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FDA Proposes New Generic Drug Warning Label Regulations

November 27, 2013

It might surprise one to learn that 80 percent of pharmaceuticals currently prescribed in the United States are generic. But would it be surprising to know that brand-name drug manufacturers and those that make generic drugs were not always subject to the same rules? Earlier this year, this blog published a post detailing the Supreme Court’s June decision not to allow drugmakers to be “sued under state law for adverse reactions to their products.” Well, there is good news to report on the consumer safety front when it comes to the marketing of these generic drugs.

The New York Times recently reported that the Food and Drug Administration (FDA) has announced it will begin to allow generic drug manufacturers to “update their labels if they received information about potential safety problems.” The report continues, “The move puts the companies on equal footing with brand-name manufacturers, but it also opens the door to lawsuits against them for the first time since the Supreme Court barred such cases […].” One such case, which we detailed in the aforementioned, involved Karen Bartlett, who was left disfigured and nearly blind when she was stricken with toxic epidermal necrolysis.

The illness, triggered by Mutual Pharmaceutical’s Sulindac (a generic version of Merck’s non-steroidal anti-inflammatory drug Clinoril) caused her to develop (according to a Reuters article) “burn-like lesions over two-thirds of her body.” A New Hampshire jury awarded the victim a $21 million verdict, which Mutual appealed, resulting in the case being heard before the U.S. Supreme Court. The court’s 5-4 decision in favor of pharmaceutical companies is an arrangement known as “blanket” or “umbrella” coverage, in which as long as generic drugmakers do not alter medications or warnings from those of the brand-name alternative, they are completely shielded from lawsuits.

When Bartlett filled her prescription for Sulindac, its label included no warnings about effects on the skin, but because the Supreme Court had previously established that manufacturers of generic drugs could not be sued for label warnings (or lack thereof), the justices reversed the original New Hampshire jury decision and Bartlett’s monetary award was stripped from her.

The F.D.A.’s Director of the Center for Drug Evaluation and Research, Dr. Janet Woodcock says she sees this as a way to “level the playing field” between brand-name manufacturers and their generic counterparts. The president of the Generic Pharmaceutical Association, an industry trade group, complains that his group is “very concerned that multiple versions of critical safety information would lead to unnecessary confusion and uncertainty for prescribers and other health care professionals, with harmful consequences for patients.” But surely any system of label warnings is better than none at all.

He goes on to question the legality and enforceability of this new rule in light of the earlier Supreme Court ruling, saying that “the agency’s authority to enact a rule that differs from the federal law is unclear.” Time will tell whether the regulation stands, but this is a rather rare step in the right direction for the FDA, whose lax oversight of pharmaceuticals has left much to be desired in recent months.


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