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HR 5311 107th Congress House Health Access to health care Administrative procedure Civil actions and liability Commerce Competition Confidential communications Congress Congressional reporting requirements Damages Department of Health and Human Services Drug approvals Drug industry Drugs Generic drugs Government Operations and Politics Government paperwork Government publicity Injunctions Intellectual property

Prescription Drug Affordability Act

Introduced: July 26, 2002 Introduced by: Thune, John Republican · South Dakota See on congress.gov
This bill died when the 107th Congress ended
It never became law before the 107th Congress (2001–2002) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 29, 2002
Referred to the Subcommittee on Health.
Jul 26, 2002
Referred to the House Committee on Energy and Commerce.
Jul 26, 2002
Introduced in House
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 Plain-English summary Congressional Research Service
Prescription Drug Affordability Act - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning the timing of generic drug availability.

Requires applicants (pharmaceutical companies) to register their patents with the Food and Drug Administration (FDA) within 30 days of approval (or issuance for subsequently issued patents).

Makes failure to timely register a bar to civil actions for patent infringement.

Requires applications for new drugs (NDA) or abbreviated new drug applications (ANDA) which rely upon investigations not conducted by or for the applicant and which concern a patent that claims both the drug and a method of use or more than one method of use to include a certification on a claim-by-claim basis that the patent is invalid or will not be infringed (known as a Paragraph IV filing/certification) by the new drug's (generic) manufacture and a statement regarding the method(s) of use claim.

Prohibits (for subsequently issued patents) an extension of the 30 month stay of FDA approval for any new drug where an ANDA or NDA contains a Paragraph IV filing/certification and the patent holder indicates an intention to bring a patent infringement suit against the new (generic) drug's manufacturer.

Makes failure to timely file a civil action for infringement a bar to later action.

Requires the first generic applicant with a Paragraph IV filing to forfeit the 180 day marketing exclusivity period to a subsequent generic applicant if the first generic applicant engages in certain behaviors (forfeiture events) which delay or prevent the marketing of the generic drug.

Revises notice requirements for Paragraph IV filings to include and protect certain proposed formulation, composition, or method of use information.

Excludes an applicants's ability to pay damages from a court's consideration of whether or not to provide injunctive relief before the expiration of the 30 month stay of approval period.

What's happening now July 29, 2002

Referred to the Subcommittee on Health.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
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APA
U.S. Congress. (2026). H.R. 5311: Prescription Drug Affordability Act. 107th Congress. Open America. https://openamerica.io/bill/107-HR-5311/
MLA
"H.R. 5311: Prescription Drug Affordability Act." 107th Congress, 2026, Open America, https://openamerica.io/bill/107-HR-5311/.
Bluebook (legal)
H.R. 5311, 107th Cong. (2026), https://openamerica.io/bill/107-HR-5311/.
Markdown link
[H.R. 5311: Prescription Drug Affordability Act](https://openamerica.io/bill/107-HR-5311/)
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