March 31, 2014—The Health Resources and Services Administration alerted 340B stakeholders by email this morning that on March 27 it posted a new version of its orphan drug designation list governing the second quarter of 2014 in order to address a problem in the version it posted on March 3.[ms-protect-content id=”2799″]
According to the email message, drug manufacturers and those hospitals affected by the orphan drug exclusion (those registered in 340B as critical access hospitals, free-standing cancer hospitals, sole community hospitals, and rural referral centers) should disregard the March 3 version and use the March 27 replacement instead. The correct version is available on OPA’s orphan drug exclusion webpage as a spreadsheet and as a PDF. HRSA explained that “the previously posted orphan drug designation list incorrectly contained drugs that have been withdrawn as orphan designated.”
Under HRSA’s July 2013 340B orphan drug exclusion regulation, hospitals must ensure that any orphan drugs purchased through 340B are not used for the rare condition or disease for which the drugs received their orphan designation. They may, however, purchase orphan drugs through 340B when the drugs are used for non-orphan indications.
For recordkeeping and tracking purposes, HRSA posts the Food and Drug Administration’s orphan drug list on the first day of the month before the end of the quarter to govern the next quarter’s purchases. March 3 was the first workday this month.
A federal district judge could rule soon in the drug industry’s lawsuit over the regulation. Pharmaceutical Research and Manufacturers of America has asked the court to decide whether HRSA had authority to issue the regulation, and if it did, whether it correctly interpreted the passage in the Affordable Care Act (ACA) that created the 340B orphan drug exclusion.[/ms-protect-content]