FDA May be OK Under Loper Bright: Article

While many health policy experts have expressed concerns that FDA will suffer under the Supreme Court’s Loper Bright decision because judges will be interpreting scientific and health-related terms rather than deferring to FDA’s judgment, University of Missouri law professor Erika Lietzan thinks Loper Bright “may not be nearly as devastating” for the agency as many scholars fear. Lietzan’s analysis is highlighted in The Regulatory Review, a publication of the University of Pennsylvania program on regulation.

Lietzan points out that during the 40 years that the so-called Chevron framework was in force, roughly half of the challenges to FDA’s statutory interpretations were resolved at step one of the analysis when it was determined that the statute was clear. She says that FDA lost many of those cases and that under Loper Bright, the agency will continue to lose many of the cases it would have lost under Chevron.

Conversely, she says, FDA won most of the cases that reached step two of the Chevron analysis when courts deferred to the agency’s statutory interpretation. Under Loper Bright, Lietzan writes, FDA may continue to win cases that it would have won under step two of the Chevron analysis. She suggests that if FDA’s interpretation is the best reading of a law, courts will arrive at the same result as FDA.

FDA may also continue to win cases under Loper Bright, Lietzan says, because courts will continue to give careful consideration to agencies’ expertise, even though they no longer have to defer to that expertise. She explains that Congress authorizes FDA to use its discretion in various matters, such as approving marketing applications, and courts must review those decisions deferentially so long as the agency is engaged in reasoned decision-making. If courts apply that deferential review to the agency’s many discretionary acts, Lietzan concludes, Loper Bright “may not be as earth-shattering as it sounds.”