IOM Report Calls on FDA To Improve Consumer Safety of Prescription Drugs

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Safety of new prescription drugs

FDA must implement "major changes" to ensure the safety of new prescription drugs, according to a report released on Friday by an Institute of Medicine committee, the New York Times reports (Harris, New York Times, 9/23). According to the report, FDA currently cannot ensure the safety of new prescription drugs because of inadequate funds, cultural and structural problems, and "unclear and insufficient regulatory authorities" (Wilde Mathews, Wall Street Journal, 9/23). The IOM Committee on the Assessment of the United States Drug Safety System issued the report at the request of FDA. The report makes a series of recommendations for FDA to improve prescription drug safety, such as:

  • A requirement that packages for new prescription drugs for two years include a symbol to inform patients that the safety profile of the medication is not fully established;

  • A restriction on direct-to-consumer advertisements for new prescription drugs for the first two years (New York Times, 9/23);

  • A requirement that FDA reevaluate the safety and effectiveness of new prescription drugs within five years of approval;

  • Additional authority for FDA to impose fines on pharmaceutical companies;

  • A requirement that pharmaceutical companies register all clinical trials they sponsor in a federal database accessible by patients and health care professionals;

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  • A requirement that most FDA advisory committees members have no potential conflicts of interest with the pharmaceutical industry; and

  • A six-year term of office for the FDA commissioner.

The 15-member committee unanimously approved the recommendations (Vedantam, Washington Post, 9/23). According the report, FDA "needs a more nuanced set of tools to signal uncertainties, to reduce advertising that drives rapid uptake of new drugs or to compel additional studies in the actual patient populations who take the drug after its approval." The report also finds that a 1992 law under which pharmaceutical companies pay user fees to finance reviews of new prescription drugs has limited "the ability of reviewers to examine safety signals as thoroughly as they might like" (New York Times, 9/23).

Committee Member Comments
Committee Chair Sheila Burke, deputy secretary and chief operating officer of the Smithsonian Institution, said, "We found an imbalance in the regulatory attention and resources available before and after approval. Staff and resources devoted to pre-approval functions are substantially greater. Regulatory authority that is well-defined and robust before approval diminishes after a drug is introduced to the market" (Bridges, AP/Chicago Sun-Times, 9/24). Susan Ellenberg, a committee member and associate dean for clinical research at the University of Pennsylvania School of Medicine, said, "You will never get to the place where there's zero risk, but we want to get as close as you can without going so far that it's a disadvantage to people who need the new drugs" (Fallik, Philadelphia Inquirer, 9/23).

Committee member R. Alta Charo, a bioethicist at the University of Wisconsin-Madison, said that clinical trials conducted prior to the approval of new prescription drugs might not provide an accurate safety profile for the general population. "A drug tested in a few hundred or thousand people is very different when used by millions, especially over long periods of time and in conjunction with other supplements," Charo said. Charo also said that FDA has "a lack of collaboration among divisions, tensions (and) inappropriate management" (Washington Post, 9/23).

Reaction
Senate Finance Committee Chair Chuck Grassley (R-Iowa) said that the report is a "watershed moment for FDA reform." Grassley said, "Public safety is at stake, along with the credibility of our nation's drug safety agency. If Congress and the administration do not act based on the clear-cut assessment of this premier review committee, then political leaders will be abdicating their responsibilities to the American people" (Cohen, Newark Star-Ledger, 9/23). Acting FDA Commissioner Andrew von Eschenbach said that the agency in recent months has improved efforts to ensure the safety of new prescription drugs through a number of measures. He added, "I'm committed to taking additional steps and will look to the initiatives recommended by the Institute of Medicine to ensure we continue to fulfill our mission" (Rockoff, Baltimore Sun, 9/23). Steven Galson, director of the FDA Center for Drug Evaluation and Research, said, "Our drug safety staff and the office of new drugs work together both in the preapproval and in the post-approval setting, so the dichotomy people are using is really not accurate" (Philadelphia Inquirer, 9/23). Pharmaceutical Research and Manufacturers of America Senior Vice President Caroline Leow in a statement said, "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 lifecycles of medicines" (Baltimore Sun, 9/23). Bill Vaughan, senior policy analyst for Consumers Union, in a statement said, "The nation's premier doctors and scientists are saying the drug safety system is broken, and they have laid out a plan to fix it. Congress simply can't ignore this real problem any longer, because too many lives are at stake" (Carey, CQ HealthBeat, 9/22).

New Coalition Announced
In related news, former HHS Secretary Tommy Thompson and Center for Science in the Public Interest Executive Director Michael Jacobson on Monday plan to announce the formation of the Coalition for a Stronger FDA, USA Today reports (Rubin, USA Today, 9/25). The coalition also will include former HHS secretaries Donna Shalala and Louis Sullivan, the American Heart Association and the Biotechnology Industry Organization. According to the AP/Washington Times, the FDA "budget has trailed the increases given to other public health agencies, most notably" NIH and CDC. Thompson said, "The ultimate object is to get the FDA the resources needed for them to do the job" (AP/Washington Times, 9/25).

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