Challenge

Patients in the US suffering from a particularly rare and debilitating metabolic disease have no approved treatment options available to them. To help support these patients, a US physician had, at one time, managed a treatment IND which allowed access to a non-FDA approved product. However, this physician could not maintain the program and it was terminated. Patients were left with nothing and were desperate to find a way of maintaining access to this much-need drug. Because the patients themselves did not know how to get the drug into the US, an advocacy group representing their interests reached out to WEP Clinical to request assistance.

Solution

WEP Clinical looked into this product and found that is an approved food product, readily available without prescription in the EU. WEP Clinical first reached out to the manufacturer to see if they would be willing to work together to provide an access program for US patients. However, this was not a viable option for the company. As such, WEP Clinical then looked into the possibility of setting up our own independent program through which we would source the drug from local wholesalers and import it into the US on a personal use importation basis. We worked with the treating physicians to validate individual patients and complete the necessary importation paperwork on their behalves. We then utilized our partnerships with trusted distribution and courier partners to deliver the product to the US, clear it through customs, and transport it on to the end users.