The agency holds an advisory committee tomorrow to review Glaxo’s Rotavirus vaccine and, as documents show, waivers were granted to two of the panel members holding conflicts of interest. The agency, of course, is allowed to do so, although the practice is controversial and, in response, the FDA issued new rules that specify when exceptions can be granted.

In the latest instance, the FDA issued waivers to John Modlin and Robert Couch, who are members of the Vaccines and Related Biological Products Advisory Committee. Modlin, who is a pediatrics professor at the Dartmouth-Hitchcock Medical Center, receives consulting fees of less than $10,000 from both Glaxo and a rival drugmaker, according to the FDA waiver forms (You can look here).

Couch, meanwhile, is the director of the Center for Immunity and Infection Research at the Baylor College of Medicine, and was granted a conflict of interest waiver despite receiving more than $300,000 through a contract and between $100,000 to $300,000 through a subcontract from a drugmaker affected by the panel’s decision on the influenza virus strain, the documents show.

The new rules, by the way, forbid anyone who has financial ties with industry worth more than $50,000 from serving on advisory committees. It would also deny voting rights to advisers with lesser conflicts. Agency critics, by the way, want the issue revisited.

In both cases, the FDA waivers were granted because the committee has a special need for their “unique expertise, experience and viewpoints with respect to the issue before the committee.” Modlin is a pediatrician with expertise in pediatric virology, and is a leading childhood infectious diseases expert, who would bring important perspective to the committee discussions…

As for Couch, FDA deputy commish for policy Randy Lutter, wrote that he’s an esteemed leader in research in respiratory infectious diseases. His research focuses on influenza. “Dr. Couch would bring important perspective to the committee discussions. I believe that participation by Dr. Couch in
the committee’s deliberations will contribute to the diversity of opinlons and expertise represented on the commrttee.”

Hat tip to Integrity in Science Watch