Angie got the information from the individual at the FDA. I can’t say that I am tremendously encouraged by the information.
I read it over and visited some of the links. What I take away from is is that the Enforcement Discretion Stephanie refers to is essentially what we already have in place that entitles us to import the 3 month dosages. I am not sure if Angie misunderstood what she said in their phone conversation or what but we are going to contact Stephanie again and get clarification on how what is provided in her information differs from the conversation she had with Angie. Either way, it’s a point of communication that we can possibly utilize to our advantage.
Today Angie spoke to a couple of people. One is Kent Richter, the gentleman in Florida who’s wife is affected by CTX. He was a wealth of information. I’ll try to cover the high points of the conversation.
He said that German pharmacies will not honor a US prescription, you have to see a German doctor to be able to get Chenofalk from a German pharmacy. This derails having the option of making a contact in German to send us the medication.
CDCA is used in the agricultural industry in the US and can be imported in raw form for such applications. Kent has imported a Kilogram of agricultural grade CDCA in the past however he said that this has become increasingly difficult, my guess is because of 9/11.
Kent knows of a Dr. in Boston who recently diagnosed a 10 year old child . We are going to try to get in touch with this Dr. to see if he has any ideas on how we can proceed here.
Also today, Angie spoke to Janet at the ULF. They had a good conversation. She was helpful and provided the name and number of a Jim Bona at the FDA. He is highly regarded as someone who can get something done. I have contacted Janet and will likely become more involved in the ULF in the near future. I encourage all of you who aren’t members to sign up asap.
Lastly, Angie spoke to Jim today and got some good news and some not so good news. First we were glad to know that Jim has 20-30 people in his office ONLY working on this issue, he said he has been living,eating,sleeping, and breathing this issue this week, so know that we have friends at the FDA who are pulling for us.
Now for the not so good news, and I didn’t know this until now. It seems that Ursula Falk, the wife of the founder of the Falk foundation is the one who is behind this whole problem, it’s not the insurance with the pharmacies, it’s that the Falk foundation doesn’t want to deal with the distribution issues anymore. Jim mentioned that Ron Leonardi from Rare Disease is meeting with Ursula this week, maybe even today to discuss this to see if she is willing to cooperate. She
may say no then we are dealing with a much larger issue.
When Angie mentioned the possibility of obtaining agricultural grade CDCA and getting it mixed ourselves Jim highly discouraged it saying that it’s not designated for human consumption and should not be used in this way.
Jim did mention that he is in talks with various universities, several of which have the ability to make and/or mix chemical compounds for research purposes and will let us know the results of those conversations as they bear good information.