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Tuesday, June 12, 2007

House to Drug Makers: "Hey, That's Our Job!"

This week, the House Energy and Commerce Committee will begin tackling its version of the Prescription Drug User Fee Act (PDUFA) reauthorization/FDA reform bill the Senate passed in early May.

The House has already uncovered disturbing (but not surprising) information about the bill. FDA drafted and provided to Congress the basis for the Senate bill. However, FDA apparently had a lot of help from the pharmaceutical industry in composing the legislative language.

According to a report in today's Washington Post:

The Food and Drug Administration met 112 times with pharmaceutical industry representatives and five times with consumer and patient groups over 15 months to develop proposed legislation, according to two lawmakers who said the agency is "inappropriately close" to the companies it regulates.

Those two lawmakers — Reps. Bart Stupak (D-MI) and Maurice Hinchey (D-NY) — and the rest of the committee would be wise to examine PDUFA reauthorization with a cautious eye. The PDUFA program allows FDA to charge drug makers for drug approvals, but the money comes with strings attached. The subsequent financial ties blur the line between public regulators and the regulated community.