Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2023
This bill requires companies that receive federal funding for research (or a license of the rights to a patent or regulatory test data) for a biomedical product or service to agree to set reasonable prices for the resulting biomedical product or service.
The Department of Health and Human Services (HHS) must determine a reasonable price based on a formula that ensures the U.S. price for the product or service is not more than the median price for the product or service in Canada and six other reference countries with, based on specified criteria, large economies and high incomes.
Companies entering these agreements also must report to HHS certain financial information related to the biomedical product or service involved.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3093 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 3093
To require persons who undertake federally funded research and
development of a biomedical product or service to enter into reasonable
pricing agreements with the Secretary of Health and Human Services, and
for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 5, 2023
Ms. Hoyle of Oregon (for herself, Mr. Doggett, Mr. Cohen, Ms. DeLauro,
Mr. Garcia of Illinois, Mr. Grijalva, Ms. Jayapal, Ms. Kaptur, Mr.
Khanna, Ms. Norton, Ms. Pingree, Mr. Pocan, Ms. Schakowsky, Ms.
Stansbury, and Ms. Tokuda) introduced the following bill; which was
referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To require persons who undertake federally funded research and
development of a biomedical product or service to enter into reasonable
pricing agreements with the Secretary of Health and Human Services, 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 ``Affordable Pricing for Taxpayer-
Funded Prescription Drugs Act of 2023''.
SEC. 2. REASONABLE PRICE AGREEMENT.
(a) In General.--All Federal agencies providing or receiving
research funding, through a grant, contract, cooperative agreement, or
other agreement, shall require in such agreement, and in any license of
the rights to a patent or regulatory test data for a biomedical product
or service, that the price of any biomedical product or service
developed with the benefit of such research be reasonable (as
determined by the Secretary) unless the Secretary waives such
reasonable price obligation under subsection (d).
(b) Prohibition Against Charging Prices Higher Than in Other Large
Economies With High Incomes.--
(1) In general.--For purposes of subsection (a), any
reasonable pricing formula shall ensure, without prejudice to
any other standards or negotiated provisions for reasonable
pricing, that residents of the United States are not charged
more for the biomedical product or service involved than the
reference price for countries with large economies and high
incomes.
(2) Reference price.--For purposes of paragraph (1), the
phrase ``reference price for countries with large economies and
high incomes'' means--
(A) the median price charged for the biomedical
product or service involved in Canada and the
additional six reference countries; or
(B) a modification to such price that is adopted by
regulation after providing notice and the opportunity
for the public to comment, if the Secretary determines
such modification to be an appropriate and reasonable
measure to protect United States residents from paying
prices that are higher than prices in other countries
with large economies and high incomes.
(c) Additional Requirements.--
(1) In general.--In carrying out subsection (a), the
Secretary may promulgate by regulation additional requirements
to ensure that the price for the biomedical product or service
described in subsection (a) be reasonable.
(2) Requirements.--The additional requirements under
paragraph (1) shall--
(A) address the public interest in ensuring that
publicly supported innovations for biomedical products
and services have reasonable prices; and
(B) take into account--
(i) the importance of providing robust
incentives to invest in biomedical research and
development; and
(ii) the challenges of administering
agreements described in subsection (a),
including in cases where third parties control
relevant intellectual property, know-how, or
other assets.
(3) Possible mechanisms.--The additional requirements for
reasonable pricing authorized by paragraph (1) may include--
(A) mechanisms to--
(i) lower prices or shorten exclusivity
periods when revenues exceed targets;
(ii) lower prices that exceed a standard of
cost per health benefit achieved; or
(iii) lower prices that constitute
significant barriers to access or fiscal
burdens on patients; or
(B) a combination of mechanisms listed in
subparagraph (A) or other mechanisms.
(d) Waiver.--
(1) In general.--The Secretary may waive part or all of a
reasonable pricing obligation under this section upon a
demonstration that such a waiver is in the public interest. A
decision to grant such a waiver shall set out the Secretary's
finding that the waiver is in the public interest.
(2) Required process.--No waiver under paragraph (1) shall
take effect before--
(A) the public is given notice of the proposed
waiver and provided a reasonable opportunity to comment
in writing and at a public hearing on the proposed
waiver; and
(B) the Secretary publishes an economic analysis to
justify the waiver.
(e) Transparency.--
(1) Reporting.--In order to evaluate additional
requirements promulgated under subsection (c), agreements
subject to subsection (a) shall include a requirement that the
manufacturer or other companies commercializing the biomedical
product or service involved report to the Secretary in formats
determined by the Secretary--
(A) the costs of each clinical trial undertaken to
support the Federal regulatory approval of the
biomedical product or service involved;
(B) subsidies of those costs by the Federal
Government; and
(C) the annual revenues generated by the biomedical
product or service involved, by county of sale.
(2) Public availability.--The Secretary shall make all
reports under paragraph (1) publicly available.
(f) No Effect on Other Requirements.--The reasonable pricing
requirements imposed under this section are in addition to any other
requirements to limit the price of biomedical products or services,
including such requirements imposed--
(1) through standards or negotiated provisions on pricing
in contracts; or
(2) under chapter 18 of title 35, United States Code, to
make the benefits of inventions funded by the Federal
Government available to the public on reasonable terms.
(g) Definitions.--In this section:
(1) The term ``biomedical product or service'' means a
drug, vaccine, medical device, diagnostic test, assistive
technology, cell- or gene-based therapy, or other technology
used to provide health care.
(2) The term ``medical device'' has the meaning given to
the term ``device'' in section 201 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321).
(3) The term ``Secretary'' means the Secretary of Health
and Human Services.
(4) The term ``six reference countries'' means the six
countries, excluding Canada, that over the previous three
calendar years--
(A) are member countries of the Organisation for
Economic Co-operation and Development;
(B) have the largest gross domestic products; and
(C) have a per capita income that is at least 50
percent of the average per capita income of the United
States.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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