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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameAntimicrobial Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee 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 Date10/7/2018Designated Fed Officer Position Title*DFO
Date Of Renewal Charter10/7/2020Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Lauren
Exempt From Renewal*NoDesignated Federal Officer Middle NameTesh
Specific Termination AuthorityDesignated Federal Officer Last Name*Hotaki
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharmD, BCPS, BCIDP
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
Committee Type*ContinuingDesignated Federal Officer Email*lauren.hotaki@fda.hhs.gov
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?*The committee met four times in FY-19.
On April 25, 2019, the committee discussed one or more possible pathways for approval of rabies virus monoclonal antibodies for use as the passive-immunization component of post-exposure prophylaxis (PEP). The committee made several recommendations. For in vitro data required prior to evaluating a mAb cocktail in place of RIG in clinical trials in rabies exposed subjects, the committee noted that preference should be given to target global, circulating rabies virus strains that cause human disease. There were several suggestions to study the mAb cocktails and HRIG both alone and in combination with rabies vaccine in the animal studies. The committee unanimously agreed that clinical trials of an investigational mAb cocktail product as part of post exposure prophylaxis (PEP) in rabies virus-exposed subjects be acceptable if the data package available to support trial initiation included elements a through c in question 2. The committee was in agreement that comparable early rabies virus neutralizing antibody levels and comparable vaccine interference of the mAb cocktail versus human rabies immune globulin (HRIG) in a clinical trial of rabies-exposed subjects is needed to support submission of a U.S. BLA for a rabies mAb cocktail as part of PEP. In addition, the committee agreed that a comparable safety profile of the mAb cocktail versus HRIG in at least 1000 subjects who receive the mAb cocktail and proven lack of mortality in ≥ 750 subjects are needed to support submission. The committee also recommended a post marketing study that accrued at least 6000 patients. The committee unanimously agreed that a data package containing the elements a through c in question 4 would be sufficient to support submission of a U.S. BLA. Most members of the committee stated that the mAb cocktail with this data package should only be approved for second-line use in situations where HRIG is not available. It was also recommended, if approved, that the label should clearly state the rationale for second line treatment. The Agency is currently evaluating recommendations made during the advisory committee meeting.

On April 26, 2019, the committee discussed the safety and effectiveness of bacitracin for intramuscular injection for the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, which is the only approved indication for bacitracin for intramuscular injection. The committee also considered whether there are other uses for bacitracin for intramuscular injection that could be studied. FDA presented background information on the regulatory history of bacitracin for intramuscular injection and information on the current use of bacitracin for intramuscular injection. The majority of the committee agreed that the benefits of bacitracin for intramuscular injection do not outweigh the risks for its approved indication of the treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug, citing such associated risks as nephrotoxicity and anaphylactic reactions. The committee noted that there are potential uses for bacitracin for intramuscular injection other than for the treatment of infants with pneumonia and empyema caused by staphylococci that could be studied. These include irrigation for surgical procedures, irrigation of central lines to disrupt biofilms, and treatment of resistant Neisseria gonorrhoeae and other sexually transmitted infections such as syphilis. All of these potential uses require proper studies. The Agency is currently evaluating recommendations made during the advisory committee meeting.
On June 6, 2019 the committee discussed new drug application (NDA) 212862, pretomanid tablets for oral administration, submitted by The Global Alliance for TB Drug Development, Inc., proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive multidrugresistant tuberculosis (TB). The majority (14) of the Committee voted “Yes”, agreeing that the Applicant provided substantial evidence of the effectiveness and sufficient evidence of the safety of pretomanid as part of a combination regimen with bedaquiline and linezolid, in adults for the treatment of pulmonary extensively drug resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis. The Committee members who voted “Yes” stressed that their vote is in support of the drug regimen of the combination of pretomanid with bedaquiline and linezolid and not necessarily pretomanid alone. These committee members also emphasized that patients should be well informed of the risks, and that strict monitoring should be implemented to support safe use prior to prescribing the drug regimen of pretomanid, bedaquiline, and linezolid. The Committee members who voted “No” (4) mentioned that the Applicant had not provided any clinical data supporting the contribution of pretomanid to the regimen for the proposed indication. Agency Action: On August 14, 2019, the Agency approved approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs.
On August 7, 2019, the committee discussed discussed supplemental new drug application (sNDA) 208215, supplement 12, DESCOVY (emtricitabine 200 milligrams (mg) and tenofovir alafenamide 25 mg tablets), submitted by Gilead Sciences, Inc., proposed for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection among individuals who are HIV-negative and at risk for HIV. Agency Action: The Agency is currently evaluating recommendations made during the advisory committee meeting.
It is expected that this committee will meet four 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.

The meeting minutes for the August 7, 2019 AMDAC meeting has not yet been posted to the committee website. It will be made available at a later date.
Hide Section - PERFORMANCE MEASURES

PERFORMANCE MEASURES

Outcome Improvement To Health Or Safety*YesAction Reorganize Priorities*Yes
Outcome Trust In GovernmentYesAction Reallocate ResourcesNo
Outcome Major Policy ChangesYesAction Issued New RegulationsYes
Outcome Advance In Scientific ResearchYesAction Proposed LegislationNo
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 Anti-Infective 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*59Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 59 recommendations from FY-03 through FY-19. See question 20a of the annual report for specific accomplishments.Access Agency WebsiteYes
% of Recs Fully Implemented*80.00%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, and therefore, the Agency has the option of not implementing the advice.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 CommentIt usually does. 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 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* Est Payments to Non-Fed Members Next FY* 
Payments to Federal Members* Est. Payments to Fed Members Next FY* 
Payments to Federal Staff* Estimated Payments to Federal Staff* 
Payments to Consultants* Est. Payments to Consultants Next FY* 
Travel Reimb. For Non-Federal Members* Est Travel Reimb Non-Fed Members nextFY* 
Travel Reimb. For Federal Members* Est Travel Reimb For Fed Members* 
Travel Reimb. For Federal Staff* Est. Travel Reimb to Fed Staff Next FY* 
Travel Reimb. For Consultants* Est Travel Reimb to Consultants Next FY* 
Other Costs Est. Other Costs Next FY* 
Total Costs$0.00Est. Total Next FY*$0.00
Federal Staff Support (FTE)* Est. Fed Staff Support Next FY* 
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-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
 COM-034923Antimicrobial Drugs Advisory Committee2018