Generic Drug Enforcement Act of 1991

Summary

Generic Drug Enforcement Act of 1991 - Amends the Federal Food, Drug, and Cosmetic Act to require that any person convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any abbreviated drug application (ADA) be debarred from submitting any ADA. Allows debarment, if there is reason to believe the person may undermine the regulatory process, of a person: (1) convicted of a Federal misdemeanor or a State felony in connection with an ADA; (2) convicted of bribery, fraud, or similar crimes; (3) convicted of obstruction of justice; (4) who materially participated in acts that were the basis for such convictions; or (5) who knowingly used the services of a debarred person. Provides for: (1) the term of debarment; (2) termination of debarment; and (3) publication of a list of debarred persons. Allows an ADA to be denied in certain circumstances, including: (1) involving 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 a bribe or a pattern of false statements, or if there are flagrant, repeated, and uncorrected violations of good manufacturing practice or good laboratory practice which may undermine the safety and efficacy of the drugs: (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 ADA 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) 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 person. 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, in whole or in part, through bribery, fraud, or a 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. Authorizes the Inspector General (IG) to investigate certain matters, including any allegation of: (1) misconduct by Food and Drug Administration (FDA) employees; (2) violation of existing provisions listing prohibited acts; (3) violation, or a class of violations, which the FDA Commissioner has requested the IG to investigate; and (4) violation, or a class of violations, for which the Secretary delegates authority to the IG or requests the IG to investigate. Mandates maintaining for public inspection, 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. Repeals provisions requiring a hearing before the Secretary reports a violation to a U.S. attorney for institution of a criminal proceeding.

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2 official files

• Introduced in Senate (text)

  Introduced in Senate · EN

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• Introduced in Senate

  summary · EN · 23 May 1991

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