3.0.0 4598 2023-01-15T04:49:14Z 2023-01-15T04:49:14Z House H HR 2004-06-16 108 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2004-07-07T16:45:47Z Referred to 2004-06-16T14:01:30Z 2004-09-29 Sponsor introductory remarks on measure. (CR H7821-7822) IntroReferral B00100 9 Library of Congress 2004-07-07 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2004-06-16 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2004-06-16 Introduced in House IntroReferral Intro-H 9 Library of Congress 2004-06-16 Introduced in House IntroReferral 1000 9 Library of Congress S001045 Rep. Stupak, Bart [D-MI-1] BART STUPAK D MI 1 N S000522 Rep. Smith, Christopher H. [R-NJ-4] CHRISTOPHER SMITH R NJ H. 4 2004-06-16 True W000267 Rep. Weldon, Dave [R-FL-15] DAVE WELDON R FL 15 2004-06-16 True K000180 Rep. Kilpatrick, Carolyn C. [D-MI-13] CAROLYN KILPATRICK D MI CHEEKS 13 2004-06-16 True W000119 Rep. Wamp, Zach [R-TN-3] ZACH WAMP R TN 3 2004-06-16 True D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2004-06-16 True B001149 Rep. Burton, Dan [R-IN-5] DAN BURTON R IN 5 2004-06-16 True D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 2004-06-16 True D000482 Rep. Doyle, Michael F. [D-PA-14] MIKE DOYLE D PA 14 2004-06-16 True B001234 Rep. Baca, Joe [D-CA-43] JOE BACA D CA 43 2004-06-16 True G000309 Rep. Gordon, Bart [D-TN-6] BART GORDON D TN 6 2004-06-16 True S000822 Rep. Stearns, Cliff [R-FL-6] CLIFF STEARNS R FL 6 2004-07-09 False C000380 Del. Christensen, Donna M. [D-VI-At Large] DONNA CHRISTENSEN D VI M. 0 2004-10-06 False M000404 Rep. McDermott, Jim [D-WA-7] JIM MCDERMOTT D WA 7 2004-10-06 False M001150 Rep. Miller, Candice S. [R-MI-10] Candice Miller R MI S. 10 2004-10-06 False Health Accreditation (Medical care) Administrative remedies Chemicals Clinics Commerce Communication in medicine Crime and Law Enforcement Department of Health and Human Services Directories Drug approvals Drug industry Drugs Environmental Protection Government Operations and Politics Government paperwork Health counseling Health education Health surveys Law Medical tests Mental depression Nervous system Pharmacies Pregnancy Pregnant women Risk Skin diseases Suicide Violence Women Women's health Health 00 2004-06-16 Introduced in House 2004-10-19T20:42:51Z 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.

]]> Accutane Safety and Risk Management Act Display Title Accutane Safety and Risk Management Act Official Title as Introduced To provide for the establishment of certain restrictions with respect to drugs containing isotretinoin (including the drug marketed as Accutane). Introduced in House IH Short Titles as Introduced Accutane Safety and Risk Management Act Introduced in House 2004-06-16T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-108hr4598ih/xml/BILLS-108hr4598ih.xml 2004-09-29 Sponsor introductory remarks on measure. (CR H7821-7822) text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.