Welcome to the forty-seventh issue of "Sticking Out Our Necks!" my monthly thyroid disease news report. This newsletter is copyright Mary Shomon, and cannot be legally reproduced without permission. Feel free, however, to forward a copy to someone who might be interested in reading it, or subscribing. ON THE WEB: My Thyroid Disease Information Source and News Report home page is located at http://www.thyroid-info.com , and I also run a comprehensive Thyroid Disease site at About, which you can visit at http://thyroid.about.com .

CONTRIBUTE: If you see something thyroid-related in the news or on the web, please feel free to let me know, send me a note, or forward the URL to me if it's on the web. My email is mshomon@thyroid-info.com , regular mail is P.O. Box 0385, Palm Harbor, FL 34682, fax is: 301-493-5224.

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It appears that there is still ongoing confusion over the issue of the FDA new drug applications, and whether or not Synthroid is legal and/or approved, and what the future holds for the levothyroxine drugs.

As of March 1, 2001, Synthroid is NOT approved by the FDA. It IS, however, LEGAL to sell, under a special dispensation given to all levothyroxine drugs in 1997 when the FDA indicated that it would require all levothyroxine drugs to go through the new drug application (NDA) process and receive approval by August of 2000. After that time, any unapproved levothyroxine drugs would become illegal to sell. As of August 2000, only one drug, Unithroid, had successfully applied for and received the FDA approval. But, due to legal wrangling and lobbying, Synthroid managed to get the deadline extended for another year, to August 2001, keeping Synthroid and the other unapproved drugs legal to sell until the deadline runs out in August of 2001. Then, in order to remain legally available, Synthroid, Levoxyl and Levothroid will either need to receive approved NDAs, or, what is expected that Synthroid will try, they will need to successfully argue that this requirement should not apply, and receive what is known as "Generally Recognized as Safe and Effective (GRAS/E)" status. GRAS/E would mean that the drug was considered an "exception" to the rule, and was not required to go through any FDA approvals. Synthroid(R), the #3 most prescribed drug in America, is also the most popular brand of levothyroxine hormone replacement on the market -- being taken by 85% of those using thyroid hormone drugs. It is estimated that 8 million people are currently being treated with levothyroxine products, the majority of them taking Synthroid. To justify their #1 market position and higher price, there is speculation that Synthroid may refuse to submit an application, and instead continue to lobby for GRAS/E status.

In a recent letter from the FDA's Association Commissioner for Regulatory Affairs, Dennis E. Baker, to representatives of Jerome Stevens Pharmaceuticals, the FDA has indicated: "At present, the August 14, 2001, deadline remains in place, and FDA has no plans to extend the date by which levothyroxine sodium products must have approved applications." (1) Jerome Stevens has expanded its production capabilities in order to be in a position for Unithroid to meet the entire U.S. demand for levothyroxine, should no other products receive approvals in the next six months. According to a press release issued by Watson Pharmaceutical, distributor of Unithroid: "Many are unaware that levothyroxine sodium has a long history of stability, potency, and consistency issues leading to recalls by the FDA. It is a notoriously unstable compound and difficult to produce. Since 1991, there have been at least 10 recalls of levothyroxine, involving 150 lots and 100 million tablets. Issues ranged from the tablets having less active ingredient than indicated, to the failure of medication to maintain its potency through the expiration date. In addition, because levothyroxine sodium was available prior to the NDA approval process, it was not subject to the same strict regulations as FDA-approved drugs with New Drug Applications (NDAs). Therefore, manufacturers were able to reformulate the product, resulting in potency fluctuations of up to 30%.(2) The potential for these issues to negatively impact patients is vast. In addition, in a recent large- scale study, it was shown that approximately 40% of the participants who were on thyroid hormone had abnormal thyroid test results.

As a result of the problems stemming from levothyroxine sodium's inherent instability, the FDA issued a mandate in August 1997 requiring that all manufacturers of levothyroxine sodium have a complete and approved NDA filed by August 2000 to continue marketing. At the request of Knoll Pharmaceutical Company, maker of Synthroid, the deadline was extended 1 year. Currently, the deadline is set at August 2001. After that, any levothyroxine sodium product without an NDA may be pulled from the market by the FDA.

To date, only the manufacturer of Unithroid has complied with the FDA mandate and received NDA approval. This means that there is only one levothyroxine sodium currently available that the FDA has approved as safe and effective, having satisfactorily addressed all issues regarding stability, potency, dissolution, and bioavailability. Watson Pharmaceuticals, Inc. has recently entered into an exclusive agreement with Jerome Stevens Pharmaceuticals to market Unithroid. Unithroid was previously produced under the names levothyroxine sodium and Thyrox(TM) for more than 10 years, with 1 billion tablets manufactured without a recall. Unithroid is now available by prescription only, and can be found at your local pharmacy. Patients with hypothyroidism should ask their physicians about their treatment options." ==============================================