Loper Bright Affecting Regulation of Synthetic Biology: Column
A Clinical Trial Vanguard online column says the Supreme Court’s decision in Loper Bright, which ended courts’ deference to federal agency interpretations under the earlier Chevron decision, is affecting the way that FDA attempts to regulate synthetic biology, “a field that routinely produces organisms, materials, and therapeutics that no statute from 1938 or 1997 anticipated. The column identifies three signals of “deference erosion and the downstream collapse of FDA’s ability to extend its existing frameworks to cover technologies that outpace the statutory text those frameworks were built on.”
The first signal, it says, is the Loper Bright decision itself that said courts must exercise independent judgment when interpreting ambiguous laws, rather than granting deference to an agency’s expertise in deciding what Congress meant. The author says FDA has long governed categories of products through broad readings of terms like “drug,” “medical device,” and “biologic.” It says synthetic biology generates the kind of product that strains statutory categories.
The second signal the column cites involves the lack of FDA guidance on what constitutes an adequate and well-controlled study for a living therapeutic whose mechanism of action changes dynamically within the patient. “FDA’s existing framework, including the real-world evidence guidance and the adaptive trial design guidance finalized in 2019, was written for a product universe that synthetic biology has already left behind,” it says. “Under Chevron, FDA could have extended those frameworks through interpretive guidance and expected courts to defer. Under Loper Bright, any sponsor who structures a trial around a novel FDA interpretation of an existing evidence framework is building on ground that a court can now reject entirely, with no deference owed to the agency’s reading.”
The third signal described in the post as potentially the most consequential is FDA’s deteriorating budget environment, given the need to build new statutory text-grounded frameworks for product categories that have no legislative home.
The column suggests that in 12 to 18 months, the first major judicial challenge to an FDA synthetic biology product designation will reach a federal circuit court exercising post-Loper Bright independent review. “When it does,” it continues, “the trial program sitting underneath that designation, with its IND, its enrolled patients, its endpoint framework, its real-world evidence strategy, will face a disruption that no protocol amendment can cure. The sponsors who will survive that moment are the ones who stopped treating FDA guidance as a legal foundation and started building directly on statutory text. The ones who did not will discover, at the worst possible time, that the framework they built their clinical program on was borrowed authority, and it has expired.”