In our day job, we generally rely on final decisions of FDA about things like drug approvals, device clearances, and rules and guidances.  We also rely on the general integrity of the FDA’s processes.  Even when there are things we do not like on the merits, like observations in form 483s or warnings letters—each is not a final determination of anything according to FDA—we often look to the process itself, which can include a number of steps after the offending statement or action is final.

We also find ourselves calling to the Congressional charge of FDA to protect public health and its various powers of enforcement as counters to the plaintiff charges that FDA’s actions or actions do not amount to condoning our client’s conduct.  Even when we read reports like IOM’s panning aspects of FDA, we still find ourselves looking at the process for the product in our case, with (we hope) thorough evaluation of evidence, layers of review, and consistency in reasoning.

The underlying facts in Ivy Sports Medicine, LLC v. Sebelius, No. 11-cv-1006 (RLW), 2013 U.S. Dist. LEXIS 51763 (D.D.C. April 10, 2013), test even our somewhat slanted view of things.  The case came up on dueling summary judgment motions on an Administrative Procedures Act (APA) review of an FDA decision on a medical device.  We have posted on cases in a similar posture before and noted the tension we, as a drug and device products defense lawyers, feel when FDA screws up.  In Ivy, the court is asked to decide whether FDA has inherent authority to correct what it considered a massive screw-up and whether it behaved rationally—as opposed to arbitrarily and capriciously—in its correction.  In other words, as a big-boned Colorado kid would demand respect for his authority in any situation, is FDA’s inherent authority to be respected when it takes unusual steps to correct a prior abuse of its authority?Continue Reading Respecting FDA’s (Inherent) Authority