Fair Accountability and Innovative Research Drug Pricing Act of 2023

Subjects: Health


<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 935 Introduced in Senate (IS)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                 S. 935

 To require reporting regarding certain drug price increases, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 22, 2023

  Ms. Baldwin (for herself, Mr. Braun, and Ms. Smith) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
 To require reporting regarding certain drug price increases, and for 
                            other purposes.

    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 ``Fair Accountability and Innovative 
Research Drug Pricing Act of 2023''.

SEC. 2. REPORTING ON JUSTIFICATION FOR DRUG PRICE INCREASES.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by adding at the end the following:

            ``PART W--DRUG PRICE REPORTING; DRUG VALUE FUND

``SEC. 399OO. REPORTING ON JUSTIFICATION FOR DRUG PRICE INCREASES.

    ``(a) Definitions.--In this section:
            ``(1) Manufacturer.--The term `manufacturer' means the 
        person--
                    ``(A) that holds the application for a drug 
                approved under section 505 of the Federal Food, Drug, 
                and Cosmetic Act or the license issued under section 
                351 of this Act; or
                    ``(B) who is responsible for setting the price for 
                the drug.
            ``(2) Qualifying drug.--The term `qualifying drug' means 
        any drug that is approved under subsection (c) or (j) of 
        section 505 of the Federal Food, Drug, and Cosmetic Act or 
        licensed under subsection (a) or (k) of section 351 of this 
        Act--
                    ``(A) that has a wholesale acquisition cost of $100 
                or more per month supply, or per a course of treatment 
                that lasts less than a month, and is--
                            ``(i)(I) subject to section 503(b)(1) of 
                        the Federal Food, Drug, and Cosmetic Act; or
                            ``(II) commonly administered by hospitals 
                        (as determined by the Secretary); and
                            ``(ii) not designated by the Secretary as a 
                        vaccine; and
                    ``(B) for which, during the previous calendar year, 
                at least 1 dollar of the total amount of sales were for 
                individuals enrolled under the Medicare program under 
                title XVIII of the Social Security Act (42 U.S.C. 1395 
                et seq.) or under a State Medicaid plan under title XIX 
                of such Act (42 U.S.C. 1396 et seq.) or under a waiver 
                of such plan.
            ``(3) United states median household income.--The term 
        `United States median household income' means median household 
        income for the United States as published by the Census Bureau 
        for the most recent year for which data is available.
            ``(4) Wholesale acquisition cost.--The term `wholesale 
        acquisition cost' has the meaning given that term in section 
        1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w-
        3a(c)(6)(B)).
    ``(b) Report.--
            ``(1) Report required.--The manufacturer of a qualifying 
        drug shall submit a report to the Secretary if, with respect to 
        the qualifying drug--
                    ``(A) there is an increase in the price of the 
                qualifying drug that results in an increase in the 
                wholesale acquisition cost of that drug that is equal 
                to--
                            ``(i) 10 percent or more over a 12-month 
                        period beginning on or after January 1, 2024; 
                        or
                            ``(ii) 25 percent or more over a 36-month 
                        period beginning on or after January 1, 2024; 
                        or
                    ``(B) the wholesale acquisition price of the 
                qualifying drug for the applicable year or per normal 
                course of treatment that lasts less than 1 year, as 
                determined by the Secretary, exceeds United States 
                median household income beginning on or after January 
                1, 2024.
            ``(2) Report deadline.--Each report described in paragraph 
        (1) shall be submitted to the Secretary not later than 30 days 
        prior to the planned effective date of such price increase.
    ``(c) Contents.--A report under subsection (b) shall, at a minimum, 
include--
            ``(1) with respect to the qualifying drug--
                    ``(A) the percentage by which the manufacturer will 
                raise the wholesale acquisition cost of the drug on the 
                planned effective date of such price increase, as 
                applicable;
                    ``(B) a justification for, and description of, each 
                manufacturer's price increase that will occur during 
                the 12-month period described in subsection (b)(1)(A) 
                or the 36-month period described in subsection 
                (b)(1)(B), as applicable;
                    ``(C) an explanation for, and description of, the 
                cost associated with a qualifying drug if such drug 
                meets the criteria under subsection (b)(1)(B), as 
                applicable;
                    ``(D) the identity of the initial developer of the 
                drug;
                    ``(E) a description of the history of the 
                manufacturer's price increases for the drug since the 
                approval of the application for the drug under section 
                505 of the Federal Food, Drug, and Cosmetic Act or the 
                issuance of the license for the drug under section 351, 
                or since the manufacturer acquired such approved 
                application or license, as applicable;
                    ``(F) the current list price of the drug;
                    ``(G) the total expenditures of the manufacturer 
                on--
                            ``(i) materials and manufacturing for such 
                        drug; and
                            ``(ii) acquiring patents and licensing for 
                        such drug;
                    ``(H) the percentage of total expenditures of the 
                manufacturer on research and development for such drug 
                that was derived from Federal funds;
                    ``(I) the total expenditures of the manufacturer on 
                research and development for such drug that is used 
                for--
                            ``(i) basic and preclinical research;
                            ``(ii) clinical research;
                            ``(iii) new drug development;
                            ``(iv) pursuing new or expanded indications 
                        for such drug through supplemental applications 
                        under section 505 of the Federal Food, Drug, 
                        and Cosmetic Act or section 351 of this Act; 
                        and
                            ``(v) carrying out postmarket requirements 
                        related to such drug, including those under 
                        section 505(o)(3) of the Federal Food, Drug, 
                        and Cosmetic Act;
                    ``(J) the total revenue and the net profit 
                generated from the qualifying drug for each calendar 
                year since the approval of the application for the drug 
                under section 505 of the Federal Food, Drug, and 
                Cosmetic Act or the issuance of the license for the 
                drug under section 351, or since the manufacturer 
                acquired such approved application or license; and
                    ``(K) the total costs associated with marketing and 
                advertising for the qualifying drug;
            ``(2) with respect to the manufacturer--
                    ``(A) the total revenue and the net profit of the 
                manufacturer for each of the 12-month periods described 
                in subsection (b)(1)(A) or for the 36-month period 
                described in subsection (b)(1)(B), as applicable;
                    ``(B) all stock-based performance metrics used by 
                the manufacturer to determine executive compensation 
                for each of the 12-month periods described in 
                subsection (b)(1)(A) or the 36-month periods described 
                in subsection (b)(1)(B)(ii), as applicable; and
                    ``(C) any additional information the manufacturer 
                chooses to provide related to drug pricing decisions, 
                such as total expenditures on--
                            ``(i) drug research and development; or
                            ``(ii) clinical trials on drugs that failed 
                        to receive approval by the Food and Drug 
                        Administration; and
            ``(3) such other related information as the Secretary 
        considers appropriate.
    ``(d) Civil Penalty.--Any manufacturer of a qualifying drug that 
fails to submit a report for the drug as required by this section shall 
be subject to a civil penalty of $100,000 for each day on which the 
violation continues.
    ``(e) Public Posting.--
            ``(1) In general.--Subject to paragraph (3), not later than 
        30 days after the submission of a report under subsection (b), 
        the Secretary shall post the report on the public website of 
        the Department of Health and Human Services.
            ``(2) Format.--In developing the format of such report for 
        public posting, the Secretary shall consult stakeholders, 
        including beneficiary groups, and shall seek feedback on the 
        content and format from consumer advocates and readability 
        experts to ensure such public reports are user-friendly to the 
        public and are written in plain language that consumers can 
        readily understand.
            ``(3) Trade secrets and confidential information.--In 
        carrying out this section the Secretary shall enforce current 
        law concerning the protection of confidential commercial 
        information and trade secrets.''.

``SEC. 399OO-1. USE OF CIVIL PENALTY AMOUNTS.

    ``The Secretary shall, without further appropriation, collect civil 
penalties under section 399OO and use the funds derived from such civil 
penalties, in addition to any other amounts available to the Secretary, 
to carry out activities described in this part and to improve consumer 
and provider information about drug value and drug price transparency.

``SEC. 399OO-2. ANNUAL REPORT TO CONGRESS.

    ``(a) In General.--Subject to subsection (b), the Secretary shall 
submit to Congress, and post on the public website of the Department of 
Health and Human Services in a way that is easy to find, use, and 
understand, an annual report--
            ``(1) summarizing the information reported pursuant to 
        section 399OO; and
            ``(2) including copies of the reports and supporting 
        detailed economic analyses submitted pursuant to such section.
    ``(b) Trade Secrets and Confidential Information.--In carrying out 
this section the Secretary shall enforce current law concerning the 
protection of confidential commercial information and trade secrets.''.
                                 &lt;all&gt;
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