A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common.
The first deals with a recent Supreme Court decision that doesn’t even have anything to do (directly) with the FDA. In Perez v. Mortgage Bankers Ass’n, No. 13-1041, slip op. (U.S. March 9 2015), the Court overturned a D.C. Circuit gloss on the Administrative Procedures Act that purported to require administrative agencies generally (which is where the FDA comes in) to go through notice and comment rulemaking whenever they flip-flop on what is a mere “interpretive” rule. The Court shot that down, giving a significant win to the government. Slip op. at 9 (“In the end, Congress decided to adopt standards that permit agencies to promulgate freely such rules − whether or not they are consistent with earlier interpretations.”).
In the short term, that means that the FDA can change its interpretive rules – those that, like Guidance Documents, do not purport to have force of law – essentially when and how it likes (not exactly, but close enough for non-government work).