Summary: Verifying Authority and Legality In Drug Compounding Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. Eliminates authority for compounding pharmacies to: (1) compound drugs before the receipt of a valid prescription order, or (2) compound any drug product that is a copy of a commercially available drug. Requires the Secretary of Health and Human Services (HHS) to develop, maintain and transmit to the appropriate state agencies a list of drug products that should not be compounded, including: (1) drug products whose compounding is reasonably likely to cause an adverse effect on their safety or effectiveness; and (2) drug products that have been withdrawn or removed from the market because they have been found to be unsafe or not effective. Authorizes the Secretary to waive the requirement that a drug product must be compounded for an individually identified patient based on a valid prescription order or similar notation if compounding the drug product is necessary to address a drug shortage, or to protect public health or well-being. Prohibits the Secretary from authorizing a state to grant such waivers. Authorizes the Secretary to waive the requirement that a drug product must be compounded for an individually identified patient based on a valid prescription order or similar notation if the pharmacy or pharmacist: (1) submits a satisfactory application to the Secretary; and (2) agrees to comply with any condition or limitation specified by the Secretary. Makes a pharmacy or pharmacist required to be registered under the FFDCA as a drug producer ineligible for a waiver. Permits the Secretary to authorize a state to grant such waivers applicable to compounded drug products sold or dispensed within the state pursuant to a memorandum of understanding between the Secretary and the state. Authorizes the Secretary to waive the prohibition against compounding any drug product that is a copy of a commercially available drug if it is necessary to protect public health or well-being. Prohibits the Secretary from authorizing a state to waive such prohibition. Subjects the facilities of any pharmacy receiving a waiver under this Act to inspection to determine compliance with this Act. Requires the Secretary to publish notice at least 30 days before cancelling a waiver, unless it is necessary to prevent an adverse impact on public health or safety. Sets forth a required label statement for any drug compounded pursuant to this Act. Requires a pharmacist or physician compounding a drug product to report any adverse event associated with the use of the product within a specified time frame.

amends cosmetic act ffdca respect regulation compounding drugs eliminates authority compounding pharmacies compound drugs receipt valid prescription order compound drug product copy commercially available drug requires secretary health_and_human_services hhs develop maintain transmit appropriate state agencies list drug products compounded including drug products compounding reasonably likely cause adverse effect safety effectiveness drug products withdrawn removed market found unsafe effective authorizes secretary waive requirement drug product compounded individually identified patient based valid prescription order similar notation compounding drug product necessary address drug shortage protect public health prohibits secretary authorizing state grant waivers authorizes secretary waive requirement drug product compounded individually identified patient based valid prescription order similar notation pharmacy pharmacist submits satisfactory application secretary agrees comply condition limitation specified secretary makes pharmacy pharmacist required registered ffdca drug producer ineligible waiver permits secretary authorize state grant waivers applicable compounded drug products sold dispensed state pursuant memorandum understanding secretary state authorizes secretary waive prohibition compounding drug product copy commercially available drug necessary protect public health prohibits secretary authorizing state waive prohibition subjects facilities pharmacy receiving waiver act inspection determine compliance act requires secretary publish notice days cancelling waiver necessary prevent adverse impact public health safety sets forth required label statement drug compounded pursuant act requires pharmacist physician compounding drug product report adverse event associated use product specified time frame


Summary: Patient Access to Drugs in Shortage Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act (SSA), with respect to use of average sales price payment methodology for drugs and biologicals, to prescribe a formula for determining the payment amount, using the volume-weighted wholesale acquisition cost, for a multiple source or a single source sterile injectable drug product with three or fewer active manufacturers, if there is no period of exclusivity in effect or available. Incorporates such payment methodology under the hospital outpatient department prospective payment system for any such drug furnished between July 1, 2013, and January 1, 2020. Amends SSA title XIX (Medicaid) to exempt from the rebate agreement requirement a multiple source drug furnished between July 1, 2013, and January 1, 2020, and for which payment may be made under Medicare part B (Supplementary Medicare Insurance). Amends the Public Health Service Act to exclude such multiple source drugs from the term "covered outpatient drug" subject to specified price limitations under the "340B" drug pricing program. Directs the Secretary to contract with an independent entity to study the effects of this Act on patient access to sterile products. Amends the Patient Protection and Affordable Care Act to exclude certain branded prescription drugs on a specified drug shortage list from the annual fee imposed on branded prescription pharmaceutical manufacturers and importers.

patient access drugs shortage act amends title xviii medicare social security act ssa respect use average sales price payment methodology drugs biologicals prescribe formula determining payment volume weighted wholesale acquisition cost multiple source single source sterile drug product fewer active manufacturers period exclusivity effect available incorporates payment methodology hospital outpatient department prospective payment system drug furnished july january amends ssa title xix medicaid exempt rebate agreement requirement multiple source drug furnished july january payment medicare amends public_health_service_act exclude multiple source drugs term covered outpatient drug subject specified price limitations 340b drug pricing program directs secretary contract independent entity study effects act patient access sterile products amends patient_protection affordable care act exclude certain branded prescription drugs specified drug shortage list annual fee imposed branded prescription pharmaceutical manufacturers importers


Summary: Health Care Innovation and Marketplace Technologies Act of 2012 - Amends the Internal Revenue Code to allow a medical care provider to deduct from gross income the amount paid or incurred for qualified health information technology placed in service during the taxable year. Amends the Small Business Act to authorize the Administrator of the Small Business Administration (SBA) to guarantee up to 90% of the amount of a loan, up to specified loan amounts, to a small business health professional to be used for the acquisition and installation of health information technology for the professional's medical practice. Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS), acting through the National Coordinator for Health Information Technology, to award grants for the development of an effective product, process, or structure that enhances the use, particularly by patients, of health information technology. Requires the Secretary, acting through the National Coordinator, to award prizes for development in areas of health information technology that are not adequately addressed by certified electronic health records (EHR) technologies and the use of such technologies. Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Wireless Health Technology. Requires the Health Information Technology Research Center to provide support for mobile health software application technology. Authorizes the National Coordinator to award grants for training health care workers in health information technology.

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


Summary: Tim Fagan's Law or Counterfeit Drug Enforcement Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human Services (HHS) within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred. Deems a drug to be misbranded if it is not manufactured in accordance with the use of technologies that the Secretary determines are technically feasible and will assist in preventing such violations. Requires the Secretary to establish alternative requirements to the extent that such requirements provide greater certainty on the chain of custody and are technically feasible. Increases funding for Food and Drug Administration (FDA) inspections, examinations, and investigations. Requires the Secretary to educate the public and health care professionals on counterfeit drugs. Directs the Secretary: (1) upon a finding that a drug intended for human use may constitute a threat to the public health to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering, distributing, selling, or prescribing the drug; and (2) amend the order to include a recall if necessary.

counterfeit drug enforcement act amends cosmetic act establish criminal fine imprisonment person knowingly causes prescription drug adulterated misbranded misrepresented approved prescription drug sells trades drug purchases trades drug knowing having reason know drug knowingly adulterated misbranded misrepresented requires manufacturer drug notify secretary health_and_human_services hhs hours receiving aware information reasonably suggests violation occurred deems drug misbranded manufactured accordance use technologies secretary determines technically feasible assist preventing violations requires secretary establish alternative requirements extent requirements provide greater certainty chain custody technically feasible increases funding food_and_drug_administration fda inspections examinations investigations requires secretary educate public health care professionals counterfeit drugs directs secretary finding drug intended human use constitute threat public health issue order requiring appropriate person including manufacturers importers distributors retailers drug cease distribution drug notify instruct health professionals cease administering distributing selling prescribing drug amend order include recall necessary


Summary: Cainaan Putuga Wendt Shock of Life Act - Directs the Secretary of Education to award matching grants to local educational agencies (LEAs) to: (1) purchase automated external defibrillators (AEDs) for use in public or private secondary schools within their district, and (2) provide training to meet the grant requirement that at least five adult employees or volunteers at each school where a purchased AED is to be used are or will be certified in its use and in cardiopulmonary resuscitation (CPR). Requires LEA grant applicants also to demonstrate that: (1) the AEDs are integrated into the schools' emergency response procedures, and (2) emergency services personnel are notified of their locations. Gives grant priority to LEAs that have secondary schools that: (1) lack an AED; (2) typically have a significant number of students, staff, and visitors present during the day; and (3) generally have a longer wait for emergency medical services than other public facilities in the community.

secretary education award matching grants local educational agencies leas purchase automated external defibrillators aeds use public private secondary schools district provide training meet grant requirement adult employees volunteers school purchased aed certified use cardiopulmonary resuscitation cpr requires lea grant applicants demonstrate aeds integrated schools emergency response procedures emergency services personnel notified locations gives grant priority leas secondary schools lack aed typically significant number students staff visitors present day generally longer wait emergency medical services public facilities community


Summary: Medical Device Access and Innovation Protection Act - Repeals the Internal Revenue Code provision, added by the Health Care and Education Reconciliation Act, that imposes an excise tax on medical devices.

medical device access innovation protection act repeals internal revenue code provision added health_care_and_education reconciliation act imposes excise tax medical devices


Summary: Preserve Access to Affordable Generics Act - Amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate a proceeding against parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug for any period of time. Allows an exception to such presumption if the parties to the agreement demonstrate by clear and convincing evidence, based on specified competitive factors, that the pro-competitive benefits of the agreement outweigh the anticompetitive effects. Exempts from the restrictions of this Act a resolution or settlement of a patent infringement claim if the only consideration granted by the brand name manufacturer to the generic manufacturer is: (1) the right to market the generic drug in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right or other statutory exclusivity that would prevent the marketing of such drug, (2) a payment for reasonable litigation expenses not exceeding $7.5 million, and (3) a covenant not to sue on any claim that the generic drug infringes a U.S. patent. Allows review of FTC enforcement orders under this Act in federal court. Imposes civil penalties for violations of this Act. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, or sale of the brand name or generic drug or the exclusivity period. Requires the Chief Executive Officer or the company official responsible for negotiating any such agreement to file a certification that materials filed with respect to such agreement are complete, final, and exclusive. Amends the Federal Food, Drug, and Cosmetic Act to forfeit the 180-day exclusivity period for the marketing of a generic drug if there is a final decision of the FTC or a court that an agreement has violated this Act. Grants the FTC exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic brand drugs. Establishes a three-year limitation period for bringing FTC enforcement actions (other than cease and desist requests) under this Act.

preserve access affordable generics act amends federal_trade_commission act authorize federal_trade_commission ftc initiate proceeding parties agreement resolving settling final interim basis patent infringement claim connection sale drug establishes presumption agreement anticompetitive effects unlawful filer abbreviated new drug generic application receives value agrees limit forego research development manufacturing marketing sales generic drug period time allows exception presumption parties agreement demonstrate clear convincing evidence based specified competitive factors pro competitive benefits agreement outweigh anticompetitive effects exempts restrictions act resolution settlement patent infringement claim consideration granted brand manufacturer generic manufacturer right market generic drug united_states prior expiration patent basis patent infringement claim patent right statutory exclusivity prevent marketing drug payment reasonable litigation expenses exceeding million covenant sue claim generic drug infringes patent allows review ftc enforcement orders act federal court imposes civil penalties violations act amends medicare_prescription_drug improvement modernization act require brand manufacturer generic manufacturer submit ftc agreements parties enter days entering agreement related manufacturing marketing sale brand generic drug exclusivity period requires chief executive officer company official responsible negotiating agreement file certification materials filed respect agreement complete final exclusive amends cosmetic act forfeit day exclusivity period marketing generic drug final decision ftc court agreement violated act grants ftc exclusive authority litigate matters relating anticompetitive practices connection sale generic brand drugs establishes year limitation period bringing ftc enforcement actions cease desist requests act


Summary: Amends the Federal Food, Drug, and Cosmetic Act to deem genetically-engineered fish to be unsafe under provisions related to new animal drugs and adulterated food.

amends cosmetic act deem genetically engineered fish unsafe provisions related new animal drugs adulterated food


Summary: Repeals the provision of the Internal Revenue Code, added by the Health Care and Education Reconciliation Act of 2010, that imposes an excise tax on medical devices. Rescinds $39 billion of appropriated but unobligated discretionary funds. Exempts unobligated funds of the Department of Defense (DOD) or the Department of Veterans Affairs (VA). Requires the Director of the Office of Management and Budget (OMB) to determine and identify from which appropriation accounts such recissions shall apply and report to the Secretary of the Treasury and Congress on such recissions.

repeals provision internal_revenue_code added health_care_and_education reconciliation act imposes excise tax medical devices rescinds billion appropriated unobligated discretionary funds exempts unobligated funds department_of_defense dod department_of_veterans_affairs requires director office_of_management_and_budget omb determine identify appropriation accounts shall apply report secretary treasury congress


Summary: Pharmaceutical Market Access and Drug Safety Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States. Prohibits the importation of a qualifying drug unless such drug is imported by a registered importeror an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary of Health and Human Services (HHS) to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions. Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences. Prohibits manufacturers from: (1) discriminating against registered exporters or importers; (2) causing there to be a difference in a prescription drug distributed in the United States and one distributed in a permitted country; (3) engaging in actions to restrict, prohibit, or delay the importation of a qualifying drug; or (4) engaging in any action that the Federal Trade Commission (FTC) determines discriminates against a person that engages or attempts to engage in the importation of a qualifying drug. States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement. Requires the Secretary to educate consumers regarding prescription drug importation. Sets forth provisions governing the sale of prescription drugs through an Internet site. Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under FFDCA. Prohibits the introduction of restricted transactions with unregistered foreign pharmacies into a payment system or the completion of such transactions using a payment system.

pharmaceutical market access drug safety act amends cosmetic act ffdca revise provisions governing importation prescription drugs waives limitation importation prescription drugs exported united_states prohibits importation qualifying drug drug imported registered individual personal use establishes registration conditions importers exporters requires secretary health_and_human_services hhs inspect places business verify chains custody inspect facilities determine compliance registration conditions sets forth provisions governing importation qualifying drugs different label drugs including standards judging differences prohibits manufacturers discriminating registered exporters importers causing difference prescription drug distributed united_states distributed permitted country engaging actions restrict prohibit delay importation qualifying drug engaging action federal_trade_commission ftc determines discriminates person engages attempts engage importation qualifying drug states resale united_states prescription drugs properly sold abroad patent infringement requires secretary educate consumers prescription drug importation sets forth provisions governing sale prescription drugs internet site includes dispensing selling prescription drug violation act prohibited act ffdca prohibits introduction restricted transactions unregistered foreign pharmacies payment system completion transactions payment system


Summary: Fair Prescription Drug Competition Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit a holder of a new, approved drug application from commencing to manufacture, market, sell, or distribute a generic version of such drug from the time of the receipt of notice from the generic manufacturer that an abbreviated new drug application has been submitted for approval until the expiration or forfeiture of the 180-day exclusivity period granted to the generic manufacturer.

fair prescription drug competition act amends cosmetic act prohibit holder new approved drug application commencing manufacture market sell distribute generic version drug time receipt notice generic manufacturer abbreviated new drug application submitted approval expiration forfeiture day exclusivity period granted generic manufacturer


Summary: Prescription Drug Abuse Prevention and Treatment Act of 2011 - Amends the Public Health Service Act to direct the Administrator of the Substance Abuse and Mental Health Services Administration to award grants to states and nonprofit entities for consumer education about opioid abuse, including methadone abuse. Amends the Controlled Substances Act to: (1) set forth training requirements for practitioners registered to prescribe or dispense methadone or other opioids; and (2) require each registered opioid treatment clinic to make acceptable arrangements for each patient who is restricted from having a take-home dose of a controlled substance related to treatment to receive a dose of that substance under appropriate supervision when the clinic is closed. Prohibits any individual or entity (except hospitals that provide direct patient supervision) from prescribing or dispensing a 40-mg diskette of methadone unless such prescription or dispensation is consistent with the current Drug Enforcement Administration (DEA) methadone policy, until the date the Controlled Substances Clinical Standards Commission: (1) publishes dosing guidelines for methadone, and (2) finds that such 40-mg diskettes are safe and clinically appropriate. Requires the Secretary of Health and Human Services (HHS) to establish such Commission to develop and publish guidelines related to methadone use, including safe dosing guidelines for all forms of methadone and benchmark guidelines for the reduction of methadone abuse. Requires states receiving controlled substances monitoring program grants to: (1) provide information, upon request, to drug enforcement officials relating to an individual who is the subject of an active drug-related investigation; and (2) require opioid-related deaths to be reported to the Administrator. Directs the Administrator to develop a Model Opioid Treatment Program Mortality Report. Requires the Administrator to establish and implement, through the National Center for Health Statistics, a National Opioid Death Registry to track opioid-related deaths.

prescription drug abuse prevention treatment act amends public_health_service_act direct administrator substance_abuse_and_mental_health_services_administration award grants states nonprofit entities consumer education opioid abuse including abuse amends controlled substances act set forth training requirements practitioners registered prescribe dispense opioids require registered opioid treatment clinic acceptable arrangements patient restricted having home dose controlled substance related treatment receive dose substance appropriate supervision clinic closed prohibits individual entity hospitals provide direct patient supervision prescribing dispensing prescription dispensation consistent current drug_enforcement_administration dea policy date controlled substances clinical standards commission publishes dosing guidelines finds safe clinically appropriate requires secretary health_and_human_services hhs establish commission develop publish guidelines related use including safe dosing guidelines forms benchmark guidelines reduction abuse requires states receiving controlled substances monitoring program grants provide information request drug enforcement officials relating individual subject active drug related investigation require opioid related deaths reported administrator directs administrator develop requires administrator establish implement national_center_for_health_statistics track opioid related deaths


Summary: Hearing Aid Assistance Tax Credit Act - Amends the Internal Revenue Code to allow an individual taxpayer to elect once every five years a nonrefundable income tax credit of up to $500 for the purchase of a qualified hearing aid for use by the taxpayer or a dependent.

hearing aid assistance tax credit act amends internal revenue code allow individual taxpayer elect years nonrefundable income tax credit purchase qualified hearing aid use taxpayer dependent


Summary: Sunscreen Labeling Protection Act of 2011 or the SUN Act - Requires the proposed rule issued by the Commissioner of Food and Drugs (FDA) pertaining to over-the-counter sunscreen drug products to take effect 180 days after enactment of this Act, unless the Commissioner issues a final rule that includes formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection before such time.

sunscreen labeling protection act sun act requires proposed rule issued fda pertaining counter sunscreen drug products effect days enactment act commissioner issues final rule includes formulation labeling testing requirements ultraviolet ultraviolet radiation protection time


Summary: Preservation of Antibiotics for Medical Treatment Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms. Requires the Secretary to withdraw approval of a nontherapeutic use of such drugs in food-producing animals two years after the date of enactment of this Act unless certain safety requirements are met. Directs specified congressional committees to hold hearings on the implementation of such a withdrawal of approval.

preservation_of_antibiotics_for_medical_treatment_act amends cosmetic act require secretary health_and_human_services hhs deny application new animal drug critical antimicrobial animal drug applicant demonstrates reasonably certainty harm human health development antimicrobial resistance attributable nontherapeutic use drug defines critical antimicrobial animal drug drug intended use food producing animals contains specified antibiotics drugs humans treat prevent disease infection caused microorganisms requires secretary withdraw approval nontherapeutic use drugs food producing animals years date enactment act certain safety requirements met directs specified congressional committees hold hearings implementation withdrawal approval


Summary: Dietary Supplement Labeling Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the registration requirements for a dietary supplement manufacturing facility to: (1) require the submission of a description, ingredient list, and label and labeling for each dietary supplement product manufactured; and (2) require a manufacturer to update its registration for new, reformulated, or discontinued products within 30 days. Requires the Secretary of Health and Human Services (HHS) to compile a list of dietary supplement ingredients and proprietary blends of ingredients that the Secretary determines could cause potentially serious adverse events, drug interactions, contraindications, or potential risks to subgroups such as children and pregnant or breastfeeding women. Directs the Secretary to enter into a contract with the Institute of Medicine to: (1) evaluate the safety of dietary supplement ingredients and proprietary blends of ingredients that the Institute determines could cause potentially serious adverse events, drug interactions, contraindications, or potential risks to subgroups; and (2) identify proprietary blends of ingredients for which the weight per serving of the ingredient in the proprietary blend should be provided on the label. Deems a dietary supplement that does not meet the requirements of this Act to be misbranded. Requires the Secretary to establish a definition for the term “conventional food” for purposes of the FFDCA, taking in account foods marketed as dietary supplements.

dietary supplement labeling act amends cosmetic act ffdca expand registration requirements dietary supplement manufacturing facility require submission description ingredient list label labeling dietary supplement product manufactured require manufacturer update registration new discontinued products days requires secretary health_and_human_services hhs compile list dietary supplement ingredients proprietary blends ingredients secretary determines cause potentially adverse events drug interactions contraindications potential risks subgroups children pregnant breastfeeding women directs secretary enter contract institute_of_medicine evaluate safety dietary supplement ingredients proprietary blends ingredients institute determines cause potentially adverse events drug interactions contraindications potential risks subgroups identify proprietary blends ingredients weight serving ingredient proprietary blend provided label deems dietary supplement meet requirements act misbranded requires secretary establish definition term conventional food purposes ffdca taking account foods marketed dietary supplements


Summary: Access to Birth Control Act - Amends the Public Health Service Act to require pharmacies to comply with certain rules related to contraceptives, including: (1) providing a customer a contraceptive without delay if it is in stock; (2) immediately informing a customer if the contraceptive is not in stock and either transferring the prescription to a pharmacy that has the contraceptive in stock or expediting the ordering of the contraceptive and notifying the customer when it arrives, based on customer preference, except for pharmacies that do not ordinarily stock contraceptives in the normal course of business; and (3) ensuring that pharmacy employees do not take certain actions relating to a request for contraception, including intimidating, threatening, or harassing customers, interfering with or obstructing the delivery of services, intentionally misrepresenting or deceiving customers about the availability of contraception or its mechanism of action, breaching or threatening to breach medical confidentiality, or refusing to return a valid, lawful prescription. Provides that a pharmacy is not prohibited from refusing to provide a contraceptive to a customer if: (1) it is unlawful to dispense the contraceptive to the customer without a valid, lawful prescription and no such prescription is presented; (2) the customer is unable to pay for the contraceptive; or (3) the employee of the pharmacy refuses to provide the contraceptive on the basis of a professional clinical judgment. Provides that this Act does not preempt state law or any professional obligation of a state board that provides greater protections for customers. Sets forth civil penalties and establishes a a private cause of action for violations of this Act.

access birth control act amends public_health_service_act require pharmacies comply certain rules related contraceptives including providing customer contraceptive delay stock immediately informing customer contraceptive stock transferring prescription pharmacy contraceptive stock expediting ordering contraceptive notifying customer arrives based customer preference pharmacies ordinarily stock contraceptives normal course business ensuring pharmacy employees certain actions relating request contraception including intimidating threatening harassing customers interfering obstructing delivery services intentionally misrepresenting deceiving customers availability contraception mechanism action breaching threatening breach medical confidentiality refusing return valid lawful prescription provides pharmacy prohibited refusing provide contraceptive customer unlawful dispense contraceptive customer valid lawful prescription prescription presented customer unable pay contraceptive employee pharmacy refuses provide contraceptive basis professional clinical judgment provides act preempt state law professional obligation state board provides greater protections customers sets forth civil penalties establishes private cause action violations act


Summary: Preserving Access to Orphan Drugs Act of 2011 - Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million. Makes this Act effective as if included in PPACA.

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


Summary: Drug Safety and Accountability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require each registered drug producer to have in effect and implement a quality management plan to ensure the quality and safety of: (1) each drug, (2) each active and inactive ingredient of each drug, and (3) materials used in the manufacture of each active ingredient. Authorizes the Secretary of Health and Human Services (HHS) to order an establishment to promptly revise its quality management plan in response to a significant threat to public health. Requires each registered drug producer to report on each producer, manufacturer, distributor, and shipper involved in the production of a drug or the production or transport of the active ingredients of a drug. Requires the Secretary to develop and maintain information systems to track and assess every establishment that is involved in the manufacturing, preparation, propagation, compounding, or processing of a drug or active ingredient of a drug. Deems a drug to be adulterated if it was produced in an establishment that does not comply with the requirements of this Act. Gives the Secretary authority to: (1) order an immediate cessation of distribution, or a recall, of a drug; and (2) administer oaths and issue subpoenas. Revises provisions regarding civil penalties for FFDCA violations related to drugs for human use, including to consider each day a violation continues to be a separate violation. Authorizes the Secretary to share information subject to a trade secret exemption with: (1) other federal, state, or local agencies, foreign government agencies, and relevant international organizations; and (2) the public, as necessary to protect the public health. Sets forth whistleblower protection provisions.

drug safety accountability act amends cosmetic act ffdca require registered drug producer effect implement quality management plan ensure quality safety drug active inactive ingredient drug materials manufacture active ingredient authorizes secretary health_and_human_services hhs order establishment promptly revise quality management plan response significant threat public health requires registered drug producer report producer manufacturer distributor shipper involved production drug production transport active ingredients drug requires secretary develop maintain information systems track assess establishment involved manufacturing preparation propagation compounding processing drug active ingredient drug deems drug adulterated produced establishment comply requirements act gives secretary authority order immediate cessation distribution recall drug administer oaths issue subpoenas revises provisions civil penalties ffdca violations related drugs human use including consider day violation continues separate violation authorizes secretary share information subject trade secret exemption federal state local agencies foreign government agencies relevant international organizations public necessary protect public health sets forth whistleblower protection provisions


Summary: Medical Device Regulatory Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS), in determining the least burdensome appropriate means of evaluating device effectiveness, to: (1) not request information unrelated or irrelevant to demonstration of reasonable assurance of device safety and effectiveness; (2) consider alternative approaches to evaluating device safety and effectiveness; (3) use all reasonable mechanisms to lessen review times and render regulatory decisions; (4) determine whether pre-clinical data can meet the statutory threshold for approval; and (5) utilize, whenever practicable, alternatives to randomized, controlled clinical trials if clinical data are needed. Requires the Secretary, in determining the least burdensome means of determining substantial equivalence, to: (1) focus on whether the device has the same intended use as the predicate device and is as safe and effective as a legally marketed device, (2) not request or accept information unrelated or irrelevant to the substantial equivalence evaluation, (3) review the labeling of the device to assess the intended use of the device and not evaluate issues that do not present a major impact on the intended use as set forth in the labeling, (4) consider alternative approaches to evaluating substantial equivalence, and (5) use all reasonable mechanisms to lessen review times and render regulatory decisions. Repeals conflict-of-interest provisions that are specific to the Food and Drug Administration (FDA) and provides for the continued applicability of conflict-of-interest provisions otherwise applicable to advisory committees, federal employees, and special government employees. Requires the Secretary to contract with an eligible entity for a review of the management and regulatory processes at the Center for Devices and Radiological Health.

medical device regulatory improvement act amends cosmetic act require secretary health_and_human_services hhs determining burdensome appropriate means evaluating device effectiveness request information unrelated irrelevant demonstration reasonable assurance device safety effectiveness consider alternative approaches evaluating device safety effectiveness use reasonable mechanisms lessen review times render regulatory decisions determine pre clinical data meet statutory threshold approval utilize practicable alternatives randomized controlled clinical trials clinical data needed requires secretary determining burdensome means determining substantial equivalence focus device intended use predicate device safe effective legally marketed device request accept information unrelated irrelevant substantial equivalence evaluation review labeling device assess intended use device evaluate issues present major impact intended use set forth labeling consider alternative approaches evaluating substantial equivalence use reasonable mechanisms lessen review times render regulatory decisions repeals conflict interest provisions specific food_and_drug_administration fda provides continued applicability conflict interest provisions applicable advisory committees federal employees special government employees requires secretary contract eligible entity review management regulatory processes center_for_devices_and_radiological_health


Summary: Freedom to Breathe Act of 2011 - Nullifies the final rule entitled "Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)." Prohibits the Secretary of Health and Human Services (HHS) from reissuing such rule in substantially the same form or issuing a new rule that prohibits the production and distribution of oral pressurized metered-dose inhalers because such inhalers may emit greenhouse gas emissions, unless the reissued or new rule is specifically authorized by a law enacted after this Act's enactment.

freedom act nullifies final rule entitled use ozone depleting substances removal essential use designation epinephrine prohibits secretary health_and_human_services hhs rule substantially form issuing new rule prohibits production distribution oral pressurized dose inhalers inhalers emit greenhouse gas emissions reissued new rule specifically authorized law enacted act enactment


Summary: Fair And Immediate Release of Generic Drugs Act or the FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name drug] or the patentholder for the brand name drug whereby the generic drug applicant agrees not to seek approval of its generic drug or not to begin the commercial marketing of its generic drug until the expiration of the exclusivity period awarded to another generic applicant). Expands the definition of “first applicant” to include an applicant that meets the following criteria: (1) the applicant is not the first generic applicant; (2) either no action for patent infringement was brought, such action was withdrawn or dismissed by a court without a decision that the patent was valid and infringed, or the court decided that the patent was invalid or not infringed; and (3) the applicant does not begin commercial marketing of such drug until 30 days after the first applicant began such commercial marketing. Prohibits a party that enters an agreement to delay seeking approval of its generic drug application or to delay the commercial marketing of a generic drug from seeking approval of its application or beginning commercial marketing before the earlier of: (1) the latest date set forth in the agreement to seek approval or market the drug without regard to any earlier date under the agreement when commercial marketing could begin, or (2) 180 days after another first applicant begins commercial marketing of such drug. Requires notice to the Secretary of the Health and Human Services (HHS) of the details of any agreement under this Act not later than ten business days after execution of the agreement. Declares that the exclusive remedy for an infringement of a patent included within a new drug application shall be an action brought under the FFDCA within the 45-day period prescribed.

fair immediate release generic drugs act fair generics act amends cosmetic act ffdca revise definition applicant purposes day exclusivity period given applicants file abbreviated new drug application generic drug makes applicants generic drug eligible exclusivity period entered disqualifying agreement agreement generic drug applicant holder application listed drug brand drug brand drug generic drug applicant agrees seek approval generic drug begin commercial marketing generic drug expiration exclusivity period awarded generic applicant expands definition applicant include applicant meets following criteria applicant generic applicant action patent infringement brought action withdrawn dismissed court decision patent valid infringed court decided patent invalid infringed applicant begin commercial marketing drug days applicant began commercial marketing prohibits party enters agreement delay seeking approval generic drug application delay commercial marketing generic drug seeking approval application beginning commercial marketing earlier latest date set forth agreement seek approval market drug regard earlier date agreement commercial marketing begin days applicant begins commercial marketing drug requires notice secretary health_and_human_services hhs details agreement act later business days execution agreement declares exclusive remedy infringement patent included new drug application shall action brought ffdca day period prescribed


Summary: Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to allow a person to request the Secretary of Health and Human Services (HHS) to classify a device regardless of whether the person has received written notice of classification into class III (premarket approval) under the initial classification procedures applicable to devices introduced or delivered for introduction into interstate commerce before May 28, 1976. Allows a person that is required to submit a report preceding the introduction of device into interstate commerce, and determines that there is no legally marketed device upon which to base a determination of substantial equivalence, to request an initial classification of the device and to recommend to the Secretary a classification. Allows the Secretary to decline to undertake such a request when the Secretary identifies a legally marketed device that would permit a determination of substantial equivalence.

novel device regulatory relief act amends cosmetic act allow person request secretary health_and_human_services hhs classify device regardless person received written notice classification class iii premarket approval initial classification procedures applicable devices introduced delivered introduction interstate commerce allows person required submit report preceding introduction device interstate commerce determines legally marketed device base determination substantial equivalence request initial classification device recommend secretary classification allows secretary decline undertake request secretary identifies legally marketed device permit determination substantial equivalence


Summary: Medical Device Patient Safety Act - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to establish a program to enhance the oversight by the Food and Drug Administration (FDA) of medical device recalls. Requires the program to routinely and systematically assess: (1) information submitted to the Secretary pursuant to a device recall order issued under the Federal Food, Drug, and Cosmetic Act (FDCA); and (2) information required to be reported by a device manufacturer to the Secretary regarding the manufacturer's correction or removal of a device. Requires the Secretary to use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. Requires such program to be designed to identify such things as recall trends, the causes of recalls, and the time to complete a recall. Requires the Secretary to develop explicit criteria for assessing whether a person subject to a recall order or the manufacturer's reporting requirement has performed an effective correction or removal action. Requires the Secretary to document and publish specified information concerning termination of a recall. Permits the Secretary to conditionally clear for introduction into interstate commerce for commercial distribution a medical device intended for human use if such medical device is cleared pursuant to specified FDCA reporting requirements concerning the introduction of devices into interstate commerce. Permits the Secretary, as part of such conditional clearance, to: (1) impose specified restrictions on the sale, distribution, or use of the device; (2) require specified labeling for the device; and (3) require the maintenance of specified records that enable the FDA to track the device and determine the safety and effectiveness of the device.

medical device patient safety act directs secretary health_and_human_services hhs acting commissioner food_and_drugs establish program enhance oversight food_and_drug_administration fda medical device recalls requires program routinely systematically assess information submitted secretary pursuant device recall order issued cosmetic act fdca information required reported device manufacturer secretary manufacturer correction removal device requires secretary use information proactively identify strategies mitigating health risks presented defective unsafe devices requires program designed identify things recall trends causes recalls time complete recall requires secretary develop explicit criteria assessing person subject recall order manufacturer reporting requirement performed effective correction removal action requires secretary document publish specified information concerning termination recall permits secretary conditionally clear introduction interstate commerce commercial distribution medical device intended human use medical device cleared pursuant specified fdca reporting requirements concerning introduction devices interstate commerce permits secretary conditional clearance impose specified restrictions sale distribution use device require specified labeling device require maintenance specified records enable fda track device determine safety effectiveness device


Summary: Online Pharmacy Safety Act - Amends the the Federal Food, Drug, and Cosmetic Act to permit the dispensing of drugs only pursuant to a "valid prescription" and requires such a prescription to include at least one in-person medical evaluation of the patient by a licensed health care practitioner. Requires the the Secretary of Health and Human Services (HHS) to establish a Registry of Legitimate Online Pharmacy Websites for the purpose of educating consumers and promoting public health and safety. Allows only those pharmacies designated as legitimate by the Secretary on the site. Sets forth criteria for determining the legitimacy of a pharmacy. Requires the Secretary to: (1) engage in a campaign to educate consumers on the availability and use of the Registry to promote public health and safety; and (2) make consumer education materials available, on the Food and Drug Administration's (FDA) website, regarding how to safely purchase drugs over the Internet.

online pharmacy safety act amends cosmetic act permit dispensing drugs pursuant valid prescription requires prescription include person medical evaluation patient licensed health care practitioner requires secretary health_and_human_services hhs establish registry legitimate online pharmacy websites purpose educating consumers promoting public health safety allows pharmacies designated legitimate secretary site sets forth criteria determining pharmacy requires secretary engage campaign educate consumers availability use registry promote public health safety consumer education materials available food_and_drug_administration fda website safely purchase drugs internet


Summary: Safe, Efficient, and Transparent Medical Device Approval Act or the SET Device Act - Directs the Secretary of Health and Human Services (HHS), within 120 days of enactment of this Act, to establish the schedule for the promulgation of a regulation requiring premarket approval for a medical device that the Secretary requires to remain in class III. Directs the Secretary, within 18 months, to: (1) issue a final regulation for each device that the Secretary requires to remain in class III, and (2) establish the required special controls for each device that is classified into class II pursuant to a determination revising such devise's classification. Amends the Federal Food, Drug, and Cosmetic Act to permit a person to: (1) submit a request for initial classification of a device that has not previously been classified under such Act if the person declares that there is no legally marketed device upon which to base a substantial equivalence determination; and (2) recommend to the Secretary a classification for the device and include in the request an initial draft proposal for applicable special and general controls that are necessary to provide reasonable assurance of safety and effectiveness. Permits the Secretary to decline to undertake a classification request if the Secretary identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence or if the Secretary determines that the device submitted is not of low-moderate risk.

safe efficient transparent medical device approval act set device act directs secretary health_and_human_services hhs days enactment act establish schedule promulgation regulation requiring premarket approval medical device secretary requires remain class iii directs secretary months issue final regulation device secretary requires remain class iii establish required special controls device classified class pursuant determination revising devise classification amends cosmetic act permit person submit request initial classification device previously classified act person declares legally marketed device base substantial equivalence determination recommend secretary classification device include request initial draft proposal applicable special general controls necessary provide reasonable assurance safety effectiveness permits secretary decline undertake classification request secretary identifies legally marketed device provide reasonable basis review substantial equivalence secretary determines device submitted low moderate risk


Summary: Transforming the Regulatory Environment to Accelerate Access to Treatments or TREAT Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to establish an advisory council within the Food and Drug Administration (FDA) to be known as the Management Review Board in order to provide advice to the Secretary regarding the FDA's management and organization. Directs the Secretary to: (1) establish within the Office of the Commissioner an office to be known as the Office of the Chief Innovation Officer (CIO); and (2) appoint a Chief Innovation Officer to lead such Office. Sets forth the following duties for the CIO: (1) to identify promising new scientific and regulatory approaches to ensure the rapid development, testing, and review of new drugs and devices; (2) to ensure that such approaches are integrated into operations at all applicable levels of the FDA and harmonized with approaches of other agencies; (3) to consider the recommendations of internal and external bodies involved in advancing innovation in regulatory science activities and to make such recommendations available on the FDA website; (4) to develop pilot programs to implement and incorporate such recommendations into the regulatory review and approval process; and (5) to implement other pilot programs and to ensure participation by cross-disciplinary teams in such implementation. Directs the Secretary to establish an Office of the Chief Medical Policy Officer within each of the following FDA offices: (1) The Office of the Director of the Center for Drug Evaluation and Research, (2) The Office of the Director of the Center for Biologics Evaluation and Research, and (3) The Office of the Director of the Center for Devices and Radiological Health. Sets forth the following duties for each Chief Medical Policy Officer: (1) to develop proactive and consistent approaches for FDA centers and divisions that review applications for drug or device approval to address emerging medical and scientific policy issues bearing on new product review processes, (2) to promote earlier and improved utilization of advisory committees throughout the drug and device development and review processes, (3) to improve reviewer access to external experts outside of the advisory committee process, (4) to periodically solicit input from industry, academia, and patient advocacy and disease research organizations on emerging scientific and medical policy issues bearing on new product review processes, and (5) to coordinate with the Chief Innovation Officer in the implementation of pilot programs. Directs the Secretary, at the request of the sponsor of a new drug, to facilitate the development and expedite the review of such drug if it is intended, whether alone or in combination with one or more other drugs, for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition. Permits the Secretary to approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, under the Public Health Service Act upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint, including an endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity or rarity of the condition and the availability of alternative treatments. Permits the Secretary, under specified conditions, to withdraw approval of a product approved under accelerated approval using expedited procedures. Directs the Secretary to appoint, within the Office of the Commissioner, a Clinical Informatics Coordinator to: (1) develop a process to validate the use of health information technology in clinical research and encourage the use of new health information technologies in clinical research protocols, and (2) establish pilot programs to explore and evaluate the methods of incorporating emerging health information technology to make the clinical research process more efficient.

transforming regulatory environment accelerate access treatments treat act amends cosmetic act direct secretary health_and_human_services hhs establish advisory council food_and_drug_administration fda known order provide advice secretary fda management organization directs secretary establish office_of_the_commissioner office known cio appoint chief innovation officer lead office sets forth following duties cio identify promising new scientific regulatory approaches ensure rapid development testing review new drugs devices ensure approaches integrated operations applicable levels fda harmonized approaches agencies consider recommendations internal external bodies involved advancing innovation regulatory science activities recommendations available fda website develop pilot programs implement incorporate recommendations regulatory review approval process implement pilot programs ensure participation cross disciplinary teams implementation directs secretary establish office chief medical policy officer following fda offices sets forth following duties chief medical policy officer develop proactive consistent approaches fda centers divisions review applications drug device approval address emerging medical scientific policy issues bearing new product review processes promote earlier improved utilization advisory committees drug device development review processes improve reviewer access external experts outside advisory committee process periodically solicit input industry academia patient advocacy disease research organizations emerging scientific medical policy issues bearing new product review processes coordinate chief innovation officer implementation pilot programs directs secretary request sponsor new drug facilitate development expedite review drug intended combination drugs treatment life threatening disease condition demonstrates potential address unmet medical needs disease condition permits secretary approve application approval product life threatening disease condition including fast track product public_health_service_act determination product effect surrogate endpoint reasonably likely predict clinical benefit clinical endpoint including endpoint measured earlier irreversible morbidity mortality reasonably likely predict effect irreversible morbidity mortality clinical benefit taking account severity condition availability alternative treatments permits secretary specified conditions withdraw approval product approved accelerated approval expedited procedures directs secretary appoint office_of_the_commissioner clinical informatics coordinator develop process validate use health information technology clinical research encourage use new health information technologies clinical research protocols establish pilot programs explore evaluate methods incorporating emerging health information technology clinical research process efficient


Summary: Medicare Orthotics and Prosthetics Improvement Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act, for application of quality standards for certain accredited suppliers of prosthetic devices, orthotics, and certain prosthetics, to require the Secretary of Health and Human Services (HHS) to designate and approve an independent accreditation organization with respect to such suppliers only if that organization is the American Board for Certification in Orthotics and Prosthetics, Inc. or the Board for Orthotist/ Prosthetist Certification (or a program with essentially equivalent accreditation and approval standards). Exempts from such standards any suppliers who: (1) are physicians, occupational therapists, or physical therapists licensed or otherwise regulated by the state in which they practice; and (2) receive Medicare payments. Applies to custom-fitted orthotics the special payment rules for certain prosthetics and custom-fabricated orthotics. Exempts from such rules off-the-shelf orthotics included in a competitive acquisition program. Modifies the Medicare payment rules for orthotics and prosthetics to account for practitioner qualifications and complexity of care. Directs the Secretary to report to Congress on: (1) HHS steps taken to ensure that the state licensure and accreditation requirements are enforced, and (2) the effects of requirements of this Act on the occurrence of Medicare fraud and abuse with respect to orthotics and prosthetics. Requires the Secretary, acting through the Chief Actuary of the Centers for Medicare and Medicaid Services, to submit to Congress a projection on the effect on cumulative federal spending under Medicare part B (Supplementary Medical Insurance) for 2013-2017 that will result from implementation of this Act. Requires the Secretary, if the Chief Actuary projects that implementation of this Act will not result in a cumulative spending reduction of at least $250 million for 2013-2017, to issue an interim final regulation to strengthen the licensure, accreditation, and quality standards applicable to orthotics and prosthetics suppliers in order to produce such a cumulative reduction by the end of 2017. Exempts from such regulation any qualified physical therapist or qualified occupational therapist.

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


Summary: Ensuring Safe Medical Devices for Patients - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to: (1) amend procedures under such Act to expand the postmarket risk identification and analysis system to include and apply to devices in a comparable manner as such system includes and applies to drugs; and (2) ensure that such amended procedures give priority for inclusion in the system to class III and class II devices that are implantable, life-supporting, or life-sustaining or that pose significant risk to users. Directs the Secretary to: (1) issue final regulations establishing a unique device identification system for medical devices by December 31, 2012, and (2) implement the system not later than one year after the final regulations are issued.

cosmetic act require secretary health_and_human_services hhs amend procedures act expand postmarket risk identification analysis system include apply devices comparable manner system includes applies drugs ensure amended procedures priority inclusion system class iii class devices implantable life supporting life sustaining pose significant risk users directs secretary issue final regulations establishing unique device identification system medical devices december implement system later year final regulations issued


Summary: Advancing Breakthrough Therapies for Patients Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a drug, to expedite the drug's development and review if: (1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Authorizes the drug's sponsor to request the Secretary to designate the drug as a breakthrough therapy. Requires the Secretary, within 60 days of such request, to determine whether the drug meets such criteria and, if so, make such designation, followed by appropriate actions to expedite its development and review for approval. Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations. Requires the Secretary to contract with an independent entity to evaluate the manner by which the Food and Drug Administration (FDA) has applied the processes for the breakthrough therapy determination, and the impact of such processes on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions. Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved.

amends cosmetic act direct secretary health_and_human_services hhs request sponsor drug expedite drug development review intended combination treat life threatening disease condition preliminary clinical evidence indicates drug demonstrate substantial improvement existing therapies clinically significant endpoints authorizes drug sponsor request secretary designate drug breakthrough therapy requires secretary days request determine drug meets criteria designation followed appropriate actions expedite development review approval directs secretary issue guidance implementing requirements respect breakthrough therapies amend promulgated regulations requires secretary contract independent entity evaluate manner food_and_drug_administration fda applied processes breakthrough therapy determination impact processes development timely availability innovative treatments patients affected life threatening conditions requires annual report secretary congress drugs breakthrough designations requested approved


Summary: Interstate Drug Monitoring Efficiency and Data Sharing Act of 2012 or the ID MEDS Act - Directs the Attorney General to establish national interoperability standards to facilitate the exchange of prescription information by states receiving grant funds under the Harold Rogers Prescription Drug Monitoring Program (Rogers Program) and the Controlled Substance Monitoring Program (CS Program). Directs the Attorney General to ensure that such standards: (1) implement open standards that are freely available to promote broad implementation; (2) provide for the use of exchange intermediaries to facilitate interstate interoperability; (3) support transmissions that are fully secured, using industry standard methods of encryption, to ensure that protected health information and personally identifiable information are not compromised during transmission; and (4) employ access control methodologies to share protected information solely in accordance with state laws and regulations. Requires a grant recipient under the Rogers Program to ensure that the state databases comply with the national interoperability standards. Allows a recipient of an enhancement grant under such Program to use grant funds to standardize the technology architecture used by the recipient to comply with such standards. Amends the Public Health Service Act to require states to ensure that databases established under the CS Program comply with such standards. Directs the Attorney General to report on enhancing the interoperability of state prescription monitoring programs with other technologies and databases used for detecting and reducing fraud, diversion, and abuse of prescription drugs.

data sharing act meds act directs attorney general establish national interoperability standards facilitate exchange prescription information states receiving grant funds harold rogers prescription drug monitoring program rogers program directs attorney general ensure standards implement open standards freely available promote broad implementation provide use exchange intermediaries facilitate interstate interoperability support transmissions fully secured industry standard methods encryption ensure protected health information personally identifiable information compromised transmission employ access control methodologies share protected information solely accordance state laws regulations requires grant recipient rogers program ensure state databases comply national interoperability standards allows recipient enhancement grant program use grant funds standardize technology architecture recipient comply standards amends public_health_service_act require states ensure databases established comply standards directs attorney general report enhancing interoperability state prescription monitoring programs technologies databases detecting reducing fraud diversion abuse prescription drugs


Summary: Patient Safety and Generic Labeling Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to allow the holder of an approved abbreviated new drug application (generic drug approval) to change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application. Allows conforming changes to be ordered to the labeling of the equivalent listed drug and each drug approved under the abbreviated new drug application process that corresponds to such listed drug.

patient safety generic labeling improvement act amends cosmetic act allow holder approved abbreviated new drug application generic drug approval change labeling drug approved manner authorized regulation holder approved new drug application allows conforming changes ordered labeling equivalent listed drug drug approved abbreviated new drug application process corresponds listed drug


Summary: Food and Drug Administration Safety and Innovation Act - Amends the Federal Food, Drug, and Cosmetic Act to reauthorize and establish new Food and Drug Administration (FDA) prescription drug user-fee programs and revises requirements relating to: (1) prescription, pediatric, and generic drugs; (2) medical devices; (3) biosimilar biological products; (4) new infectious disease drugs; and (5) drug manufacturer reporting. Prescription Drug User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary of Health and Human Services (HHS) to assess and collect prescription drug fees to support the FDA drug development and human drug application review process. Medical Device User Fee Amendments of 2012 - Extends through FY2017 the authority of the Secretary to assess and use fees for expediting the review process for medical device applications and for assuring the safety and effectiveness of such devices. Generic Drug User Fee Amendments of 2012 - Directs the Secretary to assess and collect human generic drug user fees through FY2017, including a fee for drug applications pending on October 1, 2012, a drug master file fee, a generic drug facility fee, and an active pharmaceutical ingredient facility fee. Biosimilar User Fee Act of 2012 - Establishes a new program to assess and use fees to expedite the review process for biosimilar biological product applications. Makes permanent programs to study and provide extended exclusivity periods for new drugs for use in pediatric populations. Permits the FDA to change a classification of a medical device through an administrative order rather than by regulation. Expands reporting requirements for manufacturers of prescription drugs. Provides incentives for the development of new qualified infectious disease products, including: (1) an additional five-year market exclusivity period, and (2) eligibility for priority and fast track review. Requires the Secretary to: (1) expedite the development and review of new drugs designed to treat a serious or life-threatening disease, and (2) include a risk-benefit analysis in the regulatory decision-making process for prescription drugs. Revises requirements for the reporting by drug manufacturers to HHS of a discontinuance or interruption in the production of life saving drugs. Requires the Secretary to establish a task force to develop and implement a strategic plan for enhancing the Secretary's response to preventing and mitigating drug shortages. Extends until October 1, 2017, the deadline for applications for elections relating to marketing exclusivity for certain drugs containing single enantiomers. Extends through FY2017 the authorization of appropriations for Critical Path Public-Private Partnerships to implement the FDA's Critical Path Initiative. Provides for the regulation of medical gas products. Directs the Secretary to: (1) issue guidance explaining FDA policy for promoting FDA-regulated medical products using the Internet and social media; (2) report to Congress on initiatives to combat prescription drug abuse; (3) reconsider tanning bed labeling requirements; and (4) submit an integrated management strategy identifying goals for the FDA Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.

innovation act amends cosmetic act reauthorize establish new food_and_drug_administration fda prescription drug user fee programs revises requirements relating prescription pediatric generic drugs medical devices biosimilar biological products new infectious disease drugs drug manufacturer reporting prescription drug user fee amendments extends fy2017 authority secretary health_and_human_services hhs assess collect prescription drug fees support fda drug development human drug application review process medical device user fee amendments extends fy2017 authority secretary assess use fees expediting review process medical device applications assuring safety effectiveness devices directs secretary assess collect human generic drug user fees fy2017 including fee drug applications pending october drug master file fee generic drug facility fee active pharmaceutical ingredient facility fee biosimilar user fee act establishes new program assess use fees expedite review process biosimilar biological product applications makes permanent programs study provide extended exclusivity periods new drugs use pediatric populations permits fda change classification medical device administrative order regulation expands reporting requirements manufacturers prescription drugs provides incentives development new qualified infectious disease products including additional year market exclusivity period eligibility priority fast track review requires secretary expedite development review new drugs designed treat life threatening disease include risk benefit analysis regulatory decision making process prescription drugs revises requirements reporting drug manufacturers hhs discontinuance interruption production life saving drugs requires secretary establish task force develop implement strategic plan enhancing secretary response preventing mitigating drug shortages extends october deadline applications elections relating marketing exclusivity certain drugs containing single extends fy2017 authorization appropriations implement fda critical path initiative provides regulation medical gas products directs secretary issue guidance explaining fda policy promoting fda regulated medical products internet social media report congress initiatives combat prescription drug abuse reconsider tanning bed labeling requirements submit integrated management strategy identifying goals center_for_biologics_evaluation_and_research center_for_devices_and_radiological_health