Obviously there have been several frantic behind the scenes phone calls directed at the FDA. Why else would there be so much backpedaling for such a reasonable sounding proposal? Hundreds of millions of dollars a year is such a minor portion of the US budget, isn't consumer health as important as pharmaceutical profits?
A top Food and Drug Administration official rebuffed calls by congressional Democrats to support their proposals for tougher regulations on imported drugs and new fees on drug makers, in the latest round of conflict between lawmakers and the administration over drug safety.
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, backed away from comments this week in which she seemed to acknowledge that the FDA needed an additional $225 million to beef up foreign inspections. [snip]
A group of Democratic lawmakers led by House Energy and Commerce Committee Chairman John Dingell (D., Mich.) has proposed raising hundreds of millions more to finance broader drug and medical-device inspections through fees to be levied on drug and medical-device makers.
The proposal, called the "FDA Globalization Act," has drawn fire from some drug makers, as well as congressional Republicans. Mr. Dingell and his co-sponsors have been pushing the bill following a scandal over deaths linked to contaminated heparin, a widely used blood thinner, that was derived from Chinese raw materials.
Thursday, Democrats prodded Dr. Woodcock to say that their proposal would help the agency by generating hundreds of millions of dollars for more overseas inspections.
[From Democrats, FDA Official at Odds Over Inspection Plan - WSJ.com]
The only reason I can see for the criticism is that inspecting oversea drug suppliers will turn up all sorts of shoddily inspected plants, and a history of ignoring problems.
