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Committee Detail

Hide Section - GENERAL INFORMATION

GENERAL INFORMATION

Committee NameArthritis Advisory CommitteeAgency NameDepartment of Health and Human Services
Fiscal Year2019Committee Number223
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 Date4/5/2018Designated Fed Officer Position Title*DFO
Date Of Renewal Charter4/5/2020Designated Federal Officer Prefix
Projected Termination Date Designated Federal Officer First Name*Yinghua
Exempt From Renewal*NoDesignated Federal Officer Middle NameS
Specific Termination AuthorityDesignated Federal Officer Last Name*Wang
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*yinghua.wang@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 data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of arthritis, rheumatism, and related diseases, and makes appropriate recommendations to the Commissioner of Food and Drugs.
How is membership balanced?*Members are experts in arthritis, rheumatology, pediatrics, immunology, allergy, epidemiology, clinical pharmacology, biostatistics, and related specialties. The committee also includes a technically qualified voting member 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 two times in FY-19.

On January 11, 2019, a meeting was held jointly with the Arthritis Advisory Committee to discuss supplemental new drug application (sNDA) 021-856, ULORIC (febuxostat) tablets, sponsored by Takeda Pharmaceuticals, which includes the results from the postmarketing safety trial required by FDA to evaluate the cardiovascular safety of febuxostat, entitled “Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES).” Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout. The committee’s discussion included the results from the CARES trial, the benefit risk assessment of febuxostat, and potential regulatory actions.  The majority of members (19 to 2) agreed that there is a patient population in which the benefit-risk profile for febuxostat is favorable for the treatment of hyperuricemia in patients with gout. These members noted that there is a subgroup of gout patients who have failed or could not tolerate allopurinol, in which the benefit outweighs the risk for febuxostat. The committee members suggested the following: stronger labels, boxed warning, second-line therapy in indication, update to the gout treatment guidelines by the American College of Rheumatology (ACR), and “Dear Healthcare Provider” letters to communicate the risk to patients and their providers so they can make an informed decision on the care plan. The committee members who voted “No” noted that there is clear evidence that febuxostat caused cardiovascular death, thus withdrawal is the next option in the absence of a REMS. The committee member who abstained noted that the question is ambiguous. Agency Action:  On February 21, 2019, the Agency concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol and updated the Uloric prescribing information to require a Boxed Warning, our most prominent warning, and a new patient Medication Guide.  The Agency also limited the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.

On July 25, 2019, the Committee met to discuss supplemental new drug application (sNDA) 205832, for nintedanib capsules (drug name OFEV), sponsored by Boehringer Ingelheim, for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). The focus of the discussion will be whether the application provides substantial evidence of efficacy for the proposed indication. The majority of the members (10 to 7) agreed that the benefit-risk profile is adequate to support approval of nintedanib at the proposed dose of 150 mg twice daily for the treatment of systemic sclerosis interstitial lung disease. These members noted that nintedanib provides a viable option for a disease that has a great unmet need and poor outlook. The committee members who voted “No” noted that the benefit-risk profile is not adequate to support approval of nintedanib because the magnitude and level of evidence for efficacy were small and the side effect profile remains concerning. The committee members noted the need for trials with longer term follow-up and more information on which subgroups of patients will benefit from use of this medication. Agency Action: On September 6, 2019, the Agency approved nintedanib capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis.

It is expected that this committee will meet two to four times in FY-20.
Why advice can't be obtained elsewhere?*The committee members are selected from academia, research and clinical practice. The Agency uses the committee recommendations to make the most impartial and broad decisions possible regarding approval of products, indications and labeling. The alternative means of obtaining this advice would involve the recruitment of large numbers of scientist on a full-time basis at maximum rates of compensation.
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 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 Arthritis 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 not otherwise available to the Agency; and to obtain the services of these experts only on an as needed bases 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*38Access Contact Designated Fed. Officer*Yes
Number Of Recommendations CommentThe committee made 36 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 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 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 Arthritis 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 arthritis, rheumatism, and related 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

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Hide Section - DATA FROM PREVIOUS YEARS

DATA FROM PREVIOUS YEARS

Committee

Data from Previous Years

 
ActionCommittee System IDCommittee NameFiscal Year
 COM-034860Arthritis Advisory Committee2018
 COM-001939Arthritis Advisory Committee2017
 COM-002600Arthritis Advisory Committee2016
 COM-003768Arthritis Advisory Committee2015
 COM-004487Arthritis Advisory Committee2014
 COM-006195Arthritis Advisory Committee2013
 COM-006963Arthritis Advisory Committee2012
 COM-008400Arthritis Advisory Committee2011
 COM-008716Arthritis Advisory Committee2010
 COM-010094Arthritis Advisory Committee2009
 COM-011011Arthritis Advisory Committee2008
 COM-012120Arthritis Advisory Committee2007
 COM-012600Arthritis Advisory Committee2006
 COM-013917Arthritis Advisory Committee2005
 COM-014512Arthritis Advisory Committee2004
 COM-015987Arthritis Advisory Committee2003
 COM-016516Arthritis Advisory Committee2002
 COM-017987Arthritis Advisory Committee2001
 COM-018692Arthritis Advisory Committee2000
 COM-019694Arthritis Advisory Committee1999
 COM-020668Arthritis Advisory Committee1998
 COM-021467Arthritis Advisory Committee1997