FDA Announces Plan To Improve Medication Safety Procedures
As expected, FDA officials on Friday announced plans to improve the procedures used by the agency to monitor the safety of medications after they reach the market, the Newark Star-Ledger reports. According to the Star-Ledger, FDA officials made the announcement in response to "two highly publicized incidents ... pointed to potential shortcomings" in current agency procedures -- the decision by Merck in September to withdraw from the market the arthritis medication Vioxx and research that indicated antidepressants can increase suicidality among children.
FDA Acting Commissioner Lester Crawford said that prescription drugs "provide unmistakable and significant health benefits, but experience has shown that the full magnitude of some potential risks have not always emerged" until after FDA has approved them (Schwab, Newark Star-Ledger, 11/6). He added, "Detecting, assessing, managing and communicating the risks and benefits of prescription and over-the-counter drugs is a highly complex and demanding task. FDA is determined to meet this challenge by employing cutting-edge science, transparent policy and sound decisions based on the advice of the best experts in and out of the agency" (Tansey, San Francisco Chronicle, 11/6).
Dr. Steven Galson, acting director of the FDA Center for Drug Evaluation and Research, said that the agency will implement a five-part plan to establish the "best post-market drug safety program in the world" (Alonso-Zaldivar, Los Angeles Times, 11/6).
Under the plan, FDA will name a director of the Office of Drug Safety, which monitors the safety of medications currently on the market. The position has remained vacant since October 2003 (Henderson, AP/Philadelphia Inquirer, 11/6). FDA also will ask the Institute of Medicine to convene a committee of experts to evaluate the U.S. medication safety system and recommend reforms that could help the agency identify "dangerous trends more rapidly," the Los Angeles Times reports (Los Angeles Times, 11/6).
In addition, FDA will establish a formal appeals process to allow agency scientists who suspect that their superiors have made mistakes -- in either the approval of a medication or the refusal to order the recall of a treatment -- to make a case before a committee of internal and outside experts who were not involved in the decision (Harris, New York Times, 11/6). Under the appeals process, the committee of experts would make a recommendation on cases within 30 days (Kaufman/Masters, Washington Post, 11/6). FDA also will conduct workshops on medication safety risks and issue industry guidelines on how to monitor adverse reactions to medications.
Galson said that although FDA has faced criticism in recent months, "We don't really think there is a need for overwhelming cultural change" (Los Angeles Times, 11/6). However, Eric Topol, a cardiologist at the Cleveland Clinic who published a study in 2001 that linked Vioxx to increased heart-related risks, said FDA scientists have complained that their superiors dismissed their concerns about the medication. "There has been a climate there ... of suppression of ideas and concerns," Topol said (AP/Philadelphia Inquirer, 11/6).
Larry Sasich, a research analyst with consumer group Public Citizen, added that the reform plan announced by FDA would not address the main problem -- the agency drug safety office lacks independent authority to overturn decisions by supervisors who approve medications. In addition, Sasich said that lawmakers, not IOM, should conduct the evaluation of the U.S. medication safety system because they have the authority to demand documents from private companies (San Francisco Chronicle, 11/6). Senate Finance Committee Chair Chuck Grassley (R-Iowa), whose committee has launched an investigation into FDA, on Friday called the proposed agency reform plan "welcome, albeit late in coming," adding, "It's obvious that the leadership of the agency must take on what look like deep-rooted problems when it comes to putting public health and safety first and public relations second" (New York Times, 11/6).
NPR's "All Things Considered" on Friday reported on FDA's new pharmaceutical safety measures. The segment includes comments from Dr. Matthias Egger of the University of Bern in Switzerland; Galson; David Graham, senior FDA scientist; and Richard Horton, editor of the Lancet (Knox, "All Things Considered," NPR, 11/5). The complete segment is available online in RealPlayer.
In addition, NPR's "All Things Considered" on Sunday reported on the new FDA initiative and post-market drug safety tests. The segment includes comments from Marcia Angell, former editor in chief of the New England Journal of Medicine; Janet Woodcock, acting deputy commissioner for operations at FDA; and Raymond Woosley, vice president for health sciences at the University of Arizona (Prakash, "All Things Considered," NPR, 11/7). The complete segment is available online in RealPlayer.