S. 882: Drug and Device Accountability Act of 2009

111th Congress · introduced 2009-04-23 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

federal

Follow this bill, step by step

Where it came from: introduced 2009-04-23 · official record
Who proposed it: Sen. Kennedy, Edward M. [D-MA] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Not final yet: this can still change. We check for updates every day.
If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Drug and Device Accountability Act of 2009

Plain summary

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.

Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Drug and Device Accountability Act of 2009

Source: Congressional Research Service summary (Introduced in Senate)

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The strongest published arguments

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Sen. Kennedy, Edward M. [D-MA] · 1 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Chuck Grassley (R-IA)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)

Exemption: A rule that removes certain people, property or activities from a tax or requirement.

Plain meanings written from linked sources. All words.

Sources

Congressional Research Service summary (Introduced in Senate)
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-111s882.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/111/s>

Record fed-us-cong111-s882 · catalog fed-us-congress-bills-cong111 · updated 2026-11-15 by psicol fed-bills-cong111