Dear FDA: $50K Is Still A Lot Of Money
1 CommentBy Ed Silverman // March 21st, 2007 // 3:00 pm
Be honest, now. Is $50,000 a lot of money? Just pocket change for a trip to the store or a cozy dinner for a group of friends this weekend? Or is it substantial? Should someone put such a sum in your wallet, would you remember their name?
Well, under new conflict-of-interest rules, FDA advisory committees will continue to include anyone who takes less than $50,000 in corporate grants, contracts and consulting fees, or holds less than that amount in stock. This would only happen if the FDA decides the need for that person outweighs a potential conflict. And even then, they couldn’t vote.
Still, to the average American, $50,000 pays a lot of bills. Just how did the FDA come up with this figure as a cut off? The agency isn’t saying. Randall Lutter, the FDA’s acting deputy commish for policy, didn’t answer the question during a teleconfence call earlier with the media, including Jeff May of The Star-Ledger of New Jersey, who shared his notes with Pharmalot.
“The purpose there is to strike a balance betwen access to scientific expertise and public confidence in the process,” says Lutter. Huh?
Okay, well, does the FDA know how many committee members might be excluded once the new threshold goes into effect? Not really. Only a “significant fraction,” says Lutter, would be eliminated from voting. But he’s not giving any concrete examples of members who would have been prevented from voting in the past if the new guidelines were in place.
Oh, and Lutter adds that he doesn’t think any past votes were improperly swayed by conflicts. Not clear how he knows that. The old system worked well, he argues, but he concedes more stringent rules allow better “transparency” that will improve public confidence in the process.
So, if it weren’t for all those pesky citizens expressing concern about conflicts, he wouldn’t have had to sit on the phone today answering annoying questions. Talk about transparency. For $50,000 or less, the FDA could have hired a clerk to field those calls.
Hat tip to Mr. May
[tags]Advisory Committees, Conflicts Of Interest, FDA[/tags]
pjcruz
As one who has received gifts or dollars from drug manufactures for “listening to information about their product” in the past, I think $50,000 is too high. The mark should be more like $500 to $1000 dollars annually per manufacturer up to a total of $5000. Only when the figure becomes insignificant to the receiver, will a true assessment of the drug product be done.