Court ruling could grant latitude on drug claims


PHILADELPHIA — Do you want the federal government to try to ensure medicine prescribed for you is safe for your illness?

Do you think pharmaceutical makers and their sales people should be allowed to say — and advertise — that a drug approved by the government for one illness is good for a second medical condition, even without government approval?

Freedom of speech is a cherished American ideal in the abstract and a key clause in the First Amendment to the Constitution, but it is complicated and controversial in federal regulations restricting how drug companies can promote their products to patients and doctors.

For more than a century in varying degrees, the federal government has tried to protect Americans from bad food and drugs.

But a recent federal appeals court decision — if eventually affirmed by the Supreme Court — could lead to a fundamental change in that practice.

“We would be back to the robber baron days of snake oil salesmen,” said Philadelphia attorney Stephen Sheller, whose firm handles product liability lawsuits against pharmaceutical companies.

“Why not also bring out a circus wagon?”

While Sheller has a financial stake in this situation, he is not alone in his suggestion that modern carnival barkers might be employed if the appeals court ruling is pushed forward.

A key regulation prohibits drug companies from promoting a product for any use except for the “intended use” approved by the U.S. Food and Drug Administration, even though doctors can legally prescribe it and patients can legally take it for other ailments.

Such promotion is called “off-label,” because multi-page labels full of technical language and 30-second TV ads are supposed to be specific to the condition for which the drug is approved.

The FDA regulation is overly paternalistic and unfair to companies, according to its critics.

Without it, the government argues, patients could be dangerously impacted by drug company propaganda.


Log in to comment