sivity period referred to’’ before ‘‘under 
clause (ii) of subsection (j)(5)(F)’’; 
(ii) in subsections (b)(1)(A)(i)(I) and 
(c)(1)(A)(i)(I) of section 505A— 
(I) by striking ‘‘five years’’ each 
place such term appears and inserting 
‘‘3 years’’; 
(II) by striking ‘‘seven and one- 
half years’’ each place such term ap-
pears and inserting ‘‘6 and one-half 
years’’; and 
(III) by striking ‘‘eight years’’ 
each place such term appears and in-
serting ‘‘7 years’’; and 
(iii) in section 505E, by striking ‘‘the 
4- and 5-year periods described in sub-
sections (c)(3)(E)(ii) and (j)(5)(F)(ii) of 
section 505, the 3-year periods described 
in clauses (iii) and (iv) of subsection 
(c)(3)(E) and clauses (iii) and (iv) of sub-
section (j)(5)(F)’’ and inserting ‘‘the 4- 
and 5-year periods described in subsection 
(c)(3)(E)(ii) of section 505, the 3-year pe-
riods described in clauses (iii) and (iv) of 
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subsection (c)(3)(E) and clauses (ii), (iii), 
and (iv) of subsection (j)(5)(F)’’; 
(2) NEW
CLINICAL
INVESTIGATION
EXCLU-
SIVITY.—Section 505(c)(3)(E)(iv) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
355(c)(3)(E)(iv)) is amended by inserting ‘‘, and the 
supplement shows a significant clinical benefit over 
existing therapies manufactured by the applicant in 
the 5-year period preceding the submission of the 
application,’’ before ‘‘the Secretary’’. 
(3) BIOLOGICAL PRODUCT EXCLUSIVITY.— 
(A) IN GENERAL.—Section 351(k)(7)(A) of 
the Public Health Service Act (42 U.S.C. 
262(k)(7)(A)) is amended by striking ‘‘12 
years’’ and inserting ‘‘7 years’’. 
(B) CONFORMING
AMENDMENTS.—Para-
graphs (2)(A) and (3)(A) of section 351(m) of 
the Public Health Service Act (42 U.S.C. 
262(m)) is amended by striking ‘‘12 years’’ 
each place it appears and inserting ‘‘7 years’’. 
(b) APPLICABILITY.—The amendments made by sub-
section (a) apply only with respect to a drug or biological 
product for which the listed drug (as described in section 
505(j)(7) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(j)(7)) or reference product (as such term 
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is used in section 351 of the Public Health Service Act 
(42 U.S.C. 262)) is approved under section 505(c) of the 
Federal Food, Drug, and Cosmetic Act or licensed under 
section 351(a) of the Public Health Service Act, as appli-
cable, on or after the date of enactment of this Act. 
(c) GAO STUDY.—Not later than 1 year after the 
date of enactment of this Act, the Comptroller General 
of the United States shall conduct a study and submit to 
Congress a report that includes— 
(1)(A) the number of requests for designation 
as a drug for a rare disease or condition under sec-
tion 526 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bb) the Food and Drug Adminis-
tration receives each year in the previous 10-year pe-
riod; 
(B) the number of such requests granted, de-
nied, and pending; 
(C) the names of all drugs receiving such des-
ignation during such period, including the date of 
approval and indication for which market exclusivity 
was granted; and 
(D) any drugs for which such designation has 
been revoked or amended during such period; 
(2) for each drug so designated as a drug for 
a rare disease or condition in the previous 10-year 
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period, the total annual expenditures for such drugs 
under the Medicare program under title XVIII of 
the Social Security Act (42 U.S.C. 1395 et seq.) and 
the Medicaid program under title XIX of the Social 
Security Act (42 U.S.C. 1396 et seq.), the number 
of Medicare and Medicaid beneficiaries who used 
each such drug each year during such time period, 
and any changes in price per unit during such time 
period; and 
(3) for a sample of drugs (selected by the 
Comptroller General) so designated in the previous 
10-year period, to the extent feasible— 
(A) gross revenues of the manufacturers 
with respect to each such drug, and manufac-
turer spending for marketing and patient as-
sistance programs; 
(B) the average price per drug and how 
those prices changed over time for the selected 
drugs based on industry drug pricing bench-
marks; and 
(C) the indications that were the basis of 
such designation and other approved indications 
for the drugs, and the indications for which 
each drug has most commonly been used, in-
cluding non-approved indications for which the 
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drug may be recommended by external organi-
zations such as physician or patient organiza-
tions. 
SEC. 304. IMPROVING PROGRAM INTEGRITY. 
(a) IN GENERAL.—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. 569D. CONDITIONS ON AWARD OF DRUG EXCLU-
SIVITY. 
‘‘(a) TERMINATION
OF
EXCLUSIVITY.—Notwith-
standing any other provision of this Act, any period of 
exclusivity described in subsection (b) granted to a person 
or assigned to a person on or after the date of enactment 
of this section with respect to a drug shall be terminated 
if the person to which such exclusivity was granted or any 
person to which such exclusivity is assigned commits a vio-
lation described in subsection (c)(1) with respect to such 
drug. 
‘‘(b) EXCLUSIVITIES AFFECTED.—The periods of ex-
clusivity described in this subsection are those periods of 
exclusivity granted under any of the following sections: 
‘‘(1) Clause (ii), (iii), or (iv) of section 
505(c)(3)(E). 
‘‘(2) Clause (iv) of section 505(j)(5)(B). 
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