II 

115TH CONGRESS 

1ST SESSION S. 1115 

To improve access to prescription drugs. 

IN THE SENATE OF THE UNITED STATES 

MAY 11, 2017 

Ms. COLLINS (for herself, Mrs. MCCASKILL, Mr. COTTON, and Mr. FRANKEN) 

introduced the following bill; which was read twice and referred to the 

Committee on Health, Education, Labor, and Pensions 

A BILL 

To improve access to prescription drugs. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Making Pharma5 ceutical Markets More Competitive Act’’. 


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1 TITLE I—REMOVING REGULA2 TORY BARRIERS TO COMPETI3 TION 

4 SEC. 101. IMPROVING ACCESS TO GENERIC DRUGS. 

5 Section 505(j) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 355(j)) is amended by adding at the 

7 end the following: 

8 ‘‘(11)(A) The Secretary shall prioritize the review of, 

9 and act within 240 calendar days of the date of the sub10 mission of, an original abbreviated new drug application 

11 submitted for review under this subsection, or on a supple12 ment to such an application, that is for a drug— 

13 ‘‘(i) for which there are not more than 3 ap14 proved drugs listed under paragraph (7), except that 

15 the review of an application submitted more than 30 

16 months in advance of the last applicable expiration 

17 date for a patent for which a certification under 

18 paragraph (2)(A)(vii)(III) has been submitted, or of 

19 the expiration date for an applicable period of exclu20 sivity under this Act, will not be expedited; or 

21 ‘‘(ii) that has been included on the list under 

22 section 506E. 

23 ‘‘(B) The Secretary shall require the applicant, not 

24 later than 60 days prior to the submission of an applica25 tion described in subparagraph (A), to provide complete, 


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1 accurate information regarding facilities involved in manu2 facturing processes and testing, including facilities in cor3 responding Type II active pharmaceutical ingredients drug 

4 master files submitted with an application and sites or or5 ganizations involved in bioequivalence and clinical studies 

6 used to support the application, in order to make a deter7 mination regarding whether an inspection of an establish8 ment is necessary. 

9 ‘‘(C) The Secretary may expedite an inspection or re10 inspection under section 704 of an establishment that pro11 poses to manufacture a drug described in subparagraph 

12 (A). 

13 ‘‘(D) Nothing in this paragraph shall prevent the Sec14 retary from prioritizing the review of other applications 

15 as the Secretary determines appropriate. 

16 ‘‘(12) The Secretary shall provide review status up17 dates to applicants regarding applications under this sub18 section, as appropriate, including when the application is 

19 awaiting final regulatory action by the office charged with 

20 review. 

21 ‘‘(13) The Secretary shall publish on the Internet 

22 website of the Food and Drug Administration a list of all 

23 drugs approved under subsection (b) for which all patents 

24 and periods of exclusivity under this Act have expired. 

25 Such list shall be updated at least once every 180 days.’’. 


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1 SEC. 102. REPORTING ON PENDING GENERIC DRUG APPLI2 CATIONS, PRIORITY REVIEW APPLICATIONS, 

3 AND INSPECTIONS. 

4 (a) IN GENERAL.—Not later than 180 calendar days 

5 after the date of enactment of this Act, and quarterly 

6 thereafter until October 1, 2022, the Secretary of Health 

7 and Human Services (referred to in this section as the 

8 ‘‘Secretary’’) shall post on the Internet website of the 

9 Food and Drug Administration a report that provides— 

10 (1) the number of applications filed under sec11 tion 505(j) of the Federal Food, Drug, and Cosmetic 

12 Act (21 U.S.C. 355(j)) awaiting action by the appli13 cant, including such applications that were filed 

14 prior to October 1, 2014; 

15 (2) the number of applications filed under sec16 tion 505(j) of the Federal Food, Drug, and Cosmetic 

17 Act (21 U.S.C. 355(j)) awaiting action by the Sec18 retary, including such applications that were filed 

19 prior to October 1, 2014; 

20 (3) the number of applications filed under sec21 tion 505(j) of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 355(j)) and prior approval supple23 ments withdrawn in each month covered by the re24 port; 


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1 (4) the mean and median approval and ten2 tative approval times for applications covered by the 

3 report; 

4 (5) the number of applications described in 

5 paragraphs (1), (2), and (3) that are subject to pri6 ority review; and 

7 (6) the number of such applications on which 

8 the Secretary has taken action pursuant to section 

9 506H(b) of the Federal Food, Drug, and Cosmetic 

10 Act, as added by section 101. 

11 (b) ANNUAL REPORT ON PRIORITY REVIEW APPLI12 CATIONS.— 

13 (1) IN GENERAL.—The Secretary shall submit 

14 to the Committee on Health, Education, Labor, and 

15 Pensions and the Special Committee on Aging of the 

16 Senate and the Committee on Energy and Com17 merce of the House of Representatives an annual re18 port, not later than March 31 of each year, on the 

19 following: 

20 (A) The number of applications filed under 

21 section 505(j) of the Federal Food, Drug, and 

22 Cosmetic Act (21 U.S.C. 355(j)) that are sub23 ject to priority review during the most recent 

24 calendar year and are awaiting action by the 

25 applicant. 


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1 (B) The number of applications filed under 

2 section 505(j) of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 355(j)) that are sub4 ject to priority review during the most recent 

5 calendar year and are awaiting action by the 

6 Secretary. 

7 (C) The number of applications filed under 

8 section 505(j) of the Federal Food, Drug, and 

9 Cosmetic Act (21 U.S.C. 355(j)) that are sub10 ject to priority review during the most recent 

11 calendar year and have been approved by the 

12 Secretary. 

13 (D) For each of subparagraphs (A) 

14 through (C), the number of such applications— 

15 (i) for which there are not more than 

16 3 approved drugs listed under section 

17 505(j)(7) of the Federal Food, Drug, and 

18 Cosmetic Act (21 U.S.C. 355(j)(7)); and 

19 (ii) the number of such applications 

20 that are for a drug on the drug shortage 

21 list under section 506E of the Federal 

22 Food, Drug, and Cosmetic Act (21 U.S.C. 

23 356e). 

24 (c) ANNUAL REPORT ON INSPECTIONS.—Not later 

25 than March 1 of each year, the Secretary shall post on 


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1 the Internet website of the Food and Drug Administra2 tion— 

3 (1) the average and median amount of time, 

4 following a request by staff of the Food and Drug 

5 Administration reviewing an application or report 

6 submitted under an applicable section described in 

7 subparagraph (A), (B), or (C), to schedule and com8 plete inspections of facilities necessary for— 

9 (A) approval of a drug under section 505 

10 of the Federal Food, Drug, and Cosmetic Act 

11 (21 U.S.C. 355); 

12 (B) approval of a device under section 515 

13 of such Act (21 U.S.C. 360e); and 

14 (C) clearance of a device under section 

15 510(k) of such Act (21 U.S.C. 360(k)); and 

16 (2) the average and median amount of time to 

17 schedule and complete for-cause inspections of facili18 ties of drugs and devices. 

19 TITLE II—INCENTIVIZING 

20 COMPETITION 

21 SEC. 201. EXPEDITING GENERIC COMPETITION. 

22 Chapter V of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

24 section 506G the following: 


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1 ‘‘SEC. 506H. EXPEDITING GENERIC DRUG DEVELOPMENT. 

2 ‘‘(a) IN GENERAL.—The Secretary shall, at the re3 quest of an applicant, expedite the development and review 

4 of an application under subsection (j) of section 505 for 

5 a drug— 

6 ‘‘(1) for which there are not more than 3 ap7 proved drug products listed under section 505(j)(7); 

8 or 

9 ‘‘(2) that is included on the list under section 

10 506E. 

11 ‘‘(b) REQUEST FROM SPONSORS.—A request to expe12 dite the development and review of an application under 

13 subsection (a) shall be submitted by the applicant prior 

14 to the submission of such application. 

15 ‘‘(c) OTHER APPLICATIONS.—Nothing in this section 

16 shall prevent the Secretary from expediting the develop17 ment and review of other applications as the Secretary de18 termines appropriate. 

19 ‘‘(d) ADDITIONAL COMMUNICATION.—The Secretary 

20 shall take such actions as are appropriate to expedite the 

21 development and review of the application for approval of 

22 a drug described in subsection (a), including, as appro23 priate— 

24 ‘‘(1) holding meetings with the sponsor and the 

25 review team throughout the development of the drug 

26 prior to submission of the application; 


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1 ‘‘(2) providing timely advice to, and interactive 

2 communication with, the sponsor regarding the de3 velopment of the application to ensure that the col4 lection of nonclinical and clinical data necessary for 

5 approval is as efficient as practicable; 

6 ‘‘(3) in the case of a complex product, assigning 

7 a cross-disciplinary project lead for the review team 

8 to facilitate an efficient review of the development 

9 program and application, including manufacturing 

10 inspections; and 

11 ‘‘(4) in the case of a complex product, including 

12 drug-device combinations, involving senior managers 

13 and experienced review staff, as appropriate, in a 

14 collaborative, cross-disciplinary review. 

15 ‘‘(e) REPORTING REQUIREMENT.—A sponsor of a 

16 drug expedited under this section shall report to the Sec17 retary, one year following approval of an application under 

18 section 505(j), on whether the approved drug has been 

19 marketed in interstate commerce since approval.’’. 

20 SEC. 202. LIST OF GENERIC DRUGS WITH LIMITED COM21 PETITION. 

22 Chapter V of the Federal Food, Drug, and Cosmetic 

23 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

24 section 506H, as added by section 201, the following: 


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1 ‘‘SEC. 506I. DRUG LISTING. 

2 ‘‘(a) REMOVAL, WITHDRAWAL, OR TRANSFER.—The 

3 holder of an application approved under subsection (b) or 

4 (j) of section 505 shall notify the Secretary within 180 

5 days of removing the drug that is the subject of such ap6 plication from interstate commerce, withdrawing such ap7 proved application, or transferring such approved applica8 tion, and a reason for such removal, withdrawal, or trans9 fer. If compliance with this subsection within such 180- 

10 day period is not practicable, then the holder shall comply 

11 as soon as practicable. The Secretary shall cross-reference 

12 information listed pursuant to section 506C where applica13 ble to avoid duplicative reporting. Notification to the Sec14 retary by a manufacturer in accordance with section 

15 506C(a) shall be deemed to be compliance with this sec16 tion. 

17 ‘‘(b) DRUGS WITH LIMITED COMPETITION.— 

18 ‘‘(1) INFORMATION.—The Secretary shall— 

19 ‘‘(A) maintain information with respect to 

20 applications approved under section 505(j); and 

21 ‘‘(B) publish on the Internet website of the 

22 Food and Drug Administration such informa23 tion under subparagraph (A) with respect to 

24 drugs for which there are three or fewer appli25 cation holders; and 


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1 ‘‘(C) update the information published pur2 suant to subparagraph (B) every 180 days. 

3 ‘‘(2) CONTENTS.—The public information main4 tained and published under paragraph (1)(B) shall 

5 include— 

6 ‘‘(A) the name of the drug, name of the 

7 holder of the approved application, and the 

8 marketing status for each drug; and 

9 ‘‘(B) an indication of whether the Sec10 retary considers the drug to be for the treat11 ment or prevention of a serious disease or med12 ical condition, for which there is no alternative 

13 drug that is judged by medical professionals to 

14 be an adequate substitute available in adequate 

15 supply. 

16 ‘‘(c) PUBLIC HEALTH EXCEPTION.—The Secretary 

17 may choose not to make information collected under this 

18 section publicly available if the Secretary determines that 

19 disclosure of such information would adversely affect the 

20 public health. 

21 ‘‘(d) NOTIFICATION.—When the Secretary first pub22 lishes the information under subsection (b), the Secretary 

23 shall notify relevant Federal agencies, including the Cen24 ters for Medicare & Medicaid Services and the Federal 


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1 Trade Commission, that the information has been pub2 lished and will be updated regularly.’’. 

3 SEC. 203. SUITABILITY PETITIONS. 

4 (a) IN GENERAL.—It is the sense of the Senate that 

5 the Food and Drug Administration shall meet the require6 ment under section 505(j)(2)(C) of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(C)) and sec8 tion 314.93(e) of title 21, Code of Federal Regulations, 

9 of responding to suitability petitions within 90 days of 

10 submission. 

11 (b) REPORT.—The Secretary of Health and Human 

12 Services shall include in the annual reports under section 

13 102(b)— 

14 (1) the number of pending petitions under sec15 tion 505(j)(2)(C) of the Federal Food, Drug, and 

16 Cosmetic Act (21 U.S.C. 355(j)(5)(C)); and 

17 (2) the number of such petitions pending a sub18 stantive response for more than 180 days from the 

19 date of receipt. 

20 SEC. 204. INSPECTIONS. 

21 Section 505(j) of the Federal Food, Drug, and Cos22 metic Act (21 U.S.C. 355(j)), as amended by section 101, 

23 is further amended by adding at the end the following: 

24 ‘‘(14) If the Secretary issues feedback pursuant to 

25 section 704(b)(2) with respect to information submitted 


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1 in response to a report under section 704(b)(1), and a re2 port that was issued under section 704(b)(1) is the only 

3 obstacle to approval of an application under this sub4 section or the Secretary determines that the public health 

5 benefit of approving an application under this subsection 

6 outweighs any risk to public health, the Secretary shall, 

7 within 45 days of notification by the applicant that nec8 essary changes have been made to the establishment to 

9 address any findings or deficiencies identified previously 

10 by the Secretary— 

11 ‘‘(A) re-inspect the establishment with respect 

12 to which the report was issued; or 

13 ‘‘(B) make a determination regarding the re14 sponse to such report and review of such applica15 tion.’’. 

Æ 


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