By Stuart Gordon and Karin Rives
Santa Clara County’s dogged challenge of drug manufacturers’ 340B drug pricing data has taken a new turn. A federal appeals court decided Feb. 4 to review its earlier decision to limit the county’s probe of the closely held pricing components, a move sure to worry drug makers protective of such data.
If the appeals court reconsiders its earlier decision and opens up discovery, the County of Santa Clara v. Astra USA case could offer an unprecedented expose of how manufacturers calculate and determine their prices under the 340B drug discount program – a topic of keen interest to safety-net providers that use the program to procure drugs for uninsured and underinsured patients.
The appeal’s court decision follows a November 2008 ruling in which U.S. District Court Judge William Alsup said that while he was inclined to permit the discovery, he was prohibited from doing so because of the previous decision by the appeals court to limit such a probe. The county then returned to the appeals court to ask for a review, which was granted.
Santa Clara County has accused AstraZeneca and nine other drug companies of overcharging its 340B pharmacies. The county is also seeking permission to grant all 340B facilities in California class-action status.
The case is being watched closely by 340B providers that suspect they are overpaying for drugs, and by manufacturers, which are protective of their internal pricing data for proprietary and compliance reasons.