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US supreme court considers Reglan appeal

Should generics firms be held accountable for failing to flag up drug side effects, the US Supreme Court asks

The US Supreme Court has asked the Obama Administration for its opinion about whether generic drug makers should be held accountable for failing to adequately warn about the side effects associated with their drugs. The request comes as the Justices consider whether or not they should hear an appeal made by generic drug makers such as Teva Pharmaceuticals, Actavis Elizabeth and UDL Laboratories in a tardive dyskinesia lawsuit over generic Reglan (metoclopramide).

The drug makers have been accused of failing to adequately warn about the risk of movement problems, such as tardive dyskinesia, as side effects of Reglan. Actavis, and the other generic drug makers, however argue that the claims should be pre-empted by federal laws governing generic drug labelling, which require generic drugs to carry the same label as the brand name medication.

In an order issued this week, the Supreme Court has invited the Solicitor General to file briefs in the cases expressing the views of the United States.

At issue on appeal is whether a generic drug manufacturer can change its label or otherwise warn the public of a health risk before the maker of the brand name drug. FDA regulations require that generics seeking approval have the same label as the brand name manufacturer, and it also stipulates that the generic's label has to remain consistent with the brand name label.

However, the lower appeals court ruled that the regulations do not prevent generics from requesting a label change to warn of a health risk, nor do they prevent the drug company from other methods of warning the public, such as sending out a "Dear Healthcare Professionals" letter to warn of potential risks.

In February 2009, the FDA required that manufacturers of all variations of generic metoclopramide add a black box warning about the Reglan tardive dyskinesia risk, which is the strongest warning that can be placed on a prescription medication. The generic drug makers were also required to develop mitigation and risk evaluation strategies to ensure patients are aware of the potential side effects.

2nd June 2010

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