Panel urges FDA overhaul

Institute of Medicine panel seeks major reforms at FDA, including bolstering intramural and extramural research

By | September 25, 2006

A new report from the National Academy of Sciences' Institute of Medicine (IOM) recommends strengthening the U.S. Food and Drug Administration's science capabilities by substantially increasing intramural and extramural research within the agency and appointing a chief scientist in the commissioner's office responsible for overseeing the agency's research programs. The recommendation is one of 25 measures urged by the IOM in its long-awaited report on the FDA. The report is deeply critical of the agency, stating that it is suffering from a "dysfunctional organizational culture" that funnels resources into reviewing new drugs for market approval at the expense of thorough monitoring of post-market safety. Many of the report's recommendations, which were unanimously endorsed by the 15-member panel of academics and other experts, focus on bolstering the agency's drug safety monitoring and enforcement mechanisms. To strengthen FDA's ability to conduct post-market drug safety assessments, the panel recommends creating a "robust program of intramural scientific research," boosting information technology for drug utilization databases and other datasets, and increasing extramural epidemiology research funding at the Center for Drug Evaluation and Research (CDER) to $60 million annually. "Clearly $1 million dollars-plus, which are the funds available currently for that kind of research, is not adequate," Sheila Burke, IOM committee chair and chief operating officer of the Smithsonian Institution, told reporters during a conference call on Friday. Other measures recommended in the report include giving FDA greater authority to impose fines and injunctions on drug manufacturers, requiring drug makers to conduct post-marketing risk assessment studies, and having the agency review new drugs five years after they have been on the market. The report also recommends that drug companies intending to submit applications for new drugs be required to register and post summary results of all Phase II through IV clinical trials on the Internet, regardless of the outcomes. During the first two years on the market, all new drugs would carry a black triangle or other warning symbol, and FDA could ban or restrict direct-to-consumer advertising. "A drug tested in a few hundred or a thousand people is certainly very much different when in fact it is used by millions, often over much longer periods of time and in conjunction with other drugs and supplements," Burke said. "Staff and resources devoted to pre-approval are substantially greater than those available for post-approval functions. Few high-quality studies are conducted after approval, and the data are generally quite limited." Acting FDA Commissioner Andrew von Eschenbach, whose nomination to serve as Commissioner is pending in the Senate, praised the report. "While considerable work has been done over the past two years to improve our approach to drug safety, work still remains to be done," he said in a statement. The FDA requested the IOM study two years ago, following widespread criticism that the agency and drug companies had mishandled safety issues surrounding COX-2 inhibitors, pediatric antidepressants, and other drugs. While the FDA has authority to enact some of the recommendations, most will require approval by Congress when legislators convene next year. "The new report validates what the watchdog community has been saying for the last two years: We need more vigilance over the lifecycle of drugs, the FDA needs to be more forthcoming with information about drug risks, problems are systemic, and solutions must reflect a new mindset by the agency's leadership," said Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance Committee, in a statement. Grassley and other critics have argued that a structural conflict of interest hinders FDA safety officials from exercising authority, because the Office of Drug Safety is part of CDER, which also houses the more powerful Office of New Drugs. The IOM report, however, stopped short of endorsing that idea, recommending instead that Congress give the drug safety office a "substantial" increase in funds and personnel. "It's difficult for us to say how much this would be, but certainly more is better," Burke said, noting that the Office of New Drugs has about 1,320 staff members, while the Office of Drug Safety has only about 90. The IOM also recommended that drug safety staff members be appointed to participate on interdisciplinary teams involved in reviewing applications for new drugs. "New eyes often bring new sources of ideas," said committee member Bruce Psaty, professor of medicine, epidemiology, and health services at the University of Washington-Seattle. Representatives of the pharmaceutical and biotech industries suggested that the report was somewhat overzealous. "Though there is always room for improvements, it would be a mistake to accept the notion that the FDA drug safety system is seriously flawed," said Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America, in a statement. Jim Greenwood, president of the Biotechnology Industry Organization, said his group supports increased FDA funding to improve drug safety. But he added in a statement: "When considering enhancements to the U.S. system, we must be cognizant that implementing undue hurdles in the drug review process will harm patients by delaying access to life-enhancing and life-saving products." Ted Agres Links within this article: "The Future of Drug Safety: Promoting and Protecting the Health of the Public." Board on Population Health and Public Health Practice, Committee on the Assessment of the US Drug Safety System, Institute of Medicine of the National Academy of Sciences, Washington DC. Alina Baciu, Kathleen Stratton, Sheila P. Burke, Editors. Institute of Medicine Center for Drug Evaluation and Research Smithsonian Institution "Trials of the Pharmaceutical Industry," The Scientist, Nov. 22, 2004 Statement by Dr. Andrew von Eschenbach, Acting Commissioner of Food and Drugs, Regarding The Institute of Medicine Future of Drug Safety Report, Sept. 22, 2006 "Who's minding the drug store?" The Scientist, Jan. 17, 2005 Press release: SENATOR GRASSLEY COMMENTS ON THE INSTITUTE OF MEDICINE'S ASSESSMENT OF THE U.S. DRUG SAFETY SYSTEM FDA Office of Drug Safety FDA Office of New Drugs PhRMA PhRMA statement on the IOM drug safety report BIO Greenwood Releases Statement on IOM Drug Safety Document

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