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.

Details on agency responses to committee recommendations can be found under the Performance Measures section for each committee in the fields “Agency Feedback” and “Agency Feedback Comment.”

HHS - 788 - Anesthetic and Analgesic Drug Products Advisory Committee - Authorized by Law

GENERAL INFORMATION

Committee Name	Anesthetic and Analgesic Drug Products Advisory Committee	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	788
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*	Designated Federal Officer
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	5/1/2024	Designated Federal Officer First Name*	Joyce
Date Of Renewal Charter	5/1/2026	Designated Federal Officer Middle Name
Projected Termination Date		Designated Federal Officer Last Name*	Frimpong
Exempt From Renewal*	No	Designated Federal Officer Suffix	Pharm.D.
Specific Termination Authority		Designated Federal Officer Phone*	301-796-7973
Establishment Authority*	Authorized by Law	Designated Federal Officer Fax*	301-847-8533
Specific Establishment Authority*	21 U.S.C. 394	Designated Federal Officer Email*	aadpac@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 available data concerning the safety and effectiveness of marketed and investigational human drug products including analgesics, e.g., abuse-deterrent opioids, novel analgesics, and issues related to opioid abuse, and those for use in anesthesiology and makes appropriate recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*	Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of anesthesiology, analgesics (such as: abuse deterrent opioids, novel analgesics, and issues related to opioid abuse) epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to four years. Non-Federal members of this committee will serve as Special Government Employees, representatives or Ex-Officio members. Federal members will serve as Regular Government Employees or Ex-Officios. 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 two meetings. At one of these meetings, the Committee, met in joint session with other Committees but was not the lead Committee. See the Agency Recommendations, Remarks section for a list of joint meetings in which the Committee was not the lead Committee. On January 10, 2025, the Anesthetic and Analgesic Drug Products Advisory Committee. discussed BLA 761393, condoliase injection submitted by Seikagaku Corp., for the proposed indication of the treatment of radicular leg pain associated with confirmed nerve root impingement caused by lumbar disc herniation in adults. The committee was tasked to discuss if the benefits of condoliase outweighed the risks. In general, a majority of the panelists (8 Yeses and 4 No's) voted that the Applicant had met substantial evidence of effectiveness. Agency Action: The Agency is reviewing recommendations made at the meeting. On May 5, 2025, a meeting was held jointly with the Drug Safety and Risk Management Advisory Committee. Further information regarding this meeting is provided in the Recommendation Remarks section. 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. They provide advice and input for FDA's consideration as it makes regulatory decisions. The alternate means of obtaining this advice would involve the recruitment of large numbers of scientists on a full-time basis at a maximum rate of compensation.
Why close or partially close meetings?	The Committee held no closed meetings during FY-25.
Recommendation Remarks	In FY-25, the Committee held two meetings. At one of these meetings, the Committee, met in joint session with other committees but was not the lead Committee. So that joint meetings are not counted twice in the FACA database, they will be reported under the primary or lead Committee. For the purposes of this database, the secondary Committee still reports meeting information and costs associated under this section of the report as well as the cost section. On January 10, 2025, the Anesthetic and Analgesic Drug Products Advisory Committee. discussed BLA 761393, condoliase injection submitted by Seikagaku Corp., for the proposed indication of the treatment of radicular leg pain associated with confirmed nerve root impingement caused by lumbar disc herniation in adults. The committee was tasked to discuss if the benefits of condoliase outweighed the risks. In general, a majority of the panelists (8 Yeses and 4 No's) voted that the Applicant had met substantial evidence of effectiveness. Agency Action: The Agency is still reviewing recommendations made at the meeting. 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.

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 new medical products.
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 Anesthetic and Analgesic Drug Products Advisory Committee enables the Agency to obtain required and frequently scarce professional services from medical and scientific experts not otherwise available to the Agency; and to obtain the services of these experts not otherwise available to the Agency; and to obtain the services of these experts only on an as needed 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*	63	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The Committee made 63 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.	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 Anesthetic and Analgesic Drug Products Advisory Committee supports FDA's strategic priorities by reviewing and evaluating data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of anesthesia and treatment of pain and makes appropriate recommendations to the Commissioner of Food and Drugs.

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 9:33 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

Custom Links

Committee Level Reports