An FDA Analysis of Formal Dispute Resolution in the Center for Drug Evaluation and Research

Abstract

Scientific and/or medical disputes will inevitably arise with regard to the US Food and Drug Administration’s (FDA’s) decision making related to drug development, new drug review, generic drug review, and postmarketing oversight. As these disputes can involve complex judgments and issues that are scientifically and commercially important, it is critical that FDA have procedures for effective and efficient resolution. FDA regulations allow a sponsor to obtain a review of an FDA decision by submitting a request for formal dispute resolution (an appeal). FDA’s Center for Drug Evaluation and Research (CDER) received 137 appeal issues for fiscal years 2003 through 2014. However, sponsors can appeal the same issue multiple times, and each is considered a unique appeal; CDER received and analyzed 173 of these unique appeals. Of these 173 unique appeals, CDER accepted 140 (81%) for review and refused to accept for review 25 (14%). Eight (5%) were withdrawn by the sponsor prior to CDER making a decision whether to accept the appeal for review. Of the 140 unique appeals accepted and reviewed, CDER granted 23 (16%) appeals and denied 117 (84%). The analysis also examines an array of aspects of the process, such as (1) reasons why CDER rejected appeals, (2) reasons why sponsors submitted appeals, (3) the types of appeals that sponsors submitted, (4) the characteristics of the sponsors that submitted appeals (eg, size, past regulatory experience, legal representation), and (5) CDER’s performance in meeting user fee goals associated with dispute resolution.

Keywords

appeal 30-day goal formal dispute resolution appeal issues FDA deciding official

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References

21 Code of Federal Regulations, Part 10.75—Administrative Practices and Procedures. Internal agency review of decisions.

21 Code of Federal Regulations, Part 312.48—Investigational New Drug Application. Dispute resolution.

21 Code of Federal Regulations, Part 314.103—Applications for FDA approval to market a new drug. Dispute resolution.

FDA guidance for industry and review staff Formal Dispute Resolution: Appeals Above the Division Level. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm343101.pdf. Accessed August 6, 2015.

See the letter PDUFA Reauthorization Performance Goals and Procedures; Fiscal Years 2013 Through 2017 from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf. Accessed August 2, 2015.

See the letter Biosimilar Biological Product Authorization Performance Goals and Procedures; Fiscal Years 2013 Through 2017 from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM281991.pdf. Accessed August 2, 2015.

Generic Drug User Fee Act Program Performance Goals and Procedures, http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf. Accessed August 2, 2015.

FDA guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM437431.pdf.

FDA guidance for industry Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM345649.pdf. Accessed August 2, 2015.