FDA sued for failure to publish approval of generic testosterone drug

androgel pump 435x435 FDA sued for failure to publish approval of generic testosterone drugMultinational generic drug manufacturer Perrigo Israel Pharmaceuticals sued the U.S. Food and Drug Administration (FDA) last Friday in a Washington D.C. federal court after the agency failed to take the appropriate measures that would allow sales of Perrigo’s generic testosterone gel product, even though it had received FDA approval.

Ireland-based Perrigo, the largest manufacturer of private label over-the-counter prescription drugs in the United States, said that the FDA failed to update its “Orange Book” listing Approved Drug Products with Therapeutic Equivalence Evaluations.

As a result, Perrigo’s testosterone-replacement gel, a generic equivalent of AbbVie’s AndroGel, is not included in the FDA’s therapeutic equivalents (TE) – an omission the drug maker says “continues to cause actual and imminent harm to Perrigo.”

According to the lawsuit, the FDA approved the gel more than a year ago but never updated its Orange Book as it is supposed to do within 30 days after approving a drug and giving it a therapeutic equivalence (TE) rating.

“… Despite repeated requests by Perrigo to FDA asking the agency to publish a TE rating for Perrigo’s product, and despite publishing TE ratings for numerous other drugs approved after Perrigo’s Product … FDA has not fulfilled its statutory obligation as to Perrigo,” the company alleges.

According to Law360, “Perrigo seeks a mandatory injunction compelling the FDA to publish a TE rating for the testosterone gel within 30 days. The company also seeks a declaratory judgment that the FDA’s alleged failure to publish constitutes an agency action ‘unlawfully held and unreasonably delayed.’”

Perrigo potentially could be losing millions of dollars every week its generic Androgel equivalent is shut out of the burgeoning testosterone-replacement drug market, currently one of the hottest and fastest growing prescription drug markets in the U.S.

The success of testosterone drugs such as Androgel, Testim, and Axiron is attributable not to an epidemic of low testosterone (commonly called “Low T“) in men, but to extremely aggressive and successful marketing campaigns advertising the drugs directly to consumers as something of a panacea for weight gain, low energy, muscle loss, and a drooping libido.

Testosterone drugs have generated billions of dolars for drug manufacturers in recent years, with AndroGel alone accounting for more than $2 billion in sales in the last two years.

The soaring popularity of the drugs worries some doctors and health experts who point to studies indicating that testosterone therapies that men who take testosterone supplements in any form are more likely to experience adverse health problems, including stroke, heart attack, and death.


Los Angeles Times