(2) by adding at the end the following new 
paragraph: 
‘‘(4) MEDICALLY
ACCEPTED
INDICATION
DE-
FINED.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), for purposes of paragraph (1), the 
term ‘medically accepted indication’ has the 
meaning given that term— 
‘‘(i) in the case of a covered part D 
drug 
used 
in 
an 
anticancer 
chemotherapeutic 
regimen, 
in 
section 
1861(t)(2)(B), except that in applying 
such section, ‘PDP sponsor or MA–PD 
sponsor’ shall be substituted for ‘carrier’ 
each place it appears and the compendia 
identified in section 1927(g)(1)(B)(i)(III) 
shall be deemed to be included in the com-
pendia 
described 
in 
section 
1861(t)(2)(B)(ii)(I); and 
‘‘(ii) in the case of any other covered 
part D drug, in section 1927(k)(6). 
‘‘(B) CONSIDERATION OF OTHER CRITERIA 
ON
A
CASE-BY-CASE
BASIS.—Nothing in this 
subsection shall preclude a PDP sponsor offer-
ing a prescription drug plan or an MA organi-
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zation offering an MA–PD plan from, after a 
request by an individual enrolled in the plan for 
a coverage determination under section 1860D– 
4(g)(1), providing coverage of a covered part D 
drug for the individual in the case where the 
sponsor or organization determines, based on 
guidance provided by the Secretary for deter-
mining whether the use of a covered part D 
drug is for a medically accepted indication and 
supportive clinical evidence in peer reviewed 
medical literature, that the use of the covered 
part D drug is for a medically accepted indica-
tion.’’. 
(b) EFFECTIVE DATE.—The amendments made by 
this section shall apply to plan years beginning on or after 
January 1, 2010. 
SEC. 7. MODERNIZATION OF THE FOOD AND DRUG ADMIN-
ISTRATION. 
Subchapter E of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 
amended by adding at the end the following: 
‘‘SEC. 568. POLICIES RELATED TO STUDY EVALUATION IN-
FORMATION. 
‘‘(a) IN GENERAL.— 
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‘‘(1) NONSTATISTICAL
MEASURES.—The Sec-
retary shall give consideration to clinical judgment 
and risks to the patient from the disease or condi-
tion involved in the evaluation of the safety and ef-
fectiveness of drugs, biological products, and devices 
that treat serious or life-threatening diseases or con-
ditions. This policy shall apply— 
‘‘(A) in evaluating clinical study designs 
and endpoints; and 
‘‘(B) in making decisions with respect to 
product applications for approval under section 
561(d) or 561A. 
‘‘(2) TYPES OF NONSTATISTICAL MEASURES.— 
The policy established under paragraph (1), for the 
purposes described in such paragraph— 
‘‘(A) shall include such nonstatistical infor-
mation as— 
‘‘(i) clinical evaluation information, 
such as case history reports; 
‘‘(ii) scientific and clinical studies de-
signed to measure or define mechanisms of 
action or molecular targeting; 
‘‘(iii) data from animal and computer 
models; and 
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‘‘(iv) comparison with historical data; 
and 
‘‘(B) shall incorporate the use of— 
‘‘(i) evaluations of the adverse effect 
of delaying the availability of an investiga-
tional drug to even a small subpopulation 
of seriously ill patients; and 
‘‘(ii) scientific, observational, or clin-
ical studies designed and conducted to col-
lect well-documented information. 
‘‘(b) MEETINGS.—A meeting to address any pending 
scientific, medical, regulatory, or other issue relating to 
the development, investigation, review, or other aspect of 
a drug, biological product, or device shall ordinarily be 
held not later than 15 days of the receipt of a written 
request for the meeting by the sponsor of the product, 
which may be extended to 30 days for good cause. Such 
meetings shall ordinarily be conducted in person, but may 
be conducted by telephone or other form of communication 
if both parties agree. In order to reduce the burden of 
meetings, only those Food and Drug Administration em-
ployees who are intended to actively participate in the dis-
cussion shall attend a meeting. Minutes of a meeting shall 
be promptly prepared and exchanged by both parties im-
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mediately following the meeting and shall accurately sum-
marize what occurred at the meeting. 
‘‘(c) RULE OF CONSTRUCTION.—The provisions of 
this chapter and section 351 of the Public Health Service 
Act shall be construed to incorporate the policy established 
in this section.’’. 
SEC. 8. MEMBERSHIP OF ONCOLOGY DRUGS ADVISORY 
COMMITTEE AND THE CELLULAR, TISSUE, 
AND GENE THERAPY ADVISORY COMMITTEE. 
Notwithstanding any other provision of law, member-
ship of the Oncology Drugs Advisory Committee, the Cel-
lular, Tissue, and Gene Therapy Advisory Committee of 
the Food and Drug Administration, and any other com-
mittee created by such Administration to evaluate or ad-
vise with respect to applications submitted under section 
561(d) or 561A of the Federal Food, Drug, and Cosmetic 
Act (as added by this Act), shall consist of no less than 
2 patient representatives who are voting members of the 
committee. 
Æ 
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