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 subsequently approved 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.
Specifies conditions under which the Secretary may approve a drug that contains isotretinoin as an active ingredient for a new use.
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 Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2956 Introduced in House (IH)]
109th CONGRESS
1st Session
H. R. 2956
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, 2005
Mr. Stupak 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.
(e) Additional Approved Uses.--
(1) In general.--With respect to a drug that contains
isotretinoin as an active ingredient, this section may not be
construed as prohibiting the Secretary from approving an
application under section 505 of the Federal Food, Drug, and
Cosmetic Act for such a drug for a use different than the use
described in subsection (b)(4)(A) (which different use is
referred to in this subsection as a ``new use'').
(2) Conditions.--For purposes of paragraph (1):
(A) An approval by the Secretary of a new use is
subject to the same conditions as apply under
subsection (b) with respect to the use described in
paragraph (4)(A) of such subsection.
(B) In applying such conditions to the new use, the
Secretary may authorize the program under subsection
(b) to be expanded to include the new use, or the
Secretary may require the establishment of a separate
program for the new use.
(C) The requirement of monitoring under subsection
(d) applies with respect to the new use to the same
extent and in the same manner as the requirement
applies with respect to the use described in subsection
(b)(4)(A).
(D) Section 3 applies with respect to the new use.
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 2006 and each subsequent fiscal
year, in addition to any other authorizations of appropriations that
are available for such purpose.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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