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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameGastrointestinal Drugs Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2018Committee 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 twice during FY-18.

On March 8, 2018, the committee discussed supplemental new drug application (sNDA) 203214, supplement 18, XELJANZ (tofacitinib) 5 mg and 10 mg tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response or intolerance to corticosteroids, azathioprine, 6-mercaptopurine or tumor necrosis factor (TNF) inhibitor therapy. The committee voted in the affirmative (Yes 15 – No 0 – Abstain 0) for the inclusion of the 10 mg BID dosing regimen for the proposed patient population in the product label. The panel commented that patients with ulcerative colitis are a patient population desperate for new treatment options, and it would be better to try treating with tofacitinib for a little longer than to abandon a potentially efficacious therapy at 8 weeks, when patients may have no other available therapeutic options. Additionally, the committee voted in the affirmative (15 Yes – 0 No – 0 Abstain) that the benefits of having tofacitinib 10 mg BID as an option outweigh the safety risks observed in clinical trials. It was discussed that it would be helpful for the Applicant to provide information regarding when a 5 mg BID dosing regimen is appropriate for use in patients with history of TNF blocker failure. Action: The Agency approved the product for the new supplemental indication.


On May 3, 2018, the committees discussed new drug application (NDA) 209904, for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia. The committee voted in opposition (2 Yes – 21 No – 1 Abstain) when asked if the long-term and short-term safety profile of stannsoporfin in the proposed indicated population support approval. The committee discussed that there are inadequate data to support the long-term and short-term safety profile of stannsoporfin. Additionally, the committee voted in opposition (0 Yes without a REMS – 3 Yes with a REMS – 21 No) when asked if the overall risk-benefit profile of stannsoporfin support approval. The committee discussed that there may be a group of patients who may benefit from this drug, but that the specific population needs to be more clearly identified and studied. Agency Action: The Agency is currently evaluating recommendations made during the advisory committee.

It is expected that the committee will meet 2-3 times during 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 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-18.
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*22Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 22 recommendations from FY-03 through FY-18. 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*$7,834.00Est Payments to Non-Fed Members Next FY*$19,686.00
Payments to Federal Members*$0.00Est. Payments to Fed Members Next FY*$0.00
Payments to Federal Staff*$164,212.00Estimated Payments to Federal Staff*$166,799.00
Payments to Consultants*$4,191.00Est. Payments to Consultants Next FY*$9,843.00
Travel Reimb. For Non-Federal Members*$13,247.00Est Travel Reimb Non-Fed Members nextFY*$31,974.00
Travel Reimb. For Federal Members*$1,005.00Est 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*$6,621.00Est Travel Reimb to Consultants Next FY*$9,972.00
Other Costs$52,554.00Est. Other Costs Next FY*$59,127.00
Total Costs$249,664.00Est. Total Next FY*$297,401.00
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-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