Stuart M. Gerson, Member of the Firm in the Litigation and Health Care & Life Sciences practices, in the firm’s Washington, DC, and New York offices, was quoted in MedTech Dive, in “FDA’s Lab Developed Test Rule Could Be First Check on Agency’s Power Post-Chevron,” by Susan Kelly and Elise Reuter.
Following is an excerpt:
The recent landmark U.S. Supreme Court decision to overturn the Chevron doctrine could open the door to more challenges of Food and Drug Administration regulations, including the agency’s controversial rule on lab developed tests.
In late June, the Supreme Court voted 6-3 to overturn the decades-old Chevron deference principle, meaning that courts no longer must defer to a federal agency’s interpretation of ambiguous statutes passed by Congress. The cases, Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce, were about monitoring requirements for fisheries, but they could have sweeping effects for all federal agencies. …
FDA may face more litigation post-Chevron
While attorneys expect the FDA to field more challenges in light of the recent Supreme Court rulings, the agency’s authority around product approvals, clearances and recalls is likely to remain intact.
Stuart Gerson, former acting U.S. Attorney General, expects “a lot more cases” between the two decisions. Gerson also expects more “forum shopping” across courts, when specific jurisdictions are targeted to get a favorable ruling.
“We’re moving into a period of uncertainty,” he said. “There are going to be more disputes because there’s … an enhanced way to bring them.”
However, not every challenge to FDA policy is likely to succeed. Courts will rely on agency and private party experts on technical questions, and agencies are more likely to get deference when they hold a consistent position over time, said Gerson.
