IOM Report Recommends Changes at FDA
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;
- 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 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 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 preapproval 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).
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 postapproval setting, so the dichotomy people are using is really not accurate" (Philadelphia Inquirer, 9/23).
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).
Several broadcast programs reported on the report:
- ABCNews' "World News Tonight": ABCNews correspondent Lisa Stark discusses the report (Stark, "World News Tonight," ABCNews, 9/22). Video of the segment is available online.
- NBC's "Nightly News": The segment includes comments from Charo; Galson; and David Graham, an FDA safety official; and a woman whose father died after he used the COX-2 inhibitor Vioxx (Bazell, "Nightly News," NBC, 9/22). The complete segment is available online in Windows Media.
- NPR's "All Things Considered": NPR health policy correspondent Joanne Silberner discusses the report (Silberner, "All Things Considered," NPR, 9/23). The complete segment is available online in RealPlayer.