Timely Review and Increased Access to Affordable Drugs Act

Summary

Timely Review and Increased Access to Affordable Drugs Act - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning the timing of generic drug availability. Prohibits (for subsequently issued patents) an extension of the 30 month stay of Food and Drug Administration (FDA) approval for any new drug where an abbreviated new drug application (ANDA) 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. Requires the first generic applicant (ANDA) 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 which delay or prevent the marketing of the generic drug, including failure to market and agreements with the patent holder which violate the antitrust laws. Continues current regulations concerning bioeqiovalence. States that drugs which no longer require a prescription (over-the-counter) but that are sold as if they did are deemed misbranded (mislabeled and subject to seizure).

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 29 July 2002

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 29 July 2002

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 29 July 2002

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.