243 
sponsibility of the responsible person to main-
tain its label in accordance with existing re-
quirements, including subpart B and section 
314.70 of title 21, Code of Federal Regulations 
(or any successor regulations). 
‘‘(p) RISK EVALUATION AND MITIGATION STRAT-
EGY.— 
‘‘(1) IN GENERAL.—A person may not intro-
duce or deliver for introduction into interstate com-
merce a new drug if— 
‘‘(A)(i) the application for such drug is ap-
proved under subsection (b) or (j) and is sub-
ject to section 503(b); or 
‘‘(ii) the application for such drug is ap-
proved under section 351 of the Public Health 
Service Act; and 
‘‘(B) a risk evaluation and mitigation 
strategy is required under section 505–1 with 
respect to the drug and— 
‘‘(i) the person fails to maintain com-
pliance with the requirements of the ap-
proved strategy or with other requirements 
under section 505–1, including require-
ments regarding assessments of approved 
strategies; or 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00243
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS
244 
‘‘(ii) in the case of a requirement for 
such a strategy that is first established 
after the applicable application referred to 
in subparagraph (A) was approved with re-
spect to the drug, the Secretary, after no-
tice and opportunity for a hearing, pub-
lishes in the Federal Register a statement 
that the person is not cooperating with the 
Secretary in developing such a strategy for 
the drug. 
‘‘(2) REQUIRED STATEMENT DURING APPROVAL 
PROCESS.—In the case of an application approved 
under subsection (b) or (j) for a new drug that is 
subject to section 503(b), or an application approved 
under section 351 of the Public Health Service Act, 
or a supplement to such an application that requires 
substantive data, the Secretary may not approve the 
application or supplement unless the person involved 
has complied with the following: 
‘‘(A) The person has submitted to the Sec-
retary a statement that provides the following 
information: 
‘‘(i) Whether the person believes that 
a risk evaluation and mitigation strategy 
should be required under section 505–1. 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00244
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS
245 
‘‘(ii) Whether a postmarket study or 
clinical trial should be required under sub-
section (o)(3). 
‘‘(B) In making the statement under sub-
paragraph (A), the person took into account 
each of the following factors: 
‘‘(i) The estimated size of the popu-
lation likely to use the drug involved. 
‘‘(ii) The seriousness of the disease or 
condition that is to be treated with the 
drug. 
‘‘(iii) The expected benefit of the drug 
with respect to such disease or condition. 
‘‘(iv) The expected or actual duration 
of treatment with the drug. 
‘‘(v) The seriousness of any known or 
potential adverse events that may be re-
lated to the drug and the background inci-
dence of such events in the population like-
ly to use the drug. 
‘‘(3) CERTAIN
POSTMARKET
STUDIES.—The 
failure to conduct a postmarket study under subpart 
H of part 314 of title 21, Code of Federal Regula-
tions (or any successor regulation), is deemed to be 
a violation of paragraph (1).’’. 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00245
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS
246 
(b) REQUIREMENTS
REGARDING
STRATEGIES.— 
Chapter V of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 351 et seq.) is amended by inserting after sec-
tion 505 the following section: 
‘‘SEC. 505–1. RISK EVALUATION AND MITIGATION STRATE-
GIES. 
‘‘(a) SUBMISSION OF PROPOSED STRATEGY.— 
‘‘(1) INITIAL APPROVAL.—A person who sub-
mits 
an 
application 
referred 
to 
in 
section 
505(p)(1)(A) (referred to in this section as a ‘cov-
ered application’) shall submit to the Secretary as 
part of the application a proposed risk evaluation 
and mitigation strategy if the Secretary determines 
such a strategy is necessary to ensure that the bene-
fits of the drug involved outweigh the risks of the 
drug. In making such a determination, the Secretary 
shall consider the statement submitted by the person 
under section 505(p)(2) with respect to the drug and 
shall consider the following factors: 
‘‘(A) The estimated size of the population 
likely to use the drug involved. 
‘‘(B) The seriousness of the disease or con-
dition that is to be treated with the drug. 
‘‘(C) The expected benefit of the drug with 
respect to such disease or condition. 
VerDate Aug 31 2005 
05:37 Jul 12, 2007
Jkt 059200
PO 00000
Frm 00246
Fmt 6652
Sfmt 6201
E:\BILLS\H2900.RH
H2900
bajohnson on PROD1PC77 with BILLS