Public policy specialist David Mitchell has been living with multiple myeloma since 2010 and depending on drugs like Celgene’s Revlimid to keep him alive. But in the six years he took Revlimid, he saw his copay rise from $42 for a four-week supply of the drug to $250. Now he’s suing Celgene, alleging the company illegally blocked generic competition that would have resulted in cheaper alternatives hitting the market.
Mitchell’s class action lawsuit alleges that the company refused to provide the samples of Revlimid to generic manufacturers that they needed to replicate the drug, all the while pulling in huge profits from its success. The announcement of the suit—which was posted on the website of Patients for Affordable Drugs, a nonprofit Mitchell launched earlier this year—points to Celgene’s former CEO Robert Hugin and the $100 million in compensation he received over a three-year period.
“We would have had a cheaper alternative but for Celgene's abuse of our system,” Mitchell said in an email interview with Fierce Pharma, “because a generic would have come to market.” He noted that in the years he took Revlimid, his receipts showed that the retail price of Revlimid jumped from $8,000 to $10,691 for a four-week supply.
A spokesman for Celgene declined to comment, citing the pending litigation.
Mitchell, 66, spent more than 30 years of his career at GMMB, a Washington, D.C.-based public policy communications firm that took on challenges ranging from boosting seat belt use to persuading teens not to smoke. After he retired last year, he devoted himself to trying to lower drug prices by bringing about changes in public policy.
Mitchell entered the debate over drug pricing at an opportune time. President Donald Trump rode into the White House last year on a platform that included blasting the pharmaceutical industry for “getting away with murder” on high drug prices. He wanted to allow government payers to negotiate drug prices—an idea that has proven to be wildly unpopular. But Trump has since introduced other ideas that the pharma industry can live with, including a tax repatriation holiday.
The day before Mitchell launched his suit, news emerged that Trump is working on an executive order targeted at lowering drug prices. The order will reportedly require value-based drug purchases and trade policies that protect pharma companies’ intellectual property.
That news arrived as Sen. Ron Wyden, D-Ore., was introducing the appropriately named SPIKE act, which takes aim at drug makers that push through huge price increases on certain drugs. The bill proposes requiring some pharma companies to justify price increases that pass a certain threshold and to disclose their marketing and R&D expenses.
And in May, the new FDA commissioner, Scott Gottlieb, spoke at a House budget meeting, during which he vowed to shorten the review times for generic drugs and end the “gaming” of regulations that allow drug companies to extend their patents. He also said the FDA will publish a list of drugs that have come off patent but have no generic competition.
As for Celgene, it’s unlikely to see generic competition for Revlimid until 2022. Some of the patents on the drug extend until 2027, but in 2015, Celgene reached a settlement that gives Natco Pharma a limited license to introduce a generic version of the drug five years earlier. Among the other companies wanting to develop Revlimid copycats is Mylan, which sued Celgene for antitrust violations in 2014 for refusing to supply samples. Celgene lost a battle to get that suit thrown out and is now seeking a summary judgment, according to its most recent quarterly report.
Mitchell says that during his time on Revlimid, the drug was covered by insurance that his company provided—but he still blames Celgene's "anti-competitive conduct" for the copay hikes. He says he does not yet know how many other patients might be interested in joining his lawsuit. And if he wins? “I personally will donate any amount I may receive from a settlement to research on new cancer drugs and efforts to lower the prices of drugs,” he says.