U.S. Federal District Court Judge for the District of Columbia, Rudolph Contreras, ruled Wednesday, October 14, 2015 that manufacturers need not offer 340B discounts for orphan drugs sold to a specified group of covered entities (CEs), regardless of how the orphan drug is used. To make a very long story short, in 2010, the Patient Protection … Continue Reading
Covered entities should be constantly preparing for audit. That was the message, loud and clear, from Office of Pharmacy Affairs Director, Cmdr. Krista Pedly, who spoke by webcast at the recent Winter Conference of the 340B Coalition in San Francisco. That preparation, she said, should include making use of the compliance tools available through Apexus … Continue Reading
HRSA/OPA announced the withdrawal of the so-called mega rule last November. This major piece of legislative rulemaking had been over four years in the works. The rule had spent the past six months at the Office of Management and Budget, the last step prior to publication. The DC District Court ruling in Pharmaceutical Research and … Continue Reading
