Statements by a top Food and Drug Administration (FDA) official supporting looser ethics rules for agency advisory boards are inaccurate and undercut the public trust, the Project On Government Oversight (POGO) said today in a letter to FDA Commissioner Margaret Hamburg.
POGO’s letter raises issues with statements made by Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research, asserting that the FDA’s conflict of interest rules are making it hard to recruit experts.
“The vacancy rate for FDA advisory boards has declined since 2009 and continues to fall,” said Danielle Brian, POGO’s executive director. “If the FDA is willing to look—instead of raising bogus alarms—it could find plenty of experts who have no ties to the pharmaceutical or medical device industries.”
POGO’s letter cites a Harvard study published in the journal Health Affairs that found almost 50 percent of research academics have no ties to industry and that about one-third of those researchers are full professors. The letter also points out that despite being allowed by law to grant conflict of interest waivers to 13 percent of its advisory board members, the FDA has never exceeded a 5 percent waiver rate.
POGO’s letter urges Hamburg to maintain the FDA’s high standards and to ensure that Dr. Woodcock relies on the best available information and data when making comments to the press and Congress.