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United States · Law · HR

H.R. 2454 (102nd)

Generic Drug Enforcement Act of 1992

enactedUnited States· United States Congress· EN

Introduced

23 May 1991

Last action

13 May 1992 · President

Status

Became Public Law No: 102-282.

Sponsors

Rep. Dingell, John D. [D-MI-12], Rep. Bliley, Tom [R-VA-7], Rep. Waxman, Henry A. [D-CA-33], Rep. Lent, Norman F. [R-NY-4], Rep. Scheuer, James H. [D-NY-8], Rep. Moorhead, Carlos J. [R-CA-22], Sen. Markey, Edward J. [D-MA], Rep. Rinaldo, Matthew J. [R-NJ-7], Rep. Swift, Al [D-WA-2], Rep. Dannemeyer, William E. [R-CA-39], Rep. Collins, Cardiss [D-IL-7], Rep. Ritter, Don [R-PA-15], Rep. Synar, Mike [D-OK-2], Rep. Tauzin, W. J. (Billy) [R-LA-3], Rep. Fields, Jack [R-TX-8], Sen. Wyden, Ron [D-OR], Rep. Oxley, Michael G. [R-OH-4], Rep. Hall, Ralph M. [R-TX-4], Rep. Bilirakis, Michael [R-FL-9], Rep. Eckart, Dennis E. [D-OH-11], Rep. Schaefer, Dan [R-CO-6], Rep. Richardson, Bill [D-NM-3], Rep. Barton, Joe [R-TX-6], Rep. Slattery, Jim [D-KS-2], Rep. Callahan, Sonny [R-AL-1], Rep. Sikorski, Gerry E. [D-MN-6], Rep. McMillan, J. Alex [R-NC-9], Rep. Bryant, John W. [D-TX-5], Rep. Hastert, J. Dennis [R-IL-14], Rep. Boucher, Rick [D-VA-9], Rep. Holloway, Clyde [R-LA-8], Rep. Cooper, Jim [D-TN-5], Rep. Upton, Fred [R-MI-6], Rep. Bruce, Terry L. [D-IL-19], Rep. Rowland, J. Roy [D-GA-8], Rep. Manton, Thomas J. [D-NY-7], Rep. Towns, Edolphus [D-NY-10], Rep. Studds, Gerry E. [D-MA-10], Rep. Kostmayer, Peter H. [D-PA-8], Rep. Lehman, Richard H. [D-CA-19], Rep. Harris, Claude [D-AL-7], Rep. Sharp, Philip R. [D-IN-2], Rep. McMillen, Thomas [D-MD-4], Rep. Sarpalius, Bill [D-TX-13]

Subjects

Healthcare

Source updated

3 June 2026

Healthcare

Official sourceDownload fileView documentsShare

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 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.

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

Timeline

  1. 23 May 1991

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  2. 23 May 1991

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 23 May 1991

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 10 June 1991

    Referred

    Referred to the Subcommittee on Health and the Environment.

    Source: Committee

  5. 26 June 1991

    Committee

    Subcommittee Hearings Held.

    Source: Committee

  6. 29 July 1991

    Committee

    Subcommittee Consideration and Mark-up Session Held.

    Source: Committee

  7. 29 July 1991

    Committee

    Forwarded by Subcommittee to Full Committee (Amended).

    Source: Committee

  8. 25 September 1991

    Committee

    Committee Consideration and Mark-up Session Held.

    Source: Committee

  9. 25 September 1991

    Reported

    Ordered to be Reported (Amended).

    Source: Committee

  10. 24 October 1991

    Calendars

    Placed on the Union Calendar, Calendar No. 163.

    Source: Calendars

  11. 24 October 1991

    Reported

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 102-272.

    Source: Committee

  12. 24 October 1991

    Reported

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 102-272.

    Source: Committee

  13. 28 October 1991

    Vote

    At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 5, rule I, the chair announced that further proceedings on the motion would be postponed until Oct. 29.

    Source: Floor

  14. 28 October 1991

    Floor

    DEBATE - The House proceeded with forty minutes of debate.

    Source: Floor

  15. 28 October 1991

    Floor

    Considered under suspension of the rules.

    Source: Floor

  16. 28 October 1991

    Floor

    Mr. Waxman moved to suspend the rules and pass the bill, as amended.

    Source: Floor

  17. 31 October 1991

    Passed

    Motion to reconsider laid on the table Agreed to without objection.

    Source: Floor

  18. 31 October 1991

    Vote

    On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays (2/3 required): 413 - 0 (Roll No. 359).

    Source: Floor

  19. 31 October 1991

    Vote

    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays (2/3 required): 413 - 0 (Roll No. 359).

    Source: Floor

  20. 31 October 1991

    Floor

    Considered as unfinished business.

    Source: Floor

  21. 4 November 1991

    Introduced

    Received in the Senate and read twice and referred to the Committee on Labor and Human Resources.

    Source: IntroReferral

  22. 10 April 1992

    Discharge

    Senate Committee on Labor and Human Resources discharged by Unanimous Consent.

    Source: Discharge

  23. 10 April 1992

    Committee

    Senate Committee on Labor and Human Resources discharged by Unanimous Consent.

    Source: Committee

  24. 10 April 1992

    Floor

    Measure laid before Senate by unanimous consent.

    Source: Floor

  25. 10 April 1992

    Passed

    Passed/agreed to in Senate: Passed Senate with an amendment and an amendment to the Title by Voice Vote.

    Source: Floor

  26. 28 April 1992

    Passed

    Motion to reconsider laid on the table Agreed to without objection.

    Source: ResolvingDifferences

  27. 28 April 1992

    Passed

    On motion that the House agree to the Senate amendments Agreed to by voice vote.

    Source: ResolvingDifferences

  28. 28 April 1992

    Passed

    Resolving differences -- House actions: On motion that the House agree to the Senate amendments Agreed to by voice vote.

    Source: NotUsed

  29. 28 April 1992

    Floor

    DEBATE - The House proceeded with forty minutes of debate.

    Source: Floor

  30. 28 April 1992

    ResolvingDifferences

    Mr. Waxman moved that the House suspend the rules and agree to the Senate amendments.

    Source: ResolvingDifferences

  31. 28 April 1992

    Floor

    Message on Senate action sent to the House.

    Source: Floor

  32. 1 May 1992

    Floor

    Presented to President.

    Source: Floor

  33. 1 May 1992

    President

    Presented to President.

    Source: President

  34. 13 May 1992

    Became law

    Became Public Law No: 102-282.

    Source: President

  35. 13 May 1992

    Became law

    Signed by President.

    Source: BecameLaw

  36. 13 May 1992

    President

    Signed by President.

    Source: President

Votes

No vote records are attached yet.

Versions

Documents

11 official files

Reported in House (text)

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  • Reported in House (text)

    Reported in House · EN

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  • Referred in Senate (text)

    Referred in Senate · EN

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  • Introduced in House (text)

    Introduced in House · EN

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  • Enrolled Bill (text)

    Enrolled Bill · EN

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  • Engrossed in House (text)

    Engrossed in House · EN

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  • Engrossed Amendment Senate (text)

    Engrossed Amendment Senate · EN

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  • Committee Discharged Senate (text)

    Committee Discharged Senate · EN

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  • Public Law (PDF)

    Public Law · EN · 14 May 1992

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  • Passed Senate amended

    summary · EN · 10 April 1992

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  • Passed House amended

    summary · EN · 31 October 1991

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  • Introduced in House

    summary · EN · 23 May 1991

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