H.R. 2299 · 109th Congress
Generic Drugs Access Act of 2005
- Stage
- In committee
- Sponsor
- Frank Pallone
- Introduced
- 2005-05-11
- Latest action
- 2005-05-23 · Referred to the Subcommittee on Health.
Summary
Generic Drugs Access Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to include in an approval of an abbreviated application for a new drug a finding about whether the approved drug is the therapeutic equivalent of the previously approved or listed drug involved. Sets forth criteria for a drug to be established as therapeutically equivalent.
Prohibits a state or its political subdivision from establishing or continuing any requirement that does not conform to the therapeutic equivalence requirement of this Act.