IOM Drug Safety Report Examines Clinical, not Manufacturing, Risk

September 28, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Washington, DC (Sept. 26): A much-publicized Institute of Medicine report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public," though devoted to the assessment and perception of risk, focuses on premarketing clinical reviews and postmarketing pharmacovigilance. It does not address or make recommendations on drug manufacturing or quality assurance.

Washington, DC (Sept. 26)-A much-publicized Institute of Medicine (IOM, www.iom.edu) report, The Future of Drug Safety: Promoting and Protecting the Health of the Public (1), though devoted to the assessment and perception of risk, focuses on premarketing clinical reviews and postmarketing pharmacovigilance. It does not address or make recommendations on drug manufacturing or quality assurance.

What the 256-page report does address are, first, the US Food and Drug Administration’s ability and determination to evaluate the risks that new and established drugs pose to patients who receive them and, second, the problems raised by what the report sees as eroding public faith that the agency can do the job.

The report, edited by IOM's Alinia Baciu and Kathleen Stratton, PhD, and by Sheila Burke (who chaired the 16-member Committee on the Assessment of the US Drug Safety System that wrote the report), offers some two dozen recommendations for improving the FDA's approach to drug safety.

Suggestions range from increasing agency appropriations (all observers agree that the agency's mandates have far outstripped their resources for decades) which have grown much faster than its budget for decades to appointing FDA directors for six-year terms to establishing an external "Management Advisory Board" to "advise the FDA commissioner in shepherding CDER (and the agency as a whole) to implement and sustain the changes necessary to transform the center's culture."

The report is dated Sept. 26, but IOM announced the findings and began making advance copies available on Sept. 22, which has allowed time for substantial response.

In a prepared statement, Acting FDA Commissioner Andrew von Eschenbach noted FDA's role in commissioning and supporting the report, pledged to continue what he sees as the agency's continuing efforts at self-improvement, and voiced support for the agency and its people.

Steven Galson, director of the Center for Drug Evaluation and Research (CDER, which was the primary subject of the IOM report) followed with an all-hands memo to CDER staff. Galson also noted that the IOM study was originally requested by FDA, and said, “I believe the IOM report offers a significant opportunity for CDER to reexamine how we address drug safety. The spirit of the report resonates with many of us, even if some have questions regarding specific recommendations put forward by the IOM. I also see the report as a call to action for the broader community to work with us to address the tools, resources, and approaches we use in improving drug safety.”

The Pharmaceutical Research and Manufacturers' Association (PhRMA, Washington, DC) issued its own statement, from senior vice-president Caroline Loew, promising to review the reports recommendations, but warning, “It is essential to make sure that efforts to improve the drug safety system do not hurt patient access to medicines needed to treat a range of debilitating diseases and medical conditions. It is also important to remember that all drugs have risks and the FDA has an effective system that weighs benefits and risks throughout the lifecycle of medicines."

Reference
1. Institute of Medicine, Board on Population Health and Public Health Practice, Committee on the Assessment of the US Drug Safety System, The Future of Drug Safety: Promoting and Protecting the Health of the Public, A. Baciu, K. Stratton, and S.P. Burke, Eds (National Academies Press, Washington DC, 2006), www.iom.edu/CMS/3793/26341/37329.aspx, accessed on Sept. 28, 2006).