The Gland News about Thyrogen
As many of you may know, the FDA restricted the availability of Thyrogen in May per this decree. This is a big deal for thyroid cancer patients—so many of us rely on Thyrogen for scans and blood work so we don’t have to go off our meds. What does this FDA consent decree mean for us? Can our doctors still order Thyrogen for us? What if we don’t meet the guidelines outlined in the FDA consent decree? Will we have to go off our meds?
I spoke with a representative from the Genzyme Medical Information group on Monday to get answers to these questions. (Genzyme is the manufacturer of Thyrogen.) She was most helpful and I’m happy to report I have answers. All of the answers below are based on the information given to me by the Genzyme employee.
Why did the FDA issue the consent decree in the first place?
The FDA issued this decree because they believed more manufacturing control over Thyrogen was needed. With the consent decree, the FDA is essentially telling Genzyme that the manufacturing processes of Thyrogen are sub-standard and they are therefore restricting its availability until Genzyme corrects these manufacturing issues. Of course, the Genzyme employee did not go into detail with me about how far below standard their manufacturing processes are/were.
When will the consent decree be lifted?
Genzyme is moving the manufacturing of Thyrogen to an offsite location with a contract manufacturer. This should take place by November 30, 2010. At this time, the decree will be lifted.
So is there a shortage of Thyrogen?
No. The Genzyme rep assured me there is absolutely no shortage of Thyrogen.
Based on the guidelines outlined in the consent decree, Thyrogen is not “medically necessary” for me. Does that mean I can’t get Thyrogen?
According to the Genzyme rep, the answer to this question is NO, which is great news for all of us who need Thyrogen but were under the impression that we could not receive it.
OK, so how do I get Thyrogen?
Your physician is the one who will deem you medically necessary for Thyrogen. It’s a clinical decision to be made BY YOUR DOCTOR, not by the FDA. According to Genzyme, there is no extra paperwork required. Your physician will just need to submit the order for Thyrogen as usual.
Do you feel that you need Thyrogen but can’t get it? According to Genzyme, there is no reason why you shouldn’t be able to receive it if your doctor agrees that you need it. Feel free to print this article out to show your doctor. Spread this information to other thyroid cancer patients—you can link to this post OR you have permission to embed this information along with proper citation in your own blog/website.
If you have more questions regarding Thyrogen, you can call the medical information group at Genzyme at the following number: (888) 497-6436, option 2.
Tags: Based on the guidelines outlined in the consent decree, is there a shortage of thyrogen, The gland news about Thyrogen, Thyrogen is not “medically necessary” for me. Does that mean I can’t get Thyrogen? How do I get thyrogen, when will the consent decree be lifted, Why the FDA issue the consent decree in the first place, Written by Joanna Isbill