Clerk session vote number: 359
Description: GENERIC DRUG ENFORCEMENT ACT OF 1991
Bill summary: Generic Drug Enforcement Act of 1992 - Amends the Federal Food, Drug, and Cosmetic Act to require that any person, other than an individual, convicted after the enactment of this Act 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, or assisting in the submission of, any ADA.
Requires that an individual convicted of a Federal felony for
conduct relating to the development, approval, or regulation of any drug product be debarred from providing any services to a person that has an approved or pending drug product application.
Allows debarment of a person or an individual for specified types of conduct.
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 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.
Click to hide full description.
Bill titles: To authorize the Secretary of Health and Human Services to impose debarments and other penalties for illegal activities involving the approval of abbreviated drug applications under the Federal Food, Drug, and Cosmetic Act, and for other purposes.
Links for more info on the vote: congress.gov