I 

116TH CONGRESS 

1ST SESSION H. R. 1188 

To shorten monopoly periods for prescription drugs that are the subjects 

of sudden price hikes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 13, 2019 

Mr. GOLDEN (for himself, Mr. CASTEN of Illinois, Ms. SLOTKIN, Mr. 

CISNEROS, Mr. ROSE of New York, and Ms. PINGREE) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To shorten monopoly periods for prescription drugs that 

are the subjects of sudden price hikes. 

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 ‘‘Forcing Limits on 

5 Abusive and Tumultuous Prices’’ or the ‘‘FLAT Prices 

6 Act’’. 

7 SEC. 2. REDUCED MARKET EXCLUSIVITY. 

8 (a) PENALTY.—If the manufacturer of a prescription 

9 drug approved under section 505 of the Federal Food, 


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1 Drug, and Cosmetic Act (21 U.S.C. 355) or licensed under 

2 section 351 of the Public Health Service Act (42 U.S.C. 

3 262) increases the price of such drug as described in sub4 section (b), any remaining period of market exclusivity 

5 with respect to such drug shall be reduced as follows: 

6 (1) With respect to any price increase described 

7 in subsection (b), such market exclusivity shall be 

8 reduced by 180 days. 

9 (2) For every 5 percent price increase over the 

10 10 percent, 18 percent, or 25 percent, respectively, 

11 threshold price increases described in subsection (b), 

12 such market exclusivity shall be reduced for an addi13 tional 30 days. 

14 (b) PRICE INCREASE.—A price increase described in 

15 this subsection is an increase in the wholesale acquisition 

16 cost (as defined in section 1847A(c)(6)(B) of the Social 

17 Security Act (42 U.S.C. 1395w–3a(c)(6)(B))) of a pre18 scription drug of more than 10 percent over a 1-year pe19 riod, more than 18 percent over a 2-year period, or more 

20 than 25 percent over a 3-year period. 

21 (c) REPORT ON PRICE INCREASE.— 

22 (1) IN GENERAL.—A drug manufacturer that 

23 increases the price of a prescription drug as de24 scribed in subsection (b) shall report such increase 

25 to the Secretary of Health and Human Services (reVerDate Sep 11 2014 02:15 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1188.IH H1188

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1 ferred to in this section as the ‘‘Secretary’’) within 

2 30 days of meeting the criteria for a price increase 

3 under such subsection. 

4 (2) FAILURE TO SUBMIT REPORT.—In the case 

5 of a drug manufacturer that does not submit a re6 port required under paragraph (1) within the 30-day 

7 period described in such paragraph, in addition to 

8 the penalty under subsection (a), the period of mar9 ket exclusivity with respect to such drug shall be re10 duced by 30 days for each day after the due date 

11 of the report until the report is submitted. 

12 (d) WAIVER.—The Secretary may waive, or decrease, 

13 the reduction in the period of market exclusivity that 

14 would otherwise apply under subsection (a) with respect 

15 to a prescription drug if— 

16 (1) the manufacturer of such drug submits— 

17 (A) a report under subsection (c)(1); and 

18 (B) an application for such a waiver, at 

19 such time, in such manner, and containing such 

20 information as the Secretary may require; and 

21 (2) based upon the information in such applica22 tion, the Secretary determines that— 

23 (A) the price increase is necessary to en24 able production of the drug, does not unduly reVerDate Sep 11 2014 02:15 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1188.IH H1188

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1 strict patient access to the drug, and does not 

2 negatively impact public health; and 

3 (B) such waiver or decrease constitutes a 

4 deviation from the reduction in market exclu5 sivity that would otherwise apply under sub6 section (a) only to the extent necessary to 

7 achieve drug production objectives. 

8 (e) PERIOD OF MARKET EXCLUSIVITY.—For pur9 poses of this section, the term ‘‘period of market exclu10 sivity’’ means any period of market exclusivity granted 

11 with respect to a prescription drug under clause (ii), (iii), 

12 or (iv) of section 505(c)(3)(E) of the Federal Food, Drug, 

13 and Cosmetic Act (21 U.S.C. 355(c)(3)(E)), section 

14 505(j)(5)(B)(iv) of such Act, clause (ii), (iii), or (iv) of 

15 section 505(j)(5)(F) of such Act, or paragraphs (6) or (7) 

16 of section 351(k) of the Public Health Service Act (42 

17 U.S.C. 262(k)). 

Æ 


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