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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NamePulmonary-Allergy Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee 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 Date5/30/2018Designated Fed Officer Position Title*Designated Federal Officer
Date Of Renewal Charter5/30/2020Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Cindy
Exempt From Renewal*NoDesignated Federal Officer Middle Name
Specific Termination AuthorityDesignated Federal Officer Last Name*Chee
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
Committee Type*ContinuingDesignated Federal Officer Email*cindy.chee@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 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-19.

On May 8, 2019, the committee discussed new drug application (NDA) 202049, for mannitol inhalation powder, for oral inhalation submitted by Chiesi USA, Inc., for the proposed indication of management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies. The majority of the committee (9 to 7) agreed that the data provided substantial evidence of efficacy for dry powder mannitol (DPM) for the proposed indication of the management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard therapies commenting that while the effect size was minimal as reflected by improvement in FEV1, this small increase could be clinically meaningful in some patients. The committee also commented on the ease of use of DPM having an impact on patient adherence and lowering administration time when compared to hypertonic saline. The members who voted “No” commented on the small effect on FEV1 and the lack of clarity on whether this is a clinically meaningful difference. They also commented regarding whether the small effect was sustained effect over the 26-week period as well as lack of support from secondary endpoints. Agency Action: The Agency is currently evaluating recommendations made during the advisory committee meeting.

It is expected that the committee will meet two to three times during FY-20.
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-19.
Recommendation RemarksThe committee is not required to do any reporting for FY-19.
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 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*31Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 31 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 CommentNA
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 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* 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

No Documents Found
Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 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
 COM-034660Pulmonary-Allergy Drugs Advisory Committee2018