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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.

Details on agency responses to committee recommendations can be found under the Performance Measures section for each committee in the fields “Agency Feedback” and “Agency Feedback Comment.”


HHS - 109 - Antimicrobial Drugs Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameAntimicrobial Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2022Committee Number109
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*14
Current Charter Date10/7/2022Designated Fed Officer Position Title*Designated Federal Officer
Date Of Renewal Charter10/7/2024Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*She-Chia
Exempt From Renewal*NoDesignated Federal Officer Middle NameS.
Specific Termination AuthorityDesignated Federal Officer Last Name*Chen
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharmD
Specific Establishment Authority*21 U.S.C. 394Designated Federal Officer Phone*(240) 402-5343
Effective Date Of Authority*11/28/1990Designated Federal Officer Fax*(301) 847-8533
Exempt From EO 13875 Discretionary CmteNot ApplicableDesignated Federal Officer Email*she-chia.chen@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 for use in the treatment of infectious diseases and disorders and makes appropriate recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*Members are authorities in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology, statistics, and related specialties. The committee includes one technically qualified voting member who is identified with consumer interests. The Committee may include one non-voting member who is identified with industry interests.
How frequent & relevant are cmte mtgs?*In FY-22, the Committee held two meetings.

On October 7, 2021, the Committee discussed new drug application (NDA) 215596, for maribavir oral tablets, submitted by Takeda Pharmaceuticals USA, Inc., for the treatment of adults with post-transplant cytomegalovirus infection (CMV) and/or disease, including infections resistant and/or refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet. The Committee discussed the efficacy outcome in phase 3 trial SHP620-303 and data from the phase 2 trial SHP620-202 and the overall risk-benefit assessment for maribavir including five discussion points as follows: 1) population - narrow population with unmet medical need; 2) trial design and limitations including potential bias; 3) primary efficacy outcome; 4) results from the sensitivity and subgroup analyses; 5) maribavir safety profile in comparison to other antivirals for cytomegalovirus. There were two voting questions followed by the aforementioned discussion question. The Committee unanimously (17 Yeses, 0 Noes) agreed that the overall benefit-risk assessment is favorable for the use of maribavir for the treatment of transplant receipients with CMV infection and disease refractory to treatment and with genotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir. Agency Action: On November 23, 2021, the Agency approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms) with post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV.

On November 30, 2021, the Committee discussed Emergency Use Authorization (EUA) 000108, submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules for treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. The issues that the Committee discussed included molnupiravir use during pregnancy and strategies for risk mitigation. A majority of the Committee (13 Yeses, 10 Noes) voted that molnupiravir outweighed its known and potential risks when used for the treatment of mild-moderate COVID-19 in adult patients who are within 5 days of symptom onset and are at high risk of severe COVID-19, including hospitalization or death. Agency Action: On December 23, 2021, the Agency issued an EUA for molnupiravir for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.

It is expected that the Committee will meet two to four times during FY-23.
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-22.
Recommendation RemarksThere were no reports required for this Committee in FY-22.
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 Antimicrobial 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 CommentN/A
Number Of Recommendations*62Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 62 recommendations from FY-03 through FY-22.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*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 Anti-Infective 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 infectious diseases and disorders and make appropriate recommendations to the Commissioner of Food and Drugs. 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*$12,949.00Est Payments to Non-Fed Members Next FY*$30,623.00
Payments to Federal Members*$9,571.00Est. Payments to Fed Members Next FY*$14,134.00
Payments to Federal Staff*$169,195.00Estimated Payments to Federal Staff*$177,164.00
Payments to Consultants*$0.00Est. Payments to Consultants Next FY*$0.00
Travel Reimb. For Non-Federal Members*$0.00Est Travel Reimb Non-Fed Members nextFY*$0.00
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*$0.00Est Travel Reimb to Consultants Next FY*$0.00
Other Costs$54,207.00Est. Other Costs Next FY*$68,351.00
Total Costs$245,922.00Est. Total Next FY*$290,272.00
Date Cost Last Modified10/8/2022 4:45 PMEst. Fed Staff Support Next FY*1.10
Federal Staff Support (FTE)*1.10Est Cost Remarks
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-040539Antimicrobial Drugs Advisory Committee2021
 COM-038832Antimicrobial Drugs Advisory Committee2020
 COM-036729Antimicrobial Drugs Advisory Committee2019
 COM-034923Antimicrobial Drugs Advisory Committee2018
 COM-001914Antimicrobial Drugs Advisory Committee2017
 COM-002383Antimicrobial Drugs Advisory Committee2016
 COM-004158Antimicrobial Drugs Advisory Committee2015
 COM-004499Anti-Infective Drugs Advisory Committee2014
 COM-006168Anti-Infective Drugs Advisory Committee2013
 COM-006715Anti-Infective Drugs Advisory Committee2012
 COM-008249Anti-Infective Drugs Advisory Committee2011
 COM-009017Anti-Infective Drugs Advisory Committee2010
 COM-010280Anti-Infective Drugs Advisory Committee2009
 COM-010856Anti-Infective Drugs Advisory Committee2008
 COM-011874Anti-Infective Drugs Advisory Committee2007
 COM-012655Anti-Infective Drugs Advisory Committee2006
 COM-013948Anti-Infective Drugs Advisory Committee2005
 COM-014749Anti-Infective Drugs Advisory Committee2004
 COM-015685Anti-Infective Drugs Advisory Committee2003
 COM-016720Anti-Infective Drugs Advisory Committee2002
 COM-017882Anti-Infective Drugs Advisory Committee2001
 COM-018487Anti-Infective Drugs Advisory Committee2000
 COM-019586Anti-Infective Drugs Advisory Committee1999
 COM-020333Anti-Infective Drugs Advisory Committee1998
 COM-021425Anti-Infective Drugs Advisory Committee1997