FDA's $50,000 Mystery Question

by Mark S. Senak
Eye On FDA



A lot of the commentary about the recently proposed changes to the FDA's Advisory Committee rules for participation centered on the mysterious limit of $50,000 applied to the interests of members in industry. Where did that figure, many have asked, come from?

"FDA would tighten its policy for considering eligibility for participation. 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. If the financial interests are $50,000 or less, after applying certain exemptions, the individual might be recommended to participate as a non-voting member. Only individuals with no potential conflicts would be eligible to fully participate in meetings as voting members."

I often look to compare how the European Medicines Agency (EMEA) is doing vis a vis the FDA. And because my social life is what it is, I was doing just that over the weekend.

There was a time when the EMEA was far less transparent than the FDA. Committee memberships were not known - not much was known about the backgrounds of members - transcripts of meetings were not posted, etc.

But now the EMEA does post committee makeup. It also provides a profile, albeit far briefer than the sometimes heady 100 page resumes posted by FDA of its advisory committee members. And then, most importantly, there is also posted with each member's profile a "Public Declaration of Interests and Confidentiality Undertaking of EMEA Scientific Committee Members and Experts" - which not only reveals the investment interests of members, but also the European propensity for bureaucratic titles and labels...

In the U.S., however, in order to obtain comparable Conflict of Interest information (note the shorter title) before each advisory committee the Executive Secretary summarizes the information before each meeting. It is then stated that if you want further information, you have to file a Freedom of Information Act request, which of course, is not likely for most of us.

And now, at last, to the mystery solved - the monetary cutoff for participation in the European Union is, you guessed it - 50,000 Euros.

For those who have been weeping and gnashing teeth that this cutoff is too low (and there have been many) and that if the FDA goes through with this limit, the result will be a substantial dilution of the membership of FDA Advisory committees - it is noteworthy that this has apparently not been the experience in Europe.

If you are interested in viewing the European profile of conflict of interest in Europe, here is a link to the Committee for Medicinal Products for Human Use at the EMEA. By each member's name, you will see two little icons named P and one named D. P is the Profile, D is the Declaration that reveals the financial interests information with the unbearably long title.

I'm happy I could shed a little light on the $50,000 question.


Source: EyeOnFDA.com



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