tional one-year periods only if the program has con-
ducted 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 pro-
tect 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 dis-
pensing of the drug, to determine whether the drug is 
being distributed in accordance with the program ap-
proved 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 Sec-
retary 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 de-
scribed 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 de-
scribed 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 MANUFAC-
TURERS AND DISTRIBUTORS. 
(a) IN GENERAL.—Each person who is a manufac-
turer 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 ad-
verse 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 pur-
poses of the preceding sentence. 
(b) TIMEFRAME
FOR REPORTING.—A person de-
scribed 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 Men-
tal Health, shall continue to conduct and support appro-
priate 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, includ-
ing 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 author-
ized 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. 
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