FDA has completed safety reviews for two new molecular entities as part of a pilot program to determine whether preparing postmarket safety profiles would enhance the existing system for monitoring adverse events.

The agency is "on schedule" to look at a total of five NMEs by early next year, FDA Center for Drug Evaluation and Research's Office of Medical Policy Director Robert Temple said in an interview with "The Pink Sheet."

The pilot program was launched in response to the Institute of Medicine's recommendations for improving FDA's oversight of postmarket drug safety (¹ Also see "FDA’s Postmarket Drug Safety Pilot Will Consider Between Five And 10 Drugs" - Pink Sheet, 12 February, 2007., p. 21). Information gathered during a safety review could provide the basis for labeling changes or other steps designed to minimize a drug's risks.

One of the questions to be answered by the pilot is the best time for reviewing a drug's use and associated adverse events. Originally the agency had planned to look at data collected after a year of marketing.

However, the value of the review "depends a little on how much use of the drug there is," Temple pointed out. "If something has low use, you might want to wait a lot longer."

So FDA is "looking at a range of timing - drugs that have been relatively recently approved, drugs that have been approved longer ago" and reviewing whatever data is available.

Cost is another issue. The pilot program is being conducted "out of available resources" within the Office of New Drugs and Office of Surveillance and Epidemiology, Temple noted. "If you tried to do this for every drug, that would be hard to do with present resources."

Whether the pilot reviews will become public is still undecided. "How much we'll say about the program in general, [and] how much we'll say about each drug, remains to be determined," he said.

- Cathy Dombrowski (c.dombrowski@elsevier.com)

Two Postmarket NME Safety Reviews Done; Five To Be Finished By Early ’08

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