The Supreme Court had taken an interest in a Justice Department whistleblower case over whether Gilead Sciences lied to the FDA about using an unapproved Chinese ingredient in some HIV drugs. But in an unexpected move, the DOJ is scuttling the case, saying the distraction from discovery is just not worth everyone’s time.
The False Claims Act case had been revived last year by the Ninth Circuit Court of Appeals and then appealed to the Supreme Court. The DOJ in a brief on Friday asked the top court to dismiss the review from the appeals court. It also said after reviewing the merits of the whistleblowers' claims it has decided it no longer intends to pursue the case.
It said, "if this suit proceeded past the pleading stage, both parties might file burdensome discovery which would distract from the agency’s public-health responsibilities," the brief says. Based on all those considerations, "the government has concluded that allowing this suit to proceed to discovery, and potentially a trial, would impinge on agency decision-making and discretion and would disserve the interests of the United States," the filing (PDF) says.
Law360 points out that in a memo early this year, the Justice Department disclosed its intent to drop some False Claim Act cases it finds weak or which might interfere with the government's operations.
The case against Gilead was brought by ex-employees Jeff and Sherilyn Campie, who allege the drugmaker hid from the FDA that it bought some of the active ingredient used in HIV drugs Emtriva, Truvada and Atripla from an unapproved Chinese manufacturer. Jeff Campie, who was senior director of global quality assurance at Gilead from July 2006 to July 2009, says he was terminated because he fought the company’s actions.
The couple claimed for 16 months starting in December 2007, Gilead used emtricitabine from unapproved Chinese manufacturer Synthetics China but told the FDA it came from a South Korean producer the FDA had signed off on. The company did so to save money and trigger "price reduction clauses" with other manufacturing partners, the ex-employees contend. The company did seek to have the China manufacturer approved but when it did, the suit said Gilead hid the fact that some of its APIs had failed contamination tests.
Through programs such as Medicare and Medicaid, the U.S. government spent $5 billion on Emtriva, Truvada and Atripla during 2008 and 2009 alone, drugs that did not meet FDA standards, according to the lawsuit.
Gilead argued that the government continued paying for the drugs even after learning of the company’s use of the ingredient from Synthetics China, making the matter moot.
The DOJ appears to agree in its brief to the Supreme Court. It claims that even when the FDA learns of the kind of issue presented in the Gilead case, rather than disrupt the supply by pulling the drug, "it typically seeks to address the problem through less disruptive mechanisms."
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