Court deals setback to hospital 340B drug discounts
The pharmaceutical industry scored another victory Friday in its battle to limit access to lower-priced drugs through HHS' 340B drug discount program. A U.S. district court judge ruled rural and cancer hospitals participating in 340B program could not buy high-priced orphan drugs at discounted prices if the drugs were being used off-label, according to Drug Discount Monitor, the newsletter of the Safety Net Hospitals for Pharmaceutical Access. A rule issued by HHS in 2013 said providers had to pay the higher prices—which can range up to $300,000 a year for rare-disease drugs—when treating patients who had those diseases, but not when used off-label for more common conditions. Drug company clinical research conducted after a drug receives orphan designation from the Food and Drug Administration sometimes shows it has much wider application than its original indication.