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The FDA vs. HRT
Posted by Dr. Molly Roberts on August 1st, 2008
Has the whole FDA investigation into estriol been a problem in your life or your practice? Here is a letter from Jonathan Wright, MD, who has been advocating on doctors’ and patients’ behalf to retain the right to prescribe this medication for those going through menopause. He is urgently asking for your help to get the FDA to give us the right to prescribe estriol without the red tape they are planning to add to the process. If you feel that this is a worthwhile cause, then please read through his letter, copy and paste the letter at the end, and send it to the FDA. If you are not a doctor but a patient who wants the right to make these decisions without interference from the FDA, then please edit the letter to fit your voice and send it on…(more)
I just heard back from Dr. Wright, and he sends his appreciation for all of you who are making your voices heard. If you are interested in getting involved in retaining your rights to estriol as a form of hormone replacement, then here is another version of a letter you might consider sending to the FDA. Read over both this and the previous letter. Follow your own heart and mind about this, but if you do feel strongly about it, I do encourage you to voice your opinion.
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August X, 2008
The Honorable Andrew C. von Eschenbach, M.D.
Commissioner, Food and Drug Administration
Parklawn Building
5600 Fishers Lane, Rockville, Maryland “20857”
Dear Commissioner von Eschenbach:
I prescribe hormones containing estriol and am very concerned about the Food and Drug Administration’s so-called “abbreviated” Investigational New Drug (IND) application for estriol. This process, along with the FDA’s requirement that doctors use an Investigational Review Board, will create an incredibly burdensome and costly process that, if enforced, will effectively ban most physicians from prescribing a medication we have determined to be best for our patients.
The IND also requires the use of an Institutional Review Board (IRB). The IRB process alone is so onerous that it will undoubtably serve as a deterrent to physicians prescribing estriol for their symptomatic patients.
My foremost concern is for my patients who rely on hormones containing estriol to relieve the symptoms of menopause. Quite frankly, FDA’s new policy threatens their access to this important medication. This could force them off of treatment their doctors have deemed necessary, and would either deny them treatment or subject them to the unnecessary expense and inconvenience of a new treatment regime.
I strongly believe that requiring an IND is unjustified. Millions of women have been prescribed estriol and have used it safely for decades. I do not believe FDA’s concerns and subsequent policy shift are medically justifiable, and your agency has not documented the safety issues that would warrant such an extreme action.
That said, I have concerns with FDA’s IND scheme and am concerned that even in the FDA’s modified form the process is prohibitively complicated, onerous and costly. Form 1571 remains a significant component of the IND process. As a result, I have outlined my primary concerns with the form and with the overall process below.
First, the IND places a significant financial burden on physicians, most notably by requiring us to submit our applications to an Institutional Review Boards (IRB). Submitting necessary documentation and contracting for a private IRB can easily cost between $10,000 and $25,000 and can take months. While this would be prohibitive for almost all doctors, its affect in small towns and rural areas would be especially harsh. I ask the FDA to waive this requirement.
Second, several portions of Form 1571 are inapplicable to physicians prescribing estriol. We understand that FDA is not requiring physicians to complete every line of 1571, but without greater guidance up-front from FDA, physicians will have to devote considerable resources to wade through these applications and requirements, which takes away from the time that we should be spending with patients. If FDA intends to waive elements of Form 1571, it should be more explicit. I ask FDA to clarify which elements are required and which are not so that we can determine whether the abbreviated process is feasible. At this point, it is impossible to tell.
Third, I am concerned that my treatment of patients would be disrupted if I had to wait for 30 days after filing an IND before I could prescribe hormones containing estriol. The FDA should formally waive the 30-day waiting period to ensure that patients can continue to receive uninterrupted treatment.
Fourth, IRB recordkeeping burdens on physicians are enormous. We frankly do not have the time to devote to these requirements, and would have to either hire additional administrative staff or reduce the time we spend treating patients. This only works to increase the cost of health care.
The right of a woman to choose treatments in consultation with her physician is a fundamental right and must be protected. Similarly, we must also preserve the right of physicians to practice medicine and prescribe treatments without unnecessary government interference.
Many physicians have been prescribing estriol to treat women for decades. I am distressed and confused that FDA has taken such a hard line against prescription of this hormone—prescribed safely for decades with no reports of adverse effects—with so little medical justification. FDA has not produced any evidence that estriol poses a danger to patients and, absent that, its restrictions are at best inappropriate and at worst harmful to patients.
It would be most appropriate for FDA to retract this policy altogether. However, if FDA is going to pursue an IND process for estriol, it is imperative that you to address the aforementioned concerns.
Sincerely,
Comment by Dr. Molly Roberts — August 1, 2008 @ 7:40 pm
The FDA vs. HRT…
Bookmarked your post over at Blog Bookmarker.com!…
Trackback by lighthearted — August 20, 2008 @ 4:05 am
Aleesha…
Don’t be pushed by your problems. Be led by your dreams….
Trackback by Aleesha — September 1, 2008 @ 6:20 am