A U.S. appeals court recently revived a False Claims Act lawsuit against Gilead Sciences, Inc. that claims the drug company violated FDA regulations by contracting a Chinese manufacturer to produce the active ingredient for HIV medications Atripla, Emtriva and Truvada at unregistered facilities.
The lawsuit was brought on behalf of the U.S. government by Jeff Campie and Sherilyn Campie, who are former Gilead employees, according to court documents. The former employees further allege that Gilead illegally terminated Jeff Campie, who served as Gilead’s senior director of global quality assurance from July 2006 to July 2009, after he discovered and reported the violations.
The district court previously dismissed the lawsuit twice in 2015 because it “failed to state a claim under the False Claims Act,” court documents stated. The United States Court of Appeals for the Ninth Circuit reversed that decision on Friday.
“We are disappointed with today’s ruling and intend to challenge this outcome and vigorously defend against these allegations,” a Gilead representative told Infectious Disease News.
The court documents state that the FDA approved New Drug Applications (NDAs) submitted by Gilead in the mid-2000s for Atripla (tenofovir disoproxil fumarate/emtricitabine [TDF/FTC]/efavirenz; Bristol-Myers Squibb/Gilead), Emtriva (emtricitabine, Gilead Sciences) and Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences; FTC/TDF). Gilead specified in the NDAs that the company would source FTC from registered facilities in Canada, Germany, the United States and South Korea. However, the plaintiffs contend that Gilead recruited Synthetics China to manufacture unapproved FTC at unregistered facilities as early as 2006.
For 16 months, Gilead supposedly used FTC that was produced at a Synthetics China facility in its commercial drugs, claiming that the agent was from an approved South Korean manufacturer. The company allegedly began working with Synthetics China to save money and prompt price reduction clauses with other FTC suppliers. The plaintiffs said Gilead imported the illicit FTC through its Canadian facilities by using fraudulent labeling and “obscured or augmented” paperwork.
The lawsuit states that the U.S. government spent $5 billion on HIV medications containing FTC during 2008 and 2009 alone. Payments were made directly and through government-funded programs, including Medicare, Medicaid and the Ryan White Program. However, the lawsuit claims that because the drugs were from unregistered facilities, they are “not eligible for payment under the government programs.”
Gilead ultimately sought approval from the FDA to use Synthetics China as a manufacturer for FTC in October 2008. However, the former employees argue that Gilead included products from Synthetics China in its HIV medications for at least 2 years before the approval was acquired in 2010. They further attest that Gilead falsified information they gave to the FDA in order to obtain approval. The company allegedly concealed two batches of FTC produced by Synthetics China that had microbial contamination; evidence of arsenic, chromium and nickel contaminants; and “residual solvent levels in excess of established limits.” Gilead replaced these with two new batches and submitted them to the FDA for review as part of the approval process.
“Despite being aware of manufacturing problems with Synthetics China, Gilead allegedly released 77 lots of FTC produced by Synthetics China to its contract manufacturers before the FDA approval of the Synthetics China facility,” the lawsuit states. “According to relators, had the FDA been aware of these issues, it would not have approved the use of the Synthetics China manufacturing facility.”
Gilead stopped using Synthetics China as a supplier in October 2011 due to persistent contamination issues. – by Stephanie Viguers
Disclosure: Jeff and Sherilyn Campie are formers employees of Gilead.