[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4598 Introduced in House (IH)]






108th CONGRESS
  2d Session
                                H. R. 4598

 To provide for the establishment of certain restrictions with respect 
   to drugs containing isotretinoin (including the drug marketed as 
                               Accutane).


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 16, 2004

    Mr. Stupak (for himself, Mr. Smith of New Jersey, Mr. Weldon of 
Florida, Ms. Kilpatrick, Mr. Wamp, Ms. DeGette, Mr. Burton of Indiana, 
   Ms. DeLauro, Mr. Doyle, Mr. Baca, and Mr. Gordon) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
 To provide for the establishment of certain restrictions with respect 
   to drugs containing isotretinoin (including the drug marketed as 
                               Accutane).

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Accutane Safety and Risk Management 
Act''.

SEC. 2. FEDERAL FOOD, DRUG, AND COSMETIC ACT; RESTRICTIONS REGARDING 
              DRUG ISOTRETINOIN.

    (a) In General.--Not later than the expiration of the 30-day period 
beginning on the date of the enactment of this Act, the Secretary of 
Health and Human Services (referred to in this Act as the 
``Secretary''), acting through the Commissioner of Food and Drugs, 
shall withdraw the approval under section 505 of the Federal Food, 
Drug, and Cosmetic Act of each application for a drug that contains 
isotretinoin as an active ingredient (including the drug marketed as 
Accutane). During or after such period, any holder of an application 
that is subject to the preceding sentence may file with the Secretary a 
supplemental application for such drug, and the Secretary may approve 
the supplemental application in accordance with subsection (b).
    (b) Restrictions.--Any approval by the Secretary of a supplemental 
application for a drug containing isotretinoin pursuant to subsection 
(a) shall provide that such drug is being approved as a drug subject to 
subpart H of part 314 of title 21, Code of Federal Regulations. The 
Secretary shall under such subpart H establish restrictions on the 
distribution of the drug. Such restrictions shall require that 
distribution of the drug under all the approved supplemental 
applications be exclusively through a single program, approved by the 
Secretary, that provides for the distribution of the drug in accordance 
with the following conditions:
            (1) Distribution of the drug by manufacturers is directly 
        to pharmacists (without the involvement of entities engaged in 
        the wholesale distribution of drugs), and each pharmacist 
        receiving the drug is in compliance with the following:
                    (A) The pharmacist has registered with the program.
                    (B) The pharmacist has received education on 
                potential side effects of the drug relating to birth 
                defects and mental health or behavioral issues that, as 
                of the day before the date of the enactment of this 
                Act, were described on the approved labeling for the 
                drug (including depression, suicidal ideation, suicide 
                attempts, suicide, and aggressive or violent behavior).
                    (C) The pharmacist agrees that the drug will be 
                dispensed only pursuant to prescriptions issued by 
                practitioners at treatment centers certified under 
                paragraph (2).
                    (D) The pharmacist has signed and filed with the 
                program a statement that the pharmacist understands the 
                conditions for participation in the program as a 
                pharmacist, and will maintain compliance with the 
                agreement described in subparagraph (C) and otherwise 
                comply with applicable conditions.
            (2) The program certifies clinics and medical offices as 
        treatment centers regarding the drug, makes the certifications 
        in accordance with the conditions described in subsection (c), 
        provides that the certifications are effective for one year, 
        and maintains a registry of treatment centers for which 
        certifications are in effect.
            (3) The program develops and makes available to 
        practitioners materials for educating patients on the drug, 
        including managing the risks associated with the drug, and such 
        materials include a questionnaire, to be completed monthly by 
        patients, that warns patients of the adverse side effects 
        described in paragraph (1)(B) and monitors for the development 
        of any such effects in patients.
            (4) The drug is prescribed for a patient by a practitioner 
        only in accordance with the following:
                    (A) The drug is prescribed for severe, recalcitrant 
                nodular acne that is unresponsive to conventional 
                therapy, including antibiotics.
                    (B) The patient is registered with the program.
                    (C) Using the materials referred to in paragraph 
                (3), the practitioner educates the patient on the drug, 
                including providing one-on-one, in-person counseling.
                    (D) The practitioner provides to the patient the 
                questionnaire referred to in paragraph (3), and the 
                patient completes the questionnaire.
                    (E) The patient signs a statement providing the 
                informed consent of the patient to undergo treatment 
                with the drug (or a parent or guardian of the patient 
                signs the statement, in the case of a patient who is a 
                minor or otherwise lacks legal capacity).
                    (F) The patient undergoes the appropriate blood 
                tests.
                    (G) In the case of a female patient--
                            (i) the education under subparagraph (C) 
                        includes education on the need to avoid 
                        becoming pregnant while being treated with the 
                        drug; and
                            (ii) the practitioner determines that the 
                        patient is not pregnant, as indicated by an 
                        electronic verification, provided to the 
                        practitioner by an accredited laboratory, that 
                        the patient has undergone a pregnancy test and 
                        received a negative result.
                    (H) In the case of a male patient, the education 
                under subparagraph (C) includes education on the need 
                to avoid impregnating women while being treated with 
                the drug.
                    (I) The prescription is issued only after 
                compliance with subparagraphs (B) through (H).
                    (J) The prescription is for a 30-day supply of the 
                drug, with no refills.
                    (K) Each further prescription for the drug is 
                issued by the practitioner to the patient only pursuant 
                to another in-person consultation with the 
                practitioner, and prior to issuing the prescription, 
                compliance with subparagraphs (C) through (I) is 
                repeated.
                    (L) The patient undergoes the appropriate blood 
                tests 30 days after the conclusion of treatment with 
                the drug.
            (5) Such additional conditions as the Secretary may by 
        regulation determine to be necessary to protect the public 
        health with respect to the drug.
    (c) Certification of Treatment Centers.--For purposes of subsection 
(b)(2), the conditions for the program to certify a clinic or medical 
office as a treatment center regarding a drug containing isotretinoin 
are as follows:
            (1) The program determines that each of the practitioners 
        at the clinic or office who will prescribe the drug is in 
        compliance with the following:
                    (A) The practitioner is authorized under the law of 
                the State involved to administer prescription drugs.
                    (B) The practitioner has registered with the 
                program and received education on the potential side 
                effects referred to in subsection (b)(1)(B).
                    (C) The practitioner agrees as follows:
                            (i) The practitioner will prescribe the 
                        drug for a patient in accordance with 
                        subsection (b)(4).
                            (ii) If a female patient being treated with 
                        the drug becomes pregnant, the practitioner 
                        will immediately report the pregnancy to the 
                        program and provide follow-up in accordance 
                        with the program.
                            (iii) The practitioner will not issue 
                        prescriptions for the drug by telephone or 
                        facsimile transmission, or through the 
                        Internet.
                            (iv) The practitioner will--
                                    (I) report to the Secretary any 
                                information received by the 
                                practitioner on adverse events that are 
                                associated with the use of the drug by 
                                patients of the practitioner; and
                                    (II) submit such reports quarterly, 
                                except in the case of a patient death 
                                associated with the drug, in which case 
                                the report will be submitted 
                                immediately, but in no case later than 
                                15 days after the date on which the 
                                practitioner learns of the death.
                    (D) The practitioner has signed and filed with the 
                program a statement that the practitioner understands 
                the conditions for participation in the program as a 
                practitioner, and will maintain compliance with the 
                agreements described in subparagraph (C) and otherwise 
                comply with applicable conditions.
            (2) After the initial certification of the clinic or 
        office, the program renews a certification for additional-one 
        year periods only if the program has conducted an evaluation to 
        determine whether, during the preceding one-year period, each 
        practitioner at the center who prescribes the drug has 
        maintained substantial compliance with applicable conditions of 
        the program.
            (3) Such additional conditions as the Secretary may by 
        regulation determine to be necessary to protect the public 
        health with respect to the drug.
    (d) Monitoring by Secretary.--The Secretary shall monitor the 
distribution of drugs containing isotretinoin under supplemental 
applications approved under subsection (b), including the prescribing 
and dispensing of the drug, to determine whether the drug is being 
distributed in accordance with the program approved by the Secretary 
under such subsection.

SEC. 3. REPORTING OF ADVERSE EVENTS BY MANUFACTURERS AND DISTRIBUTORS.

    (a) In General.--Each person who is a manufacturer or distributor 
of a drug containing isotretinoin shall report to the Secretary any 
information received by such person on adverse events that are 
associated with such drug. In any case in which an individual reports 
an adverse event to such person and states that the individual believes 
the drug is a factor in the event, the person shall consider the event 
to be associated with the drug for purposes of the preceding sentence.
    (b) Timeframe for Reporting.--A person described in subsection (a) 
shall submit reports under such subsection to the Secretary on a 
quarterly basis, except that in the case of a death associated with 
isotretinoin, the report shall be submitted immediately, but in no case 
later than 15 days after the date on which the person learns of the 
death.

SEC. 4. FURTHER STUDIES.

    (a) In General.--The Secretary, in consultation with the Director 
of the Centers for Disease Control and Prevention, the Director of the 
National Institutes of Health, and the Director of the National 
Institute of Mental Health, shall continue to conduct and support 
appropriate studies to explore, in adolescents and adults--
            (1) the effects of isotretinoin and retinoid acid on the 
        central nervous system, including the brain; and
            (2) the behavioral effects of isotretinoin, including 
        depression, suicidal ideation, suicide attempts, suicide, and 
        aggressive or violent behavior.
    (b) Authorization of Appropriations.--For the purpose of studies 
under subsection (a), there are authorized to be appropriated such sums 
as may be necessary for fiscal year 2005 and each subsequent fiscal 
year, in addition to any other authorizations of appropriations that 
are available for such purpose.
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