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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 - 855 - Endocrinologic and Metabolic Drugs Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameEndocrinologic and Metabolic Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number855
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 Date8/27/2020Designated Fed Officer Position Title*DFO
Date Of Renewal Charter8/27/2022Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*LaToya
Exempt From Renewal*NoDesignated Federal Officer Middle NameAnn
Specific Termination AuthorityDesignated Federal Officer Last Name*Bonner
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharmD
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*latoya.bonner@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 data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrine and metabolic disorders, and makes appropriate recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*Members are experts in internal medicine, endocrinology, pediatric endocrinology, metabolism, diabetes, bone and mineral disorders, adrenal and gonadal conditions, geriatrics, growth disorders, clinical pharmacology, statistics, obesity and epidemiology. The Committee includes one technically qualified voting member who is identified with consumer interests. The Committee has one non-voting member identified with industry interests.
How frequent & relevant are cmte mtgs?*The Committee met twice in FY-20.

On November 13, 2019, the Endocrinologic and Metabolic Drugs Advisory Committee discussed supplemental new drug application (sNDA) 204629/S-020 for empagliflozin oral tablet, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the following proposed indication: as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus. The majority of the Committee (2 to 14) voted “No”, indicating that the available data does not suggest that the benefits outweigh the risks and does not support approval of empagliflozin 2.5 mg, administered orally once daily, as an adjunct to insulin to improve glycemic control in adults with type 1 diabetes mellitus. The majority of the Committee (2 to 14) voted “No”, indicating that the available data does not suggest that the benefits outweigh the risks and does not support approval of empagliflozin 2.5 mg, administered orally once daily, as an adjunct to insulin to improve glycemic control in adults with type 1 diabetes mellitus. The members who voted “No” acknowledged the clinical significance of empagliflozin use in lowering HbA1C by approximately 0.3% and the possible corresponding benefits of that effect if it were maintained and confirmed in a second trial. These members had concerns with the study design and questioned the durability of this reduction as the Applicant did not provide data supporting glycemic control after 26 weeks. The members recommended an additional longer trial with a larger population, and an adjudication charter with increased sensitivity for capturing clinically significant ketosis and DKA events in order to better characterize the DKA risk and the durability of the HbA1c benefit. The two members who voted “Yes” articulated that the data shown was expected and the clinical outcomes were anticipated. These members noted that the product can be beneficial to the patient and instrumental to the practitioner with appropriate therapeutic monitoring. Agency Action: The Agency is still reviewing the recommendations made at this meeting.

On November 14, 2019, the Endocrinologic and Metabolic Drugs Advisory Committee discussed supplemental new drug application 202057/S-035, for VASCEPA (icosapent ethyl) capsules for oral administration, sponsored by Amarin Pharma Inc., for the following proposed indication: to reduce the risk of cardiovascular events, as an adjunct to statin therapy in adult patients with elevated triglycerides levels (135 mg/dL or greater) and other risk factors for cardiovascular disease, based on the results of a clinical study entitled “A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event (REDUCE-IT).” The Committee (16 members) unanimously voted “Yes”, that the applicant provided sufficient evidence of efficacy and safety to support the approval of Vascepa for an indication to reduce the risk of cardiovascular events. The committee stated that the REDUCE-IT trial showed a benefit of cardiovascular risk reduction for patients with established cardiovascular disease. The majority of members stated that the clinical trial supports icosapent ethyl approval for a wider population for secondary prevention; however, they noted that the product should be limited to the criteria outlined in the REDUCE-IT study for primary prevention. The Committee restated their concerns for increased risk of bleeding, and some members stated that post-marketing studies should be conducted to identify patient populations at an increased risk for bleeding. Agency Action: On December 13, 2019, the Agency approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher.

This Committee is expected to meet two to four times in 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 in FY-20.
Recommendation RemarksThis Committee was not required to do any reporting for FY-20.
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 Endocrinologic and Metabolic Drugs 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 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*51Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 51 recommendations from FY-03 through FY-20. See section Recommendation/Justifications of the ACR 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 advice.Access OtherNo
Agency Feedback*YesAccess CommentN/A
Agency Feedback Comment*Product 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 Endocrinologic and Metabolic Drugs Advisory Committee supports FDA's strategic priorities by reviewing and evaluating available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of endocrinologic and metabolic diseases and makes appropriate recommendations to the Commissioner of the Food and Drug Administration. This supports the development of safe and effective new medical technologies, and advances the status of the Agency as a science-based and science-led regulatory agency, providing global leadership in the protection of public health.
Hide Section - COSTS

COSTS

Payments to Non-Federal Members*$10,900.00Est Payments to Non-Fed Members Next FY*$18,150.00
Payments to Federal Members*$1,090.00Est. Payments to Fed Members Next FY*$1,650.00
Payments to Federal Staff*$174,682.00Estimated Payments to Federal Staff*$178,233.00
Payments to Consultants*$7,085.00Est. Payments to Consultants Next FY*$9,900.00
Travel Reimb. For Non-Federal Members*$5,988.00Est Travel Reimb Non-Fed Members nextFY*$9,011.00
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*$4,321.00Est Travel Reimb to Consultants Next FY*$6,005.00
Other Costs$49,026.00Est. Other Costs Next FY*$52,672.00
Total Costs$253,092.00Est. Total Next FY*$275,621.00
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-036463Endocrinologic and Metabolic Drugs Advisory Committee2019
 COM-034662Endocrinologic and Metabolic Drugs Advisory Committee2018
 COM-001637Endocrinologic and Metabolic Drugs Advisory Committee2017
 COM-002274Endocrinologic and Metabolic Drugs Advisory Committee2016
 COM-004179Endocrinologic and Metabolic Drugs Advisory Committee2015
 COM-004467Endocrinologic and Metabolic Drugs Advisory Committee2014
 COM-005826Endocrinologic and Metabolic Drugs Advisory Committee2013
 COM-006659Endocrinologic and Metabolic Drugs Advisory Committee2012
 COM-008075Endocrinologic and Metabolic Drugs Advisory Committee2011
 COM-009125Endocrinologic and Metabolic Drugs Advisory Committee2010
 COM-010237Endocrinologic and Metabolic Drugs Advisory Committee2009
 COM-010776Endocrinologic and Metabolic Drugs Advisory Committee2008
 COM-011909Endocrinologic and Metabolic Drugs Advisory Committee2007
 COM-012556Endocrinologic and Metabolic Drugs Advisory Committee2006
 COM-013969Endocrinologic and Metabolic Drugs Advisory Committee2005
 COM-014618Endocrinologic and Metabolic Drugs Advisory Committee2004
 COM-015726Endocrinologic and Metabolic Drugs Advisory Committee2003
 COM-016462Endocrinologic and Metabolic Drugs Advisory Committee2002
 COM-017966Endocrinologic and Metabolic Drugs Advisory Committee2001
 COM-018488Endocrinologic and Metabolic Drugs Advisory Committee2000
 COM-019863Endocrinologic and Metabolic Drugs Advisory Committee1999
 COM-020625Endocrinologic and Metabolic Drugs Advisory Committee1998
 COM-021448Endocrinologic and Metabolic Drugs Advisory Committee1997