FDA Raked Over the Coals (Again)

January has been another tough month for FDA. There were the whistleblower reports from the Center for Devices, then the Government Accounting Office blasted the Agency for lax review of high-risk medical devices. It also named FDA as one of 28 “highest risk” areas in government, right up there with EPA’s TSCA, toxic substances and control, and financial regulatory system.

Lawmakers were also outraged that FDA spent over $1 million on a consultant and a mini retreat to help it improve manager morale. More from Alicia Mundy at the Wall Street Journal. One slide shown at that retreat appeared to compare CDER director Janet Woodcock to Gandhi, Thatcher and Obama. It cost a fraction of what corporations (or Congress) would spend on an effort of this type. But, judging from the slide quality, FDA completely wasted the money. Bad move.  

But notice Dr. Woodcock’s pale complexion in the slide. It’s clearly the result of very hard work, pressure and worry . . . and testifying again and again before Congress. The ones who really need the morale-boosting are the scientists who work at FDA, whatever level they are within that organization.

Unfortunately, news of the slide and the retreat also had some people dissing Dr. W. She has always been an original thinker, pushing both industry and the Agency to become more scientific and efficient---driving Critical Path, PAT, better risk assessment/management and a number of other programs that nobody knows about that might seem completely colorless but are pretty revolutionary. Unfortunately, most people want to see FDA return to being the traffic cop issuing tickets.

During the brief period when she was Chief Medical Officer, she planned to turn the whole “locker room” situation around, and to open up debate and internal criticism from scientists within the Agency. Her reward appeared to be abrupt reassignment back to CDER.

Just as interesting as news of the consultant hijinx was another piece Ms Mundy subsequently wrote on the appointment of critic Sidney Wolfe to the FDA’s Drug Management and Safety Committee, which was discussed in the National Review blog.  Interesting times ahead.