Roche’s bid to strike a $1.5 billion False Claims Act suit around Tamiflu’s pandemic stockpiling has failed.
A Maryland federal judge on Monday denied Roche’s motion to dismiss a suit that alleges the Swiss pharma defrauded U.S. federal and state governments by misrepresenting the popular influenza med for use in a pandemic.
The suit was brought by epidemiologist and Cochrane Collaboration researcher Tom Jefferson in 2014. After six years of tussle, Roche still can’t escape the suit.
Jefferson and the nonprofit Cochrane launched their Tamiflu war in 2009 after the H1N1 influenza pandemic. The team embarked on a years-long campaign, urging Roche to release all Tamiflu data so that Cochrane could assess the drug’s clinical value.
Cochrane went so far as to push for a boycott of the seasonal flu drug. Roche said it released related data in late 2012.
Based on those data, Jefferson concluded that Tamiflu could reduce the duration of flu symptoms as well as the number of symptomatic cases among infected people.
But Jefferson didn’t find evidence that Tamiflu cut the risk of disease transmission or lower respiratory complications—which, according to him, are key goals for a pandemic drug. He blamed that lack of evidence on trial design loopholes.
According to data from a Roche-funded meta-analysis of 29,234 patients from 78 studies of hospitalized patients with H1N1, neuraminidase inhibitors such as Tamiflu reduced the risk of death by 19% over no treatment, and the benefit widened to 50% if treatment started within two days of flu symptoms. The findings were published in March 2014 in The Lancet Respiratory Medicine.
Still, Jefferson filed the suit under the U.S. False Claims Act, which allows individuals to bring claims on behalf of the government. The lawsuit alleges that Roche falsely claimed Tamiflu’s benefit, which led the U.S. government to spend about $1.5 billion on stockpiling the drug for pandemic use.
Last September, federal prosecutors wrapped up their investigation of the allegations and declined to join Jefferson’s case.
In a statement, Roche said it “has complete confidence in the safety and efficacy of Tamiflu and the company plans to vigorously defend itself against these allegations.”
The latest legal development comes as Roche is switching its focus away from Tamiflu, which fell off the patent cliff in 2016 after rising to blockbuster status in previous years, posting $3.2 billion in 2009 revenue as the H1N1 flu spread. Now, the company has a new flu drug, Xofluza, which it licenses from Japan-based Shionogi.
In clinical trials, Xofluza has shown it can move into action and stop virus release from the body significantly faster than Tamiflu. That essentially means Xofluza is more potent at stopping the virus from spreading.
Roche also hopes Xofluza’s single-dosage convenience, as compared with Tamiflu’s twice daily dosing, could attract patients. But the new option has yet to carve out a clear path for Roche amid generic Tamiflu competitors. It only brought in sales of CHF 28 million ($30 million) in the first half of 2020, far below the billion-dollar level Tamiflu used to enjoy at its peak.