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H.R. 6376, The Strengthening of FDA Integrity Act of 2008
- This item is from the 110th Congress (2007-2008) and is no longer current. Comments, voting, and wiki editing have been disabled, and the cost/savings estimate has been frozen.
Comparing revision saved on June 27, 2008, 19:30:45 (webmaster), with revision saved on October 23, 2008, 19:32:54 (webmaster):
H.R. 6376 would 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.
== Detailed Summary ==
<summary>
(Log in to editStrengthening of FDA Integrity Act of 2008 - Amends the wikiFederal Food, Drug, and beCosmetic 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 firstconditions under which persons (i.e., partnerships, corporations, and associations) are subject to providemandatory and permissive debarment preventing such persons from submitting an application for approval of a detailed summarydrug product.
Requires the Secretary of Health and Human Services, in determining the bill!)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.
</summary>
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== Status of the Legislation ==
<status>
Latest Major Action: 6/26/2008: Referred to House committee. Status: Referred to the House Committee on Energy and Commerce.
</status>
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== Points in Favor ==
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== Points Against ==
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