|
News & Analysis | REG•WATCH Blog | Press Room
Thursday, March 22, 2007
Breaking down FDA's New Conflict-of-Interest Proposal
In today's New York Times, there appears a story by reporter Gardiner Harris about FDA's new guidance intending to 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 (Note: The story refers to the proposal as "rules" but it is actually "draft guidance" which, unlike rules/regulations, does not carry the force of law.)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 There are pros and cons to the draft guidance.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?
Stay tuned to Reg•Watch for more on this.
Posted by Matt Madia
|