119-s2529

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2529 Introduced in Senate

    (IS) ]

<DOC>

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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