You read it here first. Of the 16 voting members of the two committees meeting Tuesday - the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee - three members reported conflicts of interest, and received waivers. One, in particular, appears to violate the FDA’s own, newly proposed rules for panel members.

First, Carol Koski, a retired neurology professor with the Guillain Barre Syndrome/CIDP Foundation International, reports holding up to $25,000 in stock in a competing company and Jim Neaton, a biostatistics professor at the University of Minnesota, says he is a consultant to a rival that pays up to $10,000 a year. You can read each waiver form here, here and here.

But Terry Davis, a professor of medicine and pediatrics at Louisiana State University Health Sciences Center, has stock holdings worth up to $75,000 in two companies that make products that compete with Tysabri. This appears to violate a newly proposed rule about participants on advisory panels: “If an individual has disqualifying financial interests whose combined value exceeds $50,000, after applying certain exemptions, the person would generally not be considered for participation in the meeting, regardless of the need for his or her expertise.” Mind you, $50,000 is still a lot of money.

What’s the justification for the waiver? This is what Randy Lutter, FDA’s acting deputy policy commish, offers as an excuse: “First, the stocks represent only a small percentage of Dr. Davis’ total net worth and are not so substantial as to preclude her participation in these matters. Moreover, this waiver for Dr. Davis is further justified because the affected products made by the companies in which Dr. Davis holds stock represent a quite small percentage of the total revenue of each company.”

Honestly, Randy, either the FDA has rules about conflicts or it doesn’t. If holdings are suddenly relative, why doesn’t the public get to see Davis’ net worth so a wider discussion can be held about the meaning of ‘not so substantial?’ This is exactly the sort of problem that the House and Senate should have fixed with PDUFA, but failed to do so. As a result, the public is left with a new rule for which the agency is already allowing huge loopholes and exceptions.