Hypothyroid Anyone?

http://thyroid.about.com/b/2009/08/28/fda-future-natural-thyroid.htm
What is the FDA Not Saying About The Future of Natural Desiccated Thyroid Drugs?

Thyroid Disease Blog, Mary Shoman


****The Armour Thyroid and Nature-Thyroid Shortage Information Center:
http://thyroid.about.com/od/thyroiddrugstreatments/tp/desiccated-thyroid-2009.htm


This past Wednesday, August 26th, I contacted the public affairs division of the Food and Drug Administration (FDA), indicating that I was a writer and patient advocate looking into the status of natural thyroid. I explained that I had several straightforward questions:

* Is the FDA requiring ALL natural desiccated thyroid drugs to go through the new drug application (NDA) process, or only those manufacturers that have already been shut down?

* Is/will an NDA being required for the main drugs in the category: Nature-Throid, Westhroid and Armour Thyroid?

* If an NDA will be required for the drugs still on the market, will these drugs be removed from the market during the NDA process?

* If an NDA will be required for the drugs still on the market, and these drugs will be removed, WHEN would this be effective?


It took several days, but the FDA finally released an official "statement" in response to my question.

The Agency has not conducted a class action against unapproved thyroid products. As a policy matter, however, we do not discuss potential, pending, or ongoing actions except with the firms and individuals who are the subject of those actions. As information about enforcement actions becomes available it is posted on the FDA website.

In June 2006 the Agency published the guidance "Marketed Unapproved Drugs --Compliance Policy Guide" (the CPG). This guidance outlined the Agency's enforcement policies which we believe are well-suited to protecting the public health without imposing undue burdens on consumers or unnecessarily disrupting the market. For additional information regarding the FDA's actions against unapproved drugs, please access our unapproved drugs website at the following link.

While we waited for the FDA's response, thyroid patients at the Save Natural Thyroid Coalition were themselves calling the FDA's consumer information line -- (888) 463-6332 -- and were being told a variety of things by FDA staff. Some staff at the FDA have said that all natural thyroid was going to be pulled from the market, others said that the FDA denied any involvement at all in natural thyroid, others have said that the measures are currently only applying to the companies already targeted.

What's with all the contradictions? Officially, the FDA leaves the door open to do pretty much anything they want, but doesn't tell us anything that can actually help protect the health of thyroid patients. And then, in one-on-one conversations, their staff are offering all sorts of different scenarios.

Why is the FDA unable to provide clear, specific answers to thyroid patients about this critical issue?

And let's face it, we have a very troubling situation at present:

* Weeks ago, a major "big pharma" insider, Medco, sent a nationwide notice to doctors declaring that the FDA was taking all natural desiccated thyroid drugs off the market, and that doctors should switch patients to levothyroxine drugs
* We currently have an unexplained nationwide unavailability of Thyroid USP, the raw material that is used to manufacture natural thyroid drugs.
* Since the spring, production of three different natural desiccated thyroid drugs -- Biotech, TimeCapLabs and Major -- have been shut down. We know that TimeCapLabs was shut down in response to a publicly available notification letter they received from the FDA. The second-hand information is that Biotech and Major were also shut down by the FDA.
* We have the actual letter the FDA sent to TimeCapLabs, stating that natural desiccated thyroid requires a new drug application (NDA).
* Throughout the U.S., we have dwindling to non-existent supplies of Armour, Nature-Throid and Westhroid on the market, and most patients are now unable to get new or refilled prescriptions for these medications. Given the nationwide shortage of raw material, compounded capsules of natural desiccated thyroid is also unavailable to most patients.
* RLC is saying that it will be at least 90 days before they have any new product (Nature-Throid/Westhroid) to ship.
* Forest, which makes Armour, the most prescribed brand of natural desiccated thyroid, will provide no estimate whatsoever regarding when they expect to have any product available to ship.

And now, we have the FDA responding in a vague manner to a very specific request for information that affects millions of thyroid patients, patients who rely on natural desiccated thyroid drugs to treat a life-threatening health condition.

Am I being overly suspicious or alarmist? It's possible. Am I, as one FDA person apparently told a caller, just "that lady who is stirring up trouble?" I guess that could be.

But given these highly unusual circumstances, can and should we trust that the FDA has our best interests at heart?

Given that the big drug companies -- who have undue influence the FDA -- stand to benefit financially by getting natural desiccated off the market, should we assume that the lack of a clear answer from the FDA is a positive sign?

Should we all just "wait and see" for three months or more if natural thyroid drugs again become available?

What [else] does the FDA know that they're not willing to tell us?

MORE INFORMATION:
http://www.facebook.com/pages/Save-Natural-Thyroid/121680434089


XOXO
Me