Regulate the Price of All Drugs Act

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9040 Introduced in House (IH)]

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119th CONGRESS
  2d Session
                                H. R. 9040

    To establish fair prices for prescription drugs, and for other
                               purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                              May 26, 2026

 Mr. Sherman introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committees on
the Judiciary, and Financial Services, for a period to be subsequently
   determined by the Speaker, in each case for consideration of such
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL

    To establish fair prices for prescription drugs, 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 ``Regulate the Price of All Drugs
Act''.

SEC. 2. ESTABLISHING THE PRESCRIPTION DRUG REGULATORY COMMISSION.

    (a) In General.--There is established the Prescription Drug Price
Regulatory Commission (in this section referred to as the
``Commission'').
    (b) Duties of Commission.--
            (1) In general.--Not later than the fair price
        recommendation date with respect to a fair price applicability
        year, the Commission shall, with respect to each approved
        prescription drug, submit to the Secretary of Health and Human
        Services (in this section referred to as the ``Secretary'') a
        recommendation regarding the price that the Commission
        determines to be a fair price for such drug in order for the
        manufacturer of such drug to provide access to such price--
                    (A) to any fair price eligible individual who is
                dispensed such drug during such fair price
                applicability year (and to pharmacies, mail order
                services, and other dispensers, with respect to such
                individuals who are dispensed such drugs); and
                    (B) to any hospital, physician, or other provider
                of services or supplier that furnishes or administers
                such drug to such an individual during such year.
            (2) Fair price revisions and waivers.--At any time during a
        fair price applicability year, the Commission may submit to the
        Secretary a recommendation--
                    (A) that the Secretary revise the fair price
                established for an approved prescription drug for such
                year under section 3(b); or
                    (B) that the Secretary authorize a temporary waiver
                of such fair price under section 3(c).
            (3) Required factors for consideration.--In making a
        recommendation under paragraph (1) with respect to the fair
        price of an approved prescription drug, or a recommendation
        under paragraph (2) with respect to a revision or waiver of
        such fair price, the Commission shall take into account the
        following factors with respect to such drug:
                    (A) The costs to the manufacturer of producing and
                distributing of such drug.
                    (B) The cost-effectiveness of the drug and its
                therapeutic benefit (which may be determined on the
                basis of quality-adjusted life years, equal value of
                life years gained, or such other measure as the
                Commission may specify).
                    (C) The anticipated demand for the drug during the
                fair price applicability year.
                    (D) The costs and risks to the manufacturer
                involved in researching and developing such drug, and
                the return on investment that would provide adequate
                incentive to the manufacturer to continue research.
                    (E) In the case that such drug is available for
                purchase in 1 or more comparable reference countries,
                the average price of such drug in such country.
                    (F) Such other factors as the Secretary of Health
                and Human Services may specify through rulemaking.
    (c) Members of Commission.--
            (1) In general.--The Commission shall be composed of 13
        members as follows:
                    (A) Seven members appointed by the President from
                individuals who are not officers or employees of any
                government.
                    (B) Six ex officio members appointed by the
                Secretary of Health and Human Services from each of the
                following agencies:
                            (i) The Veterans Health Administration.
                            (ii) The Defense Health Agency.
                            (iii) The Centers for Medicare & Medicaid
                        Services.
                            (iv) The Food and Drug Administration.
                            (v) The Centers for Disease Control and
                        Prevention.
                            (vi) The Federal Trade Commission.
            (2) Terms.--Each member shall be appointed for a term of 4
        years, except that the Secretary may extend the term of any
        member for 1 additional year if the Secretary determines such
        extension appropriate.
    (d) Operation.--In carrying out the duties under subsection (b),
the Commission is not subject to the provisions of chapter 10 of title
5, United States Code.
    (e) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary for each fiscal year to
carry out the activities of the Commission.

SEC. 3. PUBLICATION OF FAIR PRICES.

    (a) In General.--Not later than the fair price publication date
with respect to a fair price applicability year, the Secretary of
Health and Human Services (in this section referred to as the
``Secretary'') shall, with respect to each approved prescription drug,
establish and publish the price that the Secretary determines to be a
fair price for such drug in order for the manufacturer of such drug to
provide access to such price--
            (1) to any fair price eligible individual who is dispensed
        such drug during such fair price applicability year (and to
        pharmacies, mail order services, and other dispensers, with
        respect to such individuals who are dispensed such drugs); and
            (2) to hospitals, physicians, and other providers of
        services and suppliers that furnish or administer such drug to
        such an individual during such year.
In establishing the fair price for each such drug, the Secretary shall
take into account the recommendations made by the Prescription Drug
Price Regulatory Commission (in this section referred to as the
``Commission'') under section 2(b)(1) for such drug and such year.
    (b) Revisions.--The Secretary may revise the fair price applicable
to an approved prescription drug for a fair price applicability year
after the fair price publication date with respect to such year has
passed if--
            (1) the Secretary has received a recommendation from the
        Commission that the fair price be so revised;
            (2) in the judgment of the Secretary, revising such fair
        price is necessary to account for significant changes to--
                    (A) supply (or projected supply) or demand (or
                projected demand) for such drug; or
                    (B) any of the other factors described in section
                2(b)(3) with respect to such drug; and
            (3) the Secretary notifies the manufacturer of such drug
        not less than 30 days before such revised fair price goes into
        effect.
    (c) Temporary Fair Price Waiver.--
            (1) In general.--The Secretary may authorize a manufacturer
        of an approved prescription drug to provide access to such drug
        to a fair price eligible individual described in paragraph (1)
        of subsection (a) (or to a hospital, physician, or other
        provider of services or supplier described in paragraph (2) of
        such subsection with respect to such individual) at a price in
        excess of a fair price if, in the judgment of the Secretary,
        such authorization is necessary to maintain access to such drug
        for all fair price eligible individuals.
            (2) Duration of waiver.--An authorization under this
        subsection shall last for a period of 90 days. The Secretary
        may extend such authorization for 1 or more additional 90-day
        periods if the Secretary determines such extension is
        necessary.
    (d) Penalties for Noncompliance by a Manufacturer.--
            (1) In general.--In addition to any other penalties
        prescribed by law, any manufacturer of an approved prescription
        drug that does not provide access during a fair price
        applicability year to a price that is equal to or less than the
        fair price for such drug for such year (or, in the case that an
        authorization under subsection (c) is in effect with respect to
        such manufacturer and drug, a price that is equal to or less
        than the price authorized under such subsection)--
                    (A) to a fair price eligible individual who is
                dispensed such drug during such fair price
                applicability year (and to pharmacies, mail order
                services, and other dispensers, with respect to such
                individuals who are dispensed such drugs); or
                    (B) to a hospital, physician, or other provider of
                services or supplier that furnished or administered
                such drug to such an individual during such year;
        shall be subject to a civil penalty, for each year and for each
        drug for which the violation occurs, equal to 10 times the
        amount equal to the product of the number of units of such drug
        so furnished, dispensed, or administered during such year and
        the difference between the price for such drug made available
        for such year by such manufacturer with respect to such
        individual or hospital, physician, provider of services, or
        supplier and the fair price for such drug for such year (or the
        price authorized under subsection (c), as applicable).
            (2) Application.--The provisions of section 1128A of the
        Social Security Act (42 U.S.C. 1320a-7) (other than subsections
        (a) and (b)) shall apply to a civil monetary penalty under this
        section in the same manner as such provisions apply to a
        penalty or proceeding under section 1128A(a).

SEC. 4. FAIR PRICES FOR PRESCRIPTION DRUGS REQUIRED.

    (a) Prohibition.--Section 301 of the Federal Food, Drug, and
Cosmetic Act is amended by adding at the end the following:
    ``(jjj) Selling, or offering for sale, a drug (or biological
product) at a price that exceeds the fair price published under section
3 of the Regulate the Price of All Drugs Act.''.
    (b) Enforcement by Federal Trade Commission.--
            (1) Unfair or deceptive acts or practices.--A violation of
        section 301(jjj) of the Federal Food, Drug, and Cosmetic Act or
        a regulation promulgated under such subsection shall be treated
        as a violation of a regulation under section 18(a)(1)(B) of the
        Federal Trade Commission Act (15 U.S.C. 57a(a)(1)(B)) regarding
        unfair or deceptive acts or practices.
            (2) Powers of commission.--The Federal Trade Commission
        shall enforce subsection (jjj) of such section 301 and any
        regulation promulgated under such subsection in the same
        manner, by the same means, and with the same jurisdiction,
        powers, and duties as though all applicable terms and
        provisions of the Federal Trade Commission Act (15 U.S.C. 41 et
        seq.) were incorporated into and made a part of this section.
        Any person who violates such subsection or a regulation
        promulgated under such subsection shall be subject to the
        penalties and entitled to the privileges and immunities
        provided in the Federal Trade Commission Act.
    (c) Actions by States.--
            (1) In general.--In any case in which the attorney general
        of a State, or an official or agency of a State, has reason to
        believe that an interest of the residents of such State has
        been or is threatened or adversely affected by an act or
        practice in violation of subsection (jjj) of such section 301
        or a regulation promulgated under such subsection, the State,
        as parens patriae, may bring a civil action on behalf of the
        residents of the State in an appropriate district court of the
        United States to--
                    (A) enjoin such act or practice;
                    (B) enforce compliance with such subsection or such
                regulation;
                    (C) obtain damages, restitution, or other
                compensation on behalf of residents of the State; or
                    (D) obtain such other legal and equitable relief as
                the court may consider to be appropriate.
            (2) Notice.--Before filing an action under this subsection,
        the attorney general, official, or agency of the State involved
        shall provide to the Federal Trade Commission a written notice
        of such action and a copy of the complaint for such action. If
        the attorney general, official, or agency determines that it is
        not feasible to provide the notice described in this paragraph
        before the filing of the action, the attorney general,
        official, or agency shall provide written notice of the action
        and a copy of the complaint to the Federal Trade Commission
        immediately upon the filing of the action.
            (3) Authority of federal trade commission.--
                    (A) In general.--On receiving notice under
                paragraph (2) of an action under this subsection, the
                Federal Trade Commission shall have the right--
                            (i) to intervene in the action;
                            (ii) upon so intervening, to be heard on
                        all matters arising therein; and
                            (iii) to file petitions for appeal.
                    (B) Limitation on state action while federal action
                is pending.--If the Federal Trade Commission or the
                Attorney General of the United States has instituted a
                civil action for violation of subsection (jjj) of such
                section 301 or a regulation promulgated under such
                subsection (referred to in this subparagraph as the
                ``Federal action''), no State attorney general,
                official, or agency may bring an action under this
                subsection during the pendency of the Federal action
                against any defendant named in the complaint in the
                Federal action for any violation of such subsection or
                regulation alleged in such complaint.
            (4) Rule of construction.--For purposes of bringing a civil
        action under this subsection, nothing in this Act shall be
        construed to prevent an attorney general, official, or agency
        of a State from exercising the powers conferred on the attorney
        general, official, or agency by the laws of such State to
        conduct investigations, administer oaths and affirmations, or
        compel the attendance of witnesses or the production of
        documentary and other evidence.
    (d) Private Right of Action.--
            (1) In general.--A person injured by an act or practice in
        violation of subsection (jjj) of such section 301 or a
        regulation promulgated under such subsection may bring in an
        appropriate district court of the United States--
                    (A) an action to enjoin the violation;
                    (B) an action to recover three times the amount of
                damages for actual monetary loss from the violation, or
                to receive up to $50,000 in damages for each such
                violation, whichever is greater; or
                    (C) both such actions.
            (2) Willful or knowing violations.--If the court finds that
        the defendant acted willfully or knowingly in committing a
        violation described in paragraph (1), the court may, in its
        discretion, increase the amount of the award to an amount equal
        to not more than 3 times the amount available under paragraph
        (1)(B).
            (3) Costs and attorney's fees.--The court shall award to a
        prevailing plaintiff in an action under this subsection the
        costs of such action and reasonable attorney's fees, as
        determined by the court.
            (4) Limitation.--An action may be commenced under this
        subsection not later than 5 years after the date on which the
        person first discovered or had a reasonable opportunity to
        discover the violation.
            (5) Nonexclusive remedy.--The remedy provided by this
        subsection shall be in addition to any other remedies available
        to the person.

SEC. 5. MARCH-IN RIGHTS FOR PATENT.

    If the owner of a patent sells a drug in the United States above
the fair price published pursuant to section 3 or does not sell an
adequate quantity to meet patient demand of a drug in the United States
at the fair price published pursuant to section 3, the Secretary of
Health and Human Services may assert the right to claim from the owner
of any patent for such drug a nonexclusive, partially exclusive, or
exclusive license in any field of use, upon terms that are reasonable
under the circumstances.

SEC. 6. USE OF THE DEFENSE PRODUCTION ACT.

    The President may use the authorities under title I, title III, and
title VII of the Defense Production Act of 1950 to increase the
domestic supply of a drug if the Commission has determined that--
            (1) there are inadequate facilities or means of production
        in the United States to produce an amount of such drug that
        would satisfy patient demand for such drug; and
            (2) foreign supplies of such drug cannot be reliably and
        sustainability imported into the United States in such
        quantities as are necessary for such drug to be purchased at
        the fair price established for such drug under section 3.

SEC. 7. DEFINITIONS.

    In this Act, the following definitions apply:
            (1) Approved prescription drug.--The term ``approved
        prescription drug'' means--
                    (A) a drug which may be dispensed only upon
                prescription and that is described in subparagraph
                (A)(i), (A)(ii), or (A)(iii) of section 1927(k)(2) of
                the Social Security Act (42 U.S.C. 1396r-8(k)(2));
                    (B) a biological product described in clauses (i)
                through (iii) of subparagraph (B) of such section;
                    (C) insulin described in subparagraph (C) of such
                section and medical supplies associated with the
                injection of insulin (as defined in regulations of the
                Secretary); or
                    (D) a vaccine licensed under section 351 of the
                Public Health Service Act.
            (2) Comparable reference country.--The term ``comparable
        reference country'' means any of the following countries:
                    (A) Canada.
                    (B) France.
                    (C) Germany.
                    (D) Italy.
                    (E) Japan.
                    (F) The United Kingdom.
            (3) Fair price applicability year.--The term ``fair price
        applicability year'' means a year (beginning with 2027).
            (4) Fair price eligible individual.--The term ``fair price
        eligible individual'' means, with respect to an approved
        prescription drug, an individual who is located in the United
        States at the time such drug is furnished or administered to
        such individual.
            (5) Fair price publication date.--The term ``fair price
        publication date'' means, with respect to a fair price
        applicability year, July 1 of the preceding year.
            (6) Fair price recommendation date.--The term ``fair price
        recommendation date'' means, with respect to a fair price
        applicability year, May 1 of the preceding year.
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