Category: Government Pricing

PhRMA Sues to Enjoin HRSA Implementation of Controversial 340B Program Orphan Drug Rule

On September 27, 2013, the Pharmaceutical Research and Manufacturers of America (PhRMA), a major drug industry trade organization filed suit in the U.S. District Court for the District of Columbia to enjoin the Health Resources and Services Administration (HRSA) from implementing its July 23, 2013 final rule on “exclusion of Orphan […]

HRSA Finalizes 340B Drug Discount Program Orphan Drug Rule – 340B Discounts Available to New Covered Entities for Non-Orphan Indications

On June 22, 2013, the Health Resources and Services Administration (“HRSA”) released its final rule on the exclusion of orphan drugs for certain covered entities under the 340B Drug Discount Program.  The advance copy is currently available for viewing at the Office of the Federal Register Public Inspection Desk, and […]