PhRMA sues HHS over 340B Orphan rule

The Pharmaceutical Research and Manufacturers of America filed suit Friday in the U.S. District Court for the District of Columbia seeking to stop HHS from implementing a July final rule concerning the Orphan drug exclusion under Medicare's 340B program. The final rule excludes Orphan drugs used for an FDA-approved Orphan indication from discounting under 340B, but requires discounts when those drugs are used in non-Orphan indications. The 340B program requires manufacturers to deeply discount outpatient drugs to hospitals and clinics bearing the brunt of providing healthcare to low income and other special populations.

In its complaint, PhRMA argues HHS's interpretation of the law "is at odds with the plain statutory text," which stated the 340B program "shall not include a drug designated by the Secretary under section 526 of the Federal Food, Drug and Cosmetic Act for a rare disease or condition." ...