Re: I contacted the FDA/CDER about mifepristone...

[Guest guest]

> Carla:

> Do you have any further comments resulting from Ann's investigation

> > and subsequent analysis regarding a physician's ability to

prescribe > > mifepristone in the treatment of uterine fibroids?

The FDA letter Ann received was, I believe, a semi-form letter sent

out by mistake. Given the current FDA oversight and legal agreements

in place for the distributive control of mifepristone in the U.S.,

there is absolutely no way on earth any physician could prescribe this

drug for uterine fibroids or any other medical issue beyond abortion.

Further, the FDA tracking requirements on the distribution of

mifepristone, call for the distributor (Danco), pharmacy, physician,

and patient to all read/sign a very specific agreement prior to

distribution/use of mifepristone. It is a HIGHLY controlled

process/substance and the legal documents currently even require a

patient signature on an FDA created informed consent document

identifying the FDA approved abortificant dose, her specific pregnancy

condition, etc.

Further, the FDA documents (all of which can be read on their website)

do NOT allow for the dosing to be altered in any way, shape or form.

This de facto dosing requirement prohibits completely the off-label

use of mifepristone.

Ann's posting of that letter was meant to be " held " until we could

obtain clarification from the FDA as to why they sent it out, given

their draconian restrictions on this drug. Sorry Ann -- but I wanted

some answers prior to seeing it posted because I knew the group would

have some questions about it.

After speaking to the FDA today, it seems that it was indeed sent out

by mistake by someone unfamiliar with all of the legal hoops attached

to prescriptive use of mifepristone. I hope to learn more by tomorrow

that explains the circumstances more fully.

In the meanwhile, I have put in a plea for the FDA to consider

developing a distribution agreement with Danco that would allow

off-label use of this drug through specific compounding pharmacies

that would limit dosing to 5 mg/day. We know the drug has been

successful in clinical trials for depression, fibroids, and

meningiomas at that dose but it seems ridiculous to me that an FDA

approved drug would not be available for off-label use in this manner

for these health issues. I do believe the Feminist Majority

Foundation has made similar pleas, to no avail. Hence, their

compassionate use program.

I'm sorry this news isn't better news....

Carla