Reactions 1030 - 4 Dec 2004

US FDA addresses postmarketingdrug surveillance concerns

Two statements that address allegations regarding thepostmarketing review of rofecoxib [Vioxx], and detailinformation on the US FDA’s plans to strengthen itspostmarketing drug surveillance, have been publishedby the FDA: a statement from Dr Lester Crawford,Acting Commissioner of the FDA,1 and the testimonygiven by Dr Sandra Kweder, Deputy Director of theOffice of New Drugs, at the US Senate hearing on theworldwide withdrawal of rofecoxib.2

The FDA’s initiative to improve monitoring of recentlymarketed drugs includes:• the appointment of an Office of Drug Safety Director• the sponsorship of a major Institute of Medicine

study of the US drug safety system, particularly thepostmarketing phase

• the publication of risk management guidances fordrugs and biological products

• workshops and Advisory Committees on drug safetyand risk management issues

• a programme to adjudicate professionaldisagreement within the FDA.1,2

With regard to the Office of Drug Safety’smanagement of the partially FDA-funded postmarketingstudy of the cardiovascular safety of COX-2 inhibitorsand NSAIDS, Dr Kweder explains that the author of thestudy abstract, Dr David Graham, voluntarily revised theconclusions of his poster presentation for theInternational Society for Pharmacoepidemiology afterthey were questioned by FDA scientists.2* On his returnfrom the conference, Dr Graham was asked to submit adraft report of his findings; the FDA did not receive thisreport until after Merck’s voluntary market withdrawalof rofecoxib.1,2 More recently, Dr Graham and hiscoauthors submitted the full paper to The Lancet, and itwas accepted for publication.1 When FDA scientistsdiscovered that the paper had not been through theFDA’s peer review and clearance process, the journal’seditor was contacted and the paper was pulled.1,3 At theSenate hearing, Dr Graham suggested that the Office ofDrug Safety be granted independent regulatoryauthority, in order to better protect the public.3Dr Kweder refutes Dr Graham’s claim that the FDA didnot protect the public, saying that the study findingsleading to the decision by Merck to withdraw rofecoxibwere a result of the "FDA’s vigilance in requiring theselong-term outcome trials to address our concerns".2

* For a report on the poster presentation, see Reactions 1020: 4, 25Sept 2004; 800969937.

1. Food and Drug Administration. FDA Statement on Vioxx and RecentAllegations and the Agency’s Continued Commitment to Sound Science andPeer Review. Media Release : 17 Nov 2004. Available from: URL: http://www.fda.gov.

2. US Food and Drug Administration. Sandra Kweder, M.D. Testimony onNovember 18, 2004. Internet Document : [3 pages], 18 Nov 2004. Availablefrom: URL: http://www.fda.gov.

3. Lenzer J. FDA is incapable of protecting US against another Vioxx. BMJ 329:1253, No. 7477, 27 Nov 2004.

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» Editorial comment: On 30 Sep 2004, rofecoxib waswithdrawn worldwide by Merck & Co [see Reactions 1022: 2, 9Oct 2004; 800969957].

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Reactions 4 Dec 2004 No. 10300114-9954/10/1030-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved