‘Is Chevron Deference Dead?’: Ex-FDAer Pitts
Center for Medicine in the Public Interest president Peter Pitts, a former FDA associate commissioner for external affairs, questions whether the “Chevron deference” that favors government agencies in court cases is dead. Writing online at IP Watchdog, Pitts says the Chevron deference is from a 1984 case in which the Supreme Court provided a legal test for determining whether to grant deference to a government agency’s interpretation of a law it administers.
Pitts says the two-part test covers (1) whether Congress has spoken directly to the precise issue in question, and (2) whether the agency’s answer is a permissible construction of the law.
As part of his post, Pitts analyzes the case of Regenative Labs, which manufactures, among other products, Wharton’s Jelly Tissue Allografts, human connective tissue used to repair, replace, or supplement missing, damaged, or non-properly functioning tissue. The product is regulated as a tissue, Pitts writes, and FDA’s job is to ensure that it is manufactured according to the agency’s current good tissue practice guidance.
Pitts discusses the agency’s 3/21/22 inspection at the company’s manufacturing facility in Pensacola, FL, that resulted in the issuance of a form FDA-483. He says the company addressed the inspection observations within about 30 days and on 10/5/22 requested a standard export certificate so it could supply Wharton’s Jelly to foreign clients. “That standard request was denied and here’s where it gets confusing,” Pitts writes.
He notes the company had received an export certificate for its amniotic membrane patches manufactured at the same facility, but the inspection was cited as the reason for denying the Wharton’s Jelly certificate, although it didn’t prevent the issuance of the patch certificate. The FDA decision is an example of its lack of regulatory reproducibility that, he says, costs companies time, money, and agita, and patients access and affordability.
Pitts asks what happens to the Chevron deference when a federal agency seeks legal leverage minus the Supreme Court’s standard of “a permissible construction of the statute?”
He concludes that rather than argue that the deference is an unconstitutional limit on judicial oversight and perpetuates the “administrative state,” everyone could agree that FDA must be a leader in regulatory science and, when seeking the protection of the Chevron deference, the agency’s use of true scientific expertise, rather than simply “being FDA,” should be the standard.