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Can I Use The FDA's Expanded Access Program To Obtain An RX?

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Posted on Tue, 4 Mar 2014
Question: I'm inquiring on behalf of my 24 year old daughter but am filling out the questions for me. The diabetic pump is used to infuse insulin to diabetics. That same pump is being used successfully in England (see Professor XXXXXXX Hindmarsh of Great Ormond Street Hospital for Children in the UK) & other parts of the world to infuse cortisol consistently (more closely matching the natural body rhythms) to CAH patients who are adrenal insufficient. 1) Do you know if I can use the FDA's Expanded Access Program to obtain an RX for the pump and supplies, including liquid solo-cortef. 2) Would you be willing to write the RX for this off label use to not only improve quality of life, but also eliminate unnecessary ER visits and reduce unnecessary and costly specialists and very painful unnecessary testing?
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Answered by Dr. Shehzad Topiwala (1 hour later)
Brief Answer: Difficult Detailed Answer: I am sorry to note the cumbersome issues you have to deal with. I will not be able to prescribe this though. I dont know any endocrinologist who will either. These are experimental therapies. Your best chance is to contact top academic centers like Joslin clinic, Mayo clinic, Johns XXXXXXX Mass Gen hospital and the like, to see if any of their endocrinologists will consider this proposal. I have seen the attached medication list. I am aware of products under development that aim to replicate the body's natural production of cortisol. Hopefully someday simpler regimens not very different from the body's way of making cortisol will become commercially available.
Note: For further follow-up, discuss your blood glucose reports with our diabetologist. Click here.
Above answer was peer-reviewed by : Dr. Chakravarthy Mazumdar
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Dr. Shehzad Topiwala

Endocrinologist

Practicing since :2001

Answered : 1663 Questions

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Can I Use The FDA's Expanded Access Program To Obtain An RX?

Brief Answer: Difficult Detailed Answer: I am sorry to note the cumbersome issues you have to deal with. I will not be able to prescribe this though. I dont know any endocrinologist who will either. These are experimental therapies. Your best chance is to contact top academic centers like Joslin clinic, Mayo clinic, Johns XXXXXXX Mass Gen hospital and the like, to see if any of their endocrinologists will consider this proposal. I have seen the attached medication list. I am aware of products under development that aim to replicate the body's natural production of cortisol. Hopefully someday simpler regimens not very different from the body's way of making cortisol will become commercially available.