Notice2025-08209
Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
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Published
May 9, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders--including patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts--notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Full Text
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<title>Federal Register, Volume 90 Issue 89 (Friday, May 9, 2025)</title>
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[Federal Register Volume 90, Number 89 (Friday, May 9, 2025)]
[Notices]
[Page 19724]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08209]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0834]
Prescription Drug User Fee Act; Stakeholder Consultation Meetings
on the Prescription Drug User Fee Act Reauthorization; Request for
Notification of Stakeholder Intention To Participate
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for notification of participation.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing
this notice to request that public stakeholders--including patient and
consumer advocacy groups, healthcare professionals, and scientific and
academic experts--notify FDA of their intent to participate in periodic
consultation meetings on the reauthorization of the Prescription Drug
User Fee Act (PDUFA). The statutory authority for PDUFA expires in
September 2027. At that time, new legislation will be required for FDA
to continue collecting user fees for the prescription drug program. The
Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA
consult with a range of stakeholders in developing recommendations for
the next PDUFA program. The FD&C Act also requires that FDA hold
discussions (at least every month) with patient and consumer advocacy
groups during FDA's negotiations with the regulated industry. The
purpose of this request for notification is to ensure continuity and
progress in these monthly discussions by establishing consistent
stakeholder representation.
DATES: Submit notification of intention to participate in these series
of meetings by August 4, 2025. Stakeholder meetings will be held
monthly. It is anticipated that they will commence in September 2025.
See the SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: Submit notification of intention to participate in monthly
stakeholder meetings by email to <a href="/cdn-cgi/l/email-protection#6e3e2a3b282f3c0b0f1b1a06011c07140f1a0701002e080a0f4006061d40090118"><span class="__cf_email__" data-cfemail="d3839786959281b6b2a6a7bbbca1baa9b2a7babcbd93b5b7b2fdbbbba0fdb4bca5">[email protected]</span></a>. The
meetings will be held in person at the FDA White Oak campus, 10903 New
Hampshire Ave., Silver Spring, MD 20993 and virtually using the
Microsoft Teams platform.
FOR FURTHER INFORMATION CONTACT: Andrew Kish, Center for Drug
Evaluation and Research, Food and Drug Administration, 301-796-5215,
<a href="/cdn-cgi/l/email-protection#92d3fcf6e0f7e5bcd9fbe1fad2f4f6f3bcfafae1bcf5fde4"><span class="__cf_email__" data-cfemail="05446b617760722b4e6c766d456361642b6d6d762b626a73">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is requesting that public stakeholders--including patient and
consumer advocacy groups, healthcare professionals, and scientific and
academic experts--notify the Agency of their intent to participate in
periodic stakeholder consultation meetings on the reauthorization of
PDUFA. PDUFA authorizes FDA to collect user fees from the regulated
industry for the process for the review of human drugs. The
authorization for the current program (PDUFA VII) expires in September
2027. Without new legislation, FDA will no longer be able to collect
user fees for future fiscal years to fund the human drug review
process.
Section 736B(f)(1) of the FD&C Act (21 U.S.C. 379h-2(f)(1))
requires that FDA consult with a range of stakeholders, including
representatives from patient and consumer groups, healthcare
professionals, and scientific and academic experts, in developing
recommendations for the next PDUFA program. FDA will initiate the
reauthorization process by holding a public meeting on July 14, 2025,
where stakeholders and other members of the public will be given an
opportunity to present their views on the reauthorization. The FD&C Act
further requires that FDA continue meeting with these stakeholders at
least once every month during negotiations with the regulated industry
to continue discussions of stakeholder views on the reauthorization. It
is anticipated that these monthly stakeholder consultation meetings
will commence in September 2025.
FDA is issuing this notice to request that stakeholder
representatives from patient and consumer groups, healthcare
professional associations, as well as scientific and academic experts,
notify FDA of their intent to participate in the periodic stakeholder
consultation meetings on PDUFA reauthorization. FDA believes that
consistent stakeholder representation at these meetings will be
important to ensure progress in these discussions. If you wish to
participate in the stakeholder consultation meetings, please designate
one or more representatives from your organization who will commit to
attending these meetings and preparing for the discussions.
Stakeholders who identify themselves through this notice will be
included in all stakeholder consultation discussions while FDA
negotiates with the regulated industry. If a stakeholder decides to
participate in these monthly meetings at a later time, that stakeholder
may join the remaining monthly stakeholder consultation meetings after
notifying FDA of this intention (see ADDRESSES). These stakeholder
discussions will satisfy the consultation requirement in section
736B(f)(3) of the FD&C Act.
II. Notification of Intent To Participate in Periodic Stakeholder
Consultation Meetings
If you intend to participate in continued periodic stakeholder
consultation meetings regarding PDUFA reauthorization, please provide
notification by email to <a href="/cdn-cgi/l/email-protection#5e0e1a0b181f0c3b3f2b2a36312c37243f2a3731301e383a3f7036362d70393128"><span class="__cf_email__" data-cfemail="74243021323526111501001c1b061d0e15001d1b1a341210155a1c1c075a131b02">[email protected]</span></a> by August 4,
2025. Your email should contain complete contact information, including
name, title, affiliation, address, email address, phone number, and
notice of any special accommodations required because of disability.
Stakeholders will receive confirmation and additional information about
the first meeting after FDA receives this notification.
Dated: May 6, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08209 Filed 5-8-25; 8:45 am]
BILLING CODE 4164-01-P
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