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Committee Detail

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
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameAnesthetic and Analgesic Drug Products Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2022Committee Number788
Original Establishment Date11/28/1990Committee StatusChartered
Actual Termination Date Committee URLhttp://www.fda.gov/AdvisoryCommittees/Committee...
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*12
Current Charter Date5/1/2022Designated Fed Officer Position Title*DFO
Date Of Renewal Charter5/1/2024Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Moon Hee
Exempt From Renewal*NoDesignated Federal Officer Middle NameV.
Specific Termination AuthorityDesignated Federal Officer Last Name*Choi
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharm.D.
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(301) 796-9001
Effective Date Of Authority*11/28/1990Designated Federal Officer Fax*301-847-8533
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*moonhee.choi@fda.hhs.gov
Committee Type*Continuing
Presidential*No
Committee Function*Scientific Technical Program Advisory Board
Hide Section - RECOMMENDATION/JUSTIFICATIONS

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*Continue
Legislation to Terminate RequiredNot Applicable
Legislation StatusNot 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. 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-22, the Committee held one meeting.

On February 15, 2022, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly to discuss new drug application (NDA) 213231, for tramadol hydrochloride injection, submitted by Avenue Therapeutics, Inc., for the management of moderate to moderately severe pain in adults in a medically supervised healthcare setting. The issues that the Committees discussed included the clinical relevance of tramadol hydrochloride injection, an opioid intended for management of acute pain in a medically supervised healthcare setting, when its onset of action is delayed, and its proposed dosing is a fixed-dosing regimen.  A majority of members (8 Yeses and 14 Noes) voted that the Applicant did not submit adequate information to support the position that the benefits for their product outweigh the risks for the management of acute pain severe enough to require an opioid analgesic in an inpatient setting. Agency Action: The Agency is reviewing recommendations made at the meeting.

It is expected that the Committee will meet three to five times during FY-23.
Why advice can't be obtained elsewhere?*Members of the Committee are drawn from academia, research and/or clinical practice. Their advice and input lends credibility to FDA regulatory decisions. The alternate means of obtaining this advice would involve the recruitment of large numbers of scientist 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-22.
Recommendation RemarksThere were no reports required for this Committee in FY-22.

Although the current charter states that the committee shall hold meetings approximately three to five 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.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesYes
Outcome Major Policy ChangesYesAction Issued New RegulationsYes
Outcome Advance In Scientific ResearchYesAction Proposed LegislationYes
Outcome Effective Grant MakingNoAction Approved Grants Or Other PaymentsNo
Outcome Improved Service DeliveryNoAction OtherYes
Outcome Increased Customer SatisfactionYesAction CommentFDA approves or chooses not to approve new medical products.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentN/ANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe 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 bases 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 CommentN/A
Number Of Recommendations*60Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 60 recommendations from FY-03 through FY-22.Access Agency WebsiteYes
% of Recs Fully Implemented*84.00%Access Committee WebsiteYes
% of Recs Fully Implemented CommentThe 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 WebsiteYes
% of Recs Partially Implemented*10.00%Access PublicationsYes
% of Recs Partially Implemented CommentThe 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 adviceAccess OtherNo
Agency Feedback*YesAccess CommentN/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 https://www.fda.gov/advisory-committeesNarrative 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.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$6,756.00Est Payments to Non-Fed Members Next FY*$28,267.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$189,547.00Estimated Payments to Federal Staff*$187,929.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$0.00Est Travel Reimb Non-Fed Members nextFY*$0.00
Travel Reimb. For Federal Members*$0.00Est Travel Reimb For Fed Members*$0.00
Travel Reimb. For Federal Staff*$0.00Est. Travel Reimb to Fed Staff Next FY*$0.00
Travel Reimb. For Consultants*$0.00Est Travel Reimb to Consultants Next FY*$0.00
Other Costs$50,854.00Est. Other Costs Next FY*$57,489.00
Total Costs$247,157.00Est. Total Next FY*$273,685.00
Date Cost Last Modified10/8/2022 4:35 PMEst. Fed Staff Support Next FY*1.10
Federal Staff Support (FTE)*1.10Est Cost Remarks
Cost Remarks  
Hide Section - Interest Areas

Interest Areas

Category
Area
Food and Drugs
Food and Drugs
Health
Health Care
Safety
Treatment
Hide Section - MEMBERS,MEETINGS AND ADVISORY REPORTS

MEMBERS,MEETINGS AND ADVISORY REPORTS

To View all the members, meetings and advisory reports for this committee please click here
Hide Section - CHARTERS AND RELATED DOCS

CHARTERS AND RELATED DOCS

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-040475Anesthetic and Analgesic Drug Products Advisory Committee2021
 COM-038750Anesthetic and Analgesic Drug Products Advisory Committee2020
 COM-036633Anesthetic and Analgesic Drug Products Advisory Committee2019
 COM-034846Anesthetic and Analgesic Drug Products Advisory Committee2018
 COM-001873Anesthetic and Analgesic Drug Products Advisory Committee2017
 COM-002335Anesthetic and Analgesic Drug Products Advisory Committee2016
 COM-003825Anesthetic and Analgesic Drug Products Advisory Committee2015
 COM-004497Anesthetic and Analgesic Drug Products Advisory Committee2014
 COM-006266Anesthetic and Analgesic Drug Products Advisory Committee2013
 COM-006948Anesthetic and Analgesic Drug Products Advisory Committee2012
 COM-008391Anesthetic and Analgesic Drug Products Advisory Committee2011
 COM-008710Anesthetic and Life Support Drugs Advisory Committee2010
 COM-010096Anesthetic and Life Support Drugs Advisory Committee2009
 COM-011040Anesthetic and Life Support Drugs Advisory Committee2008
 COM-012131Anesthetic and Life Support Drugs Advisory Committee2007
 COM-012681Anesthetic and Life Support Drugs Advisory Committee2006
 COM-013803Anesthetic and Life Support Drugs Advisory Committee2005
 COM-014468Anesthetic and Life Support Drugs Advisory Committee2004
 COM-015992Anesthetic and Life Support Drugs Advisory Committee2003
 COM-016390Anesthetic and Life Support Drugs Advisory Committee2002
 COM-017913Anesthetic and Life Support Drugs Advisory Committee2001
 COM-018749Anesthetic and Life Support Drugs Advisory Committee2000
 COM-019829Anesthetic and Life Support Drugs Advisory Committee1999
 COM-020470Anesthetic and Life Support Drugs Advisory Committee1998
 COM-021722Anesthetic and Life Support Drugs Advisory Committee1997