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HR 1706 111th Congress House Commerce Administrative law and regulatory procedures Competition and antitrust Contracts and agency Federal Trade Commission (FTC) Intellectual property Marketing and advertising Prescription drugs

Protecting Consumer Access to Generic Drugs Act of 2009

Introduced: March 25, 2009 See on congress.gov
 Everywhere this bill has been 7 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 3, 2009
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 16 - 10 .
Jun 3, 2009
Subcommittee Consideration and Mark-up Session Held.
Mar 26, 2009
Referred to the Subcommittee on Commerce, Trade and Consumer Protection.
Mar 25, 2009
Referred to House Judiciary
Mar 25, 2009
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.
Mar 25, 2009
Referred to House Energy and Commerce
Mar 25, 2009
Introduced in House
 Plain-English summary Congressional Research Service

Protecting Consumer Access to Generic Drugs Act of 2009 - 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.

What's happening now June 3, 2009

Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 16 - 10 .

 Committees of jurisdiction 3