[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1818 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 1818
To significantly lower prescription drug prices for patients in the
United States by ending government-granted monopolies for manufacturers
who charge drug prices that are higher than the median prices at which
the drugs are available in other countries.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
May 20, 2025
Mr. Sanders (for himself, Mr. Blumenthal, Mr. Booker, Mr. Merkley, Mr.
Murphy, Mr. Welch, and Ms. Warren) introduced the following bill; which
was read twice and referred to the Committee on Health, Education,
Labor, and Pensions
_______________________________________________________________________
A BILL
To significantly lower prescription drug prices for patients in the
United States by ending government-granted monopolies for manufacturers
who charge drug prices that are higher than the median prices at which
the drugs are available in other countries.
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 ``Prescription Drug Price Relief Act
of 2025''.
SEC. 2. IDENTIFICATION OF EXCESSIVELY PRICED DRUGS.
(a) In General.--Not later than 30 days after the date of enactment
of this Act, the Secretary shall establish a process to conduct a
review of all brand name drugs, not less frequently than once per
calendar year, under which the Secretary determines under subsection
(b) whether the price of each such drug is excessive.
(b) Excessive Price Determinations.--
(1) International reference price.--
(A) In general.--The Secretary shall determine that
any brand name drug for which the domestic average
manufacturing price exceeds the median price charged
for such drug in the 5 reference countries to have an
excessive price. In assessing the extent to which the
price is excessive, the Secretary shall consider the
factors described in paragraph (2).
(B) Reference countries.--In this Act, the term
``reference countries'' means Canada, the United
Kingdom, Germany, France, and Japan.
(C) Requirement with respect to drugs for which
certain reference country information is not
available.--The Secretary shall make a determination
under paragraph (1) for every brand name drug for which
pricing information is available for at least 3 of the
5 reference countries.
(2) Determinations based on other factors.--With respect to
any brand name drug that is not determined to have an excessive
price by operation of paragraph (1) (including any drug for
which there is insufficient data to make such a determination
under such paragraph), the Secretary shall determine that such
drug has an excessive price if the price of the drug is higher
than reasonable taking into account the following factors:
(A) The size of the affected patient population.
(B) The value of the drug to patients, including
the impact of the price on access to the drug and the
relationship of the price of the drug to its
therapeutic health benefits.
(C) The risk adjusted value of Federal Government
subsidies and investments related to the drug.
(D) The costs associated with development of the
drug.
(E) Whether the drug provided a significant
improvement in health outcomes, compared to other
therapies available at the time of its approval.
(F) The cumulative global revenues generated by the
drug.
(G) Whether the domestic average manufacturer price
of the drug increased during any annual quarter by a
percentage that is more than the percentage increase in
the consumer price index for all urban consumers for
the respective annual quarter.
(H) Other factors the Secretary determines
appropriate.
(c) Petition for Determination.--
(1) In general.--Any person may petition the Secretary, in
accordance with section 553(e) of title 5, United States Code,
to make an excessive drug price determination for an applicable
drug under subsection (b)(2). Not later than 90 days after the
date of receipt of such a petition, subject to paragraph (2),
the Secretary shall--
(A) make a determination under subsection (b)(2)
regarding such drug; or
(B)(i) decline to make such a determination; and
(ii) make public the reasons why the Secretary has
declined to make such a determination.
(2) Exception.--The Secretary shall not make a
determination under subsection (b)(2) for a drug in response to
a petition under this section more frequently than once per
calendar year.
(3) Public availability.--The Secretary shall make any
petitions submitted under this subsection, together with any
documentation related to the petitions and the Secretary's
determinations on such petitions and rationale for such
determinations, publicly available, including by posting such
information on the database under section 5.
SEC. 3. ENDING GOVERNMENT-GRANTED MONOPOLIES FOR EXCESSIVELY PRICED
DRUGS.
(a) Excessive Drug Price Authority.--With respect to any brand name
drug, if the Secretary determines under section 2 that the price of the
drug is excessive, the Secretary--
(1) shall waive or void any government-granted
exclusivities with respect to such drug, effective on the date
that the excessive price determination under section 2 is made
for such drug; and
(2) shall grant open, non-exclusive licenses allowing any
person to make, use, offer to sell or sell, or import into the
United States such drug, and to rely upon the regulatory test
data of such drug, in accordance with section 4.
(b) Expedited Review.--The Secretary shall prioritize the review
of, and act within 8 months of the date of the submission of a generic
drug application or a biosimilar biological product application if such
application references a drug licensed under subsection (a)(2).
(c) Civil Actions.--If the Secretary determines that the
manufacturer of an excessively priced drug (as determined under section
2(a)) has increased the price of such drug during the period beginning
on the date on which such price determination is made and ending on the
date on which an entity begins manufacturing the drug under an open,
non-exclusive license under subsection (a)(2), the Secretary may file a
civil action in the United States district court for the district in
which the manufacturer is located, or in the United States district
court for the District of Columbia, to recover damages in an amount
equal to not less than the total amount of revenue derived by the
manufacturer as a result of any such price increase during such period.
In actions brought under this subsection, the district courts shall
have jurisdiction to grant all appropriate relief including injunctive
relief and compensatory damages.
SEC. 4. EXCESSIVE DRUG PRICE LICENSE.
(a) Reasonable Royalty.--
(1) In general.--An entity accepting an open, non-exclusive
license under section 3(a)(2) shall pay a reasonable royalty to
the holder of a patent that claims the drug or that claims a
use of the drug or to the holder of an application approved
under subsection 505(c) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(c)) or section 351(a) of the Public Health
Service Act (42 U.S.C. 262(a)) for which any government-granted
exclusivity with respect to the drug was terminated under
section 3(a)(1).
(2) Royalty rate.--Such royalty rate shall be--
(A) a percentage of sales, where the percentage
rate is no higher than the average royalty rate
estimated from the data provided by the Internal
Revenue Service for pharmaceutical manufacturer Federal
income tax returns; or
(B) an amount as determined by the Secretary,
taking into account--
(i) the value of the drug to patients;
(ii) the size of the affected patient
population;
(iii) the risk adjusted value of the
Federal Government subsidies and investments
related to the drug;
(iv) whether the drug provided a
significant improvement in health outcomes,
compared to other therapies available at the
time of the approval;
(v) the extent to which the brand name drug
manufacturer has recovered risk adjusted
investments related to the drug, including the
investments related to the invention,
regulatory test data, and any other relevant
research and development costs; and
(vi) any other information the Secretary
determines appropriate.
(b) Requirements.--
(1) In general.--A royalty rate under subsection (a) shall
be consistent with making drugs available to purchasers,
including Federal, State, local, and nongovernmental purchasers
and individuals, at prices that are affordable and reasonable.
Under no condition shall a royalty be set at a rate that would
cause a product for which an open, non-exclusive license was
issued under section 3 to be sold at an excessive price, as
determined under section 2.
(2) Multiple affected parties.--In the case that there is
one or more holders or investors in the patented inventions
related to the drug in addition to the brand name manufacturer,
the royalty rate shall be divided among the holders or
investors (including such manufacturer) in a manner agreed upon
by the manufacturer and other holders or investors, or, in the
absence of such an agreement, in a manner the Secretary
determines to be appropriate.
(3) Price.--An entity accepting an open, non-exclusive
license under section 3(a)(2) shall sell the drug at a price
below the excessive price determined for that drug under
section 2(b).
SEC. 5. PUBLIC EXCESSIVE DRUG PRICE DATABASE.
(a) Excessive Drug Price Database.--
(1) In general.--The Secretary shall establish and maintain
a comprehensive, up-to-date database of brand name drugs and
the excessive price determinations for such drugs under section
2.
(2) Contents.--The database shall include, at a minimum,
for each brand name drug, for the applicable calendar year--
(A) the name of the drug;
(B) the manufacturer;
(C) whether the drug was determined under section
2(b) to have an excessive price;
(D) the number of petitions the Secretary received
under section 2(c) to make an excessive price
determination for the drug, together with the
information described in section 2(c)(3);
(E) the number of open, non-exclusive licenses the
Secretary has granted under section 3(a)(2) for generic
drug or biosimilar biological product versions of the
drug; and
(F) the number of applications under subsection
(b)(2) or (j) of section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) or under section
351(k) of the Public Health Service Act (42 U.S.C.
262(k)) submitted to the Secretary, pursuant to such a
license granted under section 3(a)(2), and the number
of such applications that have been approved.
(3) Certain determinations.--With respect to a
determination made under section 2(b)(1), the Secretary shall
publish on the database such determination in accordance with
paragraph (1) within 30 days of receiving domestic and
international pricing information from manufacturers under
section 6.
(b) Annual Reports to Congress.--Not later than 60 days after the
first excessive price review under section 2 is complete, and annually
thereafter, the Secretary shall submit to Congress a report describing
the excessive drug price review for the preceding year. The report
shall contain summary data regarding--
(1) the total number of drugs that were reviewed;
(2) the total number of drugs determined to be excessively
priced under each of paragraphs (1) and (2) of section 2(b),
and the name and manufacturer of each such drug;
(3) the total number of drugs determined to be excessively
priced, listed by manufacturer;
(4) the extent to which the prices of the drugs identified
under section 2 were higher than reasonable, on average;
(5) the total number of drugs for which an open, non-
exclusive license has been granted under section 3(a)(2);
(6) the total number of generic drug or biosimilar
biological product applications received and approved that
reference a drug so licensed;
(7) the median approval time for generic drug or biosimilar
biological product applications that reference a drug so
licensed;
(8) the total number of petitions the Secretary received
under section 2(c) to make excessive price determinations for
drugs;
(9) a list of any manufacturers who failed to report
information as required under section 6; and
(10) other appropriate information, as the Secretary
determines or as Congress requests.
(c) Public Availability.--The Secretary shall make the information
in the database described in subsection (a) and the report in
subsection (b) publicly available, including on the website of the Food
and Drug Administration, in a manner that is easy to find and
understand.
SEC. 6. DRUG MANUFACTURER REPORTING.
(a) In General.--Each manufacturer shall submit to the Secretary,
in such format as the Secretary may require, an annual report that
includes the following information for each brand name drug of the
manufacturer, with respect to the previous calendar year:
(1) The average manufacturer price of the drug in the
United States and in the reference countries, for the entire
year, and broken down for each quarter of the year.
(2) The wholesale acquisition cost of the drug in the
United States and in the reference countries, for the entire
year, and broken down for each quarter of the year.
(3) Cumulative global revenues generated by the drug.
(4) Annual net sales revenue generated by the drug in the
United States and in the reference countries, for the entire
year, and broken down for each quarter of the year.
(5) Total expenditures on domestic and foreign drug
research and development related to the drug, itemized by--
(A) basic and preclinical research;
(B) clinical research, reported separately for each
clinical trial;
(C) development of alternative dosage forms and
strengths for the drug molecule or combinations,
including the molecule;
(D) other drug development activities, such as
nonclinical laboratory studies and record and report
maintenance;
(E) pursuing new or expanded indications for such
drug through supplemental applications under section
505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355); and
(F) carrying out postmarket requirements related to
such drug, including under section 505(o)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(o)(3)).
(6) Total expenditures on domestic and foreign marketing
and advertising related to the drug.
(7) Investments in human clinical trials related to the
drug, by each trial and each year, including grants, research
contracts, tax credits or deductions, and reimbursements from
public or private health plans or insurance, and any other
public sector subsidies or incentives, such as the fair market
value or priority review vouchers or other considerations.
(8) The estimated size of the affected patient population.
(9) Additional information the manufacturer chooses to
provide related to drug pricing decisions, such as information
related to the methodology used to set the price of the drug.
(10) Additional information as the Secretary determines
necessary to carry out this Act, including information for
previous years.
(b) Report Due Date.--Applicable manufacturers shall submit the
reports described in subsection (a) not later than January 15 of the
year following the date of enactment of this Act, and of each year
thereafter.
(c) Penalty for Noncompliance.--
(1) In general.--Any manufacturer that fails to submit
information for a drug as required by this section on a timely
basis or that knowingly provides false information shall be
liable for a civil monetary penalty, as determined by the
Secretary under paragraph (2), in addition to any other penalty
under other applicable provisions of law.
(2) Amount of penalty.--The amount of a civil penalty under
paragraph (1) shall be equal to the product of--
(A) an amount, as determined appropriate by the
Secretary, which is--
(i) not less than 0.5 percent of the gross
revenues from sales for the previous calendar
year of the drug for which the information was
not submitted; and
(ii) not greater than 1 percent of the
g