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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameAnesthetic and Analgesic Drug Products Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee 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 Date5/1/2018Designated Fed Officer Position Title*DFO
Date Of Renewal Charter5/1/2020Designated 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
Committee Type*ContinuingDesignated Federal Officer Email*moonhee.choi@fda.hhs.gov
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 are 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. 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 member who is identified with industry interests.
How frequent & relevant are cmte mtgs?*The committee met five times in FY-18.

On February 14, 2018, the Anesthetic and Analgesic Drug Products Advisory Committee met jointly with the Drug Safety and Risk Management Advisory Committee to discuss new drug application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. The committees were also asked to discuss the abuse potential of this non-abuse-deterrent product and whether it should be approved. The majority of the committee (19 to 2) agreed that Hydexor should not be approved. Some of the committee members who voted “No” stated that their vote was based on the lack of dosing flexibility and that the ramifications of the risks associated with Hydexor did not outweigh its benefit. Overall, the majority of the committee agreed that Hydexor poses greater risks than currently marketed hydrocodone-acetaminophen products. Some committee members added that an antiemetic may not be needed for every dose of analgesic, and that a fixed-dose combination of Hydexor would expose patients to unnecessary side effects of promethazine when it is not needed. Other committee members agreed that the applicant’s proposed risk mitigation strategies are not convincing. One committee member who voted “Yes” viewed Hydexor as another opioid option and noted that its risks are no greater than what is currently on the market. Additionally, this member noted that that the population receiving Hydexor would be those who were prone to OINV and that the medication would be taken as needed. The other committee member who voted “Yes” stated that the overall benefits outweighed the risks but also suggested that toxicity data of promethazine when patients took more than six pills a day is needed. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On February 14-15, the committee discussed supplemental new drug application (sNDA) 022496/S-009, for EXPAREL (bupivacaine liposomal injectable suspension), submitted by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia. A slight majority of the committee (6 to 4) voted “No” that the data submitted did not support approval of an additional indication for nerve block. Some of the committee members who voted “No” agreed that some efficacy was demonstrated but had major concerns with safety. Some members who voted “Yes” also indicated that they would like to see additional studies; however, they did not specify whether these should be conducted pre- or post-marketing. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On May 22, 2018, 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) 209588, for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The committees were also asked to discuss whether this product should be approved. The majority of the committee (18 to 1) voted “No”, that the benefits of Buvaya do not outweigh the risks for the indication, “the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate,” supporting approval of Buvaya. These members also agreed that although a commendable effort was made by the applicant to introduce an innovative product that may be less likely to be abused than some schedule II opioid analgesics, the factors contributing to their vote were the late onset of analgesia, and high rate of adverse events (primarily hypoxia). The committee member who voted “Yes” explained that the low abuse potential and the lack of alternative treatments available in the market were factors considered in the vote. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On June 26, 2018, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee met jointly to discuss new drug application 022324, oxycodone extended-release capsules, submitted by Pain Therapeutics, with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is intended to have abuse-deterrent properties based on its physicochemical properties. The committees were also asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse. The majority of the panel members (14 to 3) voted “No”, that the efficacy, safety and risk-benefit profile of Remoxy ER do not support the approval of this application. The committee members largely agreed that the public health risks of approving this reformulation of oxycodone does not outweigh its benefits. Other comments included that approving Remoxy ER with an abuse deterrent label may create a false sense of safety for this formulation and that the benefits of its nasal deterrence properties are not enough to justify approval with abuse deterrent labeling. Panelists voting “No” largely agreed that Remoxy ER did not demonstrate enough abuse deterrent properties via the oral and IV routes of administration. Of the committee members who voted “Yes,” the key comments were that the Applicant had met the standard for safety and efficacy and also met the criteria for abuse deterrence via the nasal and IV routes.

On August 3, 2018, 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 this meeting will meet 5-6 times in FY-19.
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 regulatory decisions made by the Agency. The alternate means of obtaining this advice would be to hire large numbers of scientists on a full time basis at great expense to the government.
Why close or partially close meetings?The committee held one partially closed meeting jointly with another committee during FY-18. On June 26, 2018, from 8 a.m. to 9:30 a.m., the joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee was closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the drug development program of an investigational opioid formulation with properties designed to deter abuse.
Recommendation RemarksThis committee was not required any reporting for FY18.

During FY-18, there was one meeting that this 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 August 3, 2018, the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee met jointly to discuss results from assessments of the transmucosal immediate-release fentanyl (TIRF) medicines’ risk evaluation and mitigation strategy (REMS), approved in December 2011. The TIRF REMS requires that healthcare providers who prescribe TIRF medicines for outpatient use are specially certified, that pharmacies that dispense TIRF medicines for inpatient and outpatient use are specially certified, and that completion of the prescriber-patient agreement form occurs prior to dispensing TIRF medicines for outpatient use. The Agency sought the committees’ assessment as to whether this REMS with elements to assure safe use (ETASU) assured safe use, was not unduly burdensome to patient access to the drugs, and to the extent practicable, minimized the burden to the healthcare delivery system. The Agency also sought the committees’ input on any possible modifications to the TIRF REMS goals and requirements, as well as input on the adequacy of the evaluations conducted in the REMS assessments to determine whether the TIRF REMS goals are being met. Most committee members agreed that the goals and objectives of the TIRF REMS are appropriate. Some members suggested strengthening the REMS to ensure TIRF medicines are used for cancer breakthrough pain only while others noted that patients with non-cancer breakthrough pain should be able to get them too. The committee members also recommended improving approaches to education and ensuring providers and patients have knowledge of TIRF REMS in practice. Regarding the decreased usage of TIRF medications, the committee members noted multiple explanations, including more appropriate use, changes in pharmacy benefits, cost considerations, cheaper alternative opioids, and stigma to fentanyl. The committees agreed that there are barriers, which are reasonable given the risks associated with TIRF medicines. Regarding the findings suggestive of increasing rates of adverse events, the committee members noted a number of plausible explanations, including a shift of patient population to high risk patients, more awareness of fentanyl and adverse effects leading to surveillance bias, and changes in the specific TIRF medicine being used that might have different risk profiles. The committee members also noted that the number of events are small and the estimates of risk are unstable due to sparse data, and therefore it is a challenge to come to any conclusion. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

This committee was not required any reporting for FY18.”
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesNo
Outcome Major Policy ChangesYesAction Issued New RegulationsYes
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
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*47Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 47 recommendations from FY-03 through FY-18. See question 20a of the annual report for specific accomplishments.Access Agency WebsiteYes
% of Recs Fully Implemented*80.00%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, and therefore, the Agency has the option of not implementing the advice.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 CommentProduct approval issues are first released to the sponsor. When appropriate, information is made available to the public. Actions related to guidance documents or other general matters 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* Est Payments to Non-Fed Members Next FY* 
Payments to Federal Members* Est. Payments to Fed Members Next FY* 
Payments to Federal Staff* Estimated Payments to Federal Staff* 
Payments to Consultants* Est. Payments to Consultants Next FY* 
Travel Reimb. For Non-Federal Members* Est Travel Reimb Non-Fed Members nextFY* 
Travel Reimb. For Federal Members* Est Travel Reimb For Fed Members* 
Travel Reimb. For Federal Staff* Est. Travel Reimb to Fed Staff Next FY* 
Travel Reimb. For Consultants* Est Travel Reimb to Consultants Next FY* 
Other Costs Est. Other Costs Next FY* 
Total Costs$0.00Est. Total Next FY*$0.00
Federal Staff Support (FTE)* Est. Fed Staff Support Next FY* 
Hide Section - Custom Links

Custom Links

     Committee Level Reports               
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

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Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 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
 COM-034846Anesthetic and Analgesic Drug Products Advisory Committee2018