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marketed under such section 505 or 351, including 
any insulin product that has been deemed to be li-
censed under section 351(a) of the Public Health 
Service Act pursuant to section 7002(e)(4) of the 
Biologics Price Competition and Innovation Act of 
2009 and continues to be marketed pursuant to such 
licensure. 
For purposes of applying paragraphs (1) and (2), a drug 
or biological product that is marketed by the same sponsor 
or manufacturer (or an affiliate thereof or a cross-licensed 
producer or distributor) as the listed drug or reference 
product described in such respective paragraph shall not 
be taken into consideration. 
‘‘(f) INFORMATION
ON
INTERNATIONAL
DRUG 
PRICES.—For purposes of determining which negotiation- 
eligible drugs to select under subsection (a) and, in the 
case of such drugs that are selected drugs, to determine 
the maximum fair price for such a drug and whether such 
maximum fair price should be renegotiated under section 
1194, the Secretary shall use data relating to the AIM 
price with respect to such drug as available or provided 
to the Secretary and shall on an ongoing basis request 
from manufacturers of selected drugs information on the 
AIM price of such a drug. 
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‘‘(g) 
NEW-ENTRANT
NEGOTIATION-ELIGIBLE 
DRUGS.— 
‘‘(1) IN GENERAL.—For purposes of this part, 
the term ‘new-entrant negotiation-eligible drug’ 
means, with respect to the selected drug publication 
date with respect to an initial price applicability 
year, a qualifying single source drug— 
‘‘(A) that is first approved or licensed, as 
described in paragraph (1), (2), or (3) of sub-
section (e), as applicable, during the year pre-
ceding such selected drug publication date; and 
‘‘(B) that the Secretary determines under 
paragraph (2) is likely to be included as a nego-
tiation-eligible drug with respect to the subse-
quent selected drug publication date. 
‘‘(2) DETERMINATION.—In the case of a quali-
fying single source drug that meets the criteria de-
scribed in subparagraph (A) of paragraph (1), with 
respect to an initial price applicability year, if the 
wholesale acquisition cost at which such drug is first 
marketed in the United States is equal to or greater 
than the median household income (as determined 
according to the most recent data collected by the 
United States Census Bureau), the Secretary shall 
determine before the selected drug publication date 
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with respect to the initial price applicability year, if 
the drug is likely to be included as a negotiation-eli-
gible drug with respect to the subsequent selected 
drug publication date, based on the projected spend-
ing under title XVIII or in the United States on 
such drug. For purposes of this paragraph the term 
‘United States’ includes the 50 States, the District 
of Columbia, and the territories of the United 
States. 
‘‘(h) CONFLICT OF INTEREST.— 
‘‘(1) IN GENERAL.—In the case the Inspector 
General of the Department of Health and Human 
Services determines the Secretary has a conflict, 
with respect to a matter described in paragraph (2), 
the individual described in paragraph (3) shall carry 
out the duties of the Secretary under this part, with 
respect to a negotiation-eligible drug, that would 
otherwise be such a conflict. 
‘‘(2) MATTER DESCRIBED.—A matter described 
in this paragraph is— 
‘‘(A) a financial interest (as described in 
section 2635.402 of title 5, Code of Federal 
Regulations (except for an interest described in 
subsection (b)(2)(iv) of such section)) on the 
date of the selected drug publication date, with 
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respect the price applicability year (as applica-
ble); 
‘‘(B) a personal or business relationship 
(as described in section 2635.502 of such title) 
on the date of the selected drug publication 
date, with respect the price applicability year; 
‘‘(C) employment by a manufacturer of a 
negotiation-eligible drug during the preceding 
10-year period beginning on the date of the se-
lected drug publication date, with respect to 
each price applicability year; and 
‘‘(D) any other matter the General Counsel 
determines appropriate. 
‘‘(3) INDIVIDUAL
DESCRIBED.—An individual 
described in this paragraph is— 
‘‘(A) the highest-ranking officer or em-
ployee of the Department of Health and 
Human Services (as determined by the organi-
zational chart of the Department) that does not 
have a conflict under this subsection; and 
‘‘(B) is nominated by the President and 
confirmed by the Senate with respect to the po-
sition. 
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‘‘SEC. 1193. MANUFACTURER AGREEMENTS. 
‘‘(a) 
IN
GENERAL.—For 
purposes 
of 
section 
1191(a)(2), the Secretary shall enter into agreements with 
manufacturers of selected drugs with respect to a price 
applicability period, by not later than June 15 following 
the selected drug publication date with respect to such se-
lected drug, under which— 
‘‘(1) during the voluntary negotiation period for 
the initial price applicability year for the selected 
drug, the Secretary and manufacturer, in accordance 
with section 1194, negotiate to determine (and, by 
not later than the last date of such period and in ac-
cordance with subsection (c), agree to) a maximum 
fair price for such selected drug of the manufacturer 
in order to provide access to such price— 
‘‘(A) to fair price eligible individuals who 
with respect to such drug are described in sub-
paragraph (A) of section 1191(c)(1) and are 
furnished or dispensed such drug during, sub-
ject to subparagraph (2), the price applicability 
period; and 
‘‘(B) to hospitals, physicians, and other 
providers of services and suppliers with respect 
to fair price eligible individuals who with re-
spect to such drug are described in subpara-
graph (B) of such section and are furnished or 
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administered such drug during, subject to sub-
paragraph (2), the price applicability period; 
‘‘(2) the Secretary and the manufacturer shall, 
in accordance with a process and during a period 
specified by the Secretary pursuant to rulemaking, 
renegotiate (and, by not later than the last date of 
such period and in accordance with subsection (c), 
agree to) the maximum fair price for such drug if 
the Secretary determines that there is a material 
change in any of the factors described in section 
1194(d) relating to the drug, including changes in 
the AIM price for such drug, in order to provide ac-
cess to such maximum fair price (as so renegoti-
ated)— 
‘‘(A) to fair price eligible individuals who 
with respect to such drug are described in sub-
paragraph (A) of section 1191(c)(1) and are 
furnished or dispensed such drug during any 
year during the price applicability period (be-
ginning after such renegotiation) with respect 
to such selected drug; and 
‘‘(B) to hospitals, physicians, and other 
providers of services and suppliers with respect 
to fair price eligible individuals who with re-
spect to such drug are described in subpara-
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