H.R. 9040

[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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