Generic Desferal Shortage Looming in U.S.
February 8, 2018 – As some of you have already heard, there is a shortage of the generic form of Desferal (commonly referred to as deferoxamine mesylate) in the United States. Cooley’s Anemia Foundation has been following this situation as it has developed and has been in touch with all of the major players. To summarize the situation, Pfizer Injectables, which supplies the majority of deferoxamine mesylate in the United States, will not be shipping any new deferoxamine until March, 2019 at the earliest and that it will not be back to supplying the full amount I has typically supplied until June, 2019 at the earliest.
Fresenius Kabi, which also manufactures deferoxamine mesylate for the U.S., is aware of the situation and is making as much of the drug available as it can; however, it will not be able to produce enough to cover the shortfall caused by Pfizer Injectables’ absence. Novartis is continuing to produce the brand name version (Desferal) and also knows of the shortage; again, however, Novartis is not going to be able to overcome the shortfall either.
We do know of at least one other company which has had plans for some time to produce deferoxamine mesylate for sale in the U.S., and this will help to alleviate the shortage; however, we do not have a definite timeline of when this source will be able to launch in the United States.
CAF has been in touch with the US Food and Drug Administration, which is well aware of the shortage and has been working with manufacturers to try to help alleviate the situation.
US thalassemia patients who use generic deferoxamine mesylate should be aware that this shortage is likely to affect them and may do so for many months. We encourage you to talk with your hematologist and/or nurse about chelating options you may want to consider until the shortage issue has been resolved.
In our conversation with the FDA, we mentioned that some patients may try to find an overseas source to supply deferoxamine mesylate. (Because this means that the drug would not have passed through FDA evaluation, CAF does NOT recommend this option; any patient considering this should do so only after consultation with their hematologist.) However, for patients investigating this option, the FDA informed us about a policy for patients who may have identified product that they would like to use from an overseas source, making the decision to use that source in conjunction with their physician. That information follows below.
CAF will continue to monitor the situation and update patients of any developments we learn about.
FDA’s Personal Importation Policy:
There is a policy called FDA’s personal importation policy where a patient is importing less than a 3 month supply of a medically necessary drug and here is how that works:
FDA does not object to individuals importing small shipments of medical drugs that are treatments not otherwise available in the US for their own use. As such, the importation of the drug would be allowable for personal use and in a quantity commensurate with personal use (generally not more than 3 month supply).
At the time of importation, if the package is stopped by FDA , the patient is provided notice that the product is stopped and contact information within FDA. The patient should be prepared to provide an affirmation that the product is for personal use, the drug is in shortage, and that the patient will be taking the medication under the care of a physician. This can be done in a short letter, there is no official form or format for this. The patient may even be able to have the pharmacy or company they are importing from include their letter and a prescription for the patient signed by a physician in the package they ship.