Preserve Access to Affordable Generics Act

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. (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.


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Sponsor

• Sen. Herbert Kohl [D, WI]
• and 10 Co-Sponsors
  • Sen. Sherrod Brown [D, OH]
  • Sen. Richard Durbin [D, IL]
  • Sen. Russell Feingold [D, WI]
  • Sen. Charles Grassley [R, IA]
  • Sen. Tim Johnson [D, SD]
  • Sen. Edward Kennedy [D, MA]
  • Sen. Amy Klobuchar [D, MN]
  • Sen. Patrick Leahy [D, VT]
  • Barack Obama
  • Sen. Charles Schumer [D, NY]
  close

Committees

• Senate Judiciary
• 1 more
  • Senate Judiciary
  close

Amendments

This bill has no amendments.

Amendments to S.316

Number	Status	Purpose

Bill Status

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Introduced		Voted on by Senate		Voted on by House		Considered By President		Bill Becomes Law
January 17, 2007

Show All Actions (11 actions)Hide Actions

All Bill Actions

• Mar 07, 2007: Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held.
• Feb 27, 2007: Committee on the Judiciary. Reported by Senator Leahy without amendment. Without written report.
• Added to calendar on Feb 27, 2007: Placed on Senate Legislative Calendar under General Orders. Calendar No. 59..
• Feb 15, 2007: Committee on the Judiciary. Date of scheduled consideration. S-216. 10:00 a.m.
• Feb 15, 2007: Committee on the Judiciary. Approved for reporting without amendment favorably.
• Feb 08, 2007: Committee on the Judiciary. Date of scheduled consideration. SD-226. 10:00 a.m.
• Jan 17, 2007: Sponsor introductory remarks on measure. (CR S679)
• Jan 17, 2007: Read twice and referred to the Committee on the Judiciary.
• Jan 17, 2007: Introductory remarks on measure. (CR S679)
• Jan 17, 2007: Committee on the Judiciary. Hearings held.
• Introduced on Jan 17, 2007.

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Related Bills:

• H.R.1432

Related Issue Areas:

• Business
• Antitrust law
• Competition
• Congress
• 14 more
• Congressional reporting requirements
• Criminal investigation
• Criminal justice
• Drug industry
• Generic drugs
• Governmental investigations
• 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 25, 2007 Full Issue

... 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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Source: FDA news (subscription), VA

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Blog Coverage

December 08, 2008 09.12.2008: Literarisches Bollwerk (Tageszeitung junge Welt)

5 Vgl. Gerrard Winstanley, Gleichheit im Reiche der Freiheit, Leipzig 1986, S. 316 6 Milton (wie Anm. 3), S. 70 (Pro populo Anglicano defensio secunda, 1654) 7 Milton, Das verlorene Paradies (deutsch/englisch), Frankfurt 2008, S. 322 ...

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Source: junge Welt

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November 26, 2008 Rez. NG: J. Lindenlaub: Die Finanzierung des Aufstiegs von Krupp ...

Auch in diesem Teil seiner Untersuchung liefert Lindenlaub interessante neue Erkenntnisse, wie die Tatsache, dass in der Verwaltung Krupps schon viele Aufgabebereiche moderner Controllingabteilungen abgedeckt wurden (S. 316-318). ...

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Source: H-Soz-u-Kult

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November 03, 2008 „Bauchaufsatz“: Über den Antrieb meines Willens zu schreiben

... vorbestimmt sei und die Menschen sich dem Schicksal oder einer Macht hingeben müssten, sondern dass in diesen Zivilisationsprozess eingegriffen werden kann "aufgrund der Kenntnis ihrer ungeplanten Gesetzmäßigkeit." (Bd. II, S. 316).

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Source: Annetts literarische Gedankenwelt

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