Deference No More: More Suits Against U.S. FDA Coming After High Court Tosses Chevron Doctrine?

Jerry Masoudi’s commentary was included in an article in The Pink Sheet which looks at the U.S. Supreme Court’s elimination of the Chevron doctrine and how the decision is expected to invite more legal challenges against the Food and Drug Administration (FDA).

Jerry said the decision “dramatically changes the balance of power between courts and administrative agencies in deciding what Congress means.” “Even though FDA has not relied on Chevron deference regularly in its rulemakings, the agency has engaged in rulemaking knowing that Chevron can serve as backstop even when the agency does not expressly rely on it,” he observed.

Jerry added that on highly technical issues, courts may as a practical matter still defer to the FDA’s views, although such deference is not automatic. “These decisions on the Chevron doctrine will not affect FDA’s case-by-case decisions on scientific issues, like product approvals. But rules underlying these processes may be open to broader challenge.”

Click here to read the full article.