FDA's New Conflict-of-Interest Proposal - the good, the bad, & the ugly

March 26, 2007

Thursday, March 22, 2007

Breaking down FDA's New Conflict-of-Interest Proposal

In today's New York Times, there appears _a story_ (http://www.nytimes.c

om/2007/03/22/washington/22fda.html?_r=1 & hp= & adxnnl=1 & oref=slogin & adxnnlx=117456\

986

6-VImTNea8RdayY+M+sUWEkw) by reporter Gardiner Harris about _FDA's new

reduce conflicts of interest on agency advisory boards. (Note: The story refers

to the proposal as " rules " but it is actually " draft guidance " which, unlike

rules/regulations, does not carry the force of law.)

The guidance is a response to an increasing problem at FDA: Scientists

determining the public safety of drugs and medical devices often have financial

ties to the products or industry on which they are commenting. There are pros

and cons to the draft guidance.

The good:

* Most advisors having obvious financial conflicts of interest of more

than $50,000 will not be able to serve on committees.

* Most advisors with less significant conflicts of interest will be

able to serve but not vote.

* The guidance addresses not just current financial conflicts of

interest, but those that have occurred in the past year.

The bad:

* The guidance is loaded with loopholes, including reserving the right

of the FDA commissioner to grant waivers.

* The guidance only addresses financial conflicts of interest, not

personal or professional. (This is politics! Relationships and egos are

important.)

* This is guidance, not a regulation. Therefore, it " does not operate

to bind FDA or the public. "

The ugly:

* An advisor with a significant financial conflict of interest may

still be able to serve (but not vote) if " the need for the individual's

services

outweigh the potential for a conflict of interest. " Doesn't a big pile of

cash undermine the objectivity of an " expert? " Shouldn't pharmaceutical

expertise funded by a pharmaceutical company be considered ill-gotten gains?

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