of a person, either living or dead, for the purpose of removing one or more of the person's organs by:

 coercion, abduction, deception, fraud, abuse of power, or transfer of payments or benefits to achieve the consent of an individual having control over such person for the purpose of removing the person's organs. "Organ" means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ specified by the Department of Health and Human Services.

Trafficking of persons for the removal of their organs is included in the definition of "severe forms of trafficking in persons."

 The Interagency Task Force To Monitor and Combat Trafficking is tasked with collecting and organizing data from human rights officers at U.S. embassies on host country's laws against trafficking of persons for the removal of their organs and any instances of violations of such laws.

(Sec. 7) The State Department shall report annually through 2024 to Congress regarding: (1) the trafficking of persons for the removal of their organs, and (2) preventive activities undertaken by the State Department and other countries.

strategy oppose predatory organ trafficking act sec bill expresses sense congress kidnapping coercion individuals extract organs profit standards ethical behavior united_states based laws illegal harvesting organs children violation human rights breach international medical ethical standards illegal harvesting trafficking human organs violates universal declaration human rights establishing efficient national organ donation systems strong enforcement mechanisms effective way combat trafficking persons removal organs sec shall policy combat trafficking persons removal organs promote establishment voluntary organ donation systems effective enforcement mechanisms promote dignity security human life sec passport act amended authorize department_of_state refuse issue passport revoke previously issued passport person convicted trafficking human organs passport international border committing offense sec trafficking_victims_protection_act amended define trafficking persons removal organs recruitment transportation transfer harboring receipt person living dead purpose removing person organs coercion abduction deception fraud abuse power transfer payments benefits achieve consent individual having control person purpose removing person organs organ means human including fetal kidney liver heart lung bone marrow eye bone skin subpart thereof human organ specified department_of_health_and_human_services trafficking persons removal organs included definition severe forms trafficking persons interagency_task_force monitor combat_trafficking tasked collecting organizing data human rights officers embassies host country laws trafficking persons removal organs instances violations laws sec state_department shall report annually congress trafficking persons removal organs preventive activities undertaken state_department countries


Summary:
E-Free Act

This bill requires the Food and Drug Administration to withdraw approval for Essure, a medical device for permanent, non-surgical female sterilization.

free act bill requires food_and_drug_administration withdraw approval medical device permanent non surgical female sterilization


Summary:
Meaningful Use Hardship Relief Act of 2015

This bill amends title XVIII (Medicare) of the Social Security Act to create a blanket exception for providers from the application of certain negative payment adjustments for failing to comply, during the 2015 reporting period, with requirements related to the meaningful use of electronic health records. Under current law, providers may be exempted due to significant hardship on a case-by-case basis.

meaningful use hardship relief act bill amends title xviii medicare social security act create blanket exception providers application certain negative payment adjustments failing comply reporting period requirements related meaningful use electronic health records current law providers exempted significant hardship case case basis


Summary:
Cardiac Arrest Survival Act of 2015

This bill 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; and (2) the owner of an AED for any harm resulting from the use of the AED, unless the harm was caused by the failure of the owner to properly maintain the AED.

This immunity applies regardless of whether: (1) the AED is marked with cautionary signage or registered with any government; or (2) the person who used the AED complied with signage, had received training on use of the AED, or was assisted or supervised, including by a licensed physician.

cardiac arrest survival act bill 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 owner aed harm resulting use aed harm caused failure owner properly maintain aed immunity applies regardless aed marked cautionary signage registered government person aed complied signage received training use aed assisted supervised including licensed physician


Summary:
Protecting Access through Competitive-pricing Transition Act of 2015 or the PACT Act of 2015

This bill amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to modify provisions relating to payment for durable medical equipment (DME) under the Medicare and Medicaid programs. (DME includes certain medically necessary equipment such as walkers, wheelchairs, and hospital beds.)

With respect to DME furnished in areas that are not competitive acquisition areas, current regulations require the Centers for Medicare & Medicaid (CMS) to phase in, over a two-year period, Medicare payment adjustments using information from competitive acquisition programs. (Through such programs, payment amounts for each area are determined based on competitive bids submitted by suppliers, rather than according to an established fee schedule.) The bill codifies this requirement and specifies that CMS shall adjust fee schedule amounts to the lesser of: (1) a specified percentage of the regional amount; and (2) the amount that would otherwise be determined according to the fee schedule, with specified adjustments.

In determining Medicare payment adjustments for areas that are not competitive acquisition areas, CMS shall solicit stakeholder input and take into account several specified factors.

CMS may not accept a bid under the competitive acquisition program unless the bidder: (1) meets applicable state licensure requirements; and (2) has submitted a cash deposit as a bond, as specified by the bill.

CMS must establish a six-year market pricing demonstration project, under which auctions are conducted in eligible areas for the furnishing of market-priced DME items and services. The bill establishes project requirements related to auction design, contract terms, transparency, and monitoring.

protecting_access competitive pricing transition act pact act bill amends titles xviii medicare xix medicaid social security act modify provisions relating payment durable medical equipment dme medicare medicaid programs dme includes certain medically necessary equipment wheelchairs hospital beds respect dme furnished areas competitive acquisition areas current regulations require centers cms phase year period medicare payment adjustments information competitive acquisition programs programs payment amounts area determined based competitive bids submitted suppliers according established fee schedule bill codifies requirement specifies cms shall adjust fee schedule amounts lesser specified percentage regional determined according fee schedule specified adjustments determining medicare payment adjustments areas competitive acquisition areas cms shall solicit stakeholder input account specified factors cms accept bid competitive acquisition program bidder meets applicable state licensure requirements submitted cash deposit bond specified bill cms establish year market pricing demonstration project auctions conducted eligible areas furnishing market priced dme items services bill establishes project requirements related auction design contract terms transparency monitoring


Summary:
Responsibility in Drug Advertising Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit direct-to-consumer advertising of a drug in the first three years after the drug's approval. The Food and Drug Administration may: (1) waive the third year of this prohibition for a drug if direct-to-consumer advertising of the drug would have an affirmative value to public health, or (2) extend the prohibition if the drug has significant adverse health effects.

responsibility drug advertising act bill amends cosmetic act prohibit direct consumer advertising drug years drug approval food_and_drug_administration waive year prohibition drug direct consumer advertising drug affirmative value public health extend prohibition drug significant adverse health effects


Summary:
(This measure has not been amended since it was reported to the House on May 10, 2016. The summary of that version is repeated here.)

Lali's Law

(Sec. 2) This bill amends the Public Health Service Act to permit the Department of Health and Human Services to make grants to states that allow standing orders (documents that allow a person to acquire, dispense, or administer a prescription medication without a person-specific prescription) for opioid overdose reversal medication (e.g., naloxone). (Opioids are drugs with effects similar to opium, such as heroin and certain pain medications.)

Grants may be used for:

 developing standing orders for opioid overdose reversal medication for pharmacies; encouraging pharmacies to dispense medication pursuant to such a standing order; implementing best practices for prescribing opioids, prescribing opioid overdose reversal medication with opioids, and discussing opioid overdose reversal medication with patients; developing training for prescribers to use in educating the public on administration of opioid overdose reversal medication; and educating the public on the availability and public health benefits of opioid overdose reversal medication. States must report on pharmacies that dispense opioid overdose reversal medication under a standing order and the number of pharmacists trained in educating the public on administration of opioid overdose reversal medication.

(Sec. 3) As an offset, this bill reduces the authorization of appropriations for Centers for Disease Control and Prevention facilities.

measure amended reported house summary version repeated law sec bill amends public_health_service_act permit department_of_health_and_human_services grants states allow standing orders documents allow person acquire dispense administer prescription medication person specific prescription opioid overdose reversal medication naloxone opioids drugs effects similar opium heroin certain pain medications grants developing standing orders opioid overdose reversal medication pharmacies encouraging pharmacies dispense medication pursuant standing order implementing best practices prescribing opioids prescribing opioid overdose reversal medication opioids discussing opioid overdose reversal medication patients developing training prescribers use educating public administration opioid overdose reversal medication educating public availability public health benefits opioid overdose reversal medication states report pharmacies dispense opioid overdose reversal medication standing order number pharmacists trained educating public administration opioid overdose reversal medication sec offset bill reduces authorization appropriations centers_for_disease_control_and_prevention facilities


Summary:
Advancing Standards in Regenerative Medicine Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to facilitate the establishment of a public-private Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. The FDA must work with this body to develop standards to support the development and review of regenerative medicine products.

advancing standards medicine act bill amends cosmetic act require food_and_drug_administration fda facilitate establishment public private standards coordinating body advanced therapies fda work body develop standards support development review medicine products


Summary:
Removing Barriers to Clinical Research Act of 2016

This bill amends title XVIII (Medicare) of the Social Security Act to expand Medicare coverage of costs associated with clinical trials. Under current law, Medicare covers routine costs of care furnished to a beneficiary enrolled in a category A (experimental) clinical trial of a medical device intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition. The bill requires Medicare to also cover, with respect to a beneficiary enrolled in a category B (non-experimental) clinical trial, routine costs of care as well as the cost of the device under investigation.

A trial of a medical device shall, for purposes of Medicare coverage, be deemed to meet the definition of a category A or category B clinical trial, as the case may be, if the trial is conducted under the Federal Food, Drug, and Cosmetic Act's investigational use exemption.

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Summary:
Reliable and Effective Growth for Regenerative Health Options that Improve Wellness or the REGROW Act

This bill amends the Public Health Service Act to require the Food and Drug Administration (FDA) to conditionally approve certain cellular therapeutic products without initiation of large-scale clinical trials. A conditionally approved cellular therapy may be marketed if certain conditions are met, including conditions on the source, processing, and function of the cells in the product. The sponsor of a conditionally approved cellular therapy must apply for approval of the product as a biological product within five years. Unless the FDA has decided not to approve the product, the product may be marketed during this five-year period and the FDA may permit continued marketing while the application is being reviewed.

An individual administering a conditionally approved cellular therapy must inform the recipient regarding conditional approval.

The premarket report for a medical device used for cellular therapy must include specified information regarding the preparation or delivery of the cellular therapy.

The approval of a medical device that is a cellular therapy must be based on laboratory performance testing and not clinical trials.

A medical device used for cellular therapy is subject to medical device classification. The FDA must not limit the use of these devices to only specific cell types unless unique to the use of the device.

The Center for Biologics Evaluation and Research has primary jurisdiction for premarket review of combination products that act primarily through cellular components.

The Department of Health and Human Services must work with stakeholders to promote the development of standards for regenerative medicine products.

reliable effective growth health options improve wellness act bill amends public_health_service_act require food_and_drug_administration fda conditionally approve certain cellular therapeutic products initiation large scale clinical trials conditionally approved cellular therapy marketed certain conditions met including conditions source processing function cells product sponsor conditionally approved cellular therapy apply approval product biological product years fda decided approve product product marketed year period fda permit continued marketing application reviewed individual administering conditionally approved cellular therapy inform recipient conditional approval premarket report medical device cellular therapy include specified information preparation delivery cellular therapy approval medical device cellular therapy based laboratory performance testing clinical trials medical device cellular therapy subject medical device classification fda limit use devices specific cell types unique use device center biologics evaluation research primary jurisdiction premarket review combination products act primarily cellular components department_of_health_and_human_services work stakeholders promote development standards medicine products


Summary:
Lower Drug Costs through Competition Act

This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications.

The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 180 days. The FDA may expedite the inspection of a facility proposed to manufacture such a drug.

Beginning FY2018, the FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application once the drug has a sustained market presence. A voucher may be used to have the FDA review and take action upon a generic drug application within 180 days of submission. The FDA must establish an additional user fee for applications subject to a voucher. This voucher program is terminated at the end of FY2021.

The FDA must periodically report on generic drug applications filed before FY2017 that are still pending.

For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations.

The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.

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Summary:
Prevent Abuse By Using Interstate Exchange Act of 2016 or the Prevent ABUSE Act of 2016

This bill requires a state that receives a prescription drug monitoring program implementation and enhancement grant to set aside at least 20% of grant funds to facilitate interstate electronic information sharing about prescriptions for controlled substances.

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Summary: This bill requires the Centers for Disease Control and Prevention to issue guidance for the safe prescribing of opioids for the treatment of acute pain. (Opioids are drugs with effects similar to opium, such as certain pain medications.)

bill requires centers_for_disease_control_and_prevention issue guidance safe prescribing opioids treatment acute pain opioids drugs effects similar opium certain pain medications