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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameAntimicrobial Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2018Committee 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 Date10/7/2016Designated Fed Officer Position Title*DFO
Date Of Renewal Charter10/7/2018Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Lauren
Exempt From Renewal*NoDesignated Federal Officer Middle NameD.
Specific Termination AuthorityDesignated Federal Officer Last Name*Tesh
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharmD, BCPS
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.tesh@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 eight times in FY-18.

On November 16, 2017, the committee discussed new drug application (NDA) 209367, ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (> or =18 years of age) with respiratory bacterial pathogens. The Agency is currently evaluating recommendations made during the advisory committee meeting. Six committee members voted “Yes” that the applicant provided substantial evidence of the safety and efficacy for the ciprofloxacin dry powder (DPI) 14-day regimen in delaying the time to first exacerbation after starting treatment. These committee members noted the following: there was consistency among the combined data, there was confidence in the safe use of this product, though more frequent assessment of patient reported outcomes is needed in future trials. It was also noted that if the ciprofloxacin DPI 14-day regimen was approved now, phase 4 studies should be conducted to obtain more data to improve and refine the use criteria for ciprofloxacin DPI. Nine committee members voted “No.” These committee members noted that there were concerns with the inconsistency in the data between the two Phase III clinical trials RESPIRE-1 and RESPIRE-2 regarding efficacy. One committee member voted “Yes” that the applicant provided substantial evidence of the safety and efficacy for the ciprofloxacin dry powder (DPI) 28-day regimen in delaying the time to first exacerbation after starting treatment. This member noted that the combined data indicated a potential signal for efficacy. Fourteen of the committee members voted “No”, that the applicant did not provide substantial evidence of the safety and efficacy for the ciprofloxacin DPI 28-day regimen in delaying the time to first exacerbation after starting treatment. The Agency is currently evaluating recommendations made during the advisory committee meeting.

On January 11, 2018, the committee discussed new drug application (NDA) 210693, ciprofloxacin dispersion for inhalation, sponsored by Aradigm Corp., for the proposed indication of treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa. Three committee members voted “Yes” that the applicant provided substantial evidence of the safety and efficacy of ciprofloxacin dispersion for inhalation in delaying the time to first exacerbation after starting treatment in non-cystic fibrosis bronchiectasis (NCFB) patients with chronic lung infections with Pseudomonas aeruginosa. The majority (12) of the committee members voted “No.” There were concerns with the inconsistency of the data between the two clinical trials, ORBIT-3 and ORBIT-4. There was 1 committee member who abstained from voting. The Agency is currently evaluating recommendations made during the advisory committee meeting.

On May 1, 2018, The committee discussed new drug application (NDA) 208627 for tecovirimat, sponsored by SIGA Technologies Inc., for the proposed indication of the reatment of smallpox disease caused by variola virus in adults and pediatric patients. This product was developed under the Animal Rule (21 CFR part 314, subpart I). The committee unanimously agreed that the risk-benefit profile of tecovirimat supports its use for the treatment of human smallpox. The members commented that the animal efficacy data was clear and the human safety study included diverse populations. The panel applauded the development of the animal rule and the applicant’s fulfilment of these criteria. Committee members also noted that tecovirimat fills this unmet need since there is no current approved treatment for smallpox. Members commented on the lack of serious safety signals, but encouraged continued safety studies in more patients and subgroups to augment the currently limited data. Agency Action: On July 13, 2018, the Agency approved TPOXX (tecovirimat) for the Treatment of patients with human smallpox disease caused by variola virus.

On May 2, 2018, the committee discussed new drug application (NDA) 210303 for plazomicin, sponsored by Achaogen Inc., for the proposed indications for the treatment of complicated urinary tract infections and blood stream infections in adults. The committee unanimously agreed (15) that the applicant provided substantial evidence of the safety and effectiveness of plazomicin for the treatment of complicated urinary tract infections in patients with limited or no treatment options. The majority of the committee (11) voted that the applicant has not provided substantial evidence of the safety and effectiveness of plazomicin for the treatment of bloodstream infections in patients with limited or no treatment options. The panel members who voted “Yes” (4) commented that the study showed some efficacy and safety for those with truly limited or no treatment options. They also commented that although there are many issues with the study, the totality of the data are compelling, and demonstrates efficacy and safety especially in the context of few to no treatment options for this lifethreatening infection. The members who voted “No” commented on the very small sample size and inadaquency of the non-inferiority analysis as a basis for approval. Members commented that the data were not convincing and did not meet the FDA’s standards for substantial evidence of efficacy. Agency Action: The Agency approved ZEMDRI (plazomicin) on June 25, 2018 for the treatment of Complicated Urinary Tract Infections (cUTI), including pyelonephritis, caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae, in patients 18 years of age and older.

On July 12, 2018, the committee discussed new drug application (NDA) 210795, tafenoquine tablet, 150 milligram (mg), sponsored by GlaxoSmithKline Intellectual Property Development Ltd. England, for the proposed indication of the radical cure (prevention of relapse) of Plasmodium vivax malaria. The committee unanimously (13) agreed that the applicant provided substantial evidence of the effectiveness of tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax malaria. The majority of the committee (12) agreed that the applicant providedsubstantial evidence of the safety of tafenoquine for the radical cure (prevention of relapse) of P. vivax malaria. One committee member voted “No”. Agency Action: On July 20, 2018 the Agency approved Krintafel for For the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.

On July 26, 2018, the committee discussed new drug application (NDA) 210607, tafenoquine tablet, 100 milligram (mg), sponsored by 60 Degrees Pharmaceuticals, LLC, for the proposed indication of prevention of malaria in adults for up to 6 months of continuous dosing. The majority of the committee (9) agreed that the applicant provided adequate evidences of the safety of tafenoquine for the prevention of malaria in adults for up to 6 months of continuous dosing. Four committee members voted “No”. Agency Action: On August 8, 2018, the Agency approved Arakoda (tafenoquine) tablets, 100 mg, for the prophylaxis of malaria in patients aged 18 years and older.

On August 7, 2018, the committee discussed new drug application (NDA) 207356, amikacin liposome inhalation suspension, sponsored by Insmed, Inc., for the proposed indication of treatment of nontubercuolous mycobacterial lung disease caused by Mycobacterium avium complex in adults as part of a combination antibacterial drug regimen. Twelve committee members voted yes, that the applicant provided substantial evidence of the effectiveness and sufficient evidence of the safety of ALIS for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex as part of a combination antibacterial drug regimen for adult patients. Two of the committee members voted “No”. Twelve committee members voted yes that the applicant provided substantial evidence of the effectiveness and sufficient evidence of the safety of ALIS for the treatment of nontuberculous mycobacterial lung disease caused by Mycobacterium avium complex as part of a combination antibacterial drug regimen for adult patients with limited or no treatment options. Two of the committee members voted “No”. Agency Action: The Agency is currently evaluating recommendations made during the advisory committee meeting.

On August 8, 2018, the committee discussed new drug applications 209816, for omadacycline tablets and 209817 for omadacycline injection, sponsored by Paratek Pharmaceuticals, Inc., for the proposed indications of community acquired bacterial pneumonia and acute bacterial skin and skin structure infections. The majority of the committee members (17) agreed that the applicant provided substantial evidence of the safety and effectiveness of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI). One committee member voted “No”. The majority of the committee members (14) agreed that the applicant provided substantial evidence of the safety and effectiveness of omadacycline for the treatment of community acquired bacterial pneumonia (CABP). Four committee members voted “No”. 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-19.
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-18.
Recommendation RemarksThere were no reports required for this committee.

The meeting minutes for both the July 12, 2018 and July 26, 2018 AMDAC meetings have not yet been posted to the committee website. They 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*55Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 55 recommendations from FY-03 through FY-18.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*$32,886.00Est Payments to Non-Fed Members Next FY*$32,811.00
Payments to Federal Members* Est. Payments to Fed Members Next FY*$5,468.00
Payments to Federal Staff*$158,507.00Estimated Payments to Federal Staff*$158,564.00
Payments to Consultants*$25,297.00Est. Payments to Consultants Next FY*$21,874.00
Travel Reimb. For Non-Federal Members*$31,980.00Est Travel Reimb Non-Fed Members nextFY*$34,399.00
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*$34,155.00Est Travel Reimb to Consultants Next FY*$24,514.00
Other Costs$74,183.00Est. Other Costs Next FY*$61,458.00
Total Costs$357,008.00Est. Total Next FY*$339,088.00
Federal Staff Support (FTE)*1.10Est. Fed Staff Support Next FY*1.10
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-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