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Public Law102th CongressHealth
H.R. 2454Became Law

Generic Drug Enforcement Act of 1992

This bill became law

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What it doesSummary passed senate amended (Apr 10, 1992)

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.

What just happenedMay 13, 1992

Became Public Law No: 102-282.

Who’s behind it

Rep. Dingell, John D. [D-MI-16](D-MI)Sponsor
43 cosponsors27 D16 R
Read on Congress.gov
43cosponsors2committees41actions1amendments1related bills16subjects
  1. May 13, 1992PresidentE40000

    Became Public Law No: 102-282.

  2. May 13, 1992BecameLaw36000

    Became Public Law No: 102-282.

  3. May 13, 1992PresidentE30000

    Signed by President.

  4. May 13, 1992BecameLaw36000

    Signed by President.

  5. May 1, 1992FloorE20000

    Presented to President.

  6. May 1, 1992President28000

    Presented to President.

  7. Apr 28, 1992Floor

    Message on House action received in Senate.

  8. Apr 28, 1992ResolvingDifferencesH41931

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

  9. Apr 28, 1992ResolvingDifferencesH41610

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

  10. Apr 28, 1992NotUsed19500

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

  11. Apr 28, 1992FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate.

  12. Apr 28, 1992ResolvingDifferencesH40140

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

  13. Apr 28, 1992Floor

    Message on Senate action sent to the House.

  14. Apr 10, 1992Floor

    Passed Senate with an amendment and an amendment to the Title by Voice Vote.

  15. Apr 10, 1992Floor17000

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

  16. Apr 10, 1992Floor

    Amendment SP 1787 agreed to in Senate by Voice Vote.

  17. Apr 10, 1992Floor

    Amendment SP 1787 proposed by Senator Cranston for Senator Kennedy.

  18. Apr 10, 1992Floor

    Measure laid before Senate by unanimous consent.

  19. Apr 10, 1992Discharge

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

    Health, Education, Labor, and Pensions Committee
  20. Apr 10, 1992Committee14500

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

    Health, Education, Labor, and Pensions Committee
  21. Nov 4, 1991IntroReferral

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

    Health, Education, Labor, and Pensions Committee
  22. Oct 31, 1991FloorH38310

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

  23. Oct 31, 1991FloorH37300

    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).

  24. Oct 31, 1991Floor8000

    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).

  25. Oct 31, 1991FloorH30000

    Considered as unfinished business.

  26. Oct 28, 1991FloorH37220

    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.

  27. Oct 28, 1991FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate.

  28. Oct 28, 1991FloorH30000

    Considered under suspension of the rules.

  29. Oct 28, 1991FloorH30300

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

  30. Oct 24, 1991CalendarsH12410

    Placed on the Union Calendar, Calendar No. 163.

  31. Oct 24, 1991CommitteeH12200

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

    Energy and Commerce Committee
  32. Oct 24, 1991Committee5000

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

    Energy and Commerce Committee
  33. Sep 25, 1991CommitteeH15000-B

    Committee Consideration and Mark-up Session Held.

    Energy and Commerce Committee
  34. Sep 25, 1991CommitteeH19000

    Ordered to be Reported (Amended).

    Energy and Commerce Committee
  35. Jul 29, 1991CommitteeH22000

    Subcommittee Consideration and Mark-up Session Held.

    Health and Environment Subcommittee
  36. Jul 29, 1991CommitteeH23000

    Forwarded by Subcommittee to Full Committee (Amended).

    Health and Environment Subcommittee
  37. Jun 26, 1991CommitteeH21000

    Subcommittee Hearings Held.

    Health and Environment Subcommittee
  38. Jun 10, 1991CommitteeH11000

    Referred to the Subcommittee on Health and the Environment.

    Health and Environment Subcommittee
  39. May 23, 1991IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  40. May 23, 1991IntroReferralIntro-H

    Introduced in House

  41. May 23, 1991IntroReferral1000

    Introduced in House

Passed Senate amendedApr 10, 199235

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.

Passed House amendedOct 31, 199136

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. Repeals such provisions two years following enactment.

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.

Introduced in HouseMay 23, 199100

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.