‘‘(1) meet not less frequently than every 180 
days; and 
‘‘(2) make recommendations to the Director of 
the Center with respect to— 
‘‘(A) which drugs and biological products 
should be the subject of a study under sub-
section (d) or (e); 
‘‘(B) the design and duration for studies 
under subsection (d) or (e); 
‘‘(C) which drugs and biological products 
may present an unreasonable risk to the health 
of patients or the general public; and 
‘‘(D) appropriate corrective actions under 
subsection (k). 
‘‘(j) PENALTIES.— 
‘‘(1) IN
GENERAL.—If the Secretary deter-
mines, after notice and opportunity for an informal 
hearing, that a sponsor of a drug or biological prod-
uct or other entity has failed to complete a study re-
quired under subsection (d) or (e) by the date or to 
the terms specified by the Secretary under such sub-
section, the Secretary may order such sponsor or 
other entity to— 
‘‘(A) complete the study in a specified 
time;
‘‘(B) revise the study to comply with the 
terms specified by the Secretary under sub-
section (d) or (e); or 
‘‘(C) pay a civil penalty. 
‘‘(2) AMOUNT OF PENALTIES.— 
‘‘(A) IN GENERAL.—The civil penalty or-
dered under paragraph (1) shall be $250,000 
for the first 30-day period after the date speci-
fied by the Secretary that the study is not com-
pleted, and shall double in amount for every 30- 
day period thereafter that the study is not com-
pleted. 
‘‘(B) LIMITATION.—In no case shall a pen-
alty under subparagraph (A) exceed $2,000,000 
for any 30-day period. 
‘‘(3) NOTIFICATION
OF
PENALTY.—The Sec-
retary shall publish in the Federal Register any civil 
penalty ordered under this subsection. 
‘‘(k) RESULT OF DETERMINATION.— 
‘‘(1) IN GENERAL.—If the Director of the Cen-
ter makes a determination that a drug or biological 
product may present an unreasonable risk to the 
health of patients or the general public under sub-
section (g), such Director shall order a corrective ac-
tion, as described under paragraph (2).
‘‘(2) CORRECTIVE ACTIONS.—The corrective ac-
tion described under subsection (g)— 
‘‘(A) may include— 
‘‘(i) requiring a change to the drug or 
biological product label by a date specified 
by the Director of the Center; 
‘‘(ii) modifying the approved indica-
tion of the drug or biological product to re-
strict use to certain patients; 
‘‘(iii) placing restriction on the dis-
tribution of the drug or biological product 
to ensure safe use; 
‘‘(iv) requiring the sponsor of the 
drug or biological product or license to es-
tablish a patient registry; 
‘‘(v) requiring patients to sign a con-
sent form prior to receiving a prescription 
of the drug or biological product; 
‘‘(vi) requiring the sponsor to monitor 
sales and usage of the drug or biological 
product to detect unsafe use; 
‘‘(vii) requiring patient or physician 
education; and
‘‘(viii) requiring the establishment of 
a risk management plan by the sponsor; 
and 
‘‘(B) shall include the requirements with 
respect to promotional material under sub-
section (l)(1). 
‘‘(3) PENALTIES.— 
‘‘(A) IN GENERAL.—If the Secretary deter-
mines, after notice and opportunity for an in-
formal hearing, that a sponsor of a drug or bio-
logical product has failed to take the corrective 
action ordered by the Director of the Center 
under this subsection or has failed to comply 
with subsection (l)(2), the Secretary may order 
such sponsor to pay a civil penalty. 
‘‘(B) AMOUNT OF PENALTIES.— 
‘‘(i) IN GENERAL.—The civil penalty 
order under subparagraph (A) shall be 
$250,000 for the first 30-day period that 
the sponsor does not comply with the order 
under paragraph (1), and shall double in 
amount for every 30-day period thereafter 
that the order is not complied with.
‘‘(ii) LIMITATION.—In no case shall a 
penalty under clause (i) exceed $2,000,000 
for any 30-day period. 
‘‘(C) NOTIFICATION
OF
PENALTY.—The 
Secretary shall publish in the Federal Register 
any civil penalty ordered under this paragraph. 
‘‘(l) PROMOTION MATERIAL.— 
‘‘(1) SAFETY
ISSUE.—If the Director of the 
Center makes a determination that a drug or bio-
logical product may present an unreasonable risk to 
the health of patients or the general public under 
subsection (g), such Director, in consultation with 
the Division of Drug Marketing, Advertising, and 
Communications of the Food and Drug Administra-
tion, shall— 
‘‘(A) notwithstanding section 502(n), re-
quire that the sponsor of such drug or biologi-
cal product submit to the Director of the Cen-
ter copies of all promotional material with re-
spect to the drug or biological product not less 
than 30 days prior to the dissemination of such 
material; and 
‘‘(B) require that all promotional material 
with respect to the drug or biological product 
include certain disclosures, which shall be dis-