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Drug industry wins 2 high court rulings

Fri., June 24, 2011

Generics not held to brand-name labeling standards

WASHINGTON – The Supreme Court gave the pharmaceutical industry a pair of victories, shielding the makers of generic drugs from most lawsuits by injured patients and declaring that drug makers had a free-speech right to buy private prescription records to boost their sales pitches to doctors.

In both decisions Thursday, the court’s conservative bloc formed the majority, and most of its liberals dissented.

About 75 percent of the prescriptions written in this country are for lower-cost generic versions of brand-name drugs. Federal law requires the original makers of these brand-name drugs to post an approved warning label and to update these warnings when reports of new problems arise.

But in a 5-4 decision, the high court said this same legal duty to warn patients of newly revealed dangers does not extend to the makers of copycat generic drugs.

Justice Clarence Thomas reasoned that the warning labels are the responsibility of the brand name maker and the U.S. Food and Drug Administration. He said that because generics are just copycats, their makers cannot be sued for inadequate warnings.

Thomas said that the federal regulatory law trumps the state liability law in this instance and therefore shields the generic makers.

But the dissenters, led by Justice Sonia Sotomayor, said the blame lies with the court’s majority. She said the generic drug maker should have alerted the FDA of the danger and then updated their warning label. “This outcome makes little sense,” she said. Justices Ruth Bader Ginsburg, Stephen G. Breyer and Elena Kagan agreed with her.

In the second decision, the court by a 6-3 vote struck down a Vermont law that barred pharmacies, drug makers and others from buying or selling prescription records from patients for “marketing” purposes. Vermont’s physicians had sought passage of the law, arguing their prescriptions were intended for private use of patients and should not become a marketing tool.

Drug makers buy this data to gear their sales pitches to physicians. Several data-mining firms have made a billion-dollar business out of buying and selling the prescription data to drug makers and researchers.

Writing for the majority, Justice Anthony M. Kennedy said “information is speech” and that, under the First Amendment, the government usually cannot restrict speech because it does not approve of the message. “If pharmaceutical marketing affects treatment decisions,” he said, “it does so because doctors find it persuasive.”


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