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Power Lunch

FDA Could Get More Enforcement Power After Drug Approval


A House of Representatives subcommittee is considering a proposal that would boost the FDA's enforcement power after drugs have been approved for market.

Would such a measure better protect consumers or stifle the production of new and better medicines? Bill Vaughan Consumers Union Senior Policy Analyst and Sam Kazman, Competitive Enterprise Institute General Counsel, took sides on the question in a "Power Lunch" debate.

Drug Regulation

A story in the New England Journal of Medicine linking GlaxoSmithKline's diabetes medicine Avandia to a 43% higher risk of heart attack has "Congressmen reacting to headlines," according to Kazman. He pointed to the "flip side of the story," which he said doesn't get media coverage: the people who "suffer and die" from illnesses while they wait for drugs to receive FDA approval.

Kazman said the "big risk" of the proposed bill is "an outcome that forces the FDA to be even more cautious." He warned that when it comes to life-saving pharmaceuticals, "overcaution can be just as deadly as lack of caution."

Second Thoughts: Makers of Avandia, Vioxx, Bextra

But Vaughan, a consumer advocate, said the current raft of regulations hasn't been a drag on market timing. He said that the U.S. approves new drugs faster than European countries do, and that approvals now average six months to a year -- compared to the 1980s, when the average was three years.

Vaughan also said that once a drug is approved, the "horse is out of the barn" -- and the FDA is nearly impotent in its attempts to "get label changes" or "ask for studies" on supposed problems.