June 19, 2006

A senior FDA official's speech urging the agency to pull back from requiring risk management plans as a part of the drug approval process signals a major change in the FDA's thinking on drug safety, an industry observer says.

Scott Gottlieb, the agency's deputy commissioner for medical and scientific affairs, announced in a June 12 speech before the American Medical Association that risk management plans (RMPs), while important in some instances, may be too prevalent. As the requirement for RMPs becomes more pervasive, the burdens could become too much for physicians and their patients, he added. "I worry about the future," Gottlieb said.

Instead, the agency should look to a more collaborative approach, placing more responsibility on the medical community's shoulders to ensure that medicines are used correctly, Gottlieb said. "I believe some of the same safety goals embodied in the RMPs could be achieved if we had more ability to collaborate more closely and effectively with physician organizations," he added.

This announcement shows that the agency has realized that there is a better way to enhance drug safety than requiring RMPs, Peter Pitts, director of the Center for Medicines in the Public Interest and a former FDA associate commissioner for external relations, told FDAnews. This speech is a "very clear signal to people within the agency" that a change is necessary, he added. Drug safety "cannot be viewed as a punitive measure."

Up to now the agency has used RMPs to show that they are doing something about drug safety, but these plans are an empty measure of success, he said. Gottlieb's speech shows the agency is ready to stop "hiding behind" RMPs and take a better approach, Pitts added. Because doctors have the final say over their patients' use of drugs, they must be more involved in the drug safety process. It is "crucial" for the collaboration that Gottlieb spoke about to take place, he said.

This speech may have been timed to coincide with ongoing Prescription Drug User Fee Act (PDUFA) negotiations and a growing call in Congress for a new FDA office to handle drug safety, Pitts said. PDUFA is a vehicle for the agency to receive much of its funding, but that funding is tied to the FDA meeting specific performance goals. The speech may be a signal to Congress that the amount of RMPs the agency requires should not be used a performance measure, Pitts said. (http://www.fdanews.com/did/5_119/)