S. 882 (111th): Drug and Device Accountability Act of 2009

Introduced:
Apr 23, 2009 (111th Congress, 2009–2010)
Sponsor:
Sen. Edward “Ted” Kennedy [D-MA]
Status:
Died (Referred to Committee)

The bill’s title was written by the bill’s sponsor. S. stands for Senate bill.

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Status

This bill was introduced on April 23, 2009, in a previous session of Congress, but was not enacted.

Progress
Introduced Apr 23, 2009
Referred to Committee Apr 23, 2009
Cosponsors
1 cosponsors (1R) (show)
Committees

Senate Health, Education, Labor, and Pensions

The committee chair determines whether a bill will move past the committee stage.

Full Title

A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety and quality of medical products and enhance the authorities of the Food and Drug Administration, and for other purposes.

Summary

No summaries available.

Text

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Last updated Apr 23, 2009.
90 pages

Primary Source

View on THOMAS (The Library of Congress)

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Citation

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

4/23/2009--Introduced.
Drug and Device Accountability Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions regarding the registration of drug and device establishments, including to:
(1) expand the information required to be included in a registration; and
(2) provide for risk-based inspections.
Includes in the definition of "drug" a precursor ingredient.
Requires the Secretary of Health and Human Services (HHS) to assess the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs.
Deems a drug to be adulterated if certain conditions related to verification of identity and purity, identification of establishments, consistency with current manufacturing technologies, and conformity with good distribution and import practices are not met.
Deems a drug or device to be misbranded unless certain conditions related to labeling for country of manufacture and provision of required information on importation are met.
Sets forth provisions governing importation of a drug and its components.
Sets forth required actions, including cessation of distribution, if there is a reasonable probability that a drug intended for human use would cause serious, adverse health consequences or death.
Establishes actions manufacturers must take regarding any defective drug.
Sets forth additional required certifications for submissions related to drugs and devices regarding accuracy and personal knowledge of information submitted.
Establishes whistleblower protection for employees providing information regarding a drug, biological product, or device.
Requires the Secretary to contract with the Institute of Medicine to evaluate:
(1) the organizational structure and operations of the Food and Drug Administration (FDA) with respect to the review of medical devices for clearance and for premarket approval under FFDCA; and
(2) the analytical and methodological tools used to conduct such reviews.
Directs the Secretary to establish a corps of inspectors dedicated to inspections of foreign establishments and facilities.
Sets forth enforcement provisions.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

The United States Code is the compilation of permanent laws enacted by Congress. Temporary and other non-permanent laws do not appear in the United States Code. (About half of the United States Code is the law itself, called positive law. The other half is merely a compilation of the laws but has no legal significance.)

Other Citations

  • 18 U.S.C. Chapter 47
  • 31 U.S.C. Chapter 37