The U.S. Food and Drug Administration sometimes finds out that a drug it has approved for the market has dire and unanticipated side effects. A report released today by the Institute of Medicine suggests steps to help the agency catch such problems earlier in the process.
A key point is for the FDA to use more vigorously its authority to order additional studies after a drug is on the market. "Right now many studies are commissioned mainly when there's a fire," said Stanford Professor Steven Goodman, MD, PhD, a co-chairman of the Institute of Medicine (IOM) committee that produced the report, in an interview with me last week. "We think it's better to initiate them when there's just smoke." Goodman is the medical school's associate dean for clinical and translational research and a professor of medicine and of health research and policy.
The report comes as Congress is considering legislation reauthorizing the user fees that help to fund the FDA and is weighing ways to improve the agency's drug-approval and tracking systems. Recent situations with the antidiabetes drug Avandia, the pain-reliever Vioxx and the cholesterol-reducing drug Crestor underscore the need to adopt new safety measures. The report proposes some factors that could indicate the need for a post-approval study. According to a release from the IOM:
[The report] identified some circumstances in which a product's benefits or risks are particularly uncertain, including "first in class" drugs that have been approved based on surrogate endpoints used previously for other drug classes, and drugs for which several endpoints provide conflicting evidence about risk, such as an anti-hypertensive drug that lowers blood pressure but increases weight. In such cases, the committee recommended that FDA require safety research after approval or provide a public rationale for why it is not necessary. Early initiation of such studies could limit the harm done by drugs with risks that are later found to be unacceptable and avoid crises in which the agency is faced with few good options, the committee said.