Washington, DCIs a generic manufacturer of a name-brand drug like Prozac hamstrung by federal rules that govern the labeling of the drug originally approved by the US Food and Drug Administration (FDA)? Or does a generic manufacturer have the right and responsibility to alter the labeling of its generic drug in an effort to warn consumers and the health care community about potential adverse reactions?
That's the crux of debate currently circulating through various courts and most recently brought to the fore by US District Court Judge A. Howard Matz of the Central District of Columbia. In his March 26 ruling, Judge Matz said that Sandoz Inc, the manufacturer of a generic form of Prozac originally licensed to Eli Lilly by the FDA, was in a position to warn about an increased risk of suicide and possessed the legal right to alter its label without approval by the FDA.
Normally, when the manufacturer of a drug federally approved by the FDA wishes to change its labeling information, the FDA must first approve the changes. The FDA can also request that the manufacturer of a name-brand drug alter its labeling information in response to concerns over adverse reactions.
But must the generic manufacturer abide by the same regulation when it comes to labeling? Generic drugmakers have argued that generic drugs are exact copies of name-brand drugs and therefore must therefore carry the exact same labels. Such a stance attempts to transfer liability over a product label from the generic manufacturer to the name-brand manufacturer.
Various rulings have revealed a split in judicial opinion, although this latest ruling in California aligns with at least three other circuit court decisions, according to Bijan Esfandiari of Baum, Hedlund, Aristei & Goldman in Los Angeles. According to the 4/06/10 issue of the National Law Journal, Esfandiari represents Rosemary Dorsett, the mother of a 26-year-old man who took his own life in 2004 after taking a generic form of Prozac (fluoxetine) for 36 days.
In 2008 the California First District Court of Appeals ruled in Conte v. Wyeth that name-brand manufacturers could be held liable in cases involving the equivalent generic medication.
However, a ruling by the US Supreme Court last year in Wyeth v. Levine prevents drug manufacturers (in most cases) from arguing that state tort claims are preempted by federal law due to the fact the FDA regulates their products.
Eli Lilly filed a summary judgment motion in the DC case claiming that the manufacturer could not have warned about any risk of suicide associated with the antidepressant given that the FDA was heavily regulating antidepressants at the time and that Lilly could not have been allowed to change or alter the labeling of their product. Sandoz Inc filed its own summary judgment in the case, claiming that in its view Sandoz could not voluntarily change its labeling without FDA approval, given that Sandoz relied on Eli Lilly.
Judge Matz, however relied on Wyeth v. Levine in his ruling against Eli Lilly's pre-emption stance. As for Sandoz, the judge interpreted FDA regulations as allowing for the voluntary changes to product labeling by a generic manufacturer. That decision echoes similar rulings in the fifth, fourth and eight circuits, according to Esfandiari.
"It really hammered another nail in preemption's coffin."
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