for the first plan year in such negotiated price pe-
riod. 
‘‘(3) COMPETITIVE LICENSING AUTHORITY.— 
‘‘(A) IN GENERAL.—Notwithstanding any 
exclusivity under clause (iii) or (iv) of section 
505(j)(5)(F) of the Federal Food, Drug, and 
Cosmetic Act, clause (iii) or (iv) of section 
505(c)(3)(E) of such Act, section 351(k)(7)(A) 
of the Public Health Service Act, or section 
527(a) of the Federal Food, Drug, and Cos-
metic Act, or by an extension of such exclusivity 
under section 505A of such Act or section 505E 
of such Act, and any other provision of law that 
provides for market exclusivity (or extension of 
market exclusivity) with respect to a drug, in 
the case that the Secretary is unable to success-
fully negotiate an appropriate price for a cov-
ered part D drug for a negotiated price period, 
the Secretary shall authorize the use of any 
patent, clinical trial data, or other exclusivity 
granted by the Federal government with respect 
to such drug as the Secretary determines ap-
propriate for purposes of manufacturing such 
drug for sale under a prescription drug plan or 
MA–PD plan. Any entity making use of a com-
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petitive license to use patent, clinical trial data, 
or other exclusivity under this section shall pro-
vide to the manufacturer holding such exclu-
sivity reasonable compensation, as determined 
by the Secretary based on the following factors: 
‘‘(i) The risk-adjusted value of any 
Federal government subsidies and invest-
ments in research and development used to 
support the development of such drug. 
‘‘(ii) The risk-adjusted value of any 
investment made by such manufacturer in 
the research and development of such 
drug. 
‘‘(iii) The impact of the price, includ-
ing license compensation payments, on 
meeting the medical need of all patients. 
‘‘(iv) The relationship between the 
price of such drug, including compensation 
payments, and the health benefits of such 
drug. 
‘‘(v) Other relevant factors determined 
appropriate by the Secretary to provide 
reasonable compensation. 
‘‘(B) REASONABLE
COMPENSATION.—The 
manufacturer described in subparagraph (A) 
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may seek recovery against the United States in 
the United States Court of Federal Claims. 
‘‘(C) INTERIM PERIOD.— 
‘‘(i) IN GENERAL.—Until 1 year after 
a drug described in subparagraph (A) is 
approved under section 505(j) of the Fed-
eral Food, Drug, and Cosmetic Act or sec-
tion 351(k) of the Public Health Service 
Act and is provided under license issued by 
the Secretary under such subparagraph, 
PDP plans and MA–PD plans shall not 
pay more for such drug than the average 
of the prices available, during the most re-
cent 12-month period for which data is 
available prior to the beginning of such ne-
gotiated price period, from the manufac-
turer to any wholesaler, retailer, provider, 
health maintenance organization, nonprofit 
entity, or governmental entity in the ten 
OECD (Organization for Economic Co-
operation and Development) countries that 
have the largest gross domestic product 
with a per capita income that is not less 
than half the per capita income of the 
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United States, as reported by the manufac-
turer to the Secretary. 
‘‘(ii) FEDERAL
PROGRAM
LICENS-
ING.—If such drug is not made available 
at the price determined, the Secretary shall 
authorize such entities to use any patent, 
clinical trial data, or other exclusivity 
granted by the Federal government with 
respect to such drug as the Secretary de-
termines appropriate for purposes of man-
ufacturing such drug for sale under any 
Federal program, including those provided 
by Medicare, Medicaid, Veterans Affairs, 
the Department of Defense, and the Coast 
Guard. 
‘‘(4) FDA EXPEDITED REVIEW OF LICENSED 
DRUG APPLICATIONS.—The Secretary shall prioritize 
review of applications under section 505(j) of the 
Federal Food, Drug, and Cosmetic Act for drugs li-
censed under paragraph (3)(A). 
‘‘(5) PROHIBITION
OF
ANTICOMPETITIVE
BE-
HAVIOR.—No drug manufacturer may engage in 
anticompetitive behavior with another manufacturer 
that may interfere with the issuance and implemen-
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tation of a competitive license or run contrary to 
public policy. 
‘‘(6) CLARIFICATION.—Nothing in this sub-
section shall be construed as preventing the sponsor 
of a prescription drug plan or an organization offer-
ing an MA–PD plan from obtaining a discount or 
reduction of the price for a covered part D drug 
below the price negotiated by the Secretary.’’. 
Æ 
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