On May 13, 1992, the U.S. Congress announced the Generic Drug Enforcement Act, sponsored by Rep. John Dingell [D-MI], imposed debarment and other penalties for illegal acts involving any abbreviated drug application (ADA) be debarred from submitting, or assisting in the submission of, any ADA.

This law, enacted in response to scandals in the 1980s, mandates that debarred entities cannot submit or assist in the submission of ANDAs, protecting the integrity of the drug approval process. Allows an ADA to be temporarily denied in certain circumstances, including: (1) those involving an active Federal criminal investigation regarding a bribe or a pattern of false statements; or (2) if a significant question has been raised regarding the integrity of the approval process or the reliability of data.

Requires, in the case of bribes or a pattern of false statements, or if there are flagrant and repeated violations of good manufacturing practice or good laboratory practice which have not been corrected and may undermine the safety and efficacy of the drugs and the person involved is under active civil or criminal Federal investigation involving such acts: (1) the suspension of distribution of all drugs the development or approval of which was related to such actions; or (2) the suspension of all drugs approved under ADAs of such person. Allows waiver of the suspension requirement if necessary to protect the public health. Provides for termination of suspensions.

Adds a requirement that an application for approval of a drug product contain: (1) a certification that the applicant did not and will not use the services of a person debarred in connection with the application; and (2) if the application is an ADA, a list of all convictions within the last five years of the applicant and affiliated persons responsible for the development or submission of ADAs.

Prescribes civil penalties for certain actions in connection with ADAs, including: (1) false statements or bribes; (2) destruction, alteration, or secretion of evidence; (3) failure to disclose facts; (4) obstruction; (5) use of a debarred person; or (6) provision of services by a debarred individual. Makes the validity, amount, and appropriateness of a civil penalty not subject to judicial review. Allows the Secretary of Health and Human Services to make a monetary award for information leading to the imposition of a civil penalty. Declares the Secretary’s decision on such an award not reviewable.

Requires withdrawal of approval of an ADA facilitated through bribery, fraud, or false statement. Allows withdrawal if the applicant has repeatedly demonstrated a lack of ability to produce the drug with the formulations or manufacturing practice in the ADA and has introduced, or attempted to introduce, the adulterated or misbranded drug into commerce.

Mandates maintaining, with regard to each ADA, the applicant’s name, the name of the drug, and the persons and dates of assignment for chemistry and bioequivalence reviews and making the information available to the public after approval of the application.