[Federal Register Volume 90, Number 95 (Monday, May 19, 2025)]
[Notices]
[Pages 21315-21318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08824]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0816]
Reauthorization of the Prescription Drug User Fee Act; Public
Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
hosting a public meeting to discuss proposed recommendations for the
reauthorization of the Prescription Drug User Fee Act (PDUFA) for
fiscal years (FYs) 2028 through 2032. PDUFA authorizes FDA to collect
user fees to support the process for the review of human drug
applications. The current legislative authority for PDUFA expires in
September 2027. At that time, new legislation will be required for FDA
to continue collecting prescription drug user fees in future fiscal
years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that
FDA begin the PDUFA reauthorization process by publishing a notice in
the Federal Register requesting public input and holding a public
meeting where the public may present its views on the reauthorization.
FDA invites public comment as the Agency begins the process to
reauthorize the program in FYs 2028 through 2032. These comments will
be published and available on FDA's website.
DATES: The hybrid public meeting will be held on July 14, 2025, from 9
a.m. to 2 p.m., and will take place in person and virtually. Submit
either electronic or written comments on this public meeting by August
14, 2025.
ADDRESSES: The public workshop will be held in person at the FDA White
Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the
Great Room, Silver Spring, MD 20993-0002 and virtually using the
Microsoft Teams platform. Entrance for the public meeting participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/about-fda/visitor-information.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time on August 14, 2025. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-N-0816 for ``Reauthorization of the Prescription Drug User Fee
Act; Public Meeting; Request for Comments.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The
[[Page 21316]]
second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Andrew Kish, Center for Drug
Evaluation and Research, Food and Drug Administration, 301-796-5215,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a hybrid public meeting to begin the
reauthorization process for PDUFA, the legislation that authorizes FDA
to collect user fees to support the process for the review of human
drugs, which reaches various components in FDA, including the Center
for Drug Evaluation and Research (CDER), the Center for Biologics
Evaluation and Research (CBER), the Office of the Commissioner (OC),
and the Office of Inspections and Investigations (OII). The current
authorization of the 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)(2) of the FD&C Act (21 U.S.C. 379h-2(f)(2)) requires
that before FDA begins negotiations with the regulated industry on
PDUFA reauthorization, the Agency performs the following: (1) publish a
notice in the Federal Register requesting public input on the
reauthorization; (2) hold a public meeting where the public may present
its views on the reauthorization; (3) provide a period of 30 days after
the public meeting to obtain written comments from the public; and (4)
publish the comments on FDA's website. This notice, the public meeting,
the 30-day comment period after the meeting, and the posting of the
comments on the FDA website will satisfy these requirements. The
purpose of the meeting is to hear stakeholder views on PDUFA as we
consider the features to propose, update, discontinue, or add in the
next PDUFA. FDA is interested in responses to the following three
questions and welcomes any other pertinent information stakeholders
would like to share:
What is your assessment of the overall performance of
PDUFA VII thus far?
What current features of PDUFA should be reduced or
discontinued to ensure the continued efficiency and effectiveness of
the human drug review process?
What new features, if any, FDA consider adding to the
program to enhance the efficiency and effectiveness of the human drug
review process?
What changes, if any, could be made to the current fee
structures and amounts to better advance the goals of the agreement,
including facilitating product development and timely access for
consumers?
II. What is PDUFA and what does it do?
The following information is provided to help potential meeting
participants better understand the history and evolution of PDUFA and
its status. PDUFA is a law that authorizes FDA to collect fees from
drug companies that submit marketing applications for certain human
drug and biological products. PDUFA was originally enacted in 1992 as
the Prescription Drug User Fee Act for a period of 5 years.
In 1997, Congress passed the Food and Drug Administration
Modernization Act of 1997 (FDAMA) which renewed the program (PDUFA II)
for an additional 5 years. Congress extended PDUFA again for another 5
years (PDUFA III), through FY 2007, in the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002. In 2007, Title I of
the Food and Drug Administration Amendments Act of 2007 (FDAAA)
reauthorized PDUFA through FY 2012 (PDUFA IV) and in 2012 the Food and
Drug Administration Safety and Innovation Act (FDASIA) reauthorized the
law again through FY 2017 (PDUFA V). Congress reauthorized PDUFA
through FY 2022 in 2017 under Title I of the FDA Reauthorization Act of
2017 (FDARA) (PDUFA VI). PDUFA was most recently renewed in 2022 under
Title 1 of the FDA User Fee Reauthorization Act of 2022 (FDAUFRA) which
lasts through FY 2027 (PDUFA VII).
PDUFA's intent is to provide additional revenues so that FDA can
hire more staff, improve systems, and establish a better managed human
drug review process to make important therapies available to patients
sooner without compromising review quality or FDA's high standards for
safety, efficacy, and quality. As part of FDA's negotiated agreement
with industry during each reauthorization, the Agency agrees to certain
performance and procedural goals and other commitments that apply to
aspects of the human drug review program. These goals apply, for
example, to the process for the review of original new human drug and
biological product applications, postmarket safety activities, and new
data standards and technology enhancements.
During the first few years of PDUFA I, the additional funding
enabled FDA to eliminate backlogs of original applications and
supplements. Phased in over the 5 years of PDUFA I, the goals were to
review and act on 90 percent of priority new drug applications (NDAs),
biologics license applications (BLAs), and efficacy supplements within
6 months of submission of a complete application; to review and act on
90 percent of standard original NDAs, BLAs, and efficacy supplements
within 12 months, and to review and act on resubmissions and
manufacturing supplements within 6 months. Over the course of PDUFA I,
FDA exceeded all these performance goals and significantly reduced
median review times of both priority and standard NDAs and BLAs.
Under PDUFA II, the review performance goals were adjusted, and new
procedural goals were added to improve FDA's interactions with industry
sponsors and to help facilitate the drug development process. The
procedural goals, for example, articulated time frames for scheduling
sponsor-requested meetings intended to address issues or questions
regarding specific drug development programs, as well as time frames
for the timely response to industry-submitted questions on special
study protocols. FDA met or exceeded all the review and procedural
goals under PDUFA II. However, concerns grew that overworked review
teams often had to return applications as ``approvable'' because they
did not have the resources and sufficient staff time to work with the
sponsors to resolve issues so that
[[Page 21317]]
applications could be approved in the first review cycle.
A sound financial footing and support for limited postmarket risk
management were key themes of PDUFA III. Base user fee resources were
significantly increased and a mechanism to account for changes in human
drug review workload was adopted. PDUFA III also expanded the scope of
user fee activities to include postmarket surveillance of new therapies
for up to 3 years after marketing approval. FDA committed to the
development of guidance for industry on risk assessment, risk
management, and pharmacovigilance, as well as guidance to review staff
and industry on good review management principles (GRMPs). Initiatives
to improve application submission and Agency-sponsor interactions
during the drug development and application review processes were also
adopted.
With PDUFA's reauthorization under FDAAA Title I (PDUFA IV), FDA
obtained a significant increase in base fee funding and committed to
full implementation of GRMPs, which included providing a planned review
timeline for premarket review, development of new guidance for industry
on innovative clinical trials, modernization of postmarket safety, and
elimination of the 3-year limitation on fee support for postmarket
surveillance. Additional provisions in FDAAA (Titles IV, V, and IX)
gave FDA additional statutory authority that increased the pre- and
postmarket review process requirements, added new deadlines, and
effectively increased review workload. Specifically, the new provisions
expanded FDA's drug safety authorities, such as the authority to
require risk evaluation mitigation strategies, order safety labeling
changes, and require postmarket studies.
Under Title I of FDASIA, the fourth renewal of PDUFA, FDA
implemented a new review program (the Program) to promote greater
transparency and increase communication between the FDA review team and
the applicant on the most innovative products reviewed by the Agency.
The Program applied to all new molecular entity (NME) NDAs and original
BLAs received by the Agency from October 1, 2012, through September 30,
2017. The Program added new opportunities for communication between the
FDA review team and the applicant during review of a marketing
application, including midcycle communications and late-cycle meetings,
while adding 60 days to the review clock to provide for this increased
interaction and to address review issues for these complex
applications. PDUFA V also required an assessment of the impact of the
Program. The independent assessment of the Program entitled
``Assessment of the Program for Enhanced Review Transparency and
Communication for NME NDAs and Original BLAs in PDUFA V,'' is available
at: https://www.fda.gov/media/101907/download.
In addition to continued commitment to a significant set of review,
processing, and procedural goals, PDUFA V also included commitments
related to enhancing regulatory science and expediting drug
development, enhancing benefit-risk assessment in regulatory decision
making, modernizing the FDA drug safety system, and improving the
efficiency of human drug review by requiring electronic submissions and
standardization of electronic drug application data.
In August 2017, FDARA was enacted, renewing the prescription drug
user fee program for a sixth time. This iteration of the program
continued and built upon the successes of PDUFA V. In PDUFA VI, FDA and
industry members agreed to continue the Program model developed in
PDUFA V to continue to promote the efficiency and effectiveness of the
first cycle review process. PDUFA VI included commitments to enhance
regulatory science and expedite drug development by focusing on
enhancing communication between FDA and sponsors during drug
development, early consultation on the use of new surrogate endpoints,
and exploring the use of real-world evidence for use in regulatory
decision making, among other enhancements. This iteration included
commitments to enhance the use of regulatory tools to support drug
development and review through incorporation of the patient's voice in
drug development, expanded use of a benefit-risk framework in drug
reviews, and advancing the use of complex innovative trial designs and
model informed drug development.
Under PDUFA VI, FDA also modernized the user fee structure to
improve program funding predictability, stability, and administrative
efficiency. The new structure eliminated the supplement fees, replaced
the establishment and product fees with a program fee, and shifted a
greater proportion of the target revenue to the new more predictable
and stable annual program fee. The agreement also included commitments
to enhance management of user fee resources through the development of
a resource capacity planning capability and financial transparency
activities. PDUFA VI included several commitments to improve the hiring
and retention of critical review staff through modernization of FDA's
hiring system.
The current authorization of PDUFA (PDUFA VII) introduces new
enhancements to address changes in the drug development landscape,
along with building on successful enhancements and refining elements
from previous authorizations. The PDUFA VII agreement strengthened
staff capacity and capability in CBER to support the development,
review, and approval of cell and gene therapy products. It incorporates
new allergenic extract products into the PDUFA program and provides
resources for review of those products. The agreement introduces
timelines and performance goals for pre-approval review of
postmarketing requirements and use-related risk analysis and human
factor protocol submissions. It also includes two new meeting types
(Type D and INTERACT) to allow for focused discussion around specific
and novel issues. PDUFA VII introduces four new pilot programs focused
on advancing different aspects of drug development and review,
including rare diseases (Rare Diseases Endpoint Advancement Pilot),
real-world evidence (Advancing Real-World Evidence Program),
manufacturing (Chemistry, Manufacturing, and Controls Development and
Readiness Pilot), and drugs for unmet therapeutic areas (Split Real
Time Application Review). The agreement continues paired meeting
programs (Model-Informed Drug Development Paired Meeting Program and
Complex Innovative Trial Design Meeting Program) that target complex
applications. It introduces a series of new enhancements related to
product quality reviews, chemistry, manufacturing, controls approaches,
and advancing utilization of innovative manufacturing technologies.
PDUFA VII builds on the financial enhancements included in PDUFA VI to
ensure optimal use of user fee resources and transparency around the
use of financial resources. The agreement commits FDA to initiatives in
leveraging cloud technology, modernizing the Agency's information
technology systems, enhancing bioinformatics support and use of digital
health technologies to support drug development and review.
More information on these commitments can be found in the PDUFA VII
commitment letter at: https://www.fda.gov/media/151712/download?attachment. A list of the deliverables developed to meet PDUFA
VII commitments is available on the FDA web page at: https://
www.fda.gov/industry/prescription-drug-user-fee-
[[Page 21318]]
amendments/completed-pdufa-vii-deliverables.
III. Public Meeting Information
A. Purpose and Scope of the Meeting
In general, the public meeting's format will include presentations
by FDA and other interested parties, which may include scientific and
academic experts, healthcare professionals, representatives of patient
and consumer advocacy groups, the prescription drug industry, and the
general public. A draft agenda and other background information for the
public meeting will be posted at: https://www.fda.gov/industry/public-meeting-reauthorization-prescription-drug-user-fee-act-pdufa-07142025.
B. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following web page: https://publicmeetingonthereauthorizationofpdufa.eventbrite.com. Please provide
complete contact information for each attendee, including name, title,
affiliation, and email.
Registration is free for both in person and virtual attendance. In
person attendance is based on space availability, with priority given
to early registrants. Early registration is recommended because seating
is limited; therefore, FDA may limit the number of participants from
each organization. If you need special accommodations due to a
disability, please contact [email protected] no later than June
30, 2025.
Opportunity for Public Comment: Those who register online by June
16, 2025, at 11:59 p.m. Eastern Time will receive a notification about
an opportunity to participate in the public comment session of the
meeting. If you wish to speak during the public comment session, follow
the instructions in the notification and identify which topic(s) you
wish to address. All requests to make a public comment during the
meeting must be received by June 30, 2025, 11:59 p.m. Eastern Time. We
will do our best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to
consolidate or coordinate their comments and request time jointly. We
will determine the amount of time allotted to each commenter, the
approximate time each comment is to begin, and will select and notify
participants by July 7, 2025. No commercial or promotional material
will be permitted to be presented at the public meeting.
Streaming Webcast of the Public Meeting: The webcast for this
public meeting is available at https://teams.microsoft.com/l/meetup-join/19%3ameeting_OWNhMmRmMTMtYjZiOS00MWQ3LWI5MTgtOTUzMzRlNDUwMWJj%40thread.v2/0?context=%7b%22Tid%22%3a%227d2fdb41-339c-4257-87f2-a665730b31fc%22%2c%22Oid%22%3a%22f8076904-2170-423d-ae92-b261e8a4d877%22%7d.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at: https://www.fda.gov/industry/public-meeting-reauthorization-prescription-drug-user-fee-act-pdufa-07142025.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Dated: May 7, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08824 Filed 5-16-25; 8:45 am]
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