For the first time, Senator Grassley has turned his scrutiny of the 340B Drug Pricing Program to pharmaceutical manufacturers.
As we previously wrote, Senator Grassley has been among the most vocal of critics in...more
Adhering to the axiom that the best defense is a good offense, SNHPA (Safety Net Hospitals for Pharmaceutical Access), an organization of close to 1000 hospitals participating in the 340B Drug Pricing Program, is attempting...more
In a March 2013 article, I wrote about members of Congress calling for increased oversight of the 340B drug discount program and, in particular, hospital use of 340B drugs. This week, Senator Charles Grassley of Iowa...more
Things are drastically changing for covered entities under the 340B program. In the last 18 months several factors have led the Health Resources and Services Administration (HRSA) to ramp up its oversight and auditing of...more
After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug...more