Generic Drug Enforcement Act of 1992
Public Law 102-282 · H.R. 2454 · 102nd Congress · began in the House
Signed by George H. W. Bush (R) on May 13, 1992 · Health
Sponsor: Rep. John Dingell (D-MI-16)
Cosponsors (43): Rep. Tom Bliley, Rep. Henry Waxman,
Passage votes
- HouseVoice vote
- SenateVoice vote
Data notes
The final version of the law, as each chamber passed it. A chamber that passed it by voice vote or unanimous consent has no count. “Method not stated” means the record does not say how the chamber voted. Where the record has a member-by-member vote, the “Who voted for it” section shows who voted yea.
Summary
The Congressional Research Service’s plain-language summary of what the law does.
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.
Committees
The committees the bill was sent to, and what each did with it.
Energy and Commerce Committee · House · markup by, referred to, reported bySubcommittee: Health and Environment Subcommittee
Data notes
A committee links to its page only where it exists in the current Congress; older and renamed committees are named without a link.
Timeline
From introduction to signing, newest first: the committees, the floor and the president. 23 actions.
- May 13, 1992Became lawBecame law · Became Public Law No: 102-282.
- Became lawBecame law · Signed by President.
- May 1, 1992PresidentPresident · Presented to President.
- Apr 28, 1992Resolving differencesResolving differences · Motion to reconsider laid on the table Agreed to without objection.
- Resolving differencesResolving differences · On motion that the House agree to the Senate amendments Agreed to by voice vote.
- Resolving differencesResolving differences · Mr. Waxman moved that the House suspend the rules and agree to the Senate amendments.
- Apr 10, 1992FloorFloor · Passed Senate with an amendment and an amendment to the Title by Voice Vote.
- FloorFloor · Amendment SP 1787 agreed to in Senate by Voice Vote.
- FloorFloor · Measure laid before Senate by unanimous consent.
- CommitteeCommittee · Discharged from Senate Health, Education, Labor, and Pensions Committee
- Nov 4, 1991CommitteeCommittee · Referred to Senate Health, Education, Labor, and Pensions Committee
- Oct 31, 1991FloorFloor · Motion to reconsider laid on the table Agreed to without objection.
- FloorFloor · 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).House roll call 359
- Oct 28, 1991FloorFloor · 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.
- FloorFloor · Mr. Waxman moved to suspend the rules and pass the bill, as amended.
- Oct 24, 1991CommitteeCommittee · Reported by House Energy and Commerce Committee
- Sep 25, 1991CommitteeCommittee · Markup by House Energy and Commerce Committee
- Jul 29, 1991CommitteeCommittee · Markup by Health and Environment Subcommittee of the House Energy and Commerce Committee
- CommitteeCommittee · Reported by Health and Environment Subcommittee of the House Energy and Commerce Committee
- Jun 26, 1991CommitteeCommittee · Hearings by Health and Environment Subcommittee of the House Energy and Commerce Committee
- Jun 10, 1991CommitteeCommittee · Referred to Health and Environment Subcommittee of the House Energy and Commerce Committee
- May 23, 1991CommitteeCommittee · Referred to House Energy and Commerce Committee
- IntroducedIntroduced · Introduced in the House
Data notes
Shows the introduction, each committee and subcommittee step the source dates (referral, hearings, markup, report, discharge), and the floor, conference, presidential and became-law steps. Calendar placements, messages between the chambers, amendments and committee report numbers are not shown for laws before the 108th Congress. Two entries the source lists twice are shown once.
Official record
The bill’s full text and every action, including introduction and committee steps, are on Congress.gov. Data through Oct 7, 2026.