Food, Drug, and Device Fraud and Abuse Prevention Act of 1990

Summary

Food, Drug, and Device Fraud and Abuse Prevention Act of 1990 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to direct the Secretary of Health and Human Services to debar from involvement in the approval process any person convicted of a criminal offense in connection with the development or approval of any product subject to Food and Drug Administration (FDA) regulation. Authorizes the Secretary to debar from involvement in the approval process persons (including parents and subsidiaries of corporations): (1) convicted of a Federal or State criminal offense related to any product or activity regulated by the FDCA, any other Act administered by the FDA, or any similar State statute; (2) convicted of bribery, fraud, obstruction of justice, or similar charges; (3) the Secretary determines has been involved in actual or attempted bribery, coercion, false statements, or failure to make required disclosures; or (4) the Secretary determines to have endangered the public health or safety through violation of any statute or regulation administered by the FDA. Directs the Secretary to refuse to accept, review, or approve certain applications by a person who is debarred or who uses the services of a debarred person in the development or application for approval of any product. Allows the Secretary to waive this sanction if necessary to protect the public health. Applies these provisions (relating to debarment and refusal to accept, review, or approve applications) to acts or omissions which occurred prior to enactment of these provisions. Provides for civil monetary penalties for false statements, bribery, coercion, involvement of a debarred person, and other acts. Authorizes a reward to whistleblowers who are not Federal officers or employees. Directs the Secretary, except when necessary to protect the public health, to suspend the approval of certain applications by a person convicted in connection with the applications of fraud, false statements, bribery, coercion, or other improper influence. Authorizes the Secretary, except when necessary to protect the public health, to suspend the approval of certain applications involving a debarred person. Applies these provisions (relating to suspension of approval) to convictions and approvals occurring prior to enactment of these provisions. Directs the Secretary to withdraw approval if there are reasonable grounds to believe the application was approved, expedited, or otherwise facilitated in whole or in part through actual or attempted bribery, coercion, or other improper influence. Provides for disclosure of information or matters before a grand jury concerning a violation of the FDCA or any other Act administered by the FDA to an attorney for the Government, or to personnel of the Department of Health and Human Services for use in any matter within FDA jurisdiction.

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2 official files

• Introduced in Senate (text)

  Introduced in Senate · EN

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• Introduced in Senate

  summary · EN · 24 May 1990

  Open at official source

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