Citizen Petition Fairness and Accuracy Act of 2007

Summary

Citizen Petition Fairness and Accuracy Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require that any citizen petition or request for stay of action related to an abbreviated new drug application include a statement that to the petitioner's best knowledge and belief, the petition: (1) includes all information and views on which the petitioner relies; (2) is well grounded in fact and is warranted by law; (3) is not submitted for an improper purpose; and (4) does not contain a materially false, misleading, or fraudulent statement. Requires the Secretary of Health and Human Services to investigate any petition that does not comply with such requirements. Allows the Secretary to impose penalties for knowingly and willfully submitting a petition for an improper purpose or that contains a materially false, misleading or fraudulent statement. Provides that such penalties may include: (1) imposition of a civil penalty; (2) suspension or revocation of the petitioner's authority to submit such a petition; and (3) dismissal of the petition. Requires the Secretary to refer such a violative petition to the Federal Trade Commission (FTC) for further action. Sets forth the factors that the Secretary shall consider in taking an enforcement action or determining the penalty. Permits any person aggrieved by a petition that may contain violations to submit a request, with a certification of good faith, for the Secretary to initiate an investigation. Subjects such person to civil penalties for knowing and intentional submission of a violative request. Requires the Secretary to take final agency action on such a petition within six months. Prohibits the Secretary from extending the review period for any reason.

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 4 January 2007

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 4 January 2007

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• Introduced in Senate

  summary · EN · 4 January 2007

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