S. 1778 · 111th Congress
Access to Affordable Medicines Act
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Never voted on. It didn't reach a floor vote before the 111th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
ShaheenSponsor2 cosponsors · 1 D, 1 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Access to Affordable Medicines Act - Amends the Federal Food, Drug, and Cosmetic Act to provide that an application for a generic drug the proposed labeling of which is different from the labeling at the time the Secretary of Health and Human Services (HHS) evaluates the application shall be eligible for approval (and such drug shall not be considered…
What it does: CRS summary · Introduced in Senate · Oct 14, 2009
Access to Affordable Medicines Act - Amends the Federal Food, Drug, and Cosmetic Act to provide that an application for a generic drug the proposed labeling of which is different from the labeling at the time the Secretary of Health and Human Services (HHS) evaluates the application shall be eligible for approval (and such drug shall not be considered misbranded) if: (1) the revision has been approved by the Secretary within 60 days of the expiration of the patent or exclusivity period for the drug; (2) the Secretary has not determined the applicable labeling text when such period expires; (3) the labeling revision does not include a change to the warnings section; (4) the Secretary does not deem that the continued presence in commerce of the labeling before the revision adversely impacts the safe use of the drug; and (5) the sponsor of the application agrees to submit revised labeling not later than 60 days after the notification of any changes required by the Secretary.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Access to Affordable Medicines Act
Latest action (Oct 14, 2009): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Oct 14, 2009
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.