Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “FDA’s Lame Duck Document Dump Prompts Congressional Scrutiny, Industry Sources Mixed,” by Nicholas Florko. (Read the full version – subscription required.)
Following is an excerpt:
Regardless of the political pressure on FDA to stop work, Brad Thompson, attorney at Epstein, Becker & Green, whose advocacy led to the creation of FDA’s good guidance practices, said the agency did nothing wrong procedurally.
“[T]here’s nothing wrong with FDA moving the freight quickly over the course of the last two months,” Thompson told IHP. “Typically I’m complaining that draft guidance stays in draft for years. Indeed, more specifically, I’ve been complaining that FDA is so driven by user fees that the agency prioritizes whatever is associated with the user fee, and let’s other stuff go like publishing most guidance documents. So the fact that FDA was motivated over the last two months to take a look at a whole bunch of guidance documents that had been sitting there idly is a good thing.”
“We probably should have a change of administration more often,” Thompson added.