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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 - 1011 - Pulmonary-Allergy Drugs Advisory Committee - Authorized by Law
Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NamePulmonary-Allergy Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2020Committee Number1011
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*12
Current Charter Date5/30/2020Designated Fed Officer Position Title*Designated Federal Officer
Date Of Renewal Charter5/30/2022Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Takyiah
Exempt From Renewal*NoDesignated Federal Officer Middle Name
Specific Termination AuthorityDesignated Federal Officer Last Name*Stevenson
Establishment Authority*Authorized by LawDesignated Federal Officer SuffixPharm.D.
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*takyiah.stevenson@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 pulmonary disease and diseases with allergic and/or immunologic mechanisms and makes appropriate recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*Members are experts in the fields of pulmonary medicine, allergy, clinical immunology, and epidemiology/statistics and are qualified by training and experience to evaluate scientific data. The Committee includes one technically qualified member who is identified with consumer interests. The Committee may include one non-voting member identified with industry interests.
How frequent & relevant are cmte mtgs?*The Committee met once during FY-20.

On August 31, 2020, the Committee discussed supplemental new drug application 209482/S-008, for TRELEGY ELLIPTA, a fixed-dose combination (fluticasone furoate, umeclidinium, and vilanterol inhalation powder oral inhalation), submitted by GlaxoSmithKline, for the following proposed labeling claim: Reduction in all-cause mortality in patients with chronic obstructive pulmonary disease (COPD). The focus of the discussion was on the efficacy data submitted to support the proposed labeling claim, including the results from the Informing the Pathway of COPD Treatment (IMPACT) trial and the influence of inhaled corticosteroids (ICS) withdrawal on the results. An overwhelming majority of the Committee members (14 to 1) agreed that the data from the IMPACT trial did not provide substantial evidence of efficacy to support the claim that TRELEGY ELLIPTA improves all-cause mortality in patients with COPD. Some members stated that the data were suggestive but not definitive. The members who voted “No” agreed that the survival difference was likely due to the adverse impact of ICS withdrawal rather than the addition of TRELEGY ELLIPTA, that the data did not meet the evidentiary standard, and many also noted concerns regarding type I error (multiplicity) control of the all-cause mortality analyses. Agency Action: The Agency is currently reviewing all recommendations made at the meeting.

It is expected that the Committee will meet two to three times during FY-21.
Why advice can't be obtained elsewhere?*Members of the Committee are drawn from academia research, and/or clinical practice. Their advice lends credibility to FDA's regulatory decisions. The alternate means of obtaining this advice would involve the recruitment of large numbers of scientists on a full-time basis at maximum rates of compensations.
Why close or partially close meetings?The Committee held no closed meetings during FY-20.
Recommendation RemarksThe Committee is not required to do any reporting for FY-20.
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 product.
Outcome Implement Laws/Reg RequirementsYesGrants Review*No
Outcome OtherNoNumber Of Grants Reviewed0
Outcome CommentNANumber Of Grants Recommended0
Cost Savings*Unable to DetermineDollar Value Of Grants Recommended$0.00
Cost Savings CommentThe utilization of the Pulmonary-Allergy Drugs Advisory Committee enabled 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 CommentNA
Number Of Recommendations*32Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe Committee made 32 recommendations from FY-03 through FY-20.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 CommentNA
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 Pulmonary-Allergy Drugs Advisory Committee supports FDA's strategic priorities by reviewing and evaluating available data concerning the safety and effectiveness of marketed and investgational human drug products for use in the treatment of pulmonary disease and diseases with allergic and/or immunologic mechanisms and makes 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*$3,815.00Est Payments to Non-Fed Members Next FY*$6,050.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$550.00
Payments to Federal Staff*$174,963.00Estimated Payments to Federal Staff*$177,005.00
Payments to Consultants*$4,360.00Est. Payments to Consultants Next FY*$2,750.00
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$46,699.00Est. Other Costs Next FY*$47,239.00
Total Costs$229,837.00Est. Total Next FY*$233,594.00
Federal Staff Support (FTE)*1.10Est. Fed Staff Support Next FY*1.10
Cost RemarksIn FY-2020, David Au, who is a Federal Member and Committee Chairperson, did not attend any meetings. As such, no Payments to Federal Members were incurred in FY-2020.Est 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-036461Pulmonary-Allergy Drugs Advisory Committee2019
 COM-034660Pulmonary-Allergy Drugs Advisory Committee2018
 COM-002041Pulmonary-Allergy Drugs Advisory Committee2017
 COM-002664Pulmonary-Allergy Drugs Advisory Committee2016
 COM-004144Pulmonary-Allergy Drugs Advisory Committee2015
 COM-004737Pulmonary-Allergy Drugs Advisory Committee2014
 COM-006252Pulmonary-Allergy Drugs Advisory Committee2013
 COM-006576Pulmonary-Allergy Drugs Advisory Committee2012
 COM-008254Pulmonary-Allergy Drugs Advisory Committee2011
 COM-008759Pulmonary-Allergy Drugs Advisory Committee2010
 COM-010289Pulmonary-Allergy Drugs Advisory Committee2009
 COM-010765Pulmonary-Allergy Drugs Advisory Committee2008
 COM-011870Pulmonary-Allergy Drugs Advisory Committee2007
 COM-012853Pulmonary-Allergy Drugs Advisory Committee2006
 COM-013957Pulmonary-Allergy Drugs Advisory Committee2005
 COM-014779Pulmonary-Allergy Drugs Advisory Committee2004
 COM-015661Pulmonary-Allergy Drugs Advisory Committee2003
 COM-016444Pulmonary-Allergy Drugs Advisory Committee2002
 COM-017985Pulmonary-Allergy Drugs Advisory Committee2001
 COM-018571Pulmonary-Allergy Drugs Advisory Committee2000
 COM-019789Pulmonary-Allergy Drugs Advisory Committee1999
 COM-020324Pulmonary-Allergy Drugs Advisory Committee1998
 COM-021710Pulmonary-Allergy Drugs Advisory Committee1997