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 Watchers: Gottlieb May Fly Under Trump Deregulatory Radar with Product-Specific Moves,” by Nicholas Florko. (Read the full version – subscription required.)
Following is an excerpt:
Brad Thompson, attorney at Epstein, Becker & Green, agreed with Levinson on FDA’s move toward individual product decisions, rather than industry-wide guidance. “FDA is not issuing guidance. Instead, they’re just approving medical devices or not, and just carrying on the day-to-day business of the agency. In industry, since we don’t have guidance to learn from, we’re learning from individual decisions we individually receive...Right now the only way companies are learning are by making submissions and then learning individually one by one in a very private way where the rest of industry is not privy to the discussion. So a whole bunch of people are each individually feeling their way around the elephant, and learning only whatever they themselves touch. Not a very good system for communicating to the industry, and leads to incredible inefficiencies and waste,” Thompson told IHP. …
Another key regulatory reform hurdle facing the agency is how to communicate with stakeholders under the good guidance practice framework, according Thompson. Thompson cautioned that good guidance practices cover more than just guidance documents. “With regard to the good guidance practices, it’s important to understand that the good guidance practices embrace more than just the narrow issue of proposing and then finalizing guidance documents. It really deals with the whole way in which FDA develops policy and solicits public involvement,” Thompson, whose advocacy resulted in the creation of the agency’s good guidance practices, told IHP. “I do think this is an area that will require some real attention by the commissioner. It has been a huge frustration,” Thompson added.
