Inpharma 1561 - 28 Oct 2006

The US FDA requires a "new visionof drug safety"

The Institute of Medicine Committee on theAssessment of the US Drug Safety System hasrecommended that " the FDA must embrace a culture ofsafety in which the risks and benefits of medications areexamined during their entire market life", according toProfessor Bruce M Psaty and Ms Sheila P Burke, fromthe University of Washington, Seattle, US, and HarvardUniversity, Cambridge, Massachusetts, US,respectively.*

The committee was assembled in response togrowing concerns about drug safety raised after thewithdrawal of rofecoxib in 2004. Based on its ownfinding and those of external reports, the committeeidentified "a lack of clear regulatory authority, chronicunderfunding, organizational difficulties, and a scarcityof post-approval data", as well as a perception thatindustry, rather than the public, are the FDA’s majorpatron.

Key recommendations from the committee included ascientific review of the current systems, theimplementation of risk-benefit analyses, bettercommunication with the public and physicians, andtimely, enforced postmarketing surveillance, amongstothers.

Professor Psaty and Ms Burke suggest that "withadditional resources, new regulatory powers, andcultural changes, the FDA can link regulatory actions tonew data in imaginative ways in an effort to improve thehealth of the public as well as industry".

See also Inpharma 1559 p4; 801034304* Professor Psaty was a member of, and Ms Burke was chair of, thecommittee.

Psaty BM, et al. Protecting the health of the public - Institute of Medicinerecommendations on drug safety. New England Journal of Medicine 355:1753-1755, No. 17, 26 Oct 2006 801034321

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Inpharma 28 Oct 2006 No. 15611173-8324/10/1561-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved