jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2009-03-11 00:00:00

Promoting Innovation and Access to Life-Saving Medicine Act - Amends the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products. Defines "biosimilar" and "interchangeability" for purposes of this Act. Allows any person to file an abbreviated biological product application with the Secretary of Health and Human Services. Requires such applications to include information demonstrating a high degree of similarity or interchangeability between the biological product and the licensed biological product (reference product). Requires the Secretary to: (1) approve an application and issue a license for a biosimilar product unless the Secretary finds and informs the applicant that the information in the application fails to demonstrate biosimilarity between the biological product and the reference product or the safety, purity, and potency of the biological product; and (2) establish requirements for the efficient review, approval, suspension, and revocation of abbreviated biological product applications. Allows an applicant to request the Secretary to make a determination as to the interchangeability of a product and its reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Grants market exclusivity to any biological product that is determined to be interchangeable for a specified period. Sets forth provisions governing patent infringement claims involving comparable biological products and legal remedies to expedite the adjudication of patent infringement disputes. Extends the period for approval of biological products to allow for studies of the use of new biological products in the pediatric population.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-03-11 00:00:00

Counterfeit Drug Prevention Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to establish criminal penalties of a fine and imprisonment for not more than 20 years, or both, for any person who commits a prohibited act relating to counterfeiting knowing that: (1) the conduct concerns the rendering of a drug as a counterfeit drug; (2) the conduct will cause a drug to be a counterfeit drug; or (3) a drug, held, sold, or dispensed is a counterfeit drug. Increases the term of imprisonment to any term of years or for life if the use of a counterfeit drug is the proximate cause of a consumer's death. Modifies provisions pertaining to criminal fines for committing certain prohibited acts involving food, drugs, devices, or cosmetics.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-03-17 00:00:00

Pathway for Biosimilars Act - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).Requires the Secretary of Health and Human Services to approve the application if: (1) the biological product is biosimilar to the reference product with respect to each condition of use for which the reference product is approved; and (2) the applicant consents to the inspection of the facility that is the subject of the application. Sets forth requirements for a determination by the Secretary that a biological product is interchangeable with a reference product.Prohibits a biological product from being evaluated against more than one reference product. Prohibits licensure under this Act of a biological product containing specified agents or toxins or a schedule I or II controlled substance unless the Secretary determines there would be no increased risk to the security or health of the public from licensing such a biological product. Prohibits the Secretary from making approval of an application under this Act effective until 12 yeas after the date on which the reference product was first licensed.Provides for confidentiality of information received pursuant to this Act.Sets forth provisions governing patent infringement actions related to this Act.Deems as patent infringement the submission of a statement under this Act by the applicant setting forth reasons why the making, use, or sale of the biosimilar product would not infringe the patent, or why the patent is invalid or unenforceable, if the purpose of such submission is to obtain approval to engage in the commercial manufacture, use, or sale before the expiration of such patent.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-03-17 00:00:00

Preservation of Antibiotics for Medical Treatment Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services 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.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2009-03-19 00:00:00

Hearing Aid Assistance Tax Credit Act - 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.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2009-03-25 00:00:00

Protecting Consumer Access to Generic Drugs Act of 2009 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period; or (2) the waiver of a patent infringement claim for damages. Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers. Amends the Federal Food, Drug, and Cosmetic Act to provide that a generic drug applicant forfeits market exclusivity for failing to market the drug 75 days after: (1) a court dismisses a declaratory judgment action for lack of subject matter jurisdiction; or (2) the applicant files with the Secretary of Health and Human Services a covenant that the patent owner will not sue the applicant for patent infringement. Deems an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-03-25 00:00:00

Voluntary State Discount Prescription Drug Plan Act of 2009 - Amends title XIX (Medicaid) of the Social Security Act to require drug manufacturers to pay rebates to state prescription drug discount programs as a condition of participating in a Medicaid rebate agreement for outpatient prescription drugs, but only if the state has elected to establish an optional state prescription drug discount program.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-03-31 00:00:00

Medicare Prescription Drug Affordability Act of 2009 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to: (1) limit Medicare part D prescription drug plan (PDP) cost increases to the Social Security cost-of-living increase; and (2) direct the Secretary of Health and Human Services to negotiate with pharmaceutical manufacturers the prices that may be charged to PDP sponsors and MedicareAdvantage (MA) organizations for covered part D drugs for part D eligible individuals who are enrolled under a PDP or under an MA-Prescription Drug (MA-PD) plan.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-04-01 00:00:00

Independent Drug Education and Outreach Act of 2009 - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the Agency for Healthcare Research and Quality, to award grants or contracts for: (1) the development and production of educational materials concerning the evidence available on the relative safety, effectiveness, and cost of prescription drugs, nonprescription drugs, and nondrug interventions for treating selected conditions, to be distributed and presented to health care providers who prescribe such drugs and their patients; and (2) the development and implementation of a program to appropriately train and deploy health professionals to distribute such materials to, and otherwise educate, physicians and other drug prescribers concerning such drugs and interventions. Requires that grantees receive no support from any entity that manufactures products used to treat the medical conditions discussed.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-04-02 00:00:00

Promoting Wellness for Individuals with Disabilities Act of 2009 - Amends the Rehabilitation Act of 1973 to require the Architectural and Transportation Barriers Compliance Board to issue and periodically review standards setting forth the minimum technical criteria for medical diagnostic equipment used in medical settings, to ensure that such equipment: (1) is accessible to and usable by individuals with disabilities; and (2) allows independent entry to, use of, and exit from the equipment by such individuals to the maximum extent possible. Applies such standards to examination tables and chairs, weight scales, mammography equipment, x-ray machines, and other radiological equipment commonly used for diagnostic purposes by health professionals. Sets forth interim standards for such equipment. Amends the Public Health Service Act to allow the Secretary of Health and Human Services to make grants for programs to promote good health, disease prevention, and wellness for individuals with disabilities and prevent secondary conditions in such individuals. Requires the Secretary to establish a National Advisory Committee on Wellness for Individuals With Disabilities to set priorities to carry out such programs, review grant proposals, make recommendations for funding, and annually evaluate the progress of such programs in implementing the priorities.Provides for training programs to improve competency and clinical skills for providing health care and communicating with patients with disabilities through training integrated into the core curriculum and patient interaction in community-based settings.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-04-02 00:00:00

Preserve Patient Access to Reputable DMEPOS Providers Act of 2009 - Amends title XVIII (Medicare) of the Social Security Act to declare that the surety bond requirement under the Medicare program for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) shall apply only to a state-licensed retail pharmacy if there has been a final adverse action that is not subject to administrative or judicial appeal taken against such pharmacy during the 10-year period preceding the issuance (or renewal) of the provider number involved. (Thus exempts from the surety bond requirement any state-licensed retail pharmacy that has not been subject to such an adverse action for at least 10 years. Such adverse actions refer to: (1) a Medicare-imposed revocation of any Medicare billing privileges; (2) suspension or revocation of a license to provide health care by any state licensing authority; (3) revocation or suspension by an accreditation organization; (4) conviction of a federal or state felony offense within the last 10 years preceding enrollment, revalidation, or re-enrollment; or (5) an exclusion or debarment from participation in a federal or state health care program.)
Topic: Health — Drug Industry
Subject: Health
Date: 2009-05-19 00:00:00

Medicare Orthotics and Prosthetics Improvement Act of 2009 - Amends title XVIII (Medicare) of the Social Security Act with respect to recognized independent accreditation organizations which apply quality standards for suppliers of items and services relating to prosthetic devices and orthotics and prosthetics. Directs the Secretary of Health and Human Services (HHS) to designate and approve an independent accreditation organization for such purposes only if it is the American Board for Certification in Orthotics and Prosthetics, Inc., the Board for Orthotist/Prosthetist Certification, or a program that the Secretary determines has accreditation and approval standards essentially equivalent to those of such a Board. Requires such organization to satisfy all applicable criteria of the provider qualification designation for each of specified categories of prosthetics and orthotics. Requires application to prosthetic devices and orthotics and prosthetics generally of existing accreditation and licensure requirements for certain custom-fabricated prosthetics and custom-fabricated orthotics, as well as those categorized as custom-fitted high or custom-fitted low. Modifies the Medicare payment methodology for prosthetic devices and orthotics and prosthetics to require the Secretary, for payment purposes, to take into account practitioner qualifications and complexity of care. Directs the Secretary to report to Congress on: (1) the steps taken by the Department of HHS to ensure that such licensure and accreditation requirements are enforced; and (2) the effect of the requirements of this Act on the occurrence of fraud and abuse under the Medicare program with respect to prosthetic devices and orthotics and prosthetics.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-05-21 00:00:00

Mercury-Free Vaccines Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to deem a banned mercury-containing vaccine to be adulterated. Amends the Public Health Service Act to provide that a vaccine is a banned mercury-containing vaccine if one dose of the vaccine contains one or more micrograms of mercury in any form. Authorizes the Secretary of Health and Human Services (HHS) to declare that an actual or potential bioterrorist incident or other public health emergency makes the administration of such vaccines advisable for a specified period. Requires the Secretary to prohibit the distribution of banned mercury-containing influenza vaccines that are approved as biological products to: (1) any child under the age of three years old (effective July 1, 2009); (2) pregnant women if the vaccine contains thimerosal (effective July 1, 2009); and (3) any child under the age of six (effective July 1, 2010). Requires the Secretary to revise the vaccine information included with mercury-containing vaccines to include: (1) a statement that indicates the presence of mercury in the vaccine; (2) information on the availability of any mercury-free or mercury-reduced alternative vaccine and instructions on how to obtain such an alternative vaccine; and (3) a recommendation against administration of any mercury-containing vaccine to a pregnant woman. Expresses the sense of Congress that the Centers for Disease Control and Prevention (CDC) should disseminate, with any vaccine-related information, a recommendation against administration of any thimerosal-containing vaccine to a pregnant woman.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-05-21 00:00:00

Vaccine Safety and Public Confidence Assurance Act of 2009 - Amends the Public Health Service Act to establish the Agency for Vaccine Safety Evaluation in the Office of the Secretary of Health and Human Services (HHS). Requires the Director for Vaccine Safety Evaluation to: (1) conduct or support safety research and monitor licensed vaccines; (2) develop a vaccine safety research agenda; (3) evaluate means to promote compliance with federal adverse reaction reporting requirements; (4) provide a clearinghouse for vaccine studies; (5) ensure that functions relating to vaccine monitoring or research on adverse reactions are not carried out by anyone with a conflict of interest; (6) oversee the Vaccine Safety Datalink Project; and (7) resolve U.S. conflicts of interest related to international agreements, partnerships, and activities. Allows the Director to establish a program of awarding fellowships for research on vaccine safety. Requires the Commissioner of Food and Drugs to provide the Director, upon request, with complete access to all vaccine-related information submitted to the Food and Drug Administration (FDA) by vaccine manufacturers. Requires the Director to require vaccine manufacturers to: (1) provide for postmarketing surveillance and clinical testing for any acute or chronic adverse reactions associated with the vaccine; and (2) register in a qualified public registry each clinical trial conducted or supported by the manufacturer with respect to the vaccine. Transfers to the Agency Centers for Disease Control and Prevention (CDC) responsibilities for the Vaccine Safety Datalink Project, the Clinical Immunization Safety Assessment Centers, or any other post-licensure vaccine safety monitoring activities. Requires the Secretary to establish an advisory council in the Agency.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-06-04 00:00:00

Prescription Coverage for Now Act of 2009 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to direct the Commissioner of Social Security, through certain information requests to the Secretary of the Treasury, to provide for the identification of individuals potentially eligible for low-income subsidies (LIS) and transmit them low-income subsidy applications if they are also part D eligible. Requires the Secretary of Health and Human Services, jointly with the Commissioner, to develop a model, simplified low-income subsidy application and process. Amends the Internal Revenue Code to require the Secretary of the Treasury, upon the Commissioner's request, to disclose tax return information to facilitate identification of individuals likely to be eligible for Medicare prescription drug program low-income subsidies. Entitles low-income subsidy beneficiaries to retroactive reimbursement for previously incurred covered drug costs. Prescribes requirements for enhanced oversight and enforcement relating to such reimbursements. Establishes an asset standard for LIS eligibility for 2011 of $27,500 (or $55,000 in the case of the combined value of the individual's assets or resources and the assets or resources of the individual's spouse), increased in subsequent years by the annual percentage increase in the consumer price index. Exempts retirement benefits from resources under the LIS programs. Increases the income eligibility to 150% of the federal poverty level (FPL) for full benefits and 200% of the FPL for partial benefits under the LIS program. Authorizes indexing of deductible and cost-sharing above the annual out-of-pocket threshold for individuals with incomes below 200% of FPL. Prohibits the treating of LIS premium and cost-sharing subsidies as benefits, or otherwise taking them into account, in determining an individual's eligibility for, or amount of benefits under, any other federal program. Requires individuals eligible for Medicare Savings Programs to be deemed subsidy eligible individuals under LIS. Establishes a special enrollment period for subsidy eligible individuals under LIS.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-06-04 00:00:00

Tim Fagan's Law or the Counterfeit Drug Enforcement Act of 2009 - 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 of reasonable probability that a drug intended for human use would cause serious health consequences or death, 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 or prescribing the drug; and (2) amend the order to include a recall if necessary.
Topic: Health — Drug Industry
Subject: Labor and employment
Date: 2009-06-09 00:00:00

Living Organ Donor Job Security Act - Amends the Family and Medical Leave Act of 1993 (FMLA) to entitle employees covered by FMLA to leave to provide a living organ donation, including for time spent for: (1) tests to determine medical suitability of the employee for donation; (2) physical, psychological, and social evaluations of the donor; (3) pretransplant outpatient services; (4) postoperative inpatient and outpatient transplantation services; (5) travel in connection with such tests, evaluations, and services; and (6) recuperation. Amends federal civil service law to entitle civilian federal employees the same leave allowance.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2009-06-17 00:00:00

Amends the Internal Revenue Code to deny a tax deduction for advertising and related expenses to promote the sale or use of any prescription drug.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-06-18 00:00:00

Amends title XVIII (Medicare) of the Social Security Act to permit a Medicare beneficiary to elect to take, or decline to take, ownership of a Group 3 Support Surface item of complex durable medical equipment (DME) after the 13-month capped rental period ends.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2009-06-19 00:00:00

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.