Today’s somewhat unusual guest post is by Reed Smith‘s Matt Loughran. It concern’s the Supreme Court’s 6-3 decision to permit the government to continue enforcement of its requirement that healthcare workers (at least those in facilities that accept Medicare/Medicaid, which is most of them) be vaccinated to avoid infecting themselves and their patients
Administrative Law
FDA Cigar/Pipe Warnings Go Up in Smoke
A Few More Words on the D.C. Cir.’s Dumping of the Drug Price Disclosure Rule
Administrative law is having a moment. Next year is the 75th anniversary of the Administrative Procedure Act (“APA”). We have mixed feelings about attending the party. The games will be saddled with unclear and unevenly applied rules. Instead of goody bags, we will be forced to disgorge treasure on the way out. But if there…
Recent Executive Orders Clamp Down on Agency Guidances
We seem to be having an administrative law moment at the DDL blog. That subject matter area is seldom sexy. It can be, frankly, quite dry. But administrative law can have a huge impact on drug and device law. Yesterday, Bexis discussed cases holding that agency rules that did not undergo required notice and comment…
Will Agency Deference Ruling Affect Preemption?
We might not have even read the Supreme Court’s recent – and long and convoluted − agency deference decision, Kisor v. Wilkie, ___ S. Ct. ___, 2019 WL 2605554 (U.S. June 26, 2019), except that it tripped several of our automatic searches by citing both Riegel v. Medtronic, Inc., 552 U.S. 312 (2008),…
More Confirming Than Surprising − CMS DTC Drug Pricing Diktat Fails in Court
We’ll get right to the point. In Merck & Co. v. United States Department of HHS, ___ F. Supp.3d ___, 2019 WL 2931591 (D.D.C. July 8, 2019), the court held that the direct-to-consumer pricing regulation proposed by the Centers for Medicare & Medicaid Services (“CMS”) – on which we’ve commented here, and here…