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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameGastrointestinal Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee Number874
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 Date3/3/2018Designated Fed Officer Position Title*Designated Federal Officer
Date Of Renewal Charter3/3/2020Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Jay
Exempt From Renewal*NoDesignated Federal Officer Middle NameR.
Specific Termination AuthorityDesignated Federal Officer Last Name*Fajiculay
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*jay.fajiculay@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 gastrointestinal diseases and makes appropriate recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*Members are authorities in the fields of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver function, motility, esophagitis, and statistics. 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 two times in FY-19.

On October 17, 2018, the committee discussed supplemental new drug application (sNDA) 021200, supplement 015, for ZELNORM (tegaserod maleate) tablets for oral administration, submitted by Sloan Pharma S.à.r.l, Bertrange, Cham Branch, proposed for the treatment of women with irritable bowel syndrome with constipation who do not have a history of cardiovascular ischemic disease, such as myocardial infarction, stroke, transient ischemic attack, or angina, and who do not have more than one risk factor for cardiovascular disease. The majority of members voted that the reintroduction of tegaserod to the U.S. market is supported by the available safety data (11 to 1) and that the therapeutic gain (treatment difference between tegaserod and placebo patients) is generally similar in magnitude between the severely symptomatic and originally approved population (12 to 0). The majority of members also voted that the patient population they would expect the benefits to outweight the risks in for patients treated with tegaserod were Irritable Bowel Syndrome with Constipation (IBS-C) females at low CV risk. These members noted that the addition of a warning label regarding the weak safety signal for psychiatric adverse events can appropriately communicate safety concerns to patients and providers. Agency Action: In March 2019, FDA approved the reintroduction of tegaserod for the treatment of IBS-C in women under 65.

On October 18, 2019, the committee discussed new drug application (NDA) 210166 for prucalopride tablets for oral administration, submitted by Shire Development, LLC, proposed for the treatment of chronic idiopathic constipation in adults. The members unanimously voted that the risk-benefit profile of prucalopride supports the approval of this application. Several members of the committee expressed concern regarding the neuropsychiatric events that occurred in patients treated with prucalopride. Given the increased predisposition of CIC patients to neuropsychiatric issues such as depression, members of the panel recommended the addition of a warning in the label detailing relevant neuropsychiatric issues. Some committee members also suggested a long-term epidemiological study for further evaluation of a potential suicidality signal. One member of the committee was concerned about the potential long-term carcinogenic effects related to prucalopride. Agency Action: In December 2018, FDA approved prucalopride for the treatment of chronic idiopathic constipation. FDA has requested that the sponsor complete 5 post-marketing studies to assess the pharmacokinetics, efficacy, and safety of prucalopride in pediatric patients with CIC and pregnant and lactating women with CIC treated with prucalopride.

It is expected that the committee will meet 2-3 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 and input lends credibility to regulatory decisions made and helps those decisions withstand intense public scrutiny. 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 RemarksNo reports are required for this committee.
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 Gastrointestinal 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 public health, for which it is difficult to assign a financial value.Grants Review CommentNA
Number Of Recommendations*24Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 24 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 Gastrointestinal 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 gastrointestinal diseases 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-001900Gastrointestinal Drugs Advisory Committee2017
 COM-002300Gastrointestinal Drugs Advisory Committee2016
 COM-004042Gastrointestinal Drugs Advisory Committee2015
 COM-004513Gastrointestinal Drugs Advisory Committee2014
 COM-006216Gastrointestinal Drugs Advisory Committee2013
 COM-006868Gastrointestinal Drugs Advisory Committee2012
 COM-008292Gastrointestinal Drugs Advisory Committee2011
 COM-009075Gastrointestinal Drugs Advisory Committee2010
 COM-010103Gastrointestinal Drugs Advisory Committee2009
 COM-010975Gastrointestinal Drugs Advisory Committee2008
 COM-012234Gastrointestinal Drugs Advisory Committee2007
 COM-012662Gastrointestinal Drugs Advisory Committee2006
 COM-014045Gastrointestinal Drugs Advisory Committee2005
 COM-014506Gastrointestinal Drugs Advisory Committee2004
 COM-015887Gastrointestinal Drugs Advisory Committee2003
 COM-016452Gastrointestinal Drugs Advisory Committee2002
 COM-017805Gastrointestinal Drugs Advisory Committee2001
 COM-018731Gastrointestinal Drugs Advisory Committee2000
 COM-019887Gastrointestinal Drugs Advisory Committee1999
 COM-020332Gastrointestinal Drugs Advisory Committee1998
 COM-021735Gastrointestinal Drugs Advisory Committee1997
 COM-034618Gastrointestinal Drugs Advisory Committee2018