June 2002 Legal Notes

 

On March 26, 2002, Jerome Stevens Pharmaceuticals, Inc. (JSP, Inc.), manufacturers of the FDA-approved thyroid drug UnithroidTM, filed a claim under the Tort Claims Act with the Food and Drug Administration. JSP, Inc. seeks $1.3 billion for FDA’s unlawful publication of its trade secrets and confidences on the worldwide web at www.fda.gov. In violation of the Food, Drug and Cosmetic Act, the federal Trade Secrets Act, and FDA’s own regulations, FDA posted trade secrets and confidences contained in JSP’s October 19, 1999 New Drug Application for stable levothyroxine sodium on the web without notice to, or approval from, the company. FDA’s unlawful publication disclosed to the world, and notably JSP’s competitors, its unique invention for a stable and safe levothyroxine sodium thyroid drug. FDA demanded that the New Drug Application be filed to protect the public from unstable thyroid drugs with potential health risks. In spite of a notice in the August 1997 Federal Register citing stability and potency problems with all thyroid hormone replacement products resulting in product recalls and the potential to cause serious health consequences to the public, the agency allowed those products to remain on the market.

FDA posted JSP’s trade secrets and confidences on the Web for a period of five months from August 22, 2000 to January 23, 2001 despite the company’s protests. JSP’s application was the first application granted by FDA for the marketing of a safe and stable levothyroxine sodium drug.

Thirteen million people in the United States are diagnosed with a thyroid disease and use levothyroxine sodium.

FDA has six months within which to act on JSP’s tort claim. If FDA denies the claim or fails to act on it by September 26, 2002, JSP shall sue the agency in the U.S. District Court for the District of Columbia. The Washington, D.C. firm Emord & Associates, P.C. represents Jerome Stevens Pharmaceuticals, Inc. in this action.