Monday, March 01, 2010

Belatacept Advisory Committee: One Sign of the Times

Bristol-Myers Squibb is, as our colleagues at "The Pink Sheet" pointed out, facing a bit of an uphill climb during today's advisory committee review of the transplant drug belatacept.

But one item in the preview materials posted by the Food & Drug Administration caught our eye as a sign of the times for advisory committees in general: FDA issued a formal conflict-of-interest waiver for Richard Mann, who heads the kidney and pancrease transplantation program at Robert Wood Johnson Medical School.

Under new rules set by the FDA Amendments Act, the agency is directed to review potential conflicts-of-interest of advisory committee members carefully, and issue waivers sparingly. (You can read more about this issue in The RPM Report, here.)

In this case, the agency wanted Mann to serve as a temporary voting member, but spotted a potential conflict: he was listed as a co-investigator on a trial involving "competing products to belatacept." The study drugs are not identified in the waiver document, but it does explain the circumstances.

Mann was listed as a co-investigator "as a matter of policy" by the medical school; he is not an active participant in the trial. In fact, he "has filed the appropratiate paperwork" to have his name removed from the study. Moreover, the size of the potential conflict is "$0-$50,000 per year."

However, FDA notes, the fact remains that his employer has an interest in competing products, and therefore Mann has an "imputed conflict of interest."

The agency considered 10 other transplant nephrologists for the committee. Four couldn't attend, one did not submit the paperwork for review, and the other five were "recused to conflicts of interest"--presumably more serious ones than Mann's.

In other words, Mann was the only transplant nephrologist available for the meeting who didn't have a direct conflict of interest. Waiver granted.

But that also means one less waiver for the agency to use later in the year. Under FDAAA, supplies of waivers are limited--essentially to a small percentage of committee members overall--so issuing this one means one fewer to use later on. And, as the standard applied to Mann shows, it will be hard to seat committees without using at least some of those precious waivers--especially for specialty products.


David, Health Blogger said...

An interesting look into the behind the scenes activity around Belatacept.

Have been going through research related to it and found this an informative read.


AmateurRealEstate said...

Did I understand this correctly, that the FDA asked for opinion from 10 nephrologists and all 10 could not or did not offer opinion?