HR 4598 · 108th Congress 2003–2005, ended

Accutane Safety and Risk Management Act

Introduced Jun 16, 2004 Originated House Sponsor Bart Stupak D-MI

Latest action · Sep 29, 2004 Sponsor introductory remarks on measure. (CR H7821-7822)

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

IntroducedJun 16, 2004
Passed HouseNot reached
Passed SenateNot reached
To the PresidentNot reached
Became lawNot reached

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.

Cosponsors 14

Members who signed on, in the order they did. Signatures ran from Jun 16, 2004 to Oct 6, 2004; 10 are original cosponsors, there from the day it was introduced.

Seat	Cosponsor		Signed on
D-TN	Bart Gordon	Original	Jun 16, 2004
D-MI	Carolyn C. Kilpatrick	Original	Jun 16, 2004
R-NJ	Christopher H. Smith	Original	Jun 16, 2004
R-IN	Dan Burton	Original	Jun 16, 2004
R-FL	Dave Weldon	Original	Jun 16, 2004
D-CO	Diana DeGette	Original	Jun 16, 2004
D-CA	Joe Baca	Original	Jun 16, 2004
D-PA	Michael F. Doyle	Original	Jun 16, 2004
D-CT	Rosa L. DeLauro	Original	Jun 16, 2004
R-TN	Zach Wamp	Original	Jun 16, 2004
R-FL	Cliff Stearns		Jul 9, 2004
R-MI	Candice S. Miller		Oct 6, 2004
D-VI	Donna M. Christensen		Oct 6, 2004
D-WA	Jim McDermott		Oct 6, 2004

Committees 1

Where it was sent and what each committee and subcommittee did with it, in order.

Chamber	Committee	What it did
House	Energy and Commerce Committee	Referred Jun 16, 2004
	Health Subcommittee	Referred Jul 7, 2004

Actions 4

Everything that happened, newest first.

Sep 29, 2004Sponsor introductory remarks on measure. (CR H7821-7822)
Jul 7, 2004Referred to the Subcommittee on Health.
Jun 16, 2004Introduced in House
Jun 16, 2004Referred to the House Committee on Energy and Commerce.

In the Congressional Record 6

Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.

Where	In the Record	Members	Date
House	Debate and remarks H10003	Bart Stupak D-MI	Nov 19, 2004
House	Debate and remarks H9992	Bart Stupak D-MI	Nov 18, 2004
House	Debate and remarks H7940	Bart Stupak D-MI	Sep 30, 2004
House	Debate and remarks H7821	Bart Stupak D-MI	Sep 29, 2004
Extensions	Debate and remarks E1465	Christopher H. Smith R-NJ	Jul 22, 2004
Extensions	Debate and remarks E1364	Christopher H. Smith R-NJ	Jul 14, 2004

Research

What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.

Printed hearings 1

Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.

Number	Hearing	Committee	Held
—	PRIVACY IN THE HANDS OF THE GOVERNMENT: THE PRIVACY OFFICER FOR THE DEPARTMENT OF HOMELAND SECURITY49 pages	Judiciary Committee	Feb 10, 2004

Titles 2

Every title it has carried, official and short, at each stage.

Official Title as Introduced: To provide for the establishment of certain restrictions with respect to drugs containing isotretinoin (including the drug marketed as Accutane).
Short Titles as Introduced: Accutane Safety and Risk Management Act

Subjects

Assigned by the Library of Congress. Policy area: Health.

Text 1

Each version as it was printed, newest first.

Jun 16, 2004Introduced in House

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.