Top Court Rules In Favor Of Drug Companies In Two Cases

The Supreme Court, in a 5-4 decision, has ruled that makers of generic drugs do not have to warn consumers of the dangers of the medicine if the brand name drug makers don't. In a separate case, the justices, in a 6-3 ruling, again sided with drug companies and overturned a Vermont law that barred them from using information gathered from prescriptions to market drugs to doctors.

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From NPR News, this is ALL THINGS CONSIDERED. I'm Robert Siegel.

MICHELE NORRIS, host:

And I'm Michele Norris.

The Supreme Court handed the pharmaceutical industry two big victories today. First, it ruled five to four that makers of generic drugs are immune from state lawsuits for failure to warn consumers about possible side effects, that is so long as they use the same warnings that appear on brand-name drugs.

But we're going to focus now on the second of those two big victories. By a six-to-three vote, the court struck down a Vermont law that barred the buying, selling and profiling of doctors' prescription records.

NPR legal affairs correspondent Nina Totenberg reports.

NINA TOTENBERG: The court's sweeping decision in the Vermont case will send ripples far beyond the marketing of pharmaceuticals. The ruling also marked the court's first excursion into data-mining and applied a strict legal test to limits on speech, even in the context of government regulation.

Here, the government's regulations were those that require pharmacies to keep records of all doctor prescriptions, and the legal question was what kind of limits can the government put on the sale of that information.

Indeed, pharmacies can and do sell those doctor prescription records to data-mining companies, with patient identifiers removed, and the data-mining companies in turn sell the information to drug-makers for use in targeting doctors to prescribe more brand-name instead of generic drugs.

When doctors in Vermont found out their prescription records were being sold this way, they went to the state legislature, which enacted a law barring the practice. The data-miners and the pharmaceutical companies then challenged the law in court, contending that the state had unconstitutionally singled out marketing for different treatment, allowing researchers and cost controllers to have access to the data but not commercial data-miners and pharmaceutical companies.

Today, they won when the U.S. Supreme Court struck down the Vermont law as unconstitutional. Writing for the six-member court majority, Justice Anthony Kennedy said the Vermont law, both on its face and in its operation, imposes a burden based on the content of the speech and the identity of the speaker. He dismissed the state's justifications, that the law was aimed at keeping medical costs down, at protecting medical privacy, physician confidentially and the integrity of the doctor-patient relationship.

If doctors don't want to get visits from drug company salesmen, said Kennedy, they can just say no.

Dr. Norman Ward, vice president of the Vermont Medical Society, said the court seems oblivious to the realities of practicing medicine in a world where drug salesmen target doctors, and doctors have neither the time nor the quick ability to check their claims.

Dr. NORMAN WARD (Vice President, Vermont Medical Society): When I write a prescription for a patient based on my best medical judgment, that is a private interaction. For that information to be subsequently sold and repackaged as marketing ammunition to use to influence my prescribing habits is distasteful to me and to many of my colleagues.

TOTENBERG: Dr. Gregory Curfman, executive director of the New England Journal of Medicine.

Dr. GREGORY CURFMAN (Executive Director, New England Journal of Medicine): Basically, it's going to allow the drug companies to have more influence on doctors' prescribing practices, to manipulate their prescribing practices and to promote the use of more expensive drugs. Almost certainly, health care costs are going to be driven up.

TOTENBERG: Vermont Senator Patrick Leahy weighed in, too.

Senator PATRICK LEAHY (Democrat, Vermont): This is just one more example of the Supreme Court using the First Amendment as a tool to bolster the rights of big business at the expense of individual Americans.

TOTENBERG: But many businesses and First Amendment lawyers hailed the decision as furthering the availability of information to the public without the government being able to put its thumb on the scale.

Most immediately, expect challenges to the Food and Drug Administration's ban on advertising drugs for so-called off-label purposes: drugs that have been approved by the FDA for treating one disease but not another.

Some business lawyers said they expect challenges to be brought to federal restrictions on the way securities are marketed. And First Amendment lawyer Bob Corn-Revere said he expects the tobacco industry to use today's ruling to challenge the new and grisly labels that the FDA has required the industry to put on cigarette packs.

Mr. BOB CORN-REVERE (Attorney): Again, it is the government both limiting what the manufacturers can do to market their products and then essentially deputizing the producers of cigarettes to convey the government's message.

TOTENBERG: Dissenting from today's ruling were Justices Breyer, Ginsburg, and Kagan. They said that by failing to take account of the regulatory context in which this case arose, the court at best had opened up a Pandora's box of challenges to ordinary regulatory practices. At worst, they said, the court's decision re-awakens the pre-New Deal threat of the court substituting judicial for democratic decision-making, where ordinary economic regulation is the issue.

Nina Totenberg, NPR News, Washington.

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