S. 1584 · 112th Congress
Drug Safety and Accountability Act of 2011
Key: what the circles and colors mean
Each circle is a bill. The ring fills as it moves through Congress:
Under the number: the Yea · Nay count of its final (or latest) recorded vote. On a member's page, the small badge is how that member voted: Y Yea / Aye, N Nay / No, P Present, – Not voting.
Gold and violet are only for Yea and Nay; they never mean a party. A member's party is the letter on their photo.
Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
BennetSponsor2 cosponsors · 2 D
0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Drug Safety and Accountability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require each registered drug producer to have in effect and implement a quality management plan to ensure the quality and safety of: (1) each drug, (2) each active and inactive ingredient of each drug, and (3) materials used in the manufacture of each…
What it does: CRS summary · Introduced in Senate · Sep 20, 2011
Drug Safety and Accountability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require each registered drug producer to have in effect and implement a quality management plan to ensure the quality and safety of: (1) each drug, (2) each active and inactive ingredient of each drug, and (3) materials used in the manufacture of each active ingredient. Authorizes the Secretary of Health and Human Services (HHS) to order an establishment to promptly revise its quality management plan in response to a significant threat to public health.
Requires each registered drug producer to report on each producer, manufacturer, distributor, and shipper involved in the production of a drug or the production or transport of the active ingredients of a drug. Requires the Secretary to develop and maintain information systems to track and assess every establishment that is involved in the manufacturing, preparation, propagation, compounding, or processing of a drug or active ingredient of a drug.
Deems a drug to be adulterated if it was produced in an establishment that does not comply with the requirements of this Act.
Gives the Secretary authority to: (1) order an immediate cessation of distribution, or a recall, of a drug; and (2) administer oaths and issue subpoenas.
Revises provisions regarding civil penalties for FFDCA violations related to drugs for human use, including to consider each day a violation continues to be a separate violation.
Authorizes the Secretary to share information subject to a trade secret exemption with: (1) other federal, state, or local agencies, foreign government agencies, and relevant international organizations; and (2) the public, as necessary to protect the public health.
Sets forth whistleblower protection provisions.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Drug Safety and Accountability Act of 2011
Latest action (Sep 20, 2011): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Sep 20, 2011
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.