In BioWorld MedTech, James C. Shehan, Chair of the firm’s FDA Regulatory practice, discusses the recent rescission of a 2020 U.S. Department of Health and Human Services (HHS) policy that required signoff by the HHS Secretary on any rulemaking by HHS agencies, including the FDA. Shehan says that, even without this additional requirement, the rulemaking process is cumbersome. He states, “I see the status quo continuing. It will continue to take a long time to issue rules.”

Shehan adds: “[D]elegation of authority in administrative agencies has been routinely upheld by the courts. … [G]overnment agencies in general are allowed to delegate these authorities absent an explicit statutory ban on such practices.” (subscription required to access article)