GovTrack’s Bill Summary
We don’t have a summary available yet.
Library of Congress Summary
The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.
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
The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.
No summary available.
House Democratic Caucus Summary
The House Democratic Caucus does not provide summaries of bills.
So, yes, we display the House Republican Conference’s summaries when available even if we do not have a Democratic summary available. That’s because we feel it is better to give you as much information as possible, even if we cannot provide every viewpoint.
We’ll be looking for a source of summaries from the other side in the meanwhile.