zli12321/Bills huggingface dataset:
Pharmaceutical Market Access and Drug Safety Act of 2009 - 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: (1) a registered importer; or (2) an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary of Health and Human Services 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.

Date: 2009-06-10
Topic: Health (Drug Industry)
Subject: Health
Drug Price Competition Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant to submit a substantially complete application that contains and lawfully maintains a certification for such drug.

Date: 2009-06-22
Topic: Health (Drug Industry)
Subject: Health
Safe Drug Disposal Act of 2009 - Amends the Controlled Substances Act to direct the Attorney General to promulgate regulations to: (1) authorize an ultimate user or care taker (a person responsible for taking care of one or more individuals or animals) to dispose of a controlled substance in accordance with a prescribed state program; (2) include five model state programs providing for such disposal through delivery to a designated facility; and (3) allow a state to work with the Attorney General to devise an alternative disposal program that is consistent with this Act. Requires each such program to: (1) require a state to enact legislation as a prerequisite to its adoption and implementation; (2) protect the public safety; (3) allow disposal of controlled substances through persons other than law enforcement personnel; (4) incorporate environmentally sound practices for disposal; (5) be cost-effective; (6) include convenient take-back options for urban and rural locations; and (6) not restrict the funding a state may use to implement it. Allows such a program to apply similarly to a drug or biological product other than a controlled substance. Directs the Comptroller General to collect data on state take-back disposal programs and periodically report to Congress. Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services: (1) in approving drug applications and in licensing biological products, to ensure that the drug or product labeling does not include any recommendation or direction to dispose of the drug by means of a wastewater treatment system, such as by flushing it down the toilet; and (2) to review the labeling of existing drugs and products and order revision of any labeling that includes such a recommendation or direction. Deems any drug or product whose labeling is in violation of such an order to be misbranded.

Date: 2009-06-24
Topic: Health (Drug Industry)
Subject: Environmental protection
Amends the Internal Revenue Code to exempt fixed-wing aircraft used to provide acute care emergency medical services from certain restrictions on tax-exempt bond financing.

Date: 2009-07-22
Topic: Health (Drug Industry)
Subject: Taxation
Protecting Americans from Drug Marketing Act - Amends the Internal Revenue Code to deny a business expense tax deduction for expenses relating to advertising or promoting the sale and use of prescription pharmaceuticals.

Date: 2009-10-08
Topic: Health (Drug Industry)
Subject: Taxation
Access to Affordable Medicines Act - Amends the Federal Food, Drug, and Cosmetic Act to provide that an application for a generic drug the proposed labeling of which is different from the labeling at the time the Secretary of Health and Human Services (HHS) evaluates the application shall be eligible for approval (and such drug shall not be considered misbranded) if: (1) the revision has been approved by the Secretary within 60 days of the expiration of the patent or exclusivity period for the drug; (2) the Secretary has not determined the applicable labeling text when such period expires; (3) the labeling revision does not include a change to the warnings section; (4) the Secretary does not deem that the continued presence in commerce of the labeling before the revision adversely impacts the safe use of the drug; and (5) the sponsor of the application agrees to submit revised labeling not later than 60 days after the notification of any changes required by the Secretary.

Date: 2009-10-14
Topic: Health (Drug Industry)
Subject: Health
Amends the Harmonized Tariff Schedule of the United States to reduce temporarily the duty no frames and mountings for spectacles, goggles, or the like, the foregoing of plastics.

Date: 2009-10-29
Topic: Health (Drug Industry)
Subject: Foreign trade and international finance
Nanotechnology Safety Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to establish within the Food and Drug Administration (FDA) a program for the scientific investigation of nanoscale materials included or intended for inclusion in FDA-regulated products to address: (1) the potential toxicology of such materials; (2) the effects of such materials on biological systems; and (3) the interaction of such materials with biological systems.

Date: 2010-01-21
Topic: Health (Drug Industry)
Subject: Health
Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

Date: 2010-04-28
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
Dietary Supplement Full Implementation and Enforcement Act of 2010 - Authorizes appropriations for FY2011-FY2014 to carry out the Dietary Supplement Health and Education Act of 1994 (DSHEA) and other provisions under the Federal Food, Drug, and Cosmetic Act (FFDCA) that apply to dietary supplements. Requires the allocation of funds appropriated to the Food and Drug Administration (FDA) for FY2010 for the purpose of enhancing food safety to be expended to effectively and fully implement and enforce DSHEA and other FFDCA provisions that apply to dietary supplements. Authorizes appropriations for FY2010-FY2014 for expanded research and development of consumer information on dietary supplements by the Office of Dietary Supplements at the National Institutes of Health (NIH). Requires the Secretary of Health and Human Services (HHS) to report to Congress annually on the implementation and enforcement of DSHEA and its amendments. Amends the FFDCA to require the Secretary to publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with safety information, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identity of a new dietary ingredient. Requires the Secretary to notify the Drug Enforcement Agency (DEA) if information in a new dietary ingredient notification is inadequate to establish that a dietary supplement containing such ingredient will reasonably be expected to be safe because the ingredient may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid.

Date: 2010-05-25
Topic: Health (Drug Industry)
Subject: Agriculture and food
Fair Pricing for Prescription Drugs Act - Pharmaceutical Market Access and Drug Safety Act of 2010 - 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: (1) a registered importer; or (2) 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. Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to direct the Secretary to negotiate with pharmaceutical manufacturers the prices that may be charged to Medicare part D prescription drug plan (PDP) sponsors and MedicareAdvantage (MA) organizations for covered part D drugs for part D eligible individuals who are enrolled under a PDP or an MA-Prescription Drug plan.

Date: 2010-05-25
Topic: Health (Drug Industry)
Subject: Health
Drug Safety and Accountability Act of 2010 - 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.

Date: 2010-08-03
Topic: Health (Drug Industry)
Subject: Health
Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2010 - Amends the Public Health Service Act to require personnel who perform or plan the technical component of either medical imaging examinations or radiation therapy procedures for medical purposes to possess, effective January 1, 2013: (1) certification in each medical imaging or radiation therapy modality and service they plan or perform from a certification organization designated by the Secretary of Health and Human Services (HHS); or (2) state licensure or certification where such services and modalities are within the scope of practice as defined by the state for such profession and where the requirements for licensure, certification, or registration meet or exceed the standards established by the Secretary. Exempts physicians, nurse practitioners, and physician assistants from the requirements of this Act. Directs the Secretary to: (1) establish minimum standards for personnel who perform, plan, evaluate, or verify patient dose for medical imaging examinations or radiation therapy procedures; (2) establish a program for designating certification organizations after consideration of specified criteria; (3) provide a process for individuals whose training or experience are determined to be equal to, or in excess of, those of a graduate of an accredited educational program in that specialty to demonstrate that their experience meets the educational standards for qualified personnel in their imaging modality or radiation therapy procedures; and (4) publish a list of approved accrediting bodies for such certification organizations. Authorizes the Secretary to develop alternative standards for rural or health professional shortage areas as appropriate to ensure access to quality medical imaging. Amends title XVIII (Medicare) of the Social Security Act to allow Medicare payment for medical imaging and radiation therapy services, only if the examination or procedure is planned or performed by an individual who meets this Act's requirements.

Date: 2010-08-05
Topic: Health (Drug Industry)
Subject: Health
Drug Court Reauthorization Act - Amends the Omnibus Crime Control and Safe Streets Act of 1968 to authorize appropriations for the drug courts program for FY2012-FY2018 and to modify certain program requirements relating to grant authority, grant applications, and the distribution and allocation of grants to states and local and tribal governments.

Date: 2011-01-05
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
Prescription Drug Affordability Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to repeal provisions restricting the importation of prescription drugs. Allows a person who meets applicable legal requirements to be an importer of prescription drugs upon application to the Secretary of Health and Human Services (HHS). Requires the Secretary to approve such an application if the drug meets all FFDCA requirements for admission into the United States, including that the drug has been approved by the Food and Drug Administration (FDA) and is not adulterated or misbranded. Prohibits the Secretary from taking any action against any of the persons involved with the interstate sale of a prescription drug through an Internet site if: (1) the sale was made in compliance with FFDCA, the Controlled Substances Act, and applicable state laws; and (2) accurate information regarding compliance with such laws is posted on the Internet site. Makes this Act effective one year after enactment, without regard to whether the Secretary has promulgated regulations.

Date: 2011-01-05
Topic: Health (Drug Industry)
Subject: Health
Protecting Our Kids' Medicine Act - Amends the Federal Food, Drug, and Cosmetic Act to require a liquid formulation of an over-the-counter drug to be packaged with a dosage delivery device meeting specified requirements.  Defines "dosage delivery device" as an object that is designed to measure the dosage of a drug in liquid form and deliver that drug to an individual and includes calibrated cups, droppers, syringes, and spoons.Sets forth requirements for such a dosage delivery device, which include that such device: (1) is calibrated in units of measure specified in the dosage directions on the outside packaging of the drug, the bottle, or written instructions on the label; (2) uses the same abbreviations  as the directions and conforms to international or national standards for abbreviations; (3) has clearly printed decimals or fractions; (4) contains leading zeros before decimal points to avoid tenfold dosing errors; (5) has smaller font sizes for numerals in fractions compared to the size of the font used for numerals not in fractions; (6) contains no extraneous or unnecessary markings that may be confusing to consumers; and (7) uses markings that are clearly visible when the drug is added to the device.Deems a drug to be misbranded if it does not meet the requirements of this Act.Makes this Act effective one year after enactment.

Date: 2011-01-19
Topic: Health (Drug Industry)
Subject: Health
Health Care Cost Reduction Act of 2012 - Amends the Internal Revenue Code to: (1) repeal the excise tax on medical devices; (2) repeal restrictions on payments from health savings accounts, Archer medical savings accounts, and health flexible spending and reimbursement arrangements to only prescription drugs or insulin (thus allowing distributions from such accounts for over-the-counter drugs); (3) allow amounts in a flexible spending arrangement (FSA), up to $500, that are not spent for medical care to be distributed to the FSA participant as taxable income after the close of a plan year (currently, such unspent amounts are forfeited); and (4) repeal the limitation on the recapture of advance payments of the tax credit for health insurance premium assistance that exceed the allowable credit amount for a taxable year.

Date: 2011-01-25
Topic: Health (Drug Industry)
Subject: Taxation
Say No to Drug Ads Act - Amends the Internal Revenue Code to deny a tax deduction for the cost of direct-to-consumer advertisement of a prescription drug.

Date: 2011-02-15
Topic: Health (Drug Industry)
Subject: Taxation
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.

Date: 2011-02-16
Topic: Health (Drug Industry)
Subject: Taxation
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 exclusivity period granted to the generic manufacturer.

Date: 2011-02-16
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2011-03-09
Topic: Health (Drug Industry)
Subject: Health
Fairness in Medicare Bidding Act or FIMBA - Amends part B (Supplementary Medical Insurance Benefits for Aged and Disabled) of title XVIII (Medicare) of the Social Security Act to repeal the Medicare competitive acquisition program for durable medical equipment and prosthetics, orthotics, and supplies (DMEPOS). Rescinds specified unobligated balances of all discretionary appropriations, except those for the Department of Defense (DOD) or the Department of Veterans Affairs (VA). Directs the Office of Management and Budget (OMB) to determine and identify each account, program, project, and activity to which this rescission and its amount shall apply.

Date: 2011-03-11
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2011-04-01
Topic: Health (Drug Industry)
Subject: Taxation
Stop Oxy Abuse Act of 2011 - Directs the Commissioner of Food and Drugs (FDA), within 90 days, to take such actions as may be necessary to modify the approval of, and limit any subsequent approval of, any drug containing controlled-release oxycodone hychloride to use for the relief of severe-only pain instead of moderate-to-severe pain. Applies any such modification to drugs introduced into interstate commerce 180 days after enactment of this Act.

Date: 2011-04-01
Topic: Health (Drug Industry)
Subject: Health
Free Speech About Science Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth conditions under which a food or dietary supplement label may characterize the relationship of a nutrient in the food or supplement to a disease or health-related claim. Permits such a label on food if the claim: (1) is based on legitimate scientific research; (2) is in compliance with other FFDCA provisions; (3) is an accurate, balanced summary of such research; (4) enables the public to comprehend the information provided in the claim and the relative significance of such information in the context of a total daily diet; and (5) identifies each party that funded research to support the claim. Permits such a label on a dietary supplement that claims to diagnose, treat, cure, or prevent a specific disease or class of diseases if: (1) the claim is based on legitimate scientific research; (2) the manufacturer has substantiation that such statement is truthful and not misleading; (3) the statement includes a disclaimer that it has not been evaluated by the Food and Drug Administration (FDA); and (4) the claim includes a citation to the research supporting such claim and identifies each party that funded such research. Prohibits the Secretary of Health and Human Services (HHS) from restricting the distribution of information that is not false or misleading and that is based on legitimate scientific research in connection with the sale of food. Amends the Federal Trade Commission Act to exempt the dissemination of legitimate scientific research in connection with the sale or distribution of a food or dietary supplement to consumers from being determined to be false advertising by virtue of the fact that the research does not directly correlate to such food or dietary supplement if the dissemination discloses that information. Places the burden of proof on the Federal Trade Commission (FTC) to establish that the literature being disseminated is not legitimate scientific research.

Date: 2011-04-05
Topic: Health (Drug Industry)
Subject: Agriculture and food
Integrity in Medicare Advanced Diagnostic Imaging Act of 2011 - Amends title XVIII (Medicare) of the Social Security Act to exclude certain advanced diagnostic imaging services from the in-office ancillary services exception to the prohibition on physician self-referral. (Thus prohibits a physician [or an immediate family member] who has an ownership or investment relationship or compensation arrangement with an entity from referring a patient to the entity for certain advanced diagnostic imaging services for which a Medicare payment otherwise may be made.)

Date: 2011-04-12
Topic: Health (Drug Industry)
Subject: Health
Hearing Aid Assistance Tax Credit Act 2011 - Amends the Internal Revenue Code to allow a nonrefundable income tax credit of up to $500 for the purchase of a qualified hearing aid for an individual who is either: (1) age 55 or older; or (2) is claimed as a dependent of the taxpayer. Denies such tax credit to any taxpayer whose modified adjusted gross income exceeds $200,000.

Date: 2011-04-12
Topic: Health (Drug Industry)
Subject: Taxation
Medicare Access to Diabetes Supplies Act of 2011 - Amends title XVIII (Medicare) of the Social Security Act to exempt from Medicare competitive acquisition programs blood glucose self-testing equipment and supplies furnished by small retail community pharmacies.

Date: 2011-05-23
Topic: Health (Drug Industry)
Subject: Health
Medicare Orthotics and Prosthetics Improvement Act of 2011 - 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. 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 Chief Actuary of the Centers for Medicare and Medicaid Services to submit to Congress a projection of the effect on cumulative federal spending under Medicare part B (Supplementary Medical Insurance) for 2012-2016 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 2012-2016, 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 2016. Exempts from such regulation any qualified physical therapist or qualified occupational therapist.

Date: 2011-05-24
Topic: Health (Drug Industry)
Subject: Health
States' Medical Marijuana Patient Protection Act - Requires the Secretary of Health and Human Services (HHS), within six months of enactment of this Act, to submit to the Administrator of the Drug Enforcement Administration (DEA) a recommendation on the listing of marijuana within the Controlled Substances Act (CSA) and to recommend listing it as other than a Schedule I or Schedule II substance. Requires the Administrator of DEA, within 12 months of enactment of this Act, based upon the recommendation of the National Academy of Sciences, to issue a notice of proposed rulemaking for the rescheduling of marijuana within the CSA, which shall include a recommendation to list marijuana as other than a Schedule I or Schedule II substance. Declares that no provision of the CSA or the Federal Food, Drug and Cosmetic Act shall prohibit or otherwise restrict, in a state in which the medical use of marijuana is legal under state law: (1) the prescription or recommendation of marijuana for medical use by a medical professional or the certification by a medical professional that a patient has a condition for which marijuana may have therapeutic benefit; (2) an individual from obtaining, manufacturing, possessing, or transporting within their state marijuana for medical purposes, provided the activities are authorized under state law; (3) a pharmacy or other entity authorized to distribute medical marijuana from obtaining, possessing, or distributing marijuana to authorized individuals; or (4) an entity authorized by a state or local government from producing, processing, or distributing marijuana for such purposes.

Date: 2011-05-25
Topic: Health (Drug Industry)
Subject: Health
Small Business Tax Equity Act of 2011 - Amends the Internal Revenue Code to allow a tax deduction for expenses incurred in the trade or business of selling marihuana intended for patients for medical purposes pursuant to state law.

Date: 2011-05-25
Topic: Health (Drug Industry)
Subject: Taxation
Freedom of Health Speech Act - Amends the Federal Trade Commission Act to prohibit the content of any publication from being considered advertising regulated under the Act unless the content is intended by a product seller to promote that product's sale and the content includes the name of the product, an express offer to sell, and a purchase price. Prohibits any content excerpted in whole or part from a peer-reviewed scientific publication from being considered advertising regulated under the Act. Prohibits the Federal Trade Commission (FTC) from attributing to an advertiser any advertising statement not actually made by that advertiser. Requires the FTC to notify an advertiser of a dietary supplement before authorizing an investigation of false advertisement and include a date by which the advertiser may voluntarily discontinue use of the statement. Prohibits the FTC from beginning an investigation of possible false advertising regarding a dietary supplement or a dietary ingredient unless the FTC already possesses clear and convincing evidence that the advertisement is false and misleading. Places the burden of proof on the FTC to show, by clear and convincing evidence, that an advertisement for a dietary supplement or dietary ingredient is false, that the advertisement actually caused consumers to be misled into believing to be true that which is false, and that, but for the false advertising content, the consumer would not have made the purchase at the price paid. Requires the FTC to prove that a health claim alleged to be false advertising is false based on expert scientific opinion and published peer-reviewed scientific evidence.

Date: 2011-05-26
Topic: Health (Drug Industry)
Subject: Commerce
Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2011 - Amends the Public Health Service Act to require personnel who perform or plan the technical component of either medical imaging examinations or radiation therapy procedures for medical purposes to possess, effective January 1, 2014: (1) certification in each medical imaging or radiation therapy modality and service they plan or perform from a certification organization designated by the Secretary of Health and Human Services (HHS); or (2) state licensure or certification where such services and modalities are within the scope of practice as defined by the state for such profession and where the requirements for licensure, certification, or registration meet or exceed the standards established by the Secretary. Exempts physicians, nurse practitioners, and physician assistants from the requirements of this Act. Directs the Secretary to: (1) establish minimum standards for personnel who perform, plan, evaluate, or verify patient dose for medical imaging examinations or radiation therapy procedures; (2) establish a program for designating certification organizations after consideration of specified criteria; (3) provide a process for the certification of individuals whose training or experience are determined to be equal to, or in excess of, those of a graduate of an accredited educational program; and (4) publish a list of approved accrediting bodies for such certification organizations. Authorizes the Secretary to develop alternative standards for rural or health professional shortage areas as appropriate to ensure access to quality medical imaging. Amends title XVIII (Medicare) of the Social Security Act to allow Medicare payment for medical imaging and radiation therapy services, only if the examination or procedure is planned or performed by an individual who meets this Act's requirements.

Date: 2011-06-02
Topic: Health (Drug Industry)
Subject: Health
Medical Gas Safety Act - Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions regarding the regulation of medical gases, including to establish a certification and approval process for medical gases. Lists designated medical gases, including oxygen, nitrous oxide, and medical air. Requires the Secretary to: (1) approve a certification for designated medical gases; and (2) establish by rule appropriate procedures for the approval of medical gases that are not designated medical gases. Requires the Secretary to establish regulations for medical gases, including: (1) appropriate current good manufacturing practice requirements, (2) separate labeling requirements, (3) separate wholesale distribution requirements, (4) a streamlined electronic process for registration and listing of medical gases, and (5) separate and proportionate product tracking and anti-counterfeiting rules for medical gases. Requires the Secretary to establish: (1) a separate risk-based inspection regime specific to medical gas manufacturers that ensures coordination with state and local inspection activities, and (2) the Medical Gas Advisory Committee to provide the Secretary with regular guidance and specific advice on medical gas regulatory activities. Directs the Secretary to assess and collect fees with respect to drugs that are non-designated medical gases, and establish the amount of fees to generate the total amount of costs of the Food and Drug Administration's (FDA's) regulation of non-designated medical gases. Exempts medical gases from new drug fees and new animal drug fees.

Date: 2011-06-16
Topic: Health (Drug Industry)
Subject: Health
Preserving Access to Life-Saving Medications Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the manufacturer of a prescription drug marketed in interstate commerce to notify the Secretary of Health and Human Services (HHS) of a discontinuance or interruption in the manufacture of such drug. Requires the notification to be submitted six months prior to the date of a discontinuance or interruption, if possible. Allows the reduction of the notification period if the manufacturer certifies to the Secretary that good cause exists for the reduction. Authorizes the Secretary to reduce the notification period based on the type of discontinuance or interruption at issue or any other factor. Treats any information provided to the Secretary under this Act as a trade secret or confidential information. Establishes civil monetary penalties for violations. Requires the Secretary to publish on the website of the Food and Drug Administration (FDA) and distribute to the appropriate health care providers and patient organizations information on discontinuances, interruptions, and drug shortages. Requires the Secretary to notify a manufacturer of: (1) any determination by the Secretary that a drug may be vulnerable to a drug shortage, and (2) the Secretary's duty to collaborate to improve continuity of supply. Prohibits the Secretary from requiring a manufacturer to: (1) manufacture a drug in the event of a discontinuance or interruption, or (2) delay or alter a discontinuance or interruption. Declares that no provision of federal law shall be construed to prohibit a manufacturer from, or penalize a manufacturer for, allocating distribution of its products in order to manage an actual or potential drug shortage. Requires the Comptroller General to examine issues related to drug shortages.

Date: 2011-06-21
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2011-07-26
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2011-07-27
Topic: Health (Drug Industry)
Subject: Health
Testimonial Free Speech Act of 2011 - Prohibits any federal official or employee from restricting the dissemination of a testimonial containing a consumer's actual perception of the mitigative, preventive, or curative properties of any food or dietary supplement based on the consumer's experience with that food or dietary supplement. Declares that a person is not violating federal law if such person disseminates a testimonial that he or she reasonably believed is covered by this Act. Applies this Act to the dissemination of a testimonial by the manufacturer of a food or dietary supplement for purposes of marketing.

Date: 2011-09-13
Topic: Health (Drug Industry)
Subject: Commerce
Pharmaceutical Stewardship Act of 2011 - Establishes the National Pharmaceutical Stewardship Organization as a nonprofit private corporation whose board of directors shall be appointed by the Administrator of the Environmental Protection Agency (EPA). Requires the Organization to begin implementation of a certified national pharmaceutical stewardship program within two years. Requires each manufacturer and brand owner of a drug marketed in the United States to participate in such program or another certified national pharmaceutical stewardship program. Establishes requirements for program certification, including requirements to: (1) provide a system to facilitate the collection and disposal of any drug that is a household waste, as defined under the Resource Conservation and Recovery Act, that is delivered to the program by an individual in the United States; and (2) collect and dispose of drugs in a manner that is safe and secure, that results in incineration of the drug in accordance with the hazardous waste incineration requirements under the Solid Waste Disposal Act, that protects patient information, and that is accessible and, in the case of a controlled substance, consistent with the Controlled Substances Act. Prohibits programs from imposing fees on individuals for delivery or disposal of a drug. Establishes a program certification process, including requiring the Administrator to consult with the Administrator of the Drug Enforcement Agency (DEA) on the adequacy of the proposed program's security measures for collection, transportation, and disposal of drugs, disposal systems, and mechanisms for secure tracking and handling. Authorizes the Administrator to suspend certification of a program if necessary to protect the public from imminent danger. Requires the Director of National Drug Control Policy to establish a campaign to increase public awareness of how drugs may be lawfully disposed consistent with public safety, public health, and environmental protection. Requires the Administrator to establish an interagency commission, to be known as the Commission on Drug Disposal and its Public Safety, Public Health, and Environmental Impacts, to develop a strategy to: (1) prevent the entry of drugs into the nation's water supply and environment consistent with current public safety standards, and (2) protect public health and promote public safety by reducing diversion and the risk of abuse and accidental overdose. Requires the Comptroller General (GAO) to report on drugs and drug byproducts in surface water and groundwater in the United States within a year.

Date: 2011-09-15
Topic: Health (Drug Industry)
Subject: Environmental protection
Safeguarding America's Pharmaceuticals Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of the Treasury to destroy imported counterfeit drugs and adulterated or misbranded imported drugs with a value of less than $2,000. Requires the manufacturer of a prescription drug to provide to its wholesale distributors or dispensers a packing list or comparable document containing identifying information, including the National Drug Code number, container size, and lot number of the drug. Requires each manufacturer or repackager of a prescription drug to: (1) apply a standardized numerical identifier that is unique to each unit of the drug to at least 50% of its drugs by January 1, 2015, and to all of its drugs by January 1, 2016; and (2) notify the Secretary of Health and Human Services (HHS) of the method it will use to meet such requirement. Requires the Secretary to establish an effective drug identification and tracking system to authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for a standardized numerical identifier. Expands the requirements for the licensing of wholesale distributors, including to require mandatory background checks. Disqualifies a person who has been convicted of certain felonies or who has engaged in a pattern of violative behavior. Establishes civil monetary penalties for violations of this Act. Requires penalties paid to the United States to be used by the Secretary of HHS to prevent and address unlawful counterfeiting and diversion of drugs. Authorizes a state to enforce the requirements of this Act under certain circumstances. Requires the Secretary of HHS to study threats to the domestic prescription drug supply chain.

Date: 2011-09-22
Topic: Health (Drug Industry)
Subject: Health
Medicare Safe Needle Disposal Coverage Act of 2011 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to cover as a part D drug any devices approved for home use by the Food and Drug Administration (FDA) for the safe and effective containment, removal, decontamination, and disposal of home-generated needles, syringes, and other sharps through a sharps container, decontamination/destructive device, or sharps-by-mail program or similar program.

Date: 2011-10-11
Topic: Health (Drug Industry)
Subject: Health
Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the process for requesting classification for a type of medical device that has not been previously classified by removing the requirement that a person can only file a request for classification of a new medical device after the Secretary of Health and Human Services (HHS) classifies the device as a class III device in response to the person filing a notice of intent to market the device.

Date: 2011-10-14
Topic: Health (Drug Industry)
Subject: Health
Guidance Accountability and Transparency Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), when issuing guidance documents that set forth initial interpretations of a statute or regulation, set forth changes in interpretation or policy that are of more than a minor nature, include complex scientific issues, or cover highly controversial issues (Level 1 guidance documents), to: (1) publish notice in the Federal Register of the Secretary's intent to prepare such a document at least three months before issuance of a draft, and (2) meet with interested stakeholders and solicit public comment during preparation and before issuance of a draft. Includes within such guidance documents a notice to industry guidance letter, a notice to industry advisory letter, and any similar notice. Sets forth other procedures if the Secretary for good cause finds compliance with such requirements is impracticable, unnecessary, or contrary to the public interest. Requires the Secretary: (1) upon issuing a draft, to designate it as proposed or final; and (2) to issue a final draft within 12 months after issuing a proposed draft. Treats the proposed draft as null and void if the Secretary fails to finalize the draft within such time. Directs the Secretary to conduct a retrospective analysis of a final Level 1 guidance document not less than every five years to ensure it is not outmoded, ineffective, insufficient, or excessively burdensome and to modify or repeal the document accordingly.

Date: 2011-10-14
Topic: Health (Drug Industry)
Subject: Health