Pressure Builds on FDA to Maintain New COI Rules

In the previous post, I discussed briefly the FDA's apparent desire to retreat from the tough new conflict of interest rules it had earlier announced, particularly, excluding "experts" funded by industry from its advisory committees. Numerous examples have occurred where industry-supported votes made the difference between keeping a dangerous drug on the market and pulling it, for example. But the FDA is now claiming that it simply can't find any real experts who are not in the pay of the industry.

Enter our old friends, journalists Shannon Brownlee and Jeanne Lenzer. Jeanne authored a news item in last week's BMJ (subscription required) highlighting the entry of our other friends, the National Physicians Alliance, into the fray. The main point raised by Brownlee, Lenzer and the NPA is that they had worked hard a little while ago to compile a list of expert physicians who take no industry cash. They were able to come up with a list of over 100 such individuals (full disclosure: I'm on the list, though just what I am an expert in remains to be determined). The NPA and the journalists objected that despite their having been supplied with this list, there's no evidence that anyone at the FDA made any effort to contact any of those physicians. How, then, said the FDA's critics, can anyone claim that these experts are too hard to find?

There is some tentative evidence that the FDA may be backpedalling on their backpedalling, so stay tuned for further exciting adventures.

Lenzer J. Doctors join protest over change to FDA rules on conflicts of interest. BMJ 2011; 343:d5269.