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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.


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 Year2020Committee 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 Date5/1/2020Designated Fed Officer Position Title*DFO
Date Of Renewal Charter5/1/2022Designated 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 CmteExempt: Consumer Product Safety CmteDesignated 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-20, the Committee met four times. At one of these meetings, the Committee met in joint session with the Drug Safety and Risk Management Advisory Committee 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 14, 2020, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly to discuss new drug application 211802 for oxycodegol, a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The Committees were asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product. The Committees voted unanimously against (27 to 0) the approval of oxycodegol due to deficiencies in the presented data. Many members felt that the potential benefits of this product did not outweigh its risks. Many were also concerned that, if this drug was approved, it could set a precedent for approval on just one efficacy study. Agency Action: The Agency is still reviewing recommendations made at the meeting.

During the morning session on January 15, 2020, 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) 213426, for tramadol 44 milligrams (mg) and celecoxib 56 mg tablet, which contains a fixed dose combination of an opioid and a non-steroid anti-inflammatory drug, submitted by Esteve Pharmaceuticals, S.A., for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The Committees were asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product. The members were split (13 to 13) on whether they recommend approval of tramadol 44mg and celecoxib 56mg tablets for the proposed indication of the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Agency Action: The Agency is still reviewing recommendations made at the meeting.

During the afternoon session on January 15, 2020, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly to discuss NDA 209653, for an extended-release oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., with the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The Committees were asked to discuss whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling, as well as to discuss the overall risk-benefit profile of the product. An overwhelming majority of the members(2 yeses to 24 noes) voted “No”, indicating that they did not recommend approval of AXIMRIS XR (oxycodone extended-release tablets) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. These members agreed that AXIMRIS XR did not offer any abuse-deterrent advantages to what is currently available on the market and added that it offered more disadvantages such as the issues involving abuse via the intranasal route. Agency Action: The Agency is still reviewing recommendations made at the meeting.

On January 16, 2020, the Anesthetic and Analgesic Drug Products Advisory met to discuss new drug application (NDA) 204803, bupivacaine extended release solution for instillation, submitted by DURECT Corp., for the proposed indication of post-surgical analgesia. The committee discussed whether the Applicant adequately demonstrated the safety and efficacy of bupivacaine extended-release solution for post-surgical analgesia and the appropriateness of the proposed patient populations. The Committee also was asked to discuss the approvability of this product. The Committee was split (6 to 6) on whether they recommend approval of Posimir, bupivacaine extended-release solution, 660 mg/5 mL (132 mg/mL), for the proposed indication of single-dose instillation into the surgical site to produce postsurgical analgesia. The Committee members who voted “Yes” agreed that short-term efficacy, including a reduction in post-operative opioid use, was demonstrated, and that the product could be an alternative to opioid analgesia. The Committee members who voted “No” generally agreed that efficacy was not demonstrated in the surgical populations evaluated. These members recommended an additional evaluation of the safety risks associated with the surgical wound and they also recommended a study to evaluate inadvertent intravenous administration. Agency Action: The Agency is still reviewing recommendations made at the meeting.

On September 10-11, 2020, 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 five to six times during FY-21.
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-20.
Recommendation RemarksThere were no reports required for this Committee in FY-20.

In FY-20, the Committee met four times. At one of these meetings, the Committee, met in joint session with another committee 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 September 10-11, 2020, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly to discuss the results of required postmarketing studies (Postmarketing Requirements 3051-1, 3051-2, 3051-3, and 3051-4) that evaluated the effect of the reformulation of OXYCONTIN (oxycodone hydrochloride extended-release tablets, manufactured by Purdue Pharma L.P., NDA 022272) on abuse, misuse, and fatal and non-fatal overdose, associated with OXYCONTIN. The Committees discussed whether these studies, in concert with other information from the published literature, have demonstrated that the reformulated OXYCONTIN product has resulted in a meaningful reduction in these outcomes. The Committees also discussed the broader public health impact of OXYCONTIN’s reformulation. The majority of the members (20 to 7) voted “Yes”, agreeing that the available evidence demonstrate that the reformulation of OxyContin meaningfully reduced abuse of the product, relative to the original formulation, by one or more non-oral routes. A majority of the members (26 to 2) voted “No”, that the available evidence does not demonstrate that the reformulation of OxyContin meaningfully reduced overall abuse of this product, relative to the original formulation. There was no consensus among these members as to whether there was sufficient evidence or whether additional information is still needed. The majority of the committee members (26 to 1) voted “No”, that the available evidence does not demonstrate that OxyContin’s reformulation meaningfully reduced the risk of opioid overdose, relative to the original formulation. Agency Action: The Agency is still reviewing recommendations made at the meeting.
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*58Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 58 recommendations from FY-03 through FY-20. See section Recommendation/Justifications of the annual report for specific accomplishments.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.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.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$25,615.00Est Payments to Non-Fed Members Next FY*$52,800.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$174,365.00Estimated Payments to Federal Staff*$177,227.00
Payments to Consultants*$8,720.00Est. Payments to Consultants Next FY*$13,200.00
Travel Reimb. For Non-Federal Members*$11,417.00Est Travel Reimb Non-Fed Members nextFY*$21,118.00
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*$5,331.00Est Travel Reimb to Consultants Next FY*$8,027.00
Other Costs$52,123.00Est. Other Costs Next FY*$58,094.00
Total Costs$277,571.00Est. Total Next FY*$330,466.00
Federal Staff Support (FTE)*1.10Est. Fed Staff Support Next FY*1.10
Cost RemarksEst 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-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