WASHINGTON, DC – A patient with incurable blood cancer filed a class action lawsuit against Celgene Corporation for abusing consumer safety rules and maintaining a monopoly over its high-cost cancer drugs. The suit alleges Celgene illegally blocked generic development for its highly effective drugs Thalomid and Revlimid—the latter of which costs more than $12,000 for a four-week treatment cycle. The lack of a lower priced substitute costs patients, taxpayers, and employers millions of dollars.
“Celgene Corporation illegally prevented a generic version of their drugs from coming to market,” said David Mitchell, the lead patient in the lawsuit and founder of Patients For Affordable Drugs. “The company’s behavior hurts patients, keeps prices high, and costs taxpayers millions. Celgene is callously taking advantage of patients—many of whom are fighting for their lives—because Revlimid accounts for 63 percent of its revenue.”
Mitchell was diagnosed with multiple myeloma in November of 2010. He took Revlimid for more than five years to keep his cancer at bay. Over that time, the price of Revlimid increased 34 percent and Mitchell’s co-payments jumped by 600 percent.
During Mitchell’s treatment, Celgene refused to provide samples of Revlimid to generic manufacturers that planned to bring a cheaper competitor to market, among its other abuses of the law. Celgene has hidden behind the bogus pretext of a risk evaluation and mitigation strategy – a system designed to ensure dangerous drugs are distributed and used safely, not to block their distribution at lower prices.
The Food and Drug Administration (FDA)and the Federal Trade Commission (FTC)called Celgene’s practice into question. The FDA told Celgene that risk evaluation and mitigation should not stand in the way of making samples available to generic manufacturers. The FTC stated: “If brand firms are able to block generic competition by denying access to the product samples needed to obtain FDA approval, this conduct may prevent the (law) from functioning as Congress intended.” In fact, Congress is considering bipartisan legislation right now to stop these types of abuses.
“Celgene’s behavior wasn’t about safety, it was about protecting its monopoly, propping up its stock, and pocketing billions in profits,” Mitchell said. As a reward for executing this illegal strategy, the former CEO of Celgene—Robert Hugin—received almost $100 million in compensation over a three-year period and was promoted to Chairman.
Mitchell made clear he personally wants no money from the suit. His goal is to stop Celgene’s anti-competitive behavior, help lower drug prices, and win restitution for patients.
“If we win this suit, I will donate every penny that I receive in damages to non-profits that support cancer research and lower drug prices,” Mitchell said. “This is about ending bad behavior by drug corporations and helping patients live longer.”
Patients For Affordable Drugs is the nation’s only independent patient organization focused exclusively on policies to lower prescription drug prices. It does not accept funding from any organizations that profit from the development or distribution of prescription drugs. The next step in the legal process is for a judge to certify the class pursuing the action against Celgene Corporation.