Yesterday I had the privilege to attend and participate in the third annual FDA Regulatory & Compliance Symposium held at Harvard University. (Or as we Martlets call it, "The McGill University of the South.)
My panel focused on federal preemption and DTC advertising issues. The title of my presentation was "FDA: Advancing the Public Health or Being Led by Political Whims." Needless to say, it was hard to limit my remarks to the requisite 45 minutes.
Two of the other panelists were Alex Sugerman-Brozan (of the Prescription Access Litigation Project) and Lauren Guth Barnes of the law firm Hagens Berman Sobol Shapiro. Perhaps the most polite way to put it is that we didn't agree on most issues.
And that's okay. A feisty, robust -- and respectful debate is always worthwhile. And this panel was certainly all of those things.
Of the many differences, I'm sure you can fill in the blanks vis-Ã -vis our divergent views on both federal preemption and DTC issues. But what I found most disturbing was that both Alex and Lauren relied, almost exclusively, on partial research data, one-sided anecdotes, and rather selective legal citations.
Their presentations were as one-sided as they were narrow and they lacked any perspective as to the unintended consequences of (what I viewed as) simplistic alternatives. They spoke of solutions driven by adjudication and legislation -- with nary a nod to science.
(Although we did find some common ground on the need for better and more disease awareness advertising and the banishment of reminder ads.)
But (and here's the good news) while their ideas are wrong -- their hearts are in the right place. I really believe that. I hope that, with more conversation (both face-to-face and otherwise) we can all work to help advance the public health through a strong and better funded FDA.
My panel focused on federal preemption and DTC advertising issues. The title of my presentation was "FDA: Advancing the Public Health or Being Led by Political Whims." Needless to say, it was hard to limit my remarks to the requisite 45 minutes.
Two of the other panelists were Alex Sugerman-Brozan (of the Prescription Access Litigation Project) and Lauren Guth Barnes of the law firm Hagens Berman Sobol Shapiro. Perhaps the most polite way to put it is that we didn't agree on most issues.
And that's okay. A feisty, robust -- and respectful debate is always worthwhile. And this panel was certainly all of those things.
Of the many differences, I'm sure you can fill in the blanks vis-Ã -vis our divergent views on both federal preemption and DTC issues. But what I found most disturbing was that both Alex and Lauren relied, almost exclusively, on partial research data, one-sided anecdotes, and rather selective legal citations.
Their presentations were as one-sided as they were narrow and they lacked any perspective as to the unintended consequences of (what I viewed as) simplistic alternatives. They spoke of solutions driven by adjudication and legislation -- with nary a nod to science.
(Although we did find some common ground on the need for better and more disease awareness advertising and the banishment of reminder ads.)
But (and here's the good news) while their ideas are wrong -- their hearts are in the right place. I really believe that. I hope that, with more conversation (both face-to-face and otherwise) we can all work to help advance the public health through a strong and better funded FDA.
