Bradley Merrill Thompson Quoted in “Republican Senators Press FDA on Use of Draft Guidances”

Bloomberg BNA Pharmaceutical Law & Industry Report

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 Bloomberg BNA Pharmaceutical Law & Industry Report, in “Republican Senators Press FDA on Use of Draft Guidances,” by Michael Williamson.

Following is an excerpt:

As for enforcement issues surrounding the agency treating draft guidances as final documents, Thompson told Bloomberg BNA “it would be the height of insanity to expect FDA to do anything other than what a draft guidance says, because the essence of writing a guidance as to codify what FDA thinks today about how a given statute and regulations should be interpreted.”

Thompson said that when there's no final document, “all they have is their current interpretation and that happens to be found in draft guidance. Of course, the longer draft guidance stays draft, it's possible that the FDA's thinking will evolve, which in some ways is even worse because industry assumes the draft guidance is still current when in fact it's not.”