mination regarding whether an inspection of an establish-
ment is necessary. 
‘‘(C) The Secretary may expedite an inspection or re-
inspection under section 704 of an establishment that pro-
poses to manufacture a drug described in subparagraph 
(A). 
‘‘(D) Nothing in this paragraph shall prevent the Sec-
retary from prioritizing the review of other applications 
as the Secretary determines appropriate. 
‘‘(12) The Secretary shall provide review status up-
dates to applicants regarding applications under this sub-
section, as appropriate, including when the application is 
awaiting final regulatory action by the office charged with 
review. 
‘‘(13) The Secretary shall publish on the Internet 
website of the Food and Drug Administration a list of all 
drugs approved under subsection (b) for which all patents 
and periods of exclusivity under this Act have expired. 
Such list shall be updated at least once every 180 days.’’. 
SEC. 102. REPORTING ON PENDING GENERIC DRUG APPLI-
CATIONS, PRIORITY REVIEW APPLICATIONS, 
AND INSPECTIONS. 
(a) IN GENERAL.—Not later than 180 calendar days 
after the date of enactment of this Act, and quarterly 
thereafter until October 1, 2022, the Secretary of Health 
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and Human Services (referred to in this section as the 
‘‘Secretary’’) shall post on the Internet website of the 
Food and Drug Administration a report that provides— 
(1) the number of applications filed under sec-
tion 505(j) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)) awaiting action by the appli-
cant, including such applications that were filed 
prior to October 1, 2014; 
(2) the number of applications filed under sec-
tion 505(j) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)) awaiting action by the Sec-
retary, including such applications that were filed 
prior to October 1, 2014; 
(3) the number of applications filed under sec-
tion 505(j) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(j)) and prior approval supple-
ments withdrawn in each month covered by the re-
port; 
(4) the mean and median approval and ten-
tative approval times for applications covered by the 
report; 
(5) the number of applications described in 
paragraphs (1), (2), and (3) that are subject to pri-
ority review; and 
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(6) the number of such applications on which 
the Secretary has taken action pursuant to section 
506H(b) of the Federal Food, Drug, and Cosmetic 
Act, as added by section 101. 
(b) ANNUAL REPORT ON PRIORITY REVIEW APPLI-
CATIONS.— 
(1) IN GENERAL.—The Secretary shall submit 
to the Committee on Health, Education, Labor, and 
Pensions and the Special Committee on Aging of the 
Senate and the Committee on Energy and Com-
merce of the House of Representatives an annual re-
port, not later than March 31 of each year, on the 
following: 
(A) The number of applications filed under 
section 505(j) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)) that are sub-
ject to priority review during the most recent 
calendar year and are awaiting action by the 
applicant. 
(B) The number of applications filed under 
section 505(j) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)) that are sub-
ject to priority review during the most recent 
calendar year and are awaiting action by the 
Secretary. 
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(C) The number of applications filed under 
section 505(j) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)) that are sub-
ject to priority review during the most recent 
calendar year and have been approved by the 
Secretary. 
(D) For each of subparagraphs (A) 
through (C), the number of such applications— 
(i) for which there are not more than 
3 approved drugs listed under section 
505(j)(7) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(7)); and 
(ii) the number of such applications 
that are for a drug on the drug shortage 
list under section 506E of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
356e). 
(c) ANNUAL REPORT ON INSPECTIONS.—Not later 
than March 1 of each year, the Secretary shall post on 
the Internet website of the Food and Drug Administra-
tion— 
(1) the average and median amount of time, 
following a request by staff of the Food and Drug 
Administration reviewing an application or report 
submitted under an applicable section described in 
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subparagraph (A), (B), or (C), to schedule and com-
plete inspections of facilities necessary for— 
(A) approval of a drug under section 505 
of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355); 
(B) approval of a device under section 515 
of such Act (21 U.S.C. 360e); and 
(C) clearance of a device under section 
510(k) of such Act (21 U.S.C. 360(k)); and 
(2) the average and median amount of time to 
schedule and complete for-cause inspections of facili-
ties of drugs and devices. 
TITLE II—INCENTIVIZING 
COMPETITION 
SEC. 201. EXPEDITING GENERIC COMPETITION. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 506G the following: 
‘‘SEC. 506H. EXPEDITING GENERIC DRUG DEVELOPMENT. 
‘‘(a) IN GENERAL.—The Secretary shall, at the re-
quest of an applicant, expedite the development and review 
of an application under subsection (j) of section 505 for 
a drug— 
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‘‘(1) for which there are not more than 3 ap-
proved drug products listed under section 505(j)(7); 
or 
‘‘(2) that is included on the list under section 
506E. 
‘‘(b) REQUEST FROM SPONSORS.—A request to expe-
dite the development and review of an application under 
subsection (a) shall be submitted by the applicant prior 
to the submission of such application. 
‘‘(c) OTHER APPLICATIONS.—Nothing in this section 
shall prevent the Secretary from expediting the develop-
ment and review of other applications as the Secretary de-
termines appropriate. 
‘‘(d) ADDITIONAL COMMUNICATION.—The Secretary 
shall take such actions as are appropriate to expedite the 
development and review of the application for approval of 
a drug described in subsection (a), including, as appro-
priate— 
‘‘(1) holding meetings with the sponsor and the 
review team throughout the development of the drug 
prior to submission of the application; 
‘‘(2) providing timely advice to, and interactive 
communication with, the sponsor regarding the de-
velopment of the application to ensure that the col-
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