PhRMA Sues Gov't Over Orphan-Drug Discounts

Oct 03, 2013

The Pharmaceutical Research and Manufacturers of America filed suit with the government's Health Resources and Services Administration (HRSA) over a final rule that puts orphan drugs back on the list of products that must be discounted heavily for healthcare providers that participate in the 340B drug discount program.

The rule would allow certain providers to buy orphan drugs at reduced prices if the drugs are used to treat non-orphan conditions or diseases.

In its lawsuit, PhRMA claims that the regulation is "inconsistent with the clear statutory direction" and is outside the scope of HHS' rulemaking authority. Read more