Megan Robertson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in BioWorld, in “Loper Bright No Free Pass Where FDA’s LDT Rule Is Concerned,” by Mark McCarty. (Read the full version – subscription required.)
Following is an excerpt:
The FDA’s final rule for lab-developed tests (LDTs) is in litigation, and a district court decision may be shortly in the works. The outcome may be altered by the Supreme Court decision in Loper Bright Enterprises v. Raimondo — a decision that overturned the Chevron doctrine requiring courts to defer to agency interpretations of ambiguous laws. …
Regulatory adventurism not dead …
Megan Robertson, of Epstein Becker & Green PC, mused that as is the case for entities in the private sector, the FDA can help itself by documenting everything it is doing. Presumably the agency routinely documents all its activities, but such documentation will be increasingly important in an era in which legal challenges seem certain to become more commonplace, she said.
