SCOTUS Rules on a Couple of Important Pharma Cases

June 27, 2011
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Clarence Thomas wrote for the 5-4 decision in which companies were shielded from lawsuits by consumers suffering from adverse effects of certain drugs. Anthony Kennedy, the SCOTUS justice often seen as the court’s swing vote, wrote for the majority opinion in another pharma case which strikes down a Vermont law that banned companies from using data mining techniques to obtain information about the prescription drugs individual doctors have a preference in prescribing.

Clarence Thomas wrote for the 5-4 decision in which companies were shielded from lawsuits by consumers suffering from adverse effects of certain drugs. Anthony Kennedy, the SCOTUS justice often seen as the court’s swing vote, wrote for the majority opinion in another pharma case which strikes down a Vermont law that banned companies from using data mining techniques to obtain information about the prescription drugs individual doctors have a preference in prescribing.

Federal law requires the makers of brand-name drugs to label their products with FDA-approved warning information and to update the 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 did not extend to the makers of copy-cat generic drugs.

I actually agree with Thomas on this decision. Fed law should trump state law in this case. Generic formulations are essentially chemical equivalents of their branded predecessors and, as such, really cannot be held accountable to novel warnings not appearing on the branded parent drug. A ruling in the reverse could open the door to flurries of suits for a range of untoward events for a multitude of generics — only adding to the cost of already fiscally overburdened healthcare delivery at the outset of reform (emphasis below, mine).

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. […] Writing for the court, Justice Anthony M. Kennedy said that “information is speech,” and that under the 1st 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”.

Exactly. This case highlights the effect Pharma representatives have always had on the prescribing patterns of physicians and protects the ultimate decision maker at the point of healthcare delivery — the provider. Is it any wonder why reps have been essentially banned from many healthcare systems in many markets nationwide? | LINK

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