Scholar argues that limited judicial deference to agencies may matter less for FDA than health experts fear.
In its recent decision in Loper Bright Enterprises v. Raimondo, the U.S. Supreme Court overruled longstanding precedent and held that courts may no longer defer to agencies’ interpretations of ambiguous statutes. Many health policy experts worry that this shift in administrative law doctrine will undermine the power of public health agencies by allowing judges to interpret scientific and health-related terms.
In a forthcoming article, however, Erika Lietzan argues that the Loper Bright decision “may not be nearly as devastating” for the U.S. Food and Drug Administration (FDA) as many scholars believe it will be.
The U.S. Congress delegates authority to FDA and other federal administrative agencies by statute. Agencies must often decide the meaning of ambiguous statutory provisions. Before Loper Bright, courts assessed agencies’ statutory interpretations according to the two-step framework derived from Chevron v. Natural Resources Defense Council. At step one, courts considered whether the statute was clear. If the statute was clear, the agency and the courts deferred to the statute. If, on the other hand, the statute was “silent or ambiguous” on an issue, courts deferred to an agency’s reasonable interpretation of the statute.
Under Loper Bright, however, courts must determine the “best reading” of an ambiguous statute—not agencies. But Lietzan—a law professor at the University of Missouri School of Law—contends that Loper Bright may not change the outcome of many of FDA’s cases.
During the 40 years that Chevron was the law, roughly half of the challenges to FDA’s statutory interpretations were resolved at step one of the analysis because the statute was clear, Lietzan explains. FDA lost many of these cases. Under Loper Bright, FDA will continue to lose many of the cases it would have lost under Chevron, according to Lietzan.
She reveals that FDA won most of the cases that reached step two of the Chevron analysis—when courts deferred to FDA’s statutory interpretation. Under Loper Bright, FDA may continue to win cases that it would have won under step two of the Chevron analysis, Lietzan contends. If FDA’s interpretation is the best reading of the statute, then courts will arrive at the same result as FDA.
Lietzan also argues that FDA “can be successful without Chevron in play” because FDA won most of its cases before the Court adopted the Chevron doctrine. Lietzan explains that in these older cases, some courts interpreted statutes without deference to FDA’s interpretation and reached the same conclusion as FDA. In doing so, courts often took FDA’s scientific and technical expertise into account without deferring to the agency’s statutory interpretations, Lietzan observes.
FDA may also still win cases under Loper Bright as it did before Chevron because courts will continue to give careful consideration to agencies’ expertise, despite not giving explicit “deference” to agencies’ statutory interpretations, Lietzan contends.
Lietzan observes that Loper Bright drew an important distinction between when an agency interprets a statute and when an agency exercises its policymaking discretion. Lietzan explains that agencies may still use their discretion “whenever Congress has purposely left an issue for the agency to decide”—and courts must respect the agencies’ decisions in these circumstances.
Agencies may have previously framed their discretionary policymaking as statutory interpretation “to take advantage of the Chevron framework,” Lietzan suggests. As a result, the distinction between statutory interpretation and policymaking “was not meaningfully policed” by courts under the Chevron doctrine, Lietzan contends. She explains that this distinction, however, is crucial under Loper Bright because courts are still to be deferential to an agency’s policymaking, even if they are not deferential to an agency’s statutory interpretations.
As an example, Lietzan observes that a statute may contain broadly worded provisions stating that drugs must be “safe and effective.” A court will review FDA’s interpretation of what “safe and effective” means without deference to FDA’s view. But a court will review FDA’s policy decision about whether a specific drug is safe and effective deferentially because Congress allowed FDA “to be the first legal decision maker on the matter,” contends Lietzan. She argues that courts “must get the distinction right.”
Lietzan explains that Congress authorizes FDA to use its discretion in various matters. For instance, Congress authorizes FDA to do so when deciding whether to grant applications to market new drugs, devices, or food additives or perform human testing of drugs. According to Lietzan, courts must review these decisions deferentially so long as “the agency engaged in reasoned decision making.” If courts apply this deferential review to FDA’s many discretionary acts, Loper Bright “may not be as earth shattering as it sounds,” Lietzan concludes.
