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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
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 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?*In FY-19, the Committee held 6 meetings. At 1 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 October 11, 2018, the Anesthetic and Analgesic Drug Products Advisory Committee met to discuss new drug application (NDA) 210730, for oliceridine 1 milligram/milliliter injection, submitted by Trevena, Inc., for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The Committee also discussed the efficacy and safety data and benefit-risk considerations. The Committee did not reach a consensus (7 Yeses to 8 Noes) on the approval of the proposed dose of oliceridine for the proposed indication of the management of moderate- to-severe acute pain in adults for whom an intravenous opioid is warranted. Committee members who voted “Yes” recommended inclusion of “not safer than traditional opioids” on the label and that further studies be required. Committee members who voted “No” stated that the benefit/risk profile was not favorable enough and that there is a need for more data regarding demographic variability, including patients with comorbidities, drug interactions, and real-world dosing. Overall, the Committee agreed that oliceridine showed efficacy compared to placebo in relatively healthy individuals. However, the Committee members noted that the controlled Phase 3 post-operative study populations were not indicative of complex populations that may have multiple drug interactions and comorbidities, and therefore agreed that the efficacy of oliceridine is not clear compared to an active comparator. Overall, the Committee found no superiority for abuse deterrence and considered Schedule II appropriate for oliceridine. Some of the Committee members agreed that people may presume that oliceridine is a safer medication, which may increase its abuse potential. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On October 12, 2018, the Committee discussed new drug application (NDA) 209128, sufentanil sublingual tablets, submitted by AcelRx Pharmaceuticals, Inc., for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. The Committee also discussed risk-benefit considerations and whether this product should be approved. The majority of the Committee members (10 to 3) agreed that the benefits of sufentanil sublingual tablets 30 mcg with the REMS proposed by FDA outweigh the risks for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. The Committee members who voted “Yes” agreed that the presented data clearly showed efficacy in the treatment of acute moderate to severe pain. Some Committee members noted that the novel sublingual dosage form of this medication would fill an unmet medical need in terms of pain relief for patients without intravenous access, unable to swallow, or in certain military settings. Other Committee members noted that having a REMS program associated with this medication and its limited use in healthcare settings will further decrease the incidence and potential for abuse. The Committee members who voted “No” stated that there is lack of proven efficacy and necessity within the inpatient setting. These Committee members agreed that the proposed patient population must be narrowed and more specifically defined. Agency Action: On November 2, 2018, the Agency approved Dsuvia (sufentanil sublingual tablets) for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting.

On November 14, 2018, a meeting was held jointly with the Drug Safety and Risk Management Advisory Committee to discuss new drug application (NDA) 209774, for an immediate-release oral tablet formulation of oxycodone, which is intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, submitted by SpecGx LLC, for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The Committees were also asked to determine whether the Applicant adequately demonstrated that the abuse-deterrent properties of the proposed product are sufficient to include this information in the product label, and whether the product should be approved. The majority of members (10 to 7) agreed that oxycodone hydrochloride immediate-release tablets (MNK-812) should be approved for the proposed indication. Some of the Committee members who supported approval based their decisions on the demonstration of bioequivalence to the comparator oxycodone hydrochloride immediate-release product and concluded that oxycodone hydrochloride immediate-release tablets (MNK-812) represents an abuse-deterrent option relative to existing non-ADF immediate-release oxycodone formulations. The Committee members who voted “No” concluded that this product would provide minimal benefit over risk and expressed concern that it may provide a false sense of security to prescribers. The majority of members (12 to 5) agreed that if approved, this product should be labelled as an abuse-deterrent product by the nasal route of abuse. The majority of members (10 to 7) did not agree that the product should be labeled as an abuse-deterrent product by the intravenous route. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On November 15, 2018, the Anesthetic and Analgesic Drug Products Advisory Committee met to discuss the assessment of opioid analgesic sparing outcomes in clinical trials of acute pain. The Committee also commented on the trial design and endpoints of these studies and how to determine the clinical relevance of the results. The majority of the Committee members (11 to 1) voted “No”, that any reduction in opioid use is not sufficient to warrant labeling as opioid sparing. These Committee members noted concerns with labeling a medication as having ‘opioid sparing’ effects and noted that the term needs to be more clearly defined to be specific to the type of surgery while taking into account patient specific characteristics. Overall, the Committee members agreed that statistically significant difference alone has no significance as it is unknown how the results translate to clinical outcomes. The one member who voted “Yes” stated that it is possible for a new drug that is shown to be equally efficacious to opioids with fewer incidences of adverse events to be labeled as opioid sparing in certain conditions. One Committee member abstained from voting explaining that the notion of opioid sparing is incorrect. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On December 17-18, 2018, a meeting was held jointly with the Drug Safety and Risk Management Advisory Committee. The Committees provided input and advice on strategies to increase the availability of naloxone products intended for use in the community. The Committees were asked to consider various options for increasing access to naloxone, weighing logistical, economic, and harm reduction aspects and whether naloxone should be co-prescribed with all or some opioid prescriptions to reduce the risk of overdose death. Because of the potential, significant costs and burdens that may be associated with naloxone co-prescribing (e.g., economic costs to consumers and health systems, adjusting to manufacturing volume growth, drug shortages), the Committees were also asked to consider the potential burdens that may be associated with naloxone co-prescribing for all or some prescription opioid patients. The members agreed that the FDA efforts should include facilitating more rapid availability of over-the-counter (OTC) naloxone and generic naloxone products, and consider using Departmental authorities to enhance the distribution of naloxone by the federal government. The Committees discussed that the major burden to co-prescribing naloxone is cost, including those to the patient, healthcare system, and secondary costs. It was noted that secondary burdens are also the failure to address the larger public health issue of increasing illicit opioid deaths and the stigma of revealing a need for naloxone to a healthcare provider. The Committees stated that targeting high-risk populations is a problem because it is difficult to define what constitutes a high-risk population; this approach may require a separate situational targeting model. A slim majority of members (12 to 11) voted “Yes” that labeling language that recommends co-prescription of naloxone for all or some patients prescribed opioids, or more targeted prescribing for patients otherwise at high risk for death from opioid overdose, would be an effective method for expanding access to naloxone and improving public health. Many members who voted “Yes” stated that while labeling may be an effective strategy to expand access to naloxone, it would not be the most effective strategy. Agency Action: The Agency is still reviewing all recommendations that were made at the meeting.

On June 11-12, 2019, 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 in FY-20.
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 no closed meetings during FY-19.
Recommendation RemarksThis Committee was not required any reporting for FY-19.

During FY-19, 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 June 11-12, 2019, the Committee met jointly with the Drug Safety and Risk Management Advisory Committee to discuss: (1) the current clinical use and situations that may warrant pain management with opioid analgesics at higher product strengths and daily doses, factors influencing prescribing practices, and specific patient populations for whom there may be utility in prescribing these medications at higher doses; (2) the magnitude and frequency of harms associated with opioid analgesics at higher product strengths and daily doses, relative to lower strengths and daily doses, including the role of opioid dose in adverse health outcomes in both patients and in others who may access the drugs (e.g., risk for developing addiction, fatal overdose), the relevance of therapy duration and physical opioid dependence, and risks in different subpopulations (e.g., patients with chronic non-cancer pain, young children, adolescents); and (3) possible FDA interventions and their expected impact on patients and public health more broadly, including, for example, potential effects on prescribing and pain management practices, patient experience and behaviors, and adverse outcomes such as addiction and overdose. The majority of members agreed that patient populations who may require higher daily doses would be end of life, hospice or palliative care as well as those with debilitating illnesses, such as cancer and complex neurological and musculoskeletal conditions and that higher doses might reduce pain and improve mobility and quality of life in these populations. The majority of the members agreed that there is a clinical need for higher dosage strength opioid analgesic products, especially for reducing pill burden and difficulty of swallowing. However, members added that the risk of an increased number of deaths from overdose on higher dosage strength opioid outweighs the inconvenience from swallowing more pills. The majority of the members agreed that there are greater risks associated with higher daily doses and higher dosage strength opioid analgesic products relative to lower daily doses and lower dosage strength products. Overall, the Committee members agree that caution should be taken with any regulatory action intended to target or reduce prescribing and use of higher dosage strength opioid analgesic products, as it may be very destabilizing to patients who have a clinical need for higher dosage strengths, as the data show that this is a vulnerable population. The Committee noted the potential negative impacts on patient health and public health might include inconvenience (e.g. more pills for patients and difficulties with insurance coverage), issues with swallowing a high number of pills, and increased potential for medication errors and diversion due to a higher volume of pills. Agency Action: The Agency is still reviewing all recommendations that were 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*53Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 53 recommendations from FY-03 through FY-19. 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 CommentWhen 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*$27,622.00Est Payments to Non-Fed Members Next FY*$53,680.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$166,062.00Estimated Payments to Federal Staff*$170,605.00
Payments to Consultants*$20,123.00Est. Payments to Consultants Next FY*$16,775.00
Travel Reimb. For Non-Federal Members*$30,535.00Est Travel Reimb Non-Fed Members nextFY*$71,734.00
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*$27,478.00Est Travel Reimb to Consultants Next FY*$21,224.00
Other Costs$52,494.00Est. Other Costs Next FY*$53,741.00
Total Costs$324,314.00Est. Total Next FY*$387,759.00
Federal Staff Support (FTE)*1.10Est. Fed Staff Support Next FY*1.10
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-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