Men who require testosterone replacement therapy have been deprived access to lower-cost, generic versions of the popular branded testosterone drug AndroGel in violation of the law, claims a new federal lawsuit. The Federal Trade Commission (FTC) is suing several major drug companies, including AbbVie and its partner Besins Healthcare, for allegedly breaking the law by blocking consumer access to cheaper versions of the drug.
According to the FTC complaint, AbbVie engaged in illegal, anticompetitive behavior when it paid Teva Pharmaceuticals, a generic drug competitor, to not produce a generic alternative to AndroGel, even though the drug's patent had already expired. And Teva, by allegedly accepting this settlement agreement, also engaged in illegal behavior, says the FTC.
Speaking about the lawsuit, FTC Chairwoman Edith Ramirez told the media that its purpose is "to stop anticompetitive conduct by AbbVie, Besins Healthcare and Teva which has forced consumers to overpay hundreds of millions for the drug AndroGel."
A topical testosterone gel product, AndroGel currently has annual sales of more than $1 billion. If sold generically, however, AndroGel's sales would likely taper dramatically, cutting into AbbVie's profits, hence its efforts to maintain a monopoly over the drug. Consequently, AbbVie has worked to delay U.S. Food and Drug Administration (FDA) approval for any generic versions of AndroGel.
This is illegal behavior, says Ramirez, whose commission is accusing both AbbVie and Besins of filing false patent infringement lawsuits against Teva and Perrigo Company, another generic drug manufacturer that had intended to manufacture cheaper versions of AndroGel.
Drug manufacturers made special agreements with each other to take advantage of consumers
According to the suit, Teva and Perrigo tried to countersue AbbVie and Besins, alleging that their patent infringement lawsuit was baseless. But Teva ended up agreeing to drop this countersuit after accepting illegal payments from AbbVie, which in turn dropped its original patent challenge. This represents illegal restraint to trade, says the FTC.These payments, according to information published by The Wall Street Journal (WSJ), were not monetary but rather an agreement that Teva would instead be allowed to produce a generic version of another unrelated drug for cholesterol, known as Tricor.
"We believe the defendants' anticompetitive conduct has forced consumers to overpay hundreds of millions of dollars for this medication," added Ramirez.
If successful, the FTC lawsuit will force all of the involved companies to forego their ill-gotten gains. The companies will also be permanently barred from ever making these types of agreements with each other in the future, as they violate the FTC Act.
The FTC has seen success with similar lawsuits in the past, including a 2013 Supreme Court victory in a case that also involved AndroGel. Though this isn't always the case, the Supreme Court has already set a precedent that the FTC is free to target drug companies believed to be engaged in anticompetitive behavior.
"Only when there are companies that act [too] arrogant and stupid, like in this case, does the government actually intercede because it has no choice," wrote one skeptical commenter at Consumer Affairs. "90 percent of criminal corporations are getting away with it, without any risk."
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