FDA Moves Cautiously to Improve Drug Safety
The Food and Drug Administration yesterday unveiled a series of initiatives intended to improve drug safety. While some changes were concrete, such as a pilot program to review the safety of drugs 18 months after they've been approved, many others seemed more vague, involving forming committees to develop new agency procedures. Nonetheless, FDA Commissioner Andrew von Eschenbach said the changes "will not just be a plan but a pathway to greater drug safety."
Drug safety has been a hot issue for consumers and the federal government in the past three years, particularly since evidence surfaced after the approval of the painkiller Vioxx that the drug raised the risk of heart trouble. The manufacturer withdrew the drug but not before the FDA was accused of ignoring signs of risk both before and after the drug was approved. Critics charged that safety issues often emerged once a drug comes into wide use, but the FDA was slow to detect and act on them. Those charges were repeated in a September 2006 report from the Institute of Medicine, which made recommendations to correct the situation. Yesterday's FDA actions were a response to that report.
The agency took a pass on two of the Institute's most visible suggestions. One proposed that drugs, for the first two years after approval, carry a special symbol indicating they are new, giving consumers a chance to take a "wait and see" attitude. Steven Galson, director of FDA's Center for Drug Evaluation and Research, pointed out that such labeling changes require Congressional action. Another Institute recommendation, that the agency post drug approval documents on its website, was disregarded because those documents contained information irrelevant to consumers and proprietary to companies, Galson said, and it would be too difficult for the agency to edit all of that out.
But the agency said it hopes to begin its pilot program to review newly approved drugs later this year. (The 18-month review period falls far short of the 5 years recommended by the Institute of Medicine, however.) In addition, it will publish a newsletter on its website summarizing any other drug safety reviews. The agency will also enhance its adverse drug events database with analytic tools that should allow it to detect more patterns of trouble. And it will partner with the Department of Veterans' Affairs to pool more data about drugs and devices, also enhancing its ability to spot problems.
Many of the other agency responses involve forming committees. To deal with concerns that agency staff responsible for pre-approval tests don't get along with staff for post-approval tracking, hindering studies of drug risks, the agency will hire external consultants to smooth communication and will form internal management teams to figure out ways to improve information flow. Internal committees will also evaluate the science policy of the agency, and an advisory board will be formed to suggest better ways the agency can communicate drug risk information to the public and to doctors. It's not clear when these panels will make their recommendations, or whether they will be adopted. "These things don't change overnight," Galson says.
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