Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in InsideHealthPolicy, in “Thompson: Problematic Guidance Patterns Remain At FDA,” by Jessica Karins. (Read the full version – subscription required.)
Following is an excerpt:
In response to a new FDA report on how the agency develops and issues guidance, a key advocate for good guidance practices said FDA is continuing to make progress, but has neglected some important areas and made little progress on changing a pattern of allowing guidance documents to remain in draft form for years or decades. ...
But Bradley Merrill Thompson, an attorney at the law firm Epstein Becker Green who has been a longtime advocate for good guidance practices and played a major role in pressing for FDA to adopt them for the first time in the 1990s, is skeptical.
Thompson said FDA’s different centers vary in how much they have improved on finalizing or withdrawing longtime draft documents, but there are still a substantial number of guidances that have remained in draft form for 20 years or more, with the older draft guidance being 30 years old.
“We’re talking literally decades that some of these things are staying in draft form, and that’s a problem,” he said. “So, I appreciate that FDA maybe understands it’s a problem, but I’m not really seeing . . . that their fixes have much effect yet.”