At the Save Natural Thyroid Coalition, activities are still underway to work behind the scenes with physicians around the country, and to help spearhead grassroots outreach efforts by patients, with the goal of promoting the awareness and legitimacy of prescription natural desiccated thyroid drugs as a safe, legal option for thyroid patients. The group also maintains an active Save Natural Thyroid Facebook page with almost 7,000 members, and a database of pharmacies where natural thyroid drug prescriptions can be filled.
The Legal Status of Natural Desiccated Thyroid
Information from the FDA is, as usual, very limited. A brief status update on "Current Drug Shortages" posted at the FDA website on March 2, 2010, states that, as of February 12, 2010:
"Forest reports manufacturing issues involving the raw material and RLC reports increased demand. FDA has not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market. This has been a long term shortage and any new information will be posted as soon as it becomes available. FDA approved levothyroxine products continue to be available from multiple manufacturers."It's good to see that the FDA felt it necessary to include the brief statement that they have not ordered Forest or RLC to remove these thyroid (desiccated) tablets from the market. This very likely reflects a concern on the part of the FDA that it not be perceived as taking action that can endanger the many thyroid patients who rely on natural thyroid drugs, and may be a response to thousands of inquiries by telephone, email and fax the FDA received from thyroid patients and practitioners regarding concerns about various FDA actions regarding natural desiccated thyroid drugs.
The FDA's statement does not address a critical issue for thyroid patients however. According to the natural desiccated drug manufacturers, the FDA has indicated that they still consider natural desiccated thyroid drugs "unapproved," and intend to call for a new drug application process for natural desiccated thyroid drugs.
This leaves us with several important questions:
- When will the FDA requirement for new drug application for natural desiccated thyroid drugs be issued?
- Will the FDA call for the faster (and less costly) abbreviated new drug application (ANDA) or the lengthier, costlier complete new drug application (NDA) process?
- Will natural desiccated thyroid drugs be allowed to remain on the market during the ANDA/NDA process?
The Status of Nature-Throid
Increasing quantities of Nature-Throid are available in pharmacies around the U.S., I had a chance to speak with Dai Jinn, Chief Pharmacist and Chief Science Officer at RLC Laboratories, on March 2, 2010, and he indicated that RLC is well-stocked with raw materials to meet increasing demand for Nature-Throid, and increasing quantities of the 1 grain are shipping to distributors and pharmacies.
While the main ingredients of Nature-Throid were not reformulated, Jinn indicated that he directed several changes to the production of Nature-Throid, to ensure optimal quality and consistency. One change was to switch from the use of sodium starch glycolate as a dissolution/ disintegrating agent) to croscarmellose sodium.
The purpose of a disintegrating agent is to help a tablet dissolve in the appropriate place in the intestinal tract, at the right time, to ensure the maximum effectiveness of the active ingredients. Jinn felt that the croscarmellose sodium would provide superior dissolution and disintegration for Nature-Throid. The new Nature-Throid 1 grain also has less of an odor, which is due to the use of a new coating, which according to Jinn allows for better quality control for the Nature-Throid tablets.
RLC has no concerns regarding availability based on demand projections, and expect their ½ grain tablets to begin shipping by April 1, 2010, and their ¼ grain by April 10, 2010.
The Status of Armour Thyroid
Forest Laboratories has their latest statement regarding the availability of Armour Thyroid posted at their Armour website, and it states:
"Forest Laboratories is working diligently to resolve the back-order situation on Armour Thyroid. We are focusing our efforts on producing the 1 grain (60 mg) and 1/2 grain (30 mg) dosage strengths because these strengths account for approximately 70 percent of Armour Thyroid use and can be used alone or in multiples to achieve common total daily dosage requirements. We have recently produced and shipped a limited supply of 1 grain and ½ grain tablets, which we expect will start becoming available to pharmacies in early February. We will continue to ship more lots of Armour Thyroid as they become available. We appreciate your understanding as we manage this Armour Thyroid back-order. If you have any questions about Armour Thyroid, please call the following toll-free hotline: 1-866-927-3260.