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H.R. 4598: Accutane Safety and Risk Management Act

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H.R. 4598: Accutane Safety and Risk Management Act

108th Congress · introduced 2004-06-16 · Health · Latest: Sponsor introductory remarks on measure. (CR H7821-7822)

federal

Follow this bill, step by step

  1. Where it came from: introduced 2004-06-16 · official record
  2. Who proposed it: Rep. Stupak, Bart [D-MI-1] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Sponsor introductory remarks on measure. (CR H7821-7822) Not final yet: this can still change. We check for updates every day.
  5. If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

Accutane Safety and Risk Management Act

Plain summary

Accutane Safety and Risk Management Act - Requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to withdraw approval within 30 days for the sale of drugs that contain isotretinoin as an active ingredient, including Accutane. Allows the Secretary to approve subsequent supplemental applications for such drugs subject to certain restrictions, including safety reporting. Requires that distribution of such drugs be limited, including by: (1) allowing distribution only directly from manufacturers to pharmacists; (2) requiring pharmacists to register, receive education on side effects, dispense only those prescriptions from physicians at certified treatment centers, and file a statement of compliance; (3) developing educational materials for patients, including monthly questionnaires for patients to monitor the development of adverse side effects; (4) requiring patients to register, receive counseling on the drug, sign a statement providing informed consent for treatment, and undergo appropriate tests; and (5) limiting prescriptions to a 30-day supply with no refills. Specifies conditions for a clinic to be certified as a treatment center for a drug containing isotretinoin, including requiring each practitioner to meet certain conditions, such as requirements for registration, an agreement to prescribe in accordance with this Act, and reporting of adverse events. Requires the Secretary to monitor the distribution of such drugs to determine whether the drug is being distributed in accordance with this Act. Requires manufacturers and distributors of isotretinoin to report any information on adverse events associated with the drug to the Secretary. Requires the Secretary to conduct and support studies to explore the effects of isotretinoin on the central nervous system and behavior, including depression, suicide, and violent behavior.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

Accutane Safety and Risk Management Act

Source: Congressional Research Service summary (Introduced in House)

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The strongest published arguments

Arguments for (supporters)

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Arguments against (opponents)

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Stupak, Bart [D-MI-1] · 14 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Christopher H. Smith (R-NJ), Diana DeGette (D-CO), Rosa L. DeLauro (D-CT)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (1)
Appropriation
Money a legislature sets aside by law for a specific purpose. Government agencies may spend public money only as it has been appropriated.

Plain meanings written from linked sources. All words.

Sources

Record fed-us-cong108-hr4598 · catalog fed-us-congress-bills-cong108 · updated 2026-11-15 by psicol fed-bills-cong108