[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 366 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                 S. 366

    To shorten monopoly periods for prescription drugs that are the 
                    subjects of sudden price hikes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            February 6, 2019

Mr. Durbin (for himself, Ms. Harris, Ms. Smith, Ms. Klobuchar, and Mr. 
  Blumenthal) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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 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.
    (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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