EXPERTS SAY LEAVE DRUG SAFETY OFFICE IN FDA, COX-2s ON THE MARKET

It would be a mistake to remove the FDA's drug safety office from the agency as a way to ensure total independence from the new drug office, says an industry expert who cautioned the FDA and lawmakers not to overreact to recent adverse events surrounding Cox-2 inhibitors.

The safety concerns involving this class of drugs is a very unusual situation, said William Wardell, president of Wardell Associates International, a prominent consulting firm for pharmaceutical, biotechnology and medical device firms. "The FDA basically does a very good job," he said of the agency's record on handling drug safety issues.

There is talk, however, of pulling the drug safety group out of the agency to give it greater independence in making decisions about products that the new drug office approves, he noted. "That would be a very bad idea," Wardell said. "You've got to have risk-benefit judgments in place. I would not create a system that is adversarial," he said, noting that drug approvals always involve a risk-benefit decision. "You want the responsibility for that all under one roof," Wardell said.

Nevertheless, lawmakers are likely to take some action that would strengthen the FDA's drug safety hand in light of recent high-profile revelations about cardiac risks associated with popular painkillers, including Pfizer's Celebrex (celecoxib), the nonsteroidal anti-inflammatory drug naproxen, marketed by Bayer under the brand name Aleve, and Merck's Vioxx (rofecoxib), which the firm withdrew in September 2004.