May 23, 2013—The manufacturer of the only FDA-approved orphan drug for children with a rare hormone deficiency that causes short stature is limiting purchases due to an imminent halt in production.
The Office of Pharmacy Affairs (OPA) posted the notice by Ipsen Biopharmaceuticals, the maker of the drug Increlex, on its website’s home page on May 22.[ms-protect-content id=”2799″]
“Due to operational problems at our third-party manufacturer, Ipsen has been forced to limit purchases of Increlex,” the notice states. “The remaining product supply will be generally available in accordance with Ipsen’s standard commercial practices and on a first come, first served basis. To prevent hoarding, controls have been implemented to prevent purchases in excess of historical levels. These policies will be applied to all customers equally. Ipsen expects that the supply of Increlex will be completely exhausted in the near future.”
In May 2012, OPA clarified its policy requiring drug manufacturers to treat 340B providers the same as non-340B providers when manufacturers develop alternate allocation systems for drugs in short supply. OPA asks companies to submit their allocation plans for review at least four weeks prior to implementation. If OPA has concerns, it works with the manufacturer “to incorporate mutually agreed upon revisions to the plan prior to posting the plan on the HRSA/OPA website.”
Ipsen said it is working to reinstate normal supplies of Increlex as soon as possible and asked that all questions be directed to (855) 463-5127 or druginfo@medcomsol.com.[/ms-protect-content]