TortsProf Blog

Editor: Christopher J. Robinette
Widener Commonwealth Law School

Friday, July 13, 2007

PDUFA Getting Closer

The House yesterday passed the Prescription Drug User Fee Act, which is close enough to the Senate version that it looks likely to become law.  The PDUFA (among other things) maintains the industry funding of the FDA through fees and increases post-marketing surveillance resources and authority.  The reactions fall out along predictable lines:

"Neither of the bills are acceptable," said Dr. Sidney M. Wolfe, director of the Health Research Group at Public Citizen, a consumer advocacy organization based in Washington, D.C.

"We have advocated for a long time repealing PDUFA. The damage that's been done by having direct industry funding of the FDA is unacceptable," Wolfe said. "When people in the FDA start describing the industry as their client -- because the majority of salaries in drug review are being paid by the industry -- there is obviously something wrong with it," he said.

But a drug industry representative defended the current system and applauded the new bills.

"Since its original enactment in 1992, PDUFA has been a resounding success for the FDA, pharmaceutical companies, taxpayers and, most importantly, patients," Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) said in a statement released Wednesday. "The resources and additional staffing made possible by the fees charged by the FDA have enabled the agency to review new medicines more efficiently, while maintaining its stringent safety and efficacy standard."

I understand the criticism from Wolfe to some extent (especially as an instance of the broader argument about regulatory capture), but it has always struck me as a little odd to worry all that much about the funding sources -- it's not like the pharmaceutical companies are going to stop applying for approvals in the U.S. just because they're annoyed by the FDA.  So, yes, the salaries of the officials do come from those fees, but it's not like they're getting bonuses or pay cuts based on what the companies say.   That money's going to keep coming in regardless of what the regulators do.

It does strike me as a bit silly to refer to the regulated entities as "clients," and I assume that the FDA is at at least as much risk of capture as other agencies -- I'm just not certain that the funding source is a huge problem.


(I do some work for pharmaceutical companies.)

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