Takeda Hit With Lawsuit Claiming Sham Clinical Trial of Colcrys
A qui tam lawsuit, unsealed last week, alleges that Takeda used a sham clinical trial to obtain FDA approval for a new version of its gout drug Colcrys — raking in hundreds of millions of dollars as a result and delaying generic competition.
The lawsuit claims Takeda raised the price of Colcrys (colchicine) from less than a dime per pill to about $5 after convincing the FDA to allow the new dosage regimen for acute gout attacks.
Judge Ruben Castillo of the U.S. District Court for the Northern District of Illinois unsealed the complaint after the federal government and nine states declined to intervene, even though Medicare Part D payments for colchicine escalated from $9.3 million in 2007 to $242 million in 2012.
The decision allows the plaintiff to pursue the case on the government’s behalf, provided any action to dismiss gets U.S. Attorney General approval. No reason was provided for declining to intervene.
The False Claims Act case, Ford v. Takeda, was filed in August 2014 by Daniel F. Ford, an investigative reporter who was prescribed Colcrys in 2011.
According to the complaint, Takeda set up the sham trial to compare a high dose of Colcrys with a lower dose of the drug, falsely claiming the higher dose was the industry standard even though it could cause acute side effects, including death. Because the drug has been used for many decades, the company knew the proper dosage before setting up the trial.
Takeda spokeswoman Sandy Rodriguez says the company will vigorously defend itself against Ford’s charges.
Earlier this year, Hikma launched Mitigare (colchicine) following the Delaware district court’s rejection of Takeda’s motion for a preliminary injunction blocking its distribution. — Jonathon Shacat