All Generic drugs Legislation - Federal Government

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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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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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 introduced. The expanded summary of the Senate passed 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 aircraft,[...]

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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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To establish a United States Health Service to provide high quality comprehensive health care for all Americans and to overcome the deficiencies in the present system of health care delivery. 7/11/2007--Introduced. Josephine Butler United States Health Service Act - Establishes the United States Health Service as an independent executive branch entity to provide health care and supplemental health services to all individuals within the United States. Requires the President to appoint members to a National Health Board to exercise the authority of the Service. Establishes an Office of the Inspector General for Health Services. Requires the Service to ensure that every individual is given certain basic health rights, including the right to receive high quality care and supplemental services from any facility within the Service capable of providing such services without charge and without discrimination. Amends the Fair Labor Standards Act of 1938 to provide [...]

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To ensure integrity in the operation of pharmacy benefit managers. 7/10/2007--Introduced. Pharmacy Benefit Manager Transparency Act of 2007 - Prohibits any pharmaceutical drug manufacturer from having a controlling interest in an entity that is a pharmacy benefit manager. Allows the Secretary of Health and Human Services to issue civil penalties for violations as necessary. Prohibits pharmacy benefit managers from making drug interchanges: (1) to a drug with a greater cost; (2) without disclosure to the individual of the savings associated with the interchange; or (3) from a drug with generic equivalents to a drug without generic equivalents, unless the latter is lower in cost than each of the generic equivalents of the drug from which the prescription would be changed. Requires pharmacy benefit managers to annually disclose all compensation received from drug manufacturers to the Antitrust Division of the Department of Justice (DOJ) and to the client plans [...]

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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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A resolution expressing the sense of the Senate 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. 6/20/2007--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 nations that are trading partners to adopt measures to protect public health intellectual property rights in excess [...]

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To amend section 340B of the Public Health Service Act to revise and expand the drug discount program under that section to improve the provision of discounts on drug purchases for certain safety net providers. 6/7/2007--Introduced. 340B Program Improvement and Integrity Act of 2007 - Amends the Public Health Service Act to expand the drug discount program to allow participation as a covered entity by certain: (1) children's hospitals; (2) critical access hospitals; (3) entities providing maternal and child health services, community mental health services, or treatment services for substance abuse; (4) Medicare-dependent, small rural hospitals; (5) sole community hospitals; and (6) rural referral centers. Prohibits enrolled hospitals from obtaining covered outpatient drugs through a group purchasing arrangement. Requires the Secretary of Health and Human Services to establish reasonable exceptions to such requirements, including for drugs unavailable through the program and [...]

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A bill to amend the Public Health Service Act to revise and expand the drug discount program under section 340B of such Act to improve the provision of discounts on drug purchases for certain safety net provides. 5/14/2007--Introduced. 340B Program Improvement and Integrity Act of 2007 - Amends the Public Health Service Act to expand the drug discount program to allow participation as a covered entity by certain children's hospitals, critical access hospitals, and rural referral centers or sole community hospitals. Prohibits enrolled hospitals from obtaining covered outpatient drugs through a group purchasing arrangement. Requires the Secretary of Health and Human Services to establish reasonable exceptions to such prohibition, including for drugs unavailable through the program and to facilitate generic substitution when a generic covered drug is available at a lower price. Expands the program to include a drug used in connection with an inpatient or outpatient service [...]

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To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. 4/17/2007--Introduced. Protecting Consumer Access to Generic Drugs Act of 2007 - 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 [...]

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A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to market exclusivity for certain drugs, and for other purposes. 4/11/2007--Introduced. Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act or the Lower PRICED Drugs Act - Amends the Federal Food, Drug, and Cosmetic Act to require an abbreviated application for a new drug containing certain antibiotics, the approved labeling for which includes a method of use that is claimed by a patent, to include a statement: (1) that identifies the relevant patent and the approved use covered by the patent; and (2) that the applicant is not seeking approval of such use. Requires the court to consider the totality of circumstances and the public interest in deciding whether to shorten the 30-month period that delays the approval of an abbreviated drug application when a patent infringement case is filed against the applicant. Limits market exclusivity provided for conducting [...]

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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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To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. 3/9/2007--Introduced. 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 Prescription Drug, Improvement, and Modernization Act of 2003 to set forth additional filing requirements related to agreements between a brand name drug company and a generic drug applicant. Requires the Chief Executive Officer [...]

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