Drug and Device Enforcement Act of 1991

Summary

Drug and Device Enforcement Act of 1991 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to direct the Secretary of Health and Human Services to debar an individual from submitting any application for approval of a new drug, or for a different or additional use of a previously approved drug, if the individual has been convicted of a Federal felony involving conduct in connection with the development or approval of any drug, or relating to the regulation of a product or activity subject to regulation by the Food and Drug Administration (FDA). Makes such debarment permanent. Subjects the following individuals to permissive debarment: (1) those convicted of a criminal offense related to a regulated product or activity; (2) those who knowingly made false statements or representations; (3) those who knowingly failed to make required disclosures; and (4) those with knowledge of certain debarment actions. Subjects persons other than individuals to permissive debarment. Establishes conditions for determining the period of debarment for such individuals and persons. Prohibits the Secretary from accepting, reviewing, or approving an application from a debarred person during the period of debarment. Allows the waiver of such sanction if necessary to promote the public health. Sets forth requirements for applications for termination of debarment. Provides authority for the Secretary to temporarily deny approval of an application for a person if there is reason to believe that the person has engaged in certain criminal activity or such person's actions raise questions regarding the integrity of the approval process or the reliability of the data in the application. Provides such persons with the opportunity for an informal hearing after refusal to approve an application. Authorizes the Secretary to temporarily suspend the marketing of approved products for reasons similar to that for denying approval of an application. Establishes civil penalties for specified violations described in this Act in connection with applications for approval of products. Provides awards for information leading to the imposition of a civil penalty. Sets forth administrative procedures for the Secretary with respect to notifications, hearings, or investigations. Allows judicial review of adverse decisions under this Act by the U.S. Court of Appeals for the District of Columbia or the circuit in which the person resides.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

No timeline events have been ingested for this record yet.

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

2 official files

• Introduced in Senate (text)

  Introduced in Senate · EN

  ViewDownloadOpen at official source

• Introduced in Senate

  summary · EN · 18 November 1991

  Open at official source

Sponsors

No sponsors or actors listed by the source.

Related records

No cross-record relationships stored yet.