Top Legislation - View All

Latest Action: 01/09/2007 - Star Print ordered on the bill.

Bill Text
A bill to expand access to preventive health care services that help reduce unintended pregnancy, reduce abortions, and improve access to women's health care. 1/4/2007--Introduced. Prevention First Act - Title X Family Planning Services Act of 2007 - Authorizes appropriations for family planning services grants and contracts under the Public Health Service Act (PHSA). Equity in Prescription Insurance and Contraceptive Coverage Act of 2007 - Amends the Employee Retirement Income Security Act of 1974 (ERISA) and PHSA to prohibit a group health plan and a health insurance issuer providing group coverage from excluding or restricting benefits in any way for prescription contraceptive drugs, devices, and outpatient services if the plan or coverage provides benefits for other outpatient prescription drugs, devices, or outpatient services. Applies such prohibitions to coverage offered in the individual market. Emergency Contraception Education Act of 2007 - Directs [...]

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Latest Action: 01/04/2007 - Sponsor introductory remarks on measure. (CR S69)

Bill Text
A bill to amend title XVIII of the Social Security Act to require the use of generic drugs under the Medicare part D prescription drug program when available unless the brand name drug is determined to be medically necessary.

1/4/2007--Introduced.

Generics First Act of 2007 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to exclude from coverage under the Medicare part D prescription drug program all nongeneric (brand name) drugs unless no generic drug has been approved, and the brand name drug is determined to be medically necessary.

Latest Action: 03/07/2007 - Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held.

Bill Text
A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. 2/27/2007--Reported to Senate without amendment.    (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.) Preserve Access to Affordable Generics Act - Amends the Clayton Act to make it unlawful for a person, in connection with the sale of a drug product, to be 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 product for any period. Excludes a resolution or settlement that includes no more than the right to market the generic product prior to the expiration of the patent. Amends the Medicare [...]

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Latest Action: 01/30/2007 - Sponsor introductory remarks on measure. (CR S1351-1352)

Bill Text
A bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs.

1/30/2007--Introduced.

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 exclusivity period granted to the generic manufacturer.

Latest Action: 03/14/2007 - Committee on Health, Education, Labor, and Pensions. Hearings held.

Bill Text
A bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. 2/1/2007--Introduced. Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product [...]

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Latest Action: 07/06/2007 - Referred to the Subcommittee on Trade.

Bill Text
Expressing the sense of the House of Representatives that the United States should reaffirm the commitments of the United States to the 2001 Doha Declaration on the TRIPS Agreement and Public Health and to pursuing trade policies that promote access to affordable medicines. 6/28/2007--Introduced. Urges the United States to: (1) honor U.S. commitments made in the 2001 World Trade Organization Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and Public Health, which allows World Trade Organization (WTO) members to fully use the flexibilities in the TRIPS Agreement to protect public health and promote access to medicines for all; (2) not place countries on the "Special 301" Priority Watch List for exercising such flexibilites, such as issuing compulsory licenses to obtain generic medicines; (3) not ask developing countries that are trading partners to adopt measures to protect public health intellectual property rights [...]

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Latest Action: 02/02/2007 - Referred to the Subcommittee on Health.

Bill Text
To provide for comprehensive health insurance coverage for all United States residents, and for other purposes. 1/24/2007--Introduced. United States National Health Insurance Act (or the Expanded and Improved Medicare for All Act) - Establishes the United States National Health Insurance (USNHI) Program (the Program) to provide all individuals residing in the United States and in U.S. territories with free health care that includes all medically necessary care, such as primary care and prevention, prescription drugs, emergency care, and mental health services. Prohibits an institution from participating in the Program unless it is a public or nonprofit institution. Allows nonprofit health maintenance organizations (HMOs) that actually deliver care in their own facilities to participate in the Program. Gives patients the freedom to choose from participating physicians and institutions. Prohibits a private health insurer from selling health insurance coverage that [...]

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Latest Action: 02/05/2007 - Referred to the House Committee on Energy and Commerce.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs.

2/5/2007--Introduced.

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.

Latest Action: 05/18/2007 - Referred to the Subcommittee on Health, Employment, Labor, and Pensions.

Bill Text
To expand access to preventive health care services that help reduce unintended pregnancy, reduce abortions, and improve access to women's health care. 2/5/2007--Introduced. Prevention First Act - Title X Family Planning Services Act of 2007 - Authorizes appropriations for family planning services grants and contracts under the Public Health Service Act (PHSA). Equity in Prescription Insurance and Contraceptive Coverage Act of 2007 - Amends the Employee Retirement Income Security Act of 1974 (ERISA) and PHSA to prohibit a group health plan and a health insurance issuer providing group coverage from excluding or restricting benefits in any way for prescription contraceptive drugs, devices, and outpatient services if the plan or coverage provides benefits for other outpatient prescription drugs, devices, or outpatient services. Applies such prohibitions to coverage offered in the individual market. Emergency Contraception Education Act of 2007 - Directs the Secretary [...]

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Latest Action: 05/10/2007 - Received in the House.

Bill Text
An act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes. 5/9/2007--Passed Senate amended.    (There are 2 other summaries) Food and Drug Administration Revitalization Act - Title I: Prescription Drug User Fees - (Sec. 101) - Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth as a purpose that authorized prescription drug fees be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety. Sets forth reporting requirements, including requiring the Secretary of Human Services (the Secretary) to present to Congress recommendations developed for achieving certain goals for the review process of human drug applications and for reauthorization of user [...]

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Latest Legislation - View All

Latest Action: 07/30/2008 - Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 110-805.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to generic new animal drugs. 7/30/2008--Reported to House amended.    (There is 1 other summary) Animal Generic Drug User Fee Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to assess and collect fees for an abbreviated application for a generic new animal drug, including application fees, product fees, and sponsor fees.Sets forth total revenue to be collected for each type of fee for FY2009-FY2013.Provides for fee adjustments. Requires the Secretary to establish such fees each fiscal year.Provides for fee waivers where the Secretary finds that the generic new animal drug is intended solely to provide for a minor use or minor species indication.Authorizes appropriations for FY2009-FY2013.Requires the Secretary to report to Congress and make publicly available information [...]

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Latest Action: 08/14/2008 - Signed by President.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the animal drug user fee program, to establish a program of fees relating to generic new animal drugs, to make certain technical corrections to the Food and Drug Administration Amendments Act of 2007, and for other purposes. 8/14/2008--Public Law.    (There are 3 other summaries) (This measure has not been amended since it was passed by the House on July 30, 2008. The summary of that version is repeated here.) Title I: Animal Drug User Fee Amendments - Animal Drug User Fee Amendments of 2008 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act to revise definitions, including defining the "process for the review of animal drug applications" to include the review of advertising and labeling prior to an approval of an animal drug application or supplemental animal application after the animal drug has been approved.(Sec. 103) Requires the [...]

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Latest Action: 01/28/2008 - Signed by President.

Bill Text
To provide for the enactment of the National Defense Authorization Act for Fiscal Year 2008, as previously enrolled, with certain modifications to address the foreign sovereign immunities provisions of title 28, United States Code, with respect to the attachment of property in certain judgements against Iraq, the lapse of statutory authorities for the payment of bonuses, special pays, and similar benefits for members of the uniformed services, and for other purposes. 1/28/2008--Public Law.    (There are 2 other summaries) (This measure has not been amended since it was passed by the House on January 16, 2008. The summary of that version is repeated here.) National Defense Authorization Act for Fiscal Year 2008 - Division A: Department of Defense Authorizations - Title I: Procurement - Subtitle A: Authorization of Appropriations - (Sec. 101) Authorizes appropriations for FY2008 for the Army, Navy and Marine Corps, and Air Force for [...]

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Latest Action: 09/27/2007 - Signed by President.

Bill Text
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 9/27/2007--Public Law.    (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential [...]

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Latest Action: 07/24/2007 - Referred to the House Committee on Energy and Commerce.

Bill Text
To amend title XIX of the Social Security Act to ensure and foster continued beneficiary access to generic drugs under the Medicaid Program by setting pharmacy reimbursement based on retail acquisition cost and to promote the use of generic drugs.

7/24/2007--Introduced.

Saving Our Community Pharmacies Act of 2007 - Amends title XIX (Medicaid) of the Social Security Act to provide for: (1) use of median retail acquisition cost as the basis for Medicaid reimbursement limits on generic drugs; and (2) establishment of an evidence-based prescription drug program.

Directs the Comptroller General to study and report to Congress on the costs of community retail pharmacies to dispense prescription drugs.