FACACLASSIC

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HHS - 855 - Endocrinologic and Metabolic Drugs Advisory Committee - Authorized by Law

GENERAL INFORMATION

Committee Name	Endocrinologic and Metabolic Drugs Advisory Committee	Agency Name	Department of Health and Human Services
Fiscal Year	2025	Committee Number	855
Original Establishment Date	11/28/1990	Committee Status	Chartered
Actual Termination Date		Committee URL	http://www.fda.gov/AdvisoryCommittees/Committee...
Actual Merged Date		Presidential Appointments*	No
New Committee This FY	No	Max Number of Members*	9
Terminated This FY	No	Designated Fed Officer Position Title*	Designated Federal Officer
Merged This FY		Designated Federal Officer Prefix
Current Charter Date	8/27/2024	Designated Federal Officer First Name*	LaToya
Date Of Renewal Charter	8/27/2026	Designated Federal Officer Middle Name
Projected Termination Date		Designated Federal Officer Last Name*	Bonner
Exempt From Renewal*	No	Designated Federal Officer Suffix	Pharm.D.
Specific Termination Authority		Designated Federal Officer Phone*	(301) 796-2855
Establishment Authority*	Authorized by Law	Designated Federal Officer Fax*	301-847-8533
Specific Establishment Authority*	21 U.S.C. 394	Designated Federal Officer Email*	latoya.bonner@fda.hhs.gov
Effective Date Of Authority*	11/28/1990
Exempt From EO 13875 Discretionary Cmte	Not Applicable
Committee Type*	Continuing
Presidential*	No
Committee Function*	Scientific Technical Program Advisory Board

RECOMMENDATION/JUSTIFICATIONS

Agency Recommendation*	Continue
Legislation to Terminate Required	Not Applicable
Legislation Status	Not 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 and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of endocrinology, metabolism, 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?*	The Committee held one meeting in FY-25. On October 31, 2024, the Endocrinologic and Metabolic Drugs Advisory Committee met to discuss new drug application 210934, for sotagliflozin oral tablet, submitted by Lexicon Pharmaceuticals, Inc., for the proposed indication, as an adjunct to insulin therapy, to improve glycemic control in adults with type 1 diabetes mellitus and chronic kidney disease. The Committee discussed the clinical benefits of sotagliflozin oral tablets on hemoglobin A1c (A1C) in patients with estimated glomerular filtration rates (eGFR) below 60 mL/min, and whether these benefits are greater in patients with type 1 diabetes (T1D) and chronic kidney disease (CKD) compared to those without CKD. Safety concerns were raised regarding the incidence and severity of diabetic ketoacidosis (DKA) in T1D patients with CKD treated with sotagliflozin. Following deliberation, the Committee voted 11 to 3 that the available data did not demonstrate that the benefits of sotagliflozin outweigh the risks for the indication of improving glycemic control in patients with T1D and CKD. Agency Action: It is expected that the Committee will meet 2-4 times during FY-26.
Why advice can't be obtained elsewhere?*	Members of the Committee are drawn from academia, research and/or clinical practice. They provide advice and input to FDA for consideration in its regulatory decision-making process. The alternate means of obtaining this advice would involve the recruitment of large numbers of scientists 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-25.
Recommendation Remarks	There were no reports required for this Committee in FY-25. Although the current charter states that the Committee shall hold meetings approximately 2-4 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.

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*	Yes	Action Reorganize Priorities*	Yes
Outcome Trust In Government	Yes	Action Reallocate Resources	Yes
Outcome Major Policy Changes	Yes	Action Issued New Regulations	Yes
Outcome Advance In Scientific Research	Yes	Action Proposed Legislation	Yes
Outcome Effective Grant Making	No	Action Approved Grants Or Other Payments	No
Outcome Improved Service Delivery	No	Action Other	Yes
Outcome Increased Customer Satisfaction	Yes	Action Comment	FDA approves or chooses not to approve new medical products.
Outcome Implement Laws/Reg Requirements	Yes	Grants Review*	No
Outcome Other	No	Number Of Grants Reviewed	0
Outcome Comment	N/A	Number Of Grants Recommended	0
Cost Savings*	Unable to Determine	Dollar Value Of Grants Recommended	$0.00
Cost Savings Comment	The 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 basis 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 Comment	N/A
Number Of Recommendations*	55	Access Contact Designated Fed. Officer*	Yes
Number Of Recommendations Comment	The Committee made 55 recommendations from FY-03 through FY-25.	Access Agency Website	Yes
% of Recs Fully Implemented*	84.00%	Access Committee Website	Yes
% of Recs Fully Implemented Comment	The 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 Website	Yes
% of Recs Partially Implemented*	10.00%	Access Publications	Yes
% of Recs Partially Implemented Comment	The 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 Other	No
Agency Feedback*	Yes	Access Comment	N/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.

COSTS

1. Payments to Non-Federal Members*		1. Est Paymnts to Non-Fed Membrs Nxt FY*
2. Payments to Federal Members*		2. Est. Payments to Fed Members Next FY*
3. Payments to Federal Staff*		3. Estimated Payments to Federal Staff*
4. Payments to Consultants*		4. Est. Payments to Consultants Next FY*
5. Travel Reimb. For Non-Federal Membrs*		5. Est Travel Reimb Non-Fed Membr nxtFY*
6. Travel Reimb. For Federal Members*		6. Est Travel Reimb For Fed Members*
7. Travel Reimb. For Federal Staff*		7. Est. Travel Reimb to Fed Staf Nxt FY*
8. Travel Reimb. For Consultants*		8. Est Travel Reimb to Consltnts Nxt FY*
10. Other Costs		10. Est. Other Costs Next FY*
11. Total Costs	$0.00	11. Est. Total Next FY*	$0.00
Date Cost Last Modified	3/14/2025 9:15 AM	Est. Fed Staff Support Next FY*
Federal Staff Support (FTE)*		Est Cost Remarks
Cost Remarks

Interest Areas

Category Area Food and Drugs Food and Drugs Health Health Care Safety Treatment

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