June 7, 2013—Bayer HealthCare Pharmaceuticals is limiting distribution of its new intrauterine device (IUD) Skyla due to high demand and productions delays, the Office of Pharmacy Affairs (OPA) has announced.
Under OPA policy, drug manufacturers can develop a limited allocation plan for 340B covered outpatient drugs when supply is inadequate to meet demand, so long as they demonstrate that 340B providers are treated the same as non-340B providers.[ms-protect-content id=”2799″] 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.”
Skyla received Food and Drug Administration approval on Jan. 9 and came on the market on Feb. 11. In a statement posted on the OPA home page, Bayer said demand has been “much greater” than anticipated at the same that there have been unspecified productions problems.
Beginning with orders placed on and after May 20, all purchasers are being limited to three units per month, with orders filled on a first-come, first-served basis until a customer reaches its limit. “A customer’s 340B participation status and the price a customer pays for Skyla will not affect its monthly allotment,” the notice states.
Bayer said customers with questions should call 1-888-842-2937.[/ms-protect-content]