Senate Beefs Up the FDA

Michael Phelan

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The day after Oxycontin manufacturer, Purdue Pharma, pleaded guilty to criminal charges that it fraudulently marketed Oxycontin for six years as a drug that was less prone to abuse and has fewer narcotic side effects, the U.S. Senate approved by a vote of 93-1 a landmark drug safety bill that would double the number of scientists at the FDA assigned to monitor drugs already on the market for dangerous side effects.

The Senate bill would also create a computerized network to scan medical, insurance, and pharmacy records for signals for dangerous side effects and expand the FDA's power to require drug makers to reduce risks. The FDA currently relies on an antiquated system based on voluntary reporting by doctors and patients to the FDA's Med Watch system. This approach is widely thought to result in the under reporting of adverse drug events by a magnitude of 100 to 1,000 times the actual number of adverse events. The system proposed by the Senate would be able to detect a signal, for example, if insurance billing records indicated that arthritis patients getting a new drug (e.g., Vioxx) were more likely to be treated for heart attack or stroke than similar patients on an older arthritis drug.
The House is expected to begin writing its own version of the drug safety bill soon. The House bill is expected to be even tougher on the pharmaceutical industry.