I 
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 Representa-
tives 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; RE-
STRICTIONS 
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 with-
draw 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 (includ-
ing 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 supple-
mental 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 re-
strictions 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 fol-
lowing 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 de-
pression, 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 cer-
tified under paragraph (2). 
(D) The pharmacist has signed and filed 
with the program a statement that the phar-
macist understands the conditions for participa-
tion in the program as a pharmacist, and will 
maintain compliance with the agreement de-
scribed in subparagraph (C) and otherwise com-
ply with applicable conditions. 
(2) The program certifies clinics and medical 
offices as treatment centers regarding the drug, 
makes the certifications in accordance with the con-
ditions described in subsection (c), provides that the 
certifications are effective for one year, and main-
tains a registry of treatment centers for which cer-
tifications 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 ques-
tionnaire, to be completed monthly by patients, that 
warns patients of the adverse side effects described 
in paragraph (1)(B) and monitors for the develop-
ment 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, re-
calcitrant nodular acne that is unresponsive to 
conventional therapy, including antibiotics. 
(B) The patient is registered with the pro-
gram.