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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 - 109 - Antimicrobial Drugs Advisory Committee - Authorized by Law


Committee NameAntimicrobial Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number109
Original Establishment Date11/28/1990Committee StatusChartered
Actual Termination Date Committee URL
New Committee This FYNoPresidential Appointments*No
Terminated This FYNoMax Number of Members*14
Current Charter Date10/7/2020Designated Fed Officer Position Title*DFO
Date Of Renewal Charter10/7/2022Designated 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*(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*
Committee Type*Continuing
Committee Function*Scientific Technical Program Advisory Board


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?*The Committee met once in FY-20.

On October 16, 2019, the Committee discussed new drug application (NDA) 209445, cefiderocol lyophilized powder for intravenous administration, submitted by Shionogi Inc., for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options. The majority of the Committee (14 to 2) voted “Yes”, that the Applicant provided substantial evidence for the treatment of cUTI including pyelonephritis in patients with limited or no alternative treatment options. The Committee noted the label should indicate warnings for mortality, with some members recommending a boxed warning to communicate the safety concern for off-label use of cefiderocol for treatment of infections other than cUTI. Additional comments advised monitoring of hematologic and liver laboratory values, as well as assessing the risk of arrhythmia and seizure potential with therapy. It was noted that the label should include details on the recommended infusion rate for the indication. The committee members who voted “No” explained that the Applicant had not provided sufficient evidence for the proposed indication. These members had concern for the mortality difference in the CREDIBLE-CR study. Agency Action: On November 14, 2019, the Agency approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options.

It is expected that the Committee will 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 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-20.
Recommendation RemarksThis Committee was not required any reporting for FY-20.

Although the current charter states that the Committee will hold meetings approximately two to four times a year, this is only an estimation based on data from previous years. Advisory committees meetings are planned and convened based on the needs of the Agency. As such, the number of projected meetings should not be construed as an exact figure.


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*60Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 60 recommendations from FY-03 through FY-20. 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 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


Payments to Non-Federal Members*$3,815.00Est Payments to Non-Fed Members Next FY*$24,200.00
Payments to Federal Members*$1,635.00Est. Payments to Fed Members Next FY*$6,600.00
Payments to Federal Staff*$156,301.00Estimated Payments to Federal Staff*$158,156.00
Payments to Consultants*$3,270.00Est. Payments to Consultants Next FY*$11,000.00
Travel Reimb. For Non-Federal Members*$6,700.00Est Travel Reimb Non-Fed Members nextFY*$37,011.00
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*$1,709.00Est Travel Reimb to Consultants Next FY*$5,721.00
Other Costs$41,645.00Est. Other Costs Next FY*$49,919.00
Total Costs$215,075.00Est. Total Next FY*$292,607.00
Federal Staff Support (FTE)*1.10Est. Fed Staff Support Next FY*1.10
Cost RemarksEst Cost Remarks
Hide Section - Interest Areas

Interest Areas

Food and Drugs
Food and Drugs
Health Care


To View all the members, meetings and advisory reports for this committee please click here


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Data from Previous Years

ActionCommittee System IDCommittee NameFiscal Year
 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