S. 316 (110th): Preserve Access to Affordable Generics Act

Introduced:
Jan 17, 2007 (110th Congress, 2007–2009)
Sponsor:
Sen. Herbert “Herb” Kohl [D-WI]
Status:
Died (Reported by Committee)
See Instead:
This bill was re-introduced as S. 369 (111th) on Feb 03, 2009.

The bill’s title was written by the bill’s sponsor. S. stands for Senate bill.

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Status

This bill was introduced on February 27, 2007, in a previous session of Congress, but was not enacted.

Progress
Introduced Jan 17, 2007
Referred to Committee Jan 17, 2007
Reported by Committee Feb 27, 2007
Referred to Committee Mar 07, 2007
Cosponsors
10 cosponsors (9D, 1R) (show)
Committees

Senate Judiciary

The committee chair determines whether a bill will move past the committee stage.

Full Title

A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.

Summary

No summaries available.

Text

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Last updated Jan 17, 2007.
12 pages

Primary Source

View on THOMAS (The Library of Congress)

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Citation

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

2/27/2007--Reported to Senate without amendment.
(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 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:
(1) are complete, final, and exclusive;
(2) include any ancillary agreements that are contingent upon, provide a contingent condition for, or are otherwise related to, the agreement; and
(3) include written descriptions of any relevant oral agreements, representations, commitments, or promises between the parties that have not been reduced to writing.
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. Requires the FTC to study the prevalence of anticompetitive agreements in the pharmaceutical industry and their impact.
Requires the Attorney General or FTC to consider whether any additional enforcement action is necessary.
Authorizes appropriations.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

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