Tim Fagan's Law

To amend the Federal Food, Drug, and Cosmetic Act to increase criminal penalties for the sale or trade of prescription drugs knowingly caused to be adulterated or misbranded, to modify requirements for maintaining records of the chain-of-custody of prescription drugs, to establish recall authority regarding drugs, and for other purposes.

11/5/2007--Introduced.
Tim Fagan's Law or the Counterfeit Drug Enforcement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who:
(1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or
(2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human Services within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred. Deems a drug to be misbranded if it is not manufactured in accordance with the use of technologies that the Secretary determines are technically feasible and will assist in preventing such violations. Requires the Secretary to establish alternative requirements to the extent that such requirements provide greater certainty on the chain of custody and are technically feasible. Increases funding for Food and Drug Administration (FDA) inspections, examinations, and investigations. Requires the Secretary to educate the public and health care professionals on counterfeit drugs. Directs the Secretary:
(1) upon a finding of reasonable probability that a drug intended for human use would cause serious health consequences or death, to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering or prescribing the drug; and
(2) amend the order to include a recall if necessary.


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Sponsor

• Rep. Steve Israel [D, NY-2]

Committees

• House Energy and Commerce

Amendments

This bill has no amendments.

Amendments to H.R.4076

Number	Status	Purpose

Bill Status

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Introduced		Voted on by House		Voted on by Senate		Considered By President		Bill Becomes Law
November 05, 2007

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All Bill Actions

• Nov 05, 2007: Referred to the House Committee on Energy and Commerce.
• Introduced on Nov 05, 2007.

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Related Issue Areas:

• Wholesale trade
• Technology
• Subpoena
• Product counterfeiting
• 35 more
• Packaging
• Medical personnel
• Medical care
• Law
• Labeling
• Intellectual property
• Informers
• Identification devices
• Health education
• Governmental investigations
• Government publicity
• Government paperwork
• Government information
• Food and Drug Administration (FDA)
• Fines (Penalties)
• Executive departments
• Drugs
• Drug industry
• Drug adulteration
• Directories
• Department of Health and Human Services
• Defective products
• Deceptive advertising
• Criminal justice information
• Criminal justice
• Criminal investigation
• Consumers
• Consumer protection
• Communications
• Communication in medicine
• Business records
• Business
• Administrative remedies
• Administrative procedure
• Medicine

Data from the Congressional Research Service

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