Preserve Access to Affordable Generics Act

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 or the company official responsible for negotiating any agreement to file a certification that materials filed with respect to such agreements are complete, final, and exclusive. Amends the Federal Food, Drug, and Cosmetic Act to provide that forfeiture of the 180-day exclusivity period for the marketing of a generic drug occurs if there is a final decision of the Federal Trade Commission (FTC) or the court that an agreement has violated this Act.


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Sponsor

• Rep. Henry Waxman [D, CA-30]
• and 1 Co-Sponsors
  • Rep. Christopher Van Hollen [D, MD-8]
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Committees

• House Judiciary
• 2 more
  • House Energy and Commerce
  • House Energy and Commerce
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Amendments

This bill has no amendments.

Amendments to H.R.1432

Number	Status	Purpose

Bill Status

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Introduced		Voted on by House		Voted on by Senate		Considered By President		Bill Becomes Law
March 09, 2007

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All Bill Actions

• Mar 12, 2007: Referred to the Subcommittee on Commerce, Trade and Consumer Protection.
• Mar 09, 2007: Referred to House Judiciary
• Mar 09, 2007: Referred to House Energy and Commerce
• Mar 09, 2007: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
• Introduced on Mar 09, 2007.

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Related Bills:

• S.316

Related Issue Areas:

• Business
• Antitrust law
• Competition
• Drug industry
• 9 more
• Generic drugs
• Intellectual property
• Marketing
• Medical care
• Medicine
• Patent infringement
• Pharmaceutical research
• Restrictive trade practices
• Science policy

Data from the Congressional Research Service

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In the News

June 26, 2007 Supreme Court Will Not Hear Tamoxifen Case

... the agency is supportive of congressional efforts to ban the practice by introducing the Preserve Access to Affordable Generics Act, S. 316 and HR 1432, ...

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June 25, 2007 Supreme Court Will Not Hear Tamoxifen Case

... the agency is supportive of congressional efforts to ban the practice by introducing the Preserve Access to Affordable Generics Act, S. 316 and HR 1432, ...

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Blog Coverage

August 27, 2008 mlb hall of fame indicators: hitters

6) luis gonzalez: 353 hr/1432 rbi/2579 h/.283 ba there's no doubt that bonds, griffey and sheffield will eventually make it to cooperstown. they will be first-ballot hofers. the other three are more interesting cases. ...

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Source: Nosebleed Seats (and other misfortunes...

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December 02, 2007 congress says squeeze and swallow

appearing in this episode:the issue: preserve access to affordable generics act (s.316, hr.1432)the villains: congress and the pharmaceutical industrythe victims: the american people metaphors: sliced, squeezed, vitamin c, sucked dry, ...

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December 02, 2007 Congress Says Squeeze and Swallow

Appearing In This Episode: The Issue: Preserve Access to Affordable Generics Act (S.316, HR.1432) The Villains: Congress and the pharmaceutical industry The Victims: The American People Metaphors: Sliced, Squeezed, Vitamin C, ...

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