FACACLASSIC

Note: An Annual Comprehensive Review, as required by §7 of the Federal Advisory Committee Act, is conducted each year on committee data entered for the previous fiscal year (referred to as the reporting year). The data for the reporting year is not considered verified until this review is complete and the data is moved to history for an agency/department. See the Data From Previous Years section at the bottom of this page for the committee’s historical, verified data.

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HHS - 847 - Drug Safety and Risk Management Advisory Committee - Authorized by Law

GENERAL INFORMATION

Committee Name	Drug Safety and Risk Management Advisory Committee	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	847
Original Establishment Date	11/28/1990	Committee Status	Chartered
Actual Termination Date		Committee URL	http://www.fda.gov/AdvisoryCommittees/Committee...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	12
Terminated This FY	No	Designated Fed Officer Position Title*	Acting Designated Federal Officer
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	5/31/2024	Designated Federal Officer First Name*	Jessica
Date Of Renewal Charter	5/31/2026	Designated Federal Officer Middle Name
Projected Termination Date		Designated Federal Officer Last Name*	Seo
Exempt From Renewal*	No	Designated Federal Officer Suffix	Pharm.D., M.P.H.
Specific Termination Authority		Designated Federal Officer Phone*	(301) 796-7699
Establishment Authority*	Authorized by Law	Designated Federal Officer Fax*	301-847-8533
Specific Establishment Authority*	21 U.S.C. 394	Designated Federal Officer Email*	jessica.seo@fda.hhs.gov
Effective Date Of Authority*	11/28/1990
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not Applicable
How does cmte accomplish its purpose?*	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 all 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 recommends actions 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.
How is membership balanced?*	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. Members will be invited to serve for overlapping terms of up to four years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry interests. There may also be an alternate industry representative.
How frequent & relevant are cmte mtgs?*	In FY-25, the Committee held 2 meetings. On November 19, 2024, the Drug Safety and Risk Management Advisory Committee and the Psychologic 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. Agency Action: 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 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 (https://www.fda.gov/media/95546/download). 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. Agency Action: The Agency is still reviewing the recommendations made at the meeting. It is expected that the Committee will meet 3-5 times during FY-26.
Why advice can't be obtained elsewhere?*	Members of the Committee are drawn from academia, research and/or clinical practice. Their advice and input is considered as part of FDA's regulatory decision-making and helps those decisions stand up to intense public scrutiny. The alternate means of obtaining this advice would be to hire large numbers of scientists on a full time basis at a great expense to the government.
Why close or partially close meetings?	The committee held no closed meetings during FY-25.
Recommendation Remarks	Although the current charter states that the Committee shall hold meetings approximately 3-6 times a year, this is only an estimation based on data from previous years. As the FDA convenes advisory committees regarding based on the needs of the Agency, it should not be construed as an exact figure.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	Yes
Outcome Trust In Government	Yes	Action Reallocate Resources	Yes
Outcome Major Policy Changes	Yes	Action Issued New Regulations	Yes
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	Yes
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	Yes	Action Comment	FDA approves or chooses not to approve an investigational new medical product or other regulatory decision-making.
Outcome Implement Laws/Reg Requirements	Yes	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	N/A	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	The utilization of the Drug Safety and Risk Management Drugs Advisory Committee enabled the Agency to obtain required and frequently scarce external input from medical and scientific experts not otherwise available to the Agency; and to obtain the services of these experts only on an as needed basis rather than on a full time basis. The service of the Committee resulted in advice for the improvement of the public health, for which it is difficult to assign a financial value.	Grants Review Comment	N/A
Number Of Recommendations*	77	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The Committee made 77 recommendations from FY-03 through FY-25.	Access Agency Website	Yes
% of Recs Fully Implemented*	84.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	The function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, therefore, the Agency has the option of not implementing the advice. This number represents an approximation of the percentage of recommendations that the agency has fully implemented or plans to fully implement.	Access GSA FACA Website	Yes
% of Recs Partially Implemented*	10.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	The function of an advisory committee is purely advisory in nature. Although the FDA most often accepts the recommendations from its committees, the advice is purely advisory in nature, and therefore, the Agency has the option of not implementing the advice.	Access Other	No
Agency Feedback*	Yes	Access Comment	N/A
Agency Feedback Comment*	When appropriate, information is made available to the public. Actions related to guidance documents or other general matters or issues are available publicly when implemented. Please see https://www.fda.gov/.	Narrative Description*	FDA’s strategic priorities in responding to the public health challenges of the 21st century are to advance regulatory science and innovation; strengthen the safety and integrity of the global supply chain; strengthen compliance and enforcement activities to support public health; expand efforts to meet the needs of special populations; advance medical countermeasures and emergency preparedness; advance food safety and nutrition; promote public health by advancing the safety and effectiveness of medical products; establish an effective tobacco regulation, prevention, and control program; and manage for organizational excellence and accountability. The Drug Safety and Risk Management Advisory Committee supports FDA's strategic priorities by reviewing and evaluating available data 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 and making appropriate recommendations to the Commissioner of Food and Drugs. The Committee also advises the Commissioner of Food and Drugs regarding the scientific and medical evaluation of all 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 recommends actions 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. This supports the development of safe and effective new medical technologies, and advances the status of the Agency as a science-based and science-led regulatory agency, providing global leadership in the protection of public health.

COSTS

1. Payments to Non-Federal Members*		1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*		2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*		3. Estimated Payments to Federal Staff*
4. Payments to Consultants*		4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*		5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*		6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*		7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*		8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs		10. Est. Other Costs Next FY*
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	3/14/2025 9:29 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Food and Drugs Food and Drugs Health Health Care Safety Treatment

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