James Boiani Quoted in “Regulatory Attorney Says Warning Letters Likely to Spike Under New FDA Administration”


James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in BioWorld, in “Regulatory Attorney Says Warning Letters Likely to Spike Under New FDA Administration,” by Mark McCarty.

Following is an excerpt:

U.S. FDA warning letters have been a staple of regulatory life since the late 1990s, but James Boiani, a regulatory attorney with Epstein, Becker & Green P.C., said it’s no stretch of the imagination that warning letter volumes will jump in 2021. This is to some extent because the volume of warning letters dropped significantly over the past four years, and Boiani advised that all FDA-regulated industries will see more warning letters unless they are communicative with the agency about inspectional findings.

The FDA and several other federal agencies were active in the enforcement space early in the COVID-19 pandemic, as demonstrated by a March 2020 statement by the FDA and the Federal Trade Commission about fraudulent products. The enforcement focus at the FDA for 2021 is likely to continue to be on products related to the COVID-19 pandemic, and Boiani predicted that drug compounding issues will return to the fore, at least in terms of manufacturing quality and patient access. Warning letter volumes had dropped by about 90% under the Trump administration, and he said all FDA-regulated industries are “more likely to see FDA 483s elevated to warning letters if companies are not being responsive to requests” about their compliance with good manufacturing practices.

MCIT unlikely to fall under regulatory review

Boiani, who spoke during a Feb. 3 webinar hosted by Medmarc Insurance Group of West Chantilly, Va., said the Biden administration’s Jan. 20 regulatory freeze could affect the Medicare Coverage for Innovative Technologies (MCIT) coverage rule for FDA breakthrough devices. “If you’re in the device space, this is one to watch,” he said, despite that the Biden administration may not see this as a top priority for reconsideration.

The Biden administration is likely to resort to legislation for FDA regulation of lab-developed tests (LDTs), which has been proposed in each of the past two iterations of Congress. The previous administration had issued a rescission order in connection with FDA regulation of LDTs, but Boiani noted that any significant problem with LDTs within the scope of the pandemic would add fuel to the legislative fire for a bill that would enable FDA regulation.