The Yin and Yang of the FDA

Speed and safety, notes the New York Times' Gardiner Harris, are the yin and yang of drug regulation: the FDA must strike a balance between people's desire for immediate access to drugs, and for the drugs to be proven safe.

In 1992, following criticism that desperately-needed AIDS drugs had been kept from the market during the FDA's typical three-year approval process, Congress enacted the Prescription Drug User Fee Act: pharmaceutical companies agreed to pay for safety testing in exchange for the FDA's accelerating the approval process.

This, say FDA drug safety officers, tipped the agency's priorities towards speed over safety, and the agency soon became dependent on industry money, which companies insisted be spent on pre-approval testing rather than tracking drugs once they hit the market.

Managers are now largely judged on how quickly their employees make a decision on new drug applications, safety officials say. Questions about the safety of already-marketed drugs are increasingly seen as sand in the gears, they say.

Drs. Johann-Liang, Ross and two other safety officials said Congress should require the F.D.A. to make regular public assessments of the safety of approved medicines, act on reports of drug problems within a month or two, and require regular reports on the agency’s adherence to these goals. Such requirements would lead to the promotion of safety-conscious managers, not just speed-conscious ones, they said.

Such charges will be discussed when the House holds meetings this week on an FDA reform bill passed last month by the Senate. The bill increases funds for drug testing, but FDA safety officers say it should also require the FDA's reviews to be publicly disclosed.

“If managers were held accountable on safety issues, they’d pay more attention to them,” said Dr. Victoria Hampshire, who was disciplined and investigated criminally in part because of her work to uncover the dangers of a heartworm medicine that killed at least 500 dogs.

Related Wired coverage here.

Potentially Incompatible Goals at F.D.A. [New York Times]