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Committee on Energy and CommerceIntroducedOctober 27th, 2009
- house Committees
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Strengthening of FDA Integrity Act of 2009
To expand the authority of the Secretary of Health and Human Services to impose debarments in order to ensure the integrity of drug, biological product, and device regulation, and for other purposes.
Strengthening of FDA Integrity Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices. Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product. Requires the Secretary of Health and Human Services (HHS), in determining the appropriateness and the period of debarment, to consider whether debarment will affect the public health because sufficient quantities of the drug would not be available. Requires the Secretary to annually report to Congress on the implementation of debarment provisions.