[Congressional Record Volume 165, Number 23 (Wednesday, February 6, 2019)]
[Senate]
[Pages S921-S922]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN (for himself, Ms. Harris, Ms. Smith, Ms. Klobuchar, 
        and Mr. Blumenthal):
  S. 366. A bill to shorten monopoly periods for prescription drugs 
that are the subjects of sudden price hikes; to the Committee on 
Health, Education, Labor, and Pensions.
  Mr. DURBIN. Mr. President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 366

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Forcing Limits on Abusive 
     and Tumultuous Prices'' or the ``FLAT Prices Act''.

     SEC. 2. REDUCED MARKET EXCLUSIVITY.

       (a) Penalty.--If the manufacturer of a prescription drug 
     approved under section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355) or licensed under section 351 of 
     the Public Health Service Act (42 U.S.C. 262) increases the 
     price of such drug as described in subsection (b), any 
     remaining period of market exclusivity with respect to such 
     drug shall be reduced as follows:
       (1) With respect to any price increase described in 
     subsection (b), such market exclusivity shall be reduced by 
     180 days.
       (2) For every 5 percent price increase over the 10 percent, 
     18 percent, or 25 percent, respectively, threshold price 
     increases described in subsection (b), such market 
     exclusivity shall be reduced for an additional 30-days.
       (b) Price Increase.--A price increase described in this 
     subsection is an increase in the wholesale acquisition cost 
     (as defined in section 1847A(c)(6)(B) of the Social Security 
     Act (42 U.S.C. 1395w-3a(c)(6)(B))) of a prescription drug of 
     more than 10 percent over a 1-year period, more than 18 
     percent over a 2-year period, or more than 25 percent over a 
     3-year period.
       (c) Report on Price Increase.--
       (1) In general.--A drug manufacturer that increases the 
     price of a prescription drug as described in subsection (b) 
     shall report such increase to the Secretary of Health and 
     Human Services (referred to in this section as the 
     ``Secretary'') within 30 days of meeting the criteria for a 
     price increase under such subsection.
       (2) Failure to submit report.--In the case of a drug 
     manufacturer that does not submit a report required under 
     paragraph (1) within the 30-day period described in such 
     paragraph, in addition to the penalty under subsection (a), 
     the period of market exclusivity with respect to such drug 
     shall be reduced by 30 days for each day after the due date 
     of the report until the report is submitted.

[[Page S922]]

       (d) Waiver.--The Secretary may waive, or decrease, the 
     reduction in the period of market exclusivity that would 
     otherwise apply under subsection (a) with respect to a 
     prescription drug if--
       (1) the manufacturer of such drug submits--
       (A) a report under subsection (c)(1); and
       (B) an application for such a waiver, at such time, in such 
     manner, and containing such information as the Secretary may 
     require; and
       (2) based upon the information in such application, the 
     Secretary determines that--
       (A) the price increase is necessary to enable production of 
     the drug, does not unduly restrict patient access to the drug 
     , and does not negatively impact public health; and
       (B) such waiver or decrease constitutes a deviation from 
     the reduction in market exclusivity that would otherwise 
     apply under subsection (a) only to the extent necessary to 
     achieve drug production objectives.
       (e) Period of Market Exclusivity.--For purposes of this 
     section, the term ``period of market exclusivity'' means any 
     period of market exclusivity granted with respect to a 
     prescription drug under clause (ii), (iii), or (iv) of 
     section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(c)(3)(E)), section 505(j)(5)(B)(iv) of 
     such Act, clause (ii), (iii), or (iv) of section 505(j)(5)(F) 
     of such Act, or paragraphs (6) or (7) of section 351(k) of 
     the Public Health Service Act (42 U.S.C. 262(k)).

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