FTC Files AndroGel Lawsuit Against AbbVie, Teva Over Generic Delay

The Federal Trade Commission (FTC) has filed a lawsuit against AbbVie, Teva Pharmaceuticals and Besins Healthcare Inc., alleging that the three drug companies worked together to delay the release of generic AndroGel, causing the healthcare system to pay millions of dollars through inflated drug costs. 

The complaint was announced by the FTC in a press release issued September 8, indicating that the lawsuit over generic Androgel was filed in the U.S. District Court for the Eastern District of Pennsylvania on Monday.

According to allegations raised in the action, AbbVie and Teva entered into an anticompetitive agreement to prevent men from gaining access to a lower cost generic version of the popular testosterone drug AndroGel.

The commission seeks to recover profits the companies gained by making men pay more for the brand name drug, when the generic should have been available. According to the FTC, AbbVie and Besins Healthcare filed patent infringement lawsuits they knew to be without merit in order to delay when AndroGel generic competitors would hit the market. While the cases were pending, AbbVie and Teva Pharmaceuticals agreed on a settlement agreement that would delay the generic drug’s release.

“The FTC is acting today to stop anticompetitive conduct by AbbVie, Besins Healthcare and Teva which has forced consumers to overpay hundreds of millions for the drug AndroGel,” FTC Chairwoman Edith Ramirez said in the press release. “This action also reinforces the Commission’s longstanding commitment to protect American consumers from collusive arrangements between branded and generic pharmaceutical companies that inflate the prices of prescription drugs and harm competition.”

The lawsuit came simultaneously with the release of Endo International’s release of a generic version of its testosterone gel Fortesta. The drug will be distributed by Qualitest, but marketed by Endo, which will also continue to market Fortesta.

Testosterone Drug Heart Concerns

The controversy over the generic drugs comes as AbbVie continues to face a growing number of AndroGel lawsuits, alleging that the drug maker failed to adequately warn consumers and the medical community about the potential link between testosterone drugs and heart problems, such as heart attacks, strokes and sudden death.

In November 2013, a study published in the Journal of the American Medical Association suggested side effects of testosterone may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

This research was followed by a study published by the medical journal PLOSOne in January 2014, which found that low testosterone treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

The FDA launched its own investigation shortly afterward, and has scheduled a meeting of two of its advisory committees next week to discuss testosterone heart risks. The committees will review the scientific evidence, hear from a number of witnesses, and make recommendations to the FDA on its course of action.

In a report released ahead of the meeting, FDA reviewers said evidence on testosterone heart attacks is inconclusive due to limitations in the studies, but warned that many men are being prescribed testosterone drugs unnecessarily and questioned their use outside of cases where men had lower testosterone due to a testicular or glandular disease or injury.

Since the FDA launched the investigation, product liability lawsuits have been filed against AbbVie, as well as the makers of competing testosterone drugs, such as Testim, Axiron, AndroDerm and others. All of the complaints involve similar allegations that men may have avoided suffering serious injuries caused by testosterone side effects if in

The drug makers have been accused of aggressively promoting testosterone treatments for use among men who had no real medical need. Plaintiffs indicate that use of testosterone drugs caused them to suffer a heart attack, stroke, deep vein thrombosis, pulmonary embolism or other serious injury, including many wrongful death lawsuits.

As the number of complaints filed in U.S. District Courts nationwide has continued to grow, the U.S. Judicial Panel on Multidistrict Litigation established coordinated pretrial proceedings for the cases last month, centralizing all testosterone litigation before U.S. District Judge U.S. District Judge Matthew Kennelly in the Northern District of Illinois.