lection of nonclinical and clinical data necessary for 
approval is as efficient as practicable; 
‘‘(3) in the case of a complex product, assigning 
a cross-disciplinary project lead for the review team 
to facilitate an efficient review of the development 
program and application, including manufacturing 
inspections; and 
‘‘(4) in the case of a complex product, including 
drug-device combinations, involving senior managers 
and experienced review staff, as appropriate, in a 
collaborative, cross-disciplinary review. 
‘‘(e) REPORTING REQUIREMENT.—A sponsor of a 
drug expedited under this section shall report to the Sec-
retary, one year following approval of an application under 
section 505(j), on whether the approved drug has been 
marketed in interstate commerce since approval.’’. 
SEC. 202. LIST OF GENERIC DRUGS WITH LIMITED COM-
PETITION. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506H, as added by section 201, the following: 
‘‘SEC. 506I. DRUG LISTING. 
‘‘(a) REMOVAL, WITHDRAWAL, OR TRANSFER.—The 
holder of an application approved under subsection (b) or 
(j) of section 505 shall notify the Secretary within 180 
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days of removing the drug that is the subject of such ap-
plication from interstate commerce, withdrawing such ap-
proved application, or transferring such approved applica-
tion, and a reason for such removal, withdrawal, or trans-
fer. If compliance with this subsection within such 180- 
day period is not practicable, then the holder shall comply 
as soon as practicable. The Secretary shall cross-reference 
information listed pursuant to section 506C where applica-
ble to avoid duplicative reporting. Notification to the Sec-
retary by a manufacturer in accordance with section 
506C(a) shall be deemed to be in compliance with this sec-
tion. 
‘‘(b) DRUGS WITH LIMITED COMPETITION.— 
‘‘(1) INFORMATION.—The Secretary shall— 
‘‘(A) maintain information with respect to 
applications approved under section 505(j); and 
‘‘(B) publish on the Internet website of the 
Food and Drug Administration such informa-
tion under subparagraph (A) with respect to 
drugs for which there are 3 or fewer application 
holders; and 
‘‘(C) update the information published pur-
suant to subparagraph (B) every 180 days. 
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‘‘(2) CONTENTS.—The public information main-
tained and published under paragraph (1)(B) shall 
include— 
‘‘(A) the name of the drug, name of the 
holder of the approved application, and the 
marketing status for each drug; and 
‘‘(B) an indication of whether the Sec-
retary considers the drug to be for the treat-
ment or prevention of a serious disease or med-
ical condition, for which there is no alternative 
drug that is judged by medical professionals to 
be an adequate substitute available in adequate 
supply. 
‘‘(c) PUBLIC HEALTH EXCEPTION.—The Secretary 
may choose not to make information collected under this 
section publicly available if the Secretary determines that 
disclosure of such information would adversely affect the 
public health. 
‘‘(d) NOTIFICATION.—When the Secretary first pub-
lishes the information under subsection (b), the Secretary 
shall notify relevant Federal agencies, including the Cen-
ters for Medicare & Medicaid Services and the Federal 
Trade Commission, that the information has been pub-
lished and will be updated regularly.’’. 
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SEC. 203. SUITABILITY PETITIONS. 
(a) IN GENERAL.—It is the sense of the Senate that 
the Food and Drug Administration shall meet the require-
ment under section 505(j)(2)(C) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(C)) and sec-
tion 314.93(e) of title 21, Code of Federal Regulations, 
of responding to suitability petitions within 90 days of 
submission. 
(b) REPORT.—The Secretary of Health and Human 
Services shall include in the annual reports under section 
102(b)— 
(1) the number of pending petitions under sec-
tion 505(j)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(5)(C)); and 
(2) the number of such petitions pending a sub-
stantive response for more than 180 days from the 
date of receipt. 
SEC. 204. INSPECTIONS. 
Section 505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)), as amended by section 101, 
is further amended by adding at the end the following: 
‘‘(14) If the Secretary issues feedback pursuant to 
section 704(b)(2) with respect to information submitted 
in response to a report under section 704(b)(1), and a re-
port that was issued under section 704(b)(1) is the only 
obstacle to approval of an application under this sub-
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section or the Secretary determines that the public health 
benefit of approving an application under this subsection 
outweighs any risk to public health, the Secretary shall, 
within 45 days of notification by the applicant that nec-
essary changes have been made to the establishment to 
address any findings or deficiencies identified previously 
by the Secretary— 
‘‘(A) re-inspect the establishment with respect 
to which the report was issued; or 
‘‘(B) make a determination regarding the re-
sponse to such report and review of such applica-
tion.’’. 
Æ 
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