Public Citizen goes on a witch hunt at the FDA

Is it wrong for the chairwoman of an FDA panel to appear at a for-profit industry conference?

Evidently the answer is 'yes' if the conference organizer touts her insights about avoiding pitfalls during a panel presentation. And it's 'hell yes' if you're Sidney Wolfe at Public Citizen, who has made a career out of making a stink about the intersection of Big Pharma money and the industry's experts.

FierceBiotech has covered its share of stories on money scandals and drug development, but this is a tempest in a proverbial tea pot.

First, let's look at the facts, via Reuters, which covers this extensively today.

Dr. Lynn Drake, a lecturer at Harvard Medical School and chairwoman of the FDA's expert panel on skin and eye diseases, was asked to appear at a conference being organized by CBI. (Full disclosure: CBI is an advertiser at Fierce. And we're a for-profit organization that also does paid events.) She says they agreed to cover her expenses and that she considered it within her educational role. She also asked the FDA and got an OK to do it.

Then the conference organizers used her picture (fairly standard, I would say) and a promotional blurb that said attendees would "walk away with strategies to successfully present before a committee and avoid potential roadblocks."

Wolfe's comment to Reuters was that her decision demonstrated poor judgment and "raises concerns that the advisory committee member is approaching the work of the committee from a pro-industry perspective."

Sounding somewhat appalled, the FDA said it seemed clear that Drake had no idea how her image and presentation would be marketed by the conference organizer. Drake dropped out immediately.

Understanding how the panel process works is a key concern in the industry, where a 'no' vote can scuttle years of effort in the clinic. It's quite similar to presenting a case to a panel of judges. Getting insights from the judges on presentation strategies can help regulatory teams do their jobs.

Certainly, if a Big Pharma company with business in front of the panel had paid Drake to attend a conference, or even offered a lavish suite, perhaps, or free tickets to a ball game, then there would be cause for a ruckus. But that didn't happen.

There was no conflict.

None of that stopped Wolfe, though, who's now demanding to see Drake's full résumé in search of more such conflicts of interest. Every government agency can stand to have a watchdog group inspecting every step they take. Trying to cause a flap on an expert panel--where the FDA has a hard enough time finding experts without conflicts willing to sit on the panels--with this poor excuse for a conflict is counterproductive.

If that's the worst thing Public Citizen can find at the FDA, we're much better off than we suspected. -- John Carroll, Editor-in-Chief. Follow me on Twitter and LinkedIn.

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