How the Supreme Court Just Neutered the FDA

In two rulings, the U.S. Supreme Court appears to have neutered the FDA's ban on the promotion of unapproved "off-label" uses of pharmaceuticals and insulated companies that make cheap generic copies of those drugs from lawsuits.

Taken together, the rulings strengthen the hand of generic companies, allowing them to push questionable uses of some drugs while making it very difficult for patients to sue those companies if they are injured by those drugs. Companies that make the original brands of those drugs, however, can still be sued easily -- but they also may get the benefit of legalized off-label selling, if the text of one decision becomes widely applied.

In IMS v. Sorrell, the court was ostensibly asked whether Vermont's law banning prescription "data mining" was constitutional or not. Vermont wanted the practice banned because it is used by drug companies to push expensive drugs over cheap ones, and because it hurts the privacy of patients' medical records.

The court ruled such databases were free speech protected by the First Amendment. But Justice Anthony Kennedy wandered off the reservation on page 22 of the ruling to state that drug companies have the right to say whatever they want about their drugs (emphasis added):

But the "fear that people would make bad decisions if given truthful information" cannot justify content-based burdens on speech. Thompson, 535 U. S., at 374; see also Virginia Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U. S. 748, 769â€"770 (1976). "The First Amendment directs us to be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good." 44 Liquormart, supra, at 503 (opinion of Stevens, J.); see also Linmark Associates, Inc. v. Willingboro, 431 U. S. 85, 97 (1977). These precepts apply with full force when the audience, in this case prescribing physicians, consists of "sophisticated and experienced" consumers. Edenfield, 507 U. S., at 775.

Some worried that this decision would spell the end of FDA off-label promotion restrictions â€"- which are limitations on commercial speech in a similar context. The decision will not calm these fears. The majority offered a distinction that might be used to permit off-label promotion to physicians but not consumers:

Generic companies cannot be sued
As described ad nauseam on this blog, off-label promotion has previously opened up drug companies to a whole raft of different and often expensive legal liabilities. It may also harm patients by subjecting them to drugs that don't work for what companies say they work for.

On the issue of injuring patients, the court ruled in a separate case, Pliva v. Mensing, that generic companies cannot be sued by patients as long as the warning labels they used are identical to the brand-name companies. The case states that brand-name companies can still be sued if they knew of problems with their products but didn't change the labels. The logic for this seemingly illogical precedent is that FDA law requires generic companies to keep their labels identical to brand name labels. The dissent, by the increasingly entertaining Justice Sonia Sotomayor, describes the new law in an easy-to-understand way:

It invents new principles of pre-emption law out of thin air ...

As a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug.

Related:

• Why Do Bloomberg and AP Want to Look at Your Medical Records?
• How Drug Companies Look at Your Private Medical Records Any Time They Want
• CA Supreme Court: Wyeth Liable Even Though Patient Never Took the Drug
• FDA to Allow "Off-Label" Unapproved Drug Promotion