Inpharma 1466 - 4 Dec 2004 US FDA addresses postmarketing drug surveillance concerns Two statements that address allegations regarding the postmarketing review of rofecoxib [Vioxx], and detail information on the US FDA’s plans to strengthen its postmarketing drug surveillance, have been published by the FDA: a statement from Dr Lester Crawford, Acting Commissioner of the FDA, 1 and the testimony given by Dr Sandra Kweder, Deputy Director of the Office of New Drugs, at the US Senate hearing on the worldwide withdrawal of rofecoxib. 2 The FDA’s initiative to improve monitoring of recently marketed 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 the postmarketing phase • the publication of risk management guidances for drugs and biological products • workshops and Advisory Committees on drug safety and risk management issues • a programme to adjudicate professional disagreement within the FDA. 1,2 With regard to the Office of Drug Safety’s management of the partially FDA-funded postmarketing study of the cardiovascular safety of COX-2 inhibitors and NSAIDS, Dr Kweder explains that the author of the study abstract, Dr David Graham, voluntarily revised the conclusions of his poster presentation for the International Society for Pharmacoepidemiology after they were questioned by FDA scientists. 2 * On his return from the conference, Dr Graham was asked to submit a draft report of his findings; the FDA did not receive this report until after Merck’s voluntary market withdrawal of rofecoxib. 1,2 More recently, Dr Graham and his coauthors submitted the full paper to The Lancet, and it was accepted for publication. 1 When FDA scientists discovered that the paper had not been through the FDA’s peer review and clearance process, the journal’s editor was contacted and the paper was pulled. 1,3 At the Senate hearing, Dr Graham suggested that the Office of Drug Safety be granted independent regulatory authority, in order to better protect the public. 3 Dr Kweder refutes Dr Graham’s claim that the FDA did not protect the public, saying that the study findings leading to the decision by Merck to withdraw rofecoxib were a result of the "FDA’s vigilance in requiring these long-term outcome trials to address our concerns". 2 * For a report on the poster presentation, see Inpharma 1456: 21, 25 Sep 2004; 800969937. 1. Food and Drug Administration. FDA Statement on Vioxx and Recent Allegations and the Agency’s Continued Commitment to Sound Science and Peer Review. Media Release : 17 Nov 2004. Available from: URL: http:// www.fda.gov. 2. US Food and Drug Administration. Sandra Kweder, M.D. Testimony on November 18, 2004. Internet Document : [3 pages], 18 Nov 2004. Available from: 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. 800999081 » Editorial comment: On 30 Sep 2004, rofecoxib was withdrawn worldwide by Merck & Co [see Inpharma 1458: 3, 9 Oct 2004; 800969957]. 1 Inpharma 4 Dec 2004 No. 1466 1173-8324/10/1466-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

US FDA addresses postmarketing drug surveillance concerns

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Inpharma 1466 - 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 Inpharma 1456: 21,25 Sep 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.

800999081

» Editorial comment: On 30 Sep 2004, rofecoxib waswithdrawn worldwide by Merck & Co [see Inpharma 1458: 3,9 Oct 2004; 800969957].