With a 215 to 144 vote, the U.S. House of Representatives passed the Food Safety Modernization Act, with only minor changes to the Senate’s version of the bill. With President Obama expected to sign off, the Act will soon become law. The chief purpose of the Act is to vest…
Allergan recently brought an injunctive action against the FDA asserting the unconstitutionality of several of its provisions regulating off-label promotion. Advancing their First Amendment argument, Allergan employs many of the same arguments put forth in Caronia (for more information on this topic, see here). However, a primary difference distinguishing Allergan…
First Amendment challenges to the FDA’s off-label promotion ban are hardly novel, however case law in this area remains relatively unsettled. Drug makers initially rejoiced with the ruling in Washington Legal Foundation, however the case was later vacated. Case law now appears to be more settled in the wake of…
In the wake of a large settlement (for more, see here), GlaxoSmithKline attorney Lauren Stevens was indicted for obstruction and making false statements to the FDA. Allegedly, the attorney withheld incriminating documents and made misrepresentations in letters sent to the FDA. In addition to actions related to poor manufacturing, charges…