Since the use of EPD was halted in this country by the FDA, I have been asked about the possibility of “personal importation” by a considerable number of patients.  I haven’t paid too much attention to this issue because initially the FDA indicated this would not be a viable option.

Recently, another EPD physician’s patient did a great deal of research into personal importation and advised us that they we told it was indeed legal for patients to order EPD from McEwen Laboratories and have it shipped to them or to qualified EPD physicians to administer it.

I spoke with Pat Holobaugh (Director of Compliance at CBER) and she told me that personal importation of EPD would depend on the discretion of individual US Customs and FDA agents at whatever port of entry EPD might come through.  I told her I needed something concrete to tell all EPD physicians, and she referred me to Ms. Kimberly A. Cressotti, CBER’s resident import expert.  Ms. Cressotti’s official title is the Consumer Safety Officer and she identified herself as the “Import/Export Expert for CBER”.  Ms. Holobaugh told that Ms. Cressotti was conversant with the history of EPD.

When Ms. Cressotti called me back, Patricia Holobaugh was present with her.  I explained that I needed to know the FDA’s position on personal importation, specifically in regards to EPD, so I could advise the other physician members of the AEPDS who participated in the American EPD trial.

Ms. Cressotti advised me that the FDA issued an official (US Customs) Import Alert about EPD (IA #57-15 – 8/11/99, IMPORT ALERT #57-15, “DETENTION WITHOUT PHYSICAL EXAMINATION OF ALLERGENS AND ALLERGEN DELIVERY SYSTEMS (ALLERGY PATCHES), ATTACHMENT REVISED 8/4/00). You can see that alert itself by going to http://www.fda.gov/ora/orasrch.htm.

You then need to search for “McEwen Laboratories” (don’t type the quotes) in left box, and be sure to choose “Import Alerts” from right box.  McEwen’s alert appears to be the attachment.

With the Import Alert, the FDA has officially prohibited entry of EPD into the USA.  (Of course, no shipment that I know of was ever stopped, since it was shipped to the US distributor and to physicians until March of this year – 8 months after the Alert.)

Her clear position was that importation of EPD into the US for personal use is “illegal”, a word she repeated several times.  She further advised me that if EPD were shipped to multiple patients or several physicians, it would “suggest commercial distribution,” which, as I interpreted it, could be a liability for McEwen Laboratories.   She left no room for doubt as to her (and therefore the FDA’s) position.

What you could do to try to make EPD available again
It would seem that interested parties might wish to contact Ms. Cressotti and/or others who have an interest in EPD in or outside the FDA.  (Ms. Cressotti’s contact information appears elsewhere on EPD web sites and on the FDA site.)  You could make them aware how much you depend upon EPD for your well-being.  Now the Import Alert and the FDA’s policy (per Ms. Cressotti) technically make EPD illegal, and it prohibits you from importing EPD for your own use.

If you contact the FDA, congressmen or others for help, it would now appear our most critical objective would be to ask the FDA to remove EPD from the Import Alert list, and specifically ask them to allow patients to import it the same as the FDA allows import of many other non-FDA approved drugs from other countries.

Those of you who know about EPD know its value.  I have personally felt for 10 years that there is no other type of immunotherapy that is superior.  However, the manufacturer is a veritable minnow in a pharmaceutical sea of whales, and an IND to study EPD the way the FDA requires is going to be complicated.  The McEwens are working on getting the IND together as best they can.  Until they do, we can only offer support and try to make EPD lawfully available to patients who need it.  So please, as you all have done in the past, hang in there and do the best you can to help.