Waiving Concerns About Conflicts of Interest

Abstract

In their Policy Forum “Uncapping conflict of interest?” (7 June, p. [1172][1]), S. F. Wood and J. K. Mador argue for caps on the Food and Drug Adminstration (FDA) waivers of conflicts of interest (COIs) among members of advisory committees, but they do not identify substantial weaknesses in their arguments. A systematic study by an FDA contractor tested and rejected the hypothesis that advisers with waived and disclosed COIs vote in favor of those interests more frequently than advisers with no such conflicts ([ 1 ][2]). Golec et al. independently report similar results ([ 2 ][3]). If advisers with disclosed COIs vote like advisers with no such conflicts on questions such as product approvals and blackbox warnings, it is not clear how limiting the number of committee members with COIs would improve committee recommendations. Wood and Mador claim that many able and willing experts lack conflicts, but do not mention descriptions of unsuccessful searches for COI-free advisers typically found in the FDA's COI waivers [e.g., ([ 3 ][4], [ 4 ][5])]. Granting more COI waivers may increase the FDA's access to expertise, because advisers with waived COIs have more expertise than other advisers ([ 5 ][6]). The FDA, however, does not report (and may not collect) sufficient data to confirm whether the reduction in waivers has affected its access to expertise. The authors critique FDA's focus on financial ties less than 12 months old, implying that grants and contracts that ended shortly before the 1-year window still constitute COIs. In fact, federal rules define a COI in terms of whether the particular matter—e.g., the drug approval—will have a direct and predictable effect on the adviser's financial interest ([ 6 ][7]), regardless of the time frame. Wood and Mador also fail to acknowledge the FDA's impartiality determinations ([ 7 ][8], [ 8 ][9]), which cover noncurrent financial ties. Caps would have value if the system were otherwise flawed, but the FDA's processes are more robust than Wood and Mador acknowledge. Finally, the authors do not address possible indirect effects of the COI waiver cap. The FDA's division directors, who identify most advisory committee experts, might prefer that each meeting avoid surpassing the COI waiver cap. If risk-averse, they might find such a strategy sensible because FDA leadership has stated that it would be better to have no COIs—even though forgoing expert advisers with COIs might leave the FDA with less access to expertise overall ([ 5 ][6]). 1. [↵][10]1. N. Ackerley 2. et al ., Financial Conflict-of-Interest Disclosure and Voting Patterns at FDA Advisory Committee Meetings (Eastern Research Group, Arlington, VA, 2009). 2. [↵][11]1. J. H. Golec, 2. J. C. Cooper, 3. R. Choi , “FDA advisory committees: An empirical examination of conflicts of interest” (Searle Civil Justice Institute, George Mason University, Fairfax, VA, 2013); [www.masonlec.org/research/lec-research][12]. 3. [↵][13]Arthritis Advisory Committee meeting—Dr. Gabriel ([www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM301427.pdf][14]). 4. [↵][15]Endocrinologic and Metabolic Drugs Advisory Committee meeting—Dr. Stanley ([www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM325470.pdf][16]). 5. [↵][17]1. N. Ackerley 2. et al ., “Measuring Conflict of Interest and Expertise on FDA Advisory Committees” (Eastern Research Group, Lexington, MA, 2007); [www.fda.gov/oc/advisory/ergcoireport.pdf][18]. 6. [↵][19]5 CFR § 2640.103 ([www.gpo.gov/fdsys/pkg/CFR-2010-title5-vol3/pdf/CFR-2010-title5-vol3-sec2640-103.pdf][20]). 7. [↵][21]5 CFR § 2635.502 ([www.gpo.gov/fdsys/pkg/CFR-2003-title5-vol3/pdf/CFR-2003-title5-vol3-sec2635-502.pdf][22]). 8. [↵][23]FDA, “Guidance for the public, FDA advisory committee members, and FDA staff on procedures for determining conflict of interest and eligibility for participation in FDA advisory committees” (2008); [www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/LawsRegulationsGuidance/default.htm][24]. [1]: pending:yes [2]: #ref-1 [3]: #ref-2 [4]: #ref-3 [5]: #ref-4 [6]: #ref-5 [7]: #ref-6 [8]: #ref-7 [9]: #ref-8 [10]: #xref-ref-1-1 View reference 1 in text [11]: #xref-ref-2-1 View reference 2 in text [12]: http://www.masonlec.org/research/lec-research [13]: #xref-ref-3-1 View reference 3 in text [14]: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM301427.pdf [15]: #xref-ref-4-1 View reference 4 in text [16]: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM325470.pdf [17]: #xref-ref-5-1 View reference 5 in text [18]: http://www.fda.gov/oc/advisory/ergcoireport.pdf [19]: #xref-ref-6-1 View reference 6 in text [20]: http://www.gpo.gov/fdsys/pkg/CFR-2010-title5-vol3/pdf/CFR-2010-title5-vol3-sec2640-103.pdf [21]: #xref-ref-7-1 View reference 7 in text [22]: http://www.gpo.gov/fdsys/pkg/CFR-2003-title5-vol3/pdf/CFR-2003-title5-vol3-sec2635-502.pdf [23]: #xref-ref-8-1 View reference 8 in text [24]: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/LawsRegulationsGuidance/default.htm