FLAT Prices Act

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 fol- lowing bill; which was referred to the Committee on Energy and Com- merce A BILL To shorten monopoly periods for prescription drugs that are the subjects of sudden price hikes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Forcing Limits on 4 Abusive and Tumultuous Prices’’ or the ‘‘FLAT Prices 5 Act’’. 6 SEC. 2. REDUCED MARKET EXCLUSIVITY. 7 (a) PENALTY.—If the manufacturer of a prescription 8 drug approved under section 505 of the Federal Food, 9 VerDate Sep 11 2014 02:15 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1188.IH H1188 pbinns on DSK79D2C42PROD with BILLS 2 •HR 1188 IH Drug, and Cosmetic Act (21 U.S.C. 355) or licensed under 1 section 351 of the Public Health Service Act (42 U.S.C. 2 262) increases the price of such drug as described in sub- 3 section (b), any remaining period of market exclusivity 4 with respect to such drug shall be reduced as follows: 5 (1) With respect to any price increase described 6 in subsection (b), such market exclusivity shall be 7 reduced by 180 days. 8 (2) For every 5 percent price increase over the 9 10 percent, 18 percent, or 25 percent, respectively, 10 threshold price increases described in subsection (b), 11 such market exclusivity shall be reduced for an addi- 12 tional 30 days. 13 (b) PRICE INCREASE.—A price increase described in 14 this subsection is an increase in the wholesale acquisition 15 cost (as defined in section 1847A(c)(6)(B) of the Social 16 Security Act (42 U.S.C. 1395w–3a(c)(6)(B))) of a pre- 17 scription drug of more than 10 percent over a 1-year pe- 18 riod, more than 18 percent over a 2-year period, or more 19 than 25 percent over a 3-year period. 20 (c) REPORT ON PRICE INCREASE.— 21 (1) IN GENERAL.—A drug manufacturer that 22 increases the price of a prescription drug as de- 23 scribed in subsection (b) shall report such increase 24 to the Secretary of Health and Human Services (re- 25 VerDate Sep 11 2014 02:15 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1188.IH H1188 pbinns on DSK79D2C42PROD with BILLS 3 •HR 1188 IH ferred to in this section as the ‘‘Secretary’’) within 1 30 days of meeting the criteria for a price increase 2 under such subsection. 3 (2) FAILURE TO SUBMIT REPORT.—In the case 4 of a drug manufacturer that does not submit a re- 5 port required under paragraph (1) within the 30-day 6 period described in such paragraph, in addition to 7 the penalty under subsection (a), the period of mar- 8 ket exclusivity with respect to such drug shall be re- 9 duced by 30 days for each day after the due date 10 of the report until the report is submitted. 11 (d) WAIVER.—The Secretary may waive, or decrease, 12 the reduction in the period of market exclusivity that 13 would otherwise apply under subsection (a) with respect 14 to a prescription drug if— 15 (1) the manufacturer of such drug submits— 16 (A) a report under subsection (c)(1); and 17 (B) an application for such a waiver, at 18 such time, in such manner, and containing such 19 information as the Secretary may require; and 20 (2) based upon the information in such applica- 21 tion, the Secretary determines that— 22 (A) the price increase is necessary to en- 23 able production of the drug, does not unduly re- 24 VerDate Sep 11 2014 02:15 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1188.IH H1188 pbinns on DSK79D2C42PROD with BILLS 4 •HR 1188 IH strict patient access to the drug, and does not 1 negatively impact public health; and 2 (B) such waiver or decrease constitutes a 3 deviation from the reduction in market exclu- 4 sivity that would otherwise apply under sub- 5 section (a) only to the extent necessary to 6 achieve drug production objectives. 7 (e) PERIOD OF MARKET EXCLUSIVITY.—For pur- 8 poses of this section, the term ‘‘period of market exclu- 9 sivity’’ means any period of market exclusivity granted 10 with respect to a prescription drug under clause (ii), (iii), 11 or (iv) of section 505(c)(3)(E) of the Federal Food, Drug, 12 and Cosmetic Act (21 U.S.C. 355(c)(3)(E)), section 13 505(j)(5)(B)(iv) of such Act, clause (ii), (iii), or (iv) of 14 section 505(j)(5)(F) of such Act, or paragraphs (6) or (7) 15 of section 351(k) of the Public Health Service Act (42 16 U.S.C. 262(k)). 17 Æ VerDate Sep 11 2014 02:15 Feb 26, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H1188.IH H1188 pbinns on DSK79D2C42PROD with BILLS