251 
‘‘(B) based on appropriate medical judg-
ment, may jeopardize the patient and may re-
quire a medical or surgical intervention to pre-
vent an outcome described under subparagraph 
(A). 
‘‘(5) SERIOUS RISK.—The term ‘serious risk’ 
means a risk of a serious adverse drug experience. 
‘‘(6) SIGNAL OF A SERIOUS RISK.—The term 
‘signal of a serious risk’ means information related 
to a serious adverse drug experience associated with 
use of a drug and derived from— 
‘‘(A) a clinical trial; 
‘‘(B) adverse event reports; 
‘‘(C) a postapproval study, including a 
study under section 505(o)(3); 
‘‘(D) peer-reviewed biomedical literature; 
or 
‘‘(E) data derived from a postmarket risk 
identification and analysis system under section 
505(k)(3). 
‘‘(7) RESPONSIBLE
PERSON.—The term ‘re-
sponsible person’ has the meaning indicated for such 
term in subsection (e)(2). 
‘‘(8) UNEXPECTED SERIOUS RISK.—The term 
‘unexpected serious risk’ means a serious adverse 
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drug experience that is not listed in the labeling of 
a drug, or that may be symptomatically and 
pathophysiologically related to an adverse drug expe-
rience identified in the labeling, but differs from 
such adverse drug experience because of greater se-
verity, specificity, or prevalence. 
‘‘(c) CONTENTS.—A proposed risk evaluation and 
mitigation strategy under subsection (a) shall— 
‘‘(1) include the timetable required under sub-
section (d); and 
‘‘(2) to the extent required by the Secretary, in-
clude additional elements described in subsections 
(e) and (f). 
‘‘(d) MINIMAL STRATEGY.—For purposes of sub-
section (c)(1), the risk evaluation and mitigation strategy 
for a drug shall require a timetable for submission of as-
sessments of the strategy that— 
‘‘(1) is not less frequent than once annually for 
the first 3 years after the strategy is initially ap-
proved; 
‘‘(2) includes an assessment in the seventh year 
after the strategy is so approved; and 
‘‘(3) subject to paragraph (2), for subsequent 
years— 
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‘‘(A) is at a frequency specified in the 
strategy; 
‘‘(B) is increased or reduced in frequency 
as necessary as provided for in subsection 
(g)(4)(A); and 
‘‘(C) is eliminated after the 3-year period 
described in paragraph (1) if the Secretary de-
termines that serious risks of the drug have 
been adequately identified and assessed and are 
being adequately managed. 
‘‘(e) ADDITIONAL POTENTIAL ELEMENTS OF STRAT-
EGY.— 
‘‘(1) IN GENERAL.—The Secretary may under 
subsection (c)(2) require that the risk evaluation 
and mitigation strategy for a drug include 1 or more 
of the additional elements described in this sub-
section if the Secretary makes the determination re-
quired with respect to the element involved. 
‘‘(2) MEDGUIDE; PATIENT PACKAGE INSERT.— 
The risk evaluation and mitigation strategy for a 
drug may require that, as applicable, the person sub-
mitting the covered application or the holder of the 
approved such application (referred to in this section 
as the ‘responsible person’) develop for distribution 
to each patient when the drug is dispensed— 
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