Notice2026-10371
Advisory Committee; Drug Safety and Risk Management Advisory Committee; Renewal
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Published
May 26, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the renewal of the Drug Safety and Risk Management Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Drug Safety and Risk Management Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the May 31, 2028, expiration date.
Full Text
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<title>Federal Register, Volume 91 Issue 100 (Tuesday, May 26, 2026)</title>
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[Federal Register Volume 91, Number 100 (Tuesday, May 26, 2026)]
[Notices]
[Pages 30656-30659]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10371]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0008]
Advisory Committee; Drug Safety and Risk Management Advisory
Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Drug Safety and Risk Management Advisory Committee by
the Commissioner of Food and Drugs (the Commissioner). The Commissioner
has determined that it is in the public interest to renew the Drug
Safety and Risk Management Advisory Committee for an additional 2 years
beyond the charter expiration date. The new charter will be in effect
until the May 31, 2028, expiration date.
DATES: Authority for the Drug Safety and Risk Management Advisory
Committee will expire on May 31, 2026, unless the Commissioner formally
determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Advisory Committee Oversight and
Management Staff, Office of the Chief Scientist, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3215, Silver
Spring, MD 20993-0002, (301) 796-8220, <a href="/cdn-cgi/l/email-protection#6425272b2937371106090d17170d0b0a17240200054a0c0c174a030b12"><span class="__cf_email__" data-cfemail="9ddcded2d0cecee8fff0f4eeeef4f2f3eeddfbf9fcb3f5f5eeb3faf2eb">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Drug Safety and
Risk Management Advisory Committee (the Committee). The Committee is a
discretionary Federal advisory committee established to provide advice
to the Commissioner. The Committee advises and informs the Commissioner
or designee(s) about the scientific and medical evaluation of
information with regard to safety, efficacy, and abuse potential of
drugs or other substances, and makes recommendations as appropriate.
The Committee reviews and evaluates information on risk management,
risk communication, and quantitative evaluation of spontaneous reports
for drugs for human use and for any other product for which the Food
and Drug Administration has regulatory responsibility. The Committee
also advises the Commissioner of Food and Drugs regarding the
scientific and medical evaluation of information gathered by the
Department of Health and Human Services and the Department of Justice
with regard to safety, efficacy, and abuse potential of drugs or other
substances, and makes recommendations as appropriate to be taken by the
Department of Health and Human Services with regard to the marketing,
investigation, and control of such drugs or other substances. The
Committee may consider the quality and relevance of FDA's research
program, which provides scientific support for the regulation of these
products, and makes appropriate recommendations to the Commissioner.
The Committee shall consist of at least six voting members
including the Chair. Subject to legal and regulatory requirements,
members and the Chair are selected by and serve at the discretion of
the Commissioner or designee. Each member, including the Chair, will be
selected from among authorities knowledgeable in the fields of risk
communication, risk management, drug safety, medical, behavioral, and
biological sciences as they apply to risk management, and drug abuse.
Members may be invited to serve for terms of up to four years, or
for less time at the discretion of the Commissioner or designee. Non-
Federal members of this committee will serve as Special Government
Employees or representatives. Federal members will serve as Regular
Government Employees or Ex-Officios.
In addition to the voting members, the Commissioner or designee may
identify consumer and/or industry representatives to join the Committee
(or serve as alternate representatives) as non-voting representative
member(s), via a process consistent with legal and regulatory
requirements. Individuals currently employed at FDA-regulated
companies, such as pharmaceutical and medical device manufacturers,
shall not be selected to serve as members of the Committee unless this
Committee is expected to address issues for which inclusion of an
industry representative is required by statute. If this Committee
includes an industry representative, the Commissioner or designee will
determine whether to invite them to participate in meetings on a case-
by-case basis, according to applicable legal and regulatory
requirements.
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees to
serve temporarily as voting members and to designate Special Government
Employees to serve temporarily as voting members when: (1) expertise is
required that is not available among current voting standing members of
the Committee (when additional voting members are added to the
Committee to provide needed expertise, a quorum will be based on the
combined total of regular and added members), or (2) to comprise a
quorum when, because of unforeseen circumstances, a quorum is or will
be lacking.
A quorum for the Committee is a majority of the current voting
members present at the time, provided that FDA may specify a quorum
that is less than a majority of the current voting members because of
the size of the Committee and the variety in the types of issues that
it will consider, or other reason determined appropriate in accordance
with legal and regulatory requirements. 21 CFR 14.22(d).
If functioning as a medical device panel, an additional non-voting
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representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in
addition to the voting members.
Members appointed to an advisory committee serve for the duration
of the committee, or until their terms expire, they resign, or they are
removed from membership by the Commissioner or designee. Committee
members' terms may be ended prior to their date of expiration, for
reasons determined to be good cause. Good cause includes excessive
absenteeism from committee meetings, a demonstrated bias that
interferes with the ability to render objective advice, failure to
abide by established procedures, or violation of other applicable rules
and regulations.
Further information regarding the most recent charter and other
information can be found at <a href="https://www.fda.gov/advisory-committees/human-drug-advisory-committees/drug-safety-and-risk-management-advisory-committee">https://www.fda.gov/advisory-committees/human-drug-advisory-committees/drug-safety-and-risk-management-advisory-committee</a> or by contacting the Advisory Committee Oversight
and Management Staff (see FOR FURTHER INFORMATION CONTACT). Because the
committee's name and description of duties remain unchanged, 21 CFR
14.100 will not be amended.
Renewal Requirements and Justification: The Commissioner has
determined that renewal of the Drug Safety and Risk Management Advisory
Committee is in the public interest. This determination is based on the
Committee's essential role in providing independent expert advice on
risk management, risk communication, and quantitative evaluation of
spontaneous reports for drugs for human use and for any other product
for which the Food and Drug Administration has regulatory
responsibility, the continued need for specialized expertise in this
therapeutic area, and the Committee's demonstrated value in supporting
FDA's regulatory mission. The following information supports this
determination in accordance with applicable legal and regulatory
requirements.
Public Interest Determination
Pursuant to 41 CFR 102-3.60(a), to establish, renew, reestablish,
or merge a discretionary (agency discretion) advisory committee, an
agency must first consult with the General Services Administration's
Committee Management Secretariat (the Secretariat) and, as part of the
consultation, provide a written public interest determination approved
by the head of the agency to the Secretariat with a copy to the Office
of Management and Budget. In addition, pursuant to 41 CFR 102-3.35, an
agency shall follow the same consultation process and document in
writing the same determination of need before creating a subcommittee
under a discretionary committee that is not made up entirely of members
of a parent advisory committee.
Information on the following factors for the committee is provided
to the Secretariat to demonstrate that renewing the committee is in the
public interest:
1. Annual budget: The overall annual budget for this committee is
$130,550.00.
<bullet> Federal personnel on a full-time equivalent (FTE) basis:
The estimated person years of Federal staff support required is 0.25 at
an estimated annual cost of $50,875.00.
<bullet> Other Federal internal costs: The anticipated total value
in USD of other internal costs, such as cost associated with IT and
supplies for meetings, is $17,269.00.
<bullet> Proposed payments to members: The estimated annual payment
to members is $13,404.00.
<bullet> Proposed number of members: The anticipated number of
members is 6.
<bullet> Reimbursable costs: The estimated annual reimbursable
costs, including travel and related expenses for members is $42,300.00.
2. If applicable, the total dollar value of grants expected to be
recommended during the fiscal year: N/A.
3. Criteria for selecting members to ensure the committee has the
necessary expertise and fairly balanced membership:
Ensuring Necessary Expertise:
Members and the Chair are selected by the Commissioner or designee
from among authorities knowledgeable in the fields of risk
communication, risk management, drug safety, medical, behavioral, and
biological sciences as they apply to risk management, and drug abuse.
Nominees should be acknowledged experts with demonstrated skills in
critical evaluation of data and effective communication. Members must
have background, education, and experience commensurate with the
committee's function of advising FDA on the existing and relevant
evidence of benefits and risks of marketed and investigational human
drug products. Scientific and technical competence is critical. FDA
also follows the requirements in section 505(n)(3) regarding membership
of drug product advisory committees. (21 U.S.C. 355(n)(3)).
Ensuring Fair Balance:
Appointments are made without discrimination. The committee is
reviewed in totality for balance, characterized by inclusion of
necessary knowledge, insight, and scientific perspective from the
relevant community or expertise area. Nominations are sought from all
geographic locations within the United States and its territories, and
from diverse sources including professional and scientific societies,
academia, government agencies, industry and trade associations,
consumer and patient organizations, and current Agency staff.
4. List of all other Federal advisory committees of the agency:
FDA maintains the following Federal advisory committees:
<bullet> Anesthetic and Analgesic Drug Products Advisory Committee
<bullet> Antimicrobial Drugs Advisory Committee
<bullet> Blood Products Advisory Committee
<bullet> Cardiovascular and Renal Drugs Advisory Committee
<bullet> Cellular Tissue and Gene Therapies Advisory Committee
<bullet> Dermatologic and Ophthalmic Drugs Advisory Committee
<bullet> Device Good Manufacturing Practice Advisory Committee
<bullet> Digital Health Advisory Committee
<bullet> Endocrinologic and Metabolic Drugs Advisory Committee
<bullet> Gastrointestinal Drugs Advisory Committee
<bullet> Genetic and Metabolic Disease Advisory Committee
<bullet> Medical Devices Advisory Committee
<bullet> National Mammography Quality Assurance Advisory Committee
(Administratively Inactive)
<bullet> Nonprescription Drugs Advisory Committee
<bullet> Oncologic Drugs Advisory Committee
<bullet> Patient Engagement Advisory Committee
<bullet> Pediatrics Advisory Committee
<bullet> Peripheral and Central Nervous System Advisory Committee
<bullet> Pharmacy Compounding Advisory Committee
<bullet> Pharmacy Compounding Drugs AC
<bullet> Psychopharmacologic Drugs Advisory Committee
<bullet> Pulmonary-Allergy Drugs Advisory Committee
<bullet> Risk Communication Advisory Committee (Administratively
Inactive)
<bullet> Science Board to the Food and Drug Administration
<bullet> Technical and Electronic Product Safety Standards AC
<bullet> Technical and Electronic Products Safety Standards Advisory
Committee
<bullet> Tobacco Products Advisory Committee
5. Justification that the information or advice provided by the
Federal advisory committee or subcommittee is not
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available from another Federal advisory committee, another Federal
Government source, or any other more cost-effective and less burdensome
source:
The Committee advises and informs the Commissioner or designee(s)
about the scientific and medical evaluation of information with regard
to safety, efficacy, and abuse potential of drugs or other substances,
and makes recommendations as appropriate.
The Committee reviews and evaluates information on risk management,
risk communication, and quantitative evaluation of spontaneous reports
for drugs for human use and for any other product for which the Food
and Drug Administration has regulatory responsibility. The Committee
also advises the Commissioner of Food and Drugs regarding the
scientific and medical evaluation of information gathered by the
Department of Health and Human Services (HHS) and the Department of
Justice with regard to safety, efficacy, and abuse potential of drugs
or other substances, and makes recommendations as appropriate to be
taken by HHS with regard to the marketing, investigation, and control
of such drugs or other substances.
The topics considered by DSaRM require specialized expertise in
risk communication, risk management, drug safety, medical, behavioral,
and biological sciences as they apply to risk management, and drug
abuse. Potential topics that may need committee input in the near
future include topics related to drug safety and efficacy, risk
management and potential abuse. This Committee generally meets as a
Joint meeting when other Committees are tasked to evaluate risk
management associated with products relating to their disease states.
There is no other committee within the Agency that can address these
issues without diminishing the depth and relevance of the expert input
provided to the Agency.
6. If the consultation is a committee renewal, a summary of the
previous accomplishments of the committee and the reasons it needs to
continue:
For the last three years, DSaRM has co-led three joint advisory
committee meetings with: Anesthetic and Analgesic Drug Products
Advisory Committee, Psychopharmacologic Drugs Advisory Committee, and
Dermatologic and Ophthalmic Drugs Advisory Committee.
On May 5, 2025, the Drug Safety and Risk Management Advisory
Committee and the Anesthetic and Analgesic Drug Products Advisory
Committee met jointly to discuss the findings of the completed
extended-release/long-acting opioid analgesic (ER/LA OA) postmarketing
requirements (PMRs) 3033-1 and 3033-2 (<a href="https://www.fda.gov/media/95546/download">https://www.fda.gov/media/95546/download</a>). These PMRs are prospective (3033-1) and retrospective (3033-
2) epidemiologic studies that examined the serious risks and predictors
of misuse, abuse, addiction, and fatal and non-fatal opioid overdose in
patients with long-term use of opioid analgesics for management of
chronic pain, including patients prescribed ER/LA OAs. The Committees
discussed their interpretation of the findings from PMRs 3033-1 and
3033-2 on the incidence and prevalence of misuse, abuse, Opioid Use
Disorder (OUD), and fatal and nonfatal overdose in patients using OAs
long-term, their thoughts on the most important findings, as well as
any novel findings they believed FDA should communicate to healthcare
providers, patients, and other members of the public.
Impact: After reviewing those results, public comments, medical
research and recognizing the absence of adequate and well-controlled
studies on long-term opioid effectiveness, the FDA decided to require
safety labeling changes to help health care professionals and patients
make treatment decisions influenced by the latest evidence shown in the
May 2025 Advisory Committee meeting. The FDA implemented safety
labeling requirements to all opioid pain medications to further
extrapolate on the risks associated with their long-term use. Letters
were sent to relevant applicants outlining the required changes:
Clearer Risk Information, Dosing Warnings, Clarified Use Limits,
Treatment Guidance, Safe Discontinuation, Overdose Reversal Agents,
Drug Interactions, more Risk Information with Overdose (toxic
leukoencephalopathy) and Digestive Health. The companies were given 30
days to submit their labeling updates for review.
On November 19, 2024, the Drug Safety and Risk Management Advisory
Committee and the Psychopharmacologic Drugs Advisory Committee met
jointly to discuss the reevaluation of the Clozapine Risk Evaluation
and Mitigation Strategy (REMS) and possible changes to minimize burden
on patients, pharmacies, and prescribers while maintaining safe use of
clozapine. The issues the Committees discussed included whether
clozapine healthcare providers have sufficient knowledge and access to
resources about the risk of neutropenia and need for absolute
neutrophil count (ANC) monitoring, and whether ANC monitoring would be
performed without the requirements of the REMS. The Committees were in
near unanimous agreement (14 Noes and 1 Yes) that the following REMS
requirements are not necessary to ensure safe use of clozapine:
documentation of ANC results by providers and verification of those
results by pharmacies, and requirements for education of healthcare
providers about the risk of severe neutropenia and need for ANC
monitoring.
Impact: As of February 24, 2025, the Agency no longer expects
prescribers, pharmacies, and patients to participate in the REMS
program for clozapine or to report results of absolute neutrophil count
(ANC) blood tests before pharmacies dispense clozapine. FDA still
recommends that prescribers monitor patients' ANC according to the
monitoring frequencies described in the prescribing information.
On March 28-29, 2023, the Drug Safety and Risk Management Advisory
Committee met jointly with the Ophthalmic Drugs Advisory Committee to
discuss proposed changes to the iPLEDGE Risk Evaluation and Mitigation
Strategy (REMS) requirements to minimize burden on patients,
pharmacies, and prescribers while maintaining safe use of isotretinoin
oral capsules for patients. The majority of the members (4 Yeses, 17
Noes, 1 Abstention) voted ``No'' to the question as to whether the
iPLEDGE REMS should retain the 19-day lockout period requirement before
patients can take an additional pregnancy test to be eligible to
receive isotretinoin. Regarding the vote question as to when should the
REMS require prescribers to document counseling for patients who cannot
become pregnant in the iPLEDGE system, ten (10) members voted that the
REMS should only require prescribers to document counseling patients
who cannot become pregnant with the first prescription as part of
patient enrollment; one (1) member voted that the requirement should
remain the same because there was no data to inform a change, six (6)
members voted that the requirement should be switched to every 120 days
with two of these members commenting they were comfortable with
documentation only at treatment initiation, and five (5) members voted
that the requirement should be changed to another frequency. Regarding
recommendations on the pregnancy registry requirement and ways in which
it could be streamlined to encourage more participation to yield high
quality data, members agreed it is not necessary to continue to collect
``follow-up data'' (i.e., pregnancy and fetal outcome information) and
that
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more effective communication and transparency are needed regarding how
patients' data will be used if they participate in the iPLEDGE
Pregnancy Registry. Impact: On February 9, 2026, the FDA approved
significant modifications to the iPLEDGE REMS for isotretinoin oral
capsules for patients by reducing burden on patients, prescribers, and
pharmacists, effective August 8, 2026. The groundbreaking changes
include allowing at-home pregnancy test, removing the 19-day lockout/
waiting period and reducing document requirements for patient
counseling.
7. Explanation of why the committee/subcommittee is essential to
the conduct of agency business:
The Committee advises and informs the Commissioner of Food and
Drugs and appropriate designee(s) about the scientific and medical
evaluation of all information about safety, efficacy, and abuse
potential of drugs or other substances, and recommends actions to be
taken. The recommendations of this Committee will help FDA make
informed decisions about the product(s) or issues under consideration.
However, the FDA will retain full regulatory decision-making authority
on the issues associated with the product/s or issues under
consideration. The committee also plays a critical role in enabling FDA
to meet the requirements of sections 505(n)(1) and (s)(1) of the
Federal Food, Drug, and Cosmetic Act by providing expert scientific
advice and recommendations. Without the Drug Safety and Risk Management
Advisory Committee, FDA's ability to obtain external expert input on
issues related to safety, efficacy, and abuse potential of drugs or
other substances would be significantly limited.
In conclusion, this public interest determination documents that
renewing the committee is in the public interest, essential to the
conduct of agency business, and that the information to be obtained is
not already available through another advisory committee or source
within the Federal Government.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at <a href="http://www.fda.gov/AdvisoryCommittees/default.htm">http://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10371 Filed 5-22-26; 8:45 am]
BILLING CODE 4164-01-P
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