Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Politico’s Prescription Pulse newsletter, in “Experts Split on HHS Sunset Rule,” by Zachary Brennan, David Lim, and Gabrielle Wanneh.
Following is an excerpt:
HHS on Wednesday rolled out a proposed rule that would require its agencies, including the FDA, to review all regulations within two years and determine if any can be cut, Zachary writes.
FDA’s workload may be lessened by a review it did in response to Trump’s 2017 executive order requiring agencies to cut two regulations for every new regulation added. But experts are divided on whether the latest policy will have a major effect on the agency’s work or public health. …
FDA regulations “are just high level implementations of statute, and frankly not very useful but also not very frustrating,” said Bradley Merrill Thompson, a medical device attorney at Epstein Becker Green. “All the real meat is in guidance, and at least as I read it, it doesn't appear to me that this initiative extends to guidance.”