Protecting Consumer Access to Generic Drugs Act of 2007

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 and for the benefit of consumers. Amends the Federal Food, Drug, and Cosmetic Act to provide that a generic drug applicant forfeits market exclusivity for failing to market the drug 75 days after:
(1) a court dismisses a declaratory judgment action for lack of subject matter jurisdiction; or
(2) the applicant files with the Secretary of Health and Human Services a covenant that the patent owner will not sue the applicant for patent infringement. Deems an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include:
(1) a description of the subject matter of other agreements between the parties; and
(2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.


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Sponsor

• Rep. Bobby Rush [D, IL-1]
• and 13 Co-Sponsors
  • Rep. George Butterfield [D, NC-1]
  • Rep. Diana DeGette [D, CO-1]
  • Rep. John Dingell [D, MI-15]
  • Rep. Michael Doyle [D, PA-14]
  • Rep. Charles Gonzalez [D, TX-20]
  • Rep. Barton Gordon [D, TN-6]
  • Rep. Edward Markey [D, MA-7]
  • Rep. James Marshall [D, GA-8]
  • Rep. Janice Schakowsky [D, IL-9]
  • Rep. Bart Stupak [D, MI-1]
  • Rep. Christopher Van Hollen [D, MD-8]
  • Rep. Henry Waxman [D, CA-30]
  • Rep. Albert Wynn [D, MD-4]
  close

Committees

• House Judiciary
• 3 more
  • House Energy and Commerce
  • House Judiciary
  • House Energy and Commerce
  close

Amendments

This bill has no amendments.

Amendments to H.R.1902

Number	Status	Purpose

Bill Status

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

Show All Actions (9 actions)Hide Actions

All Bill Actions

• May 04, 2007: Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
• May 02, 2007: Subcommittee Hearings Held.
• May 01, 2007: Subcommittee Consideration and Mark-up Session Held.
• May 01, 2007: Referred to the Subcommittee on Commerce, Trade and Consumer Protection.
• Apr 18, 2007: Referred to the Subcommittee on Commerce, Trade and Consumer Protection.
• Apr 17, 2007: Referred to House Judiciary
• Apr 17, 2007: Referred to House Energy and Commerce
• Apr 17, 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 Apr 17, 2007.

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Related Issue Areas:

• Health policy
• Business
• Claims
• Competition
• 18 more
• Consumer protection
• Consumers
• Contracts
• Drug industry
• Drugs
• Generic drugs
• Government information
• Government paperwork
• Intellectual property
• Marketing
• Medical care
• Medicine
• Patent infringement
• Patents
• Pharmaceutical research
• Prescription pricing
• Restrictive trade practices
• Science policy

Data from the Congressional Research Service

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In the News

July 30, 2007 FTC And DOJ Issue Joint Report Regarding Antitrust Enforcement And ...

... though no law has yet been passed. See Senate Bill 316, entitled the "Preserve Access to Affordable Generics Act;" HR 1432; and HR 1902.

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July 29, 2007 Letter: Repeal tax on Social Security benefits

... and all Americans to slip by -- support the Liberty Committee and Congressman Ron Paul’s HR 1902, the Social Security benefits tax reduction act, ...

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Blog Coverage

March 10, 2008 FTC Testifies Before US Senate on Barriers to Entry of Generic Drugs

... and that, “We believe the bill introduced by Chairman Rush, Chairman Dingell, Chairman Waxman, and other members of the Committee, HR 1902, represents a fundamentally sound approach to eliminating the exclusion payment problem.” .

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Source: Acaciahilary's Weblog

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December 22, 2007 Pharma Reverse Payments Still Legal

The House introduced HR 1902 last May to make these payments illegal, but powerful lobbyists brought thier efforts to bear and got the bill stuck in multiple committees. It's still there....sitting there....nothing happening with it. ...

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December 17, 2007 FTC Testifies Before US Senate on Barriers to Entry of Generic Drugs

HR 1902 Called a "Fundamentally Sound" Approach to Eliminating Anticompetitive Pharmaceutical Exclusion Payments.

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