James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Law360 Healthcare Authority, in “Will Trump Admin. ‘Wash Its Hands’ of FDA Lab-Test Rule?” by Mark Payne. (Read the full version – subscription required.)
Following is an excerpt:
A federal court decision that laboratory-developed tests fall outside the U.S. Food and Drug Administration's oversight puts the Trump administration at a juncture where it will have to decide how — or whether — to argue for expanded agency authority. …
James A. Boiani, a member of Epstein Becker Green, said that while current FDA officials might seek to retain some of the agency's authority under the now-vacated rule, it's unlikely the administration will want to test it at the appellate level.
While the district court holding is only narrowly tailored to lab-developed tests and doesn't touch on other regulatory regimes, that could change in the circuit court or even at the U.S. Supreme Court.
"The more you appeal, the more possibilities that a higher-level court could throw in something else that disrupts other regulatory issues," he said.
