February, 2003 -- Synthroid has become eligible for generic competition, and this development has moved the drug's manufacturer, Abbott Laboratories, into marketing action once again, to defend its market share.

According to reports in the Chicago Sun Times, Abbott Laboratories is suggesting that allowing "generic" versions of Synthroid could pose safety problems, and the company is requesting a re-evaluation by the government.

While Synthroid is eligible for generic competition, a generic drug would need to prove "bioequivalence" with Synthroid--a term that means that the drug is considered interchangeable, performs the same function in the body as well as Synthroid.

Abbott spokeswoman Jennifer Furey told the Chicago Sun Times , "We will ask the FDA to look at their guidance dealing with bio-equivalence for this class of drug that manages thyroid diseases. We're saying that needs to be evaluated primarily because of patient safety. You have a class of patients, thyroid cancer survivors, pregnant women who depend on having a consistent amount of levothyroxine sodium in their system. If that varies by even the slightest bit, it can cause cancer to return, problems in the baby. There are serious safety concerns that we're worried about."

The move could be a stalling tactic by the Synthroid manufacturer, which is struggling to maintain its juggernaut market position in a shifting market for thyroid drugs.

Interestingly, a similar argument about consistency was used by Synthroid back in the early 1990s to justify charging substantially more for the product than its competition, and was a standard part of the company's marketing pitch. This marketing pitch lands them squarely back in territory that got the drug, formerly manufactured by Boots Pharmaceuticals, Knoll Pharmaceuticals and BASF, into trouble throughout the 1990s.

Back in April of 1997, the news was released that the Journal of the American Medical Association was finally publishing the long-awaited results of a study -- commissioned by Synthroid’s manufacturer itself -- that looked at the bioequivalence of Synthroid compared to other brand names and generic levothyroxine. The researchers found that there was no difference in effectiveness among the different drugs, and that the products could be considered bioequivalent to Synthroid. The manufacturer, however, prevented the research from being published for a number of years, not wishing to release results that contradicted their marketing pitch that Synthroid -- usually one of the top two or three largest selling prescription medicine in the U.S., and the most expensive of all the brands of levothyroxine -- has no bioequivalent and justifiably costs more than competing brands.

The publication of the suppressed research resulted in a class action lawsuit against the manufacturer, charging that patients overpaid for the drug over a several year period, and that the overpayments should be refunded. The lawsuit was "settled" just a few months after it was filed in 1997, however, six years later, thyroid patients who overpaid for Synthroid have yet to receive any payments from the settlement. (Click here for the latest lawsuit payment update.)

Synthroid was also the subject of a contentious battle to try to avoid the federally mandated new drug application process, but the manufacturer lost its bid to delay and bypass the FDA new drug approval process, and was required to go through formal approval. In a letter turning down the company's request to bypass the formal approvals process, the FDA said: "The history of potency failures...indicates that Synthroid has not been reliably potent and stable."

The drug was forced to go through the FDA new drug application process in order to remain on the market, and was finally approved last year, almost two years after some of the competitive levothyroxines were approved.

Synthroid has been a highly profitable drug for Abbott, generating $520 million in global sales in 2002, up 11.3 percent from the previous year. As of 2002, it was the second-most prescribed medication in the United States and among Abbott's top-selling drugs.

LEARN MORE ABOUT SYNTHROID

You can learn the entire history of this controversial drug in our chronological "Synthroid Information Center", covering news and views on the drug, its history, issues and concerns since 1997.