[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2529 Introduced in Senate (IS)]
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119th CONGRESS
1st Session
S. 2529
To increase the clarity and predictability of the process for
developing applications for Rx-to-nonprescription switches.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 30, 2025
Mr. Husted (for himself and Ms. Hassan) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To increase the clarity and predictability of the process for
developing applications for Rx-to-nonprescription switches.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. INCREASING THE CLARITY AND PREDICTABILITY OF THE PROCESS FOR
DEVELOPING APPLICATIONS FOR RX-TO-NONPRESCRIPTION
SWITCHES.
(a) In General.--Section 505(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(b)) is amended by adding at the end the
following:
``(7) Rx-to-nonprescription switches.--
``(A) Meetings.--Any person planning to submit an
application for an Rx-to-nonprescription switch may
submit to the Secretary a written request for a
meeting, for purposes of developing a plan for such
application that addresses the potential risks to
public health of such switch and the evidence necessary
to support such application, including the design of
any necessary studies, and the format and content of
the planned application. The Secretary may grant such a
meeting, as appropriate, consistent with established
procedures for granting meetings with, and providing
to, applications under this section. Each such meeting
shall be documented in meeting minutes.
``(B) Guidance.--
``(i) In general.--Not later than 18 months
after the date of enactment of this paragraph,
the Secretary shall issue guidance to increase
the clarity and predictability of the process
and standards for approval of applications for
nonprescription drugs under this section,
including in the case of applications for an
Rx-to-nonprescription switch, especially with
respect to prescription drugs with well-
established safety profiles for which an
applicant may seek approval for nonprescription
use.
``(ii) Contents.--The guidance under clause
(i) shall--
``(I) describe how published
reports in medical literature, any
previous finding of safety or
effectiveness for the drug under this
section, the results of significant
human experience with the drug,
unpublished studies and other data, and
other sources of information may be
used to support an application for a
nonprescription drug, including in the
context of an application for an Rx-to-
nonprescription switch;
``(II) set forth procedures for
sponsors to request meetings described
in subparagraph (A) and document the
recommendations made in such meetings;
``(III) describe evidentiary
expectations to support approval of an
application for a nonprescription drug,
including in the context of an
application for an Rx-to-
nonprescription switch, including how
sponsors can demonstrate that consumers
can appropriately self-select and use
the drug and comprehend the
nonprescription drug label; and
``(IV) provide recommendations for
how mechanisms, in addition to the
required Drug Facts Label, such as
mobile applications and decisions aids,
can be incorporated into the
information submitted in support of an
application for an Rx-to-
nonprescription switch.
``(C) Plan to engage with stakeholders.--Not later
than 1 year after the date of enactment of this
paragraph, the Secretary shall develop and make
publicly available on the website of the Food and Drug
Administration a plan to engage stakeholders on steps
and factors for application holders and other
stakeholders to consider in identifying approved
prescription drugs that may be promising candidates for
applications for an Rx-to-nonprescription switch.
``(D) Definition.--The term `Rx-to-nonprescription
switch' means the approval of an application, or
supplemental application, as applicable, submitted
under this section by the holder of an approved
application for a prescription drug seeking approval to
market such drug as a nonprescription drug, including
for--
``(i) a full Rx-to-nonprescription switch,
under which a drug previously approved for
prescription use only is--
``(I) approved for nonprescription
use under the same conditions of use as
applied to the drug when approved for
prescription use; or
``(II) approved for nonprescription
use subject to one or more additional
conditions for nonprescription use; and
``(ii) a partial Rx-to-nonprescription
switch, under which the drug is approved for
nonprescription use only under certain
conditions of use described in the approved
labeling, while the drug otherwise remains
approved for prescription use only.
``(E) Rule of construction.--Nothing in this
paragraph shall be construed to--
``(i) supersede or modify the authority of
the Secretary under section 505G with respect
to the regulation of OTC monograph drugs; or
``(ii) authorize the disclosure by the
Secretary of confidential commercial
information or trade secrets.''.
(b) GAO Report.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report that
evaluates--
(A) the number applications for an Rx-to-
nonprescription switch approved during the period
beginning on October 1, 2022, and ending on the date of
the report;
(B) the number of drugs for which an application
for an Rx-to-nonprescription switch was approved during
such period subject to an additional condition for
nonprescription use;
(C) among the drugs for which an application for a
full or partial Rx-to-nonprescription switch was
approved during such period, the average length of time
from receipt by the Food and Drug Administration of the
application to the approval of such application;
(D) the number of partial Rx-to-nonprescription
switch applications approved during such period, and
the number of applications for such a partial switch
not approved;
(E) any barriers to timely and predictable review
of applications for an Rx-to-nonprescription switch;
(F) engagement by the Food and Drug Administration
with public stakeholders, including public meetings or
additional activities to support review of applications
for an Rx-to-nonprescription switch; and
(G) opportunities for collaboration between the
Center for Drug Evaluation and Research and the Centers
for Medicare & Medicaid Services for the purpose of
analyzing health insurance claims data for commonly
prescribed drugs that appear to be suitable for an Rx-
to-nonprescription switch.
(2) Definition.--In this subsection, the term ``Rx-to-
nonprescription switch'' has the meaning given such term in
paragraph (7) of section 505(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 244(b)), as added by subsection (a).
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