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FDA Approval - Why Now?

© Keri

According to the Congressional Office of Technology Assessment, a drug company spends on average $359 million US to develop a new drug. As much as one-third of the revenue may go into research and development. Once the drug has been tested under laboratory conditions and is ready for human trials, the first application is submitted to the FDA. If the drug meets expectations and is proven effective, application is made for full approval and the patent on the drug.

Although the FDA was established in 1932, it was not until 1962 that congress required that drugs be both safe and effective. CDER (Center for Drug Evaluation and Research), a division of the FDA, is primarily responsible for the approval of new drugs.

In 1997, the FDA issued notice that oral levothyroxine products must apply for new drug approval or show a history of being generally safe and effective. The decision was based in part on the "new information showing significant stability and potency problems with orally administered levothyroxine sodium products" Federal Register, see below. This aroused considerable interest as approximately 13 million Americans depend on levothyroxine replacement and two-thirds of them take the major brand. We are talking multi-millions of dollars here.

Because these drugs are necessary for the health of so many, the FDA allowed a three year window for companies to comply. In 2000, the makers of Synthroid TM, the most prescribed replacement, applied for an extension. As noted in a previous article, the FDA denied Abbott Laboratories' petition for generally recognized safe and effective status. Two forms of levothyroxine have passed the new drug approval process.

Last year, Knoll Pharmaceuticals, the makers of Synthroid TM, settled a long-running class-action suit claiming that Knoll and BASF (their parent company) had violated consumer protection laws by attempting to prevent the publication of a study showing that generic and competitive name brands were equal in effectiveness to Synthroid. In 1999, Knoll settled with 37 states in a lawsuit claiming that they used unfair advertising to promote their product.

A recent search for recalls at Safety Alerts yielded twenty-four recalls for levothyroxine produced by various manufacturers over the past two years. The reasons for these recalls included subpotency, superpotency, incorrect packaging, incorrect labeling, etc.

While these findings support the FDA in their request that manufacturers prove the safety and effectiveness of their product, FDA approval does not in itself prove that each batch of the product will comply with the safety standard.