Court ruling could grant latitude on drug claims

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

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

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

For more than a century, to varying degrees, the federal government has tried to protect Americans from bad food and drugs. But a recent federal appeals court decision - if 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 lawyer 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 the 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, though doctors can legally prescribe it and patients can legally take it for other ailments. Such promotion is called "off-label," because multipage 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 companies' propaganda.

The case of a drug salesman named Alfred Caronia could redefine the FDA's protocol for approving medicines and directing how they can be used. In 2009, Caronia was convicted in federal court in Brooklyn, N.Y., for promoting the drug Xyrem for uses not approved by the FDA. On Dec. 3, the U.S. Court of Appeals for the Second Circuit overturned the conviction. The reason: The FDA rules denied Caronia's right to free speech.

Xyrem was approved to treat excessive daytime sleepiness in patients with narcolepsy. Prosecutors twice recorded Caronia promoting Xyrem for off-label or unapproved uses such as fibromyalgia, muscle disorders, chronic pain, and fatigue.

Caronia worked on Long Island and part of New York City for Orphan Medical Inc., now part of Jazz Pharmaceuticals, which is headquartered in Ireland but has two of its three U.S. offices in Center City and Langhorne, Bucks County. Orphan and a company-paid doctor, Peter Gleason, pleaded guilty to charges in the case, which was prosecuted by the U.S. Attorney's Office in Brooklyn.

The two-judge majority opinion in the appeals court decision was very carefully worded, perhaps narrowly so, with recent Supreme Court decisions about corporate free speech in mind, one lawyer suggested.

Beyond Caronia, the decision was a victory for pro-business groups that assert the First Amendment protects the right of individuals to speak truthfully about off-label uses of FDA-approved drugs.

Pharmaceutical Research and Manufacturers of America (PhRMA), which represents drugmakers, said in a statement after the appeals court decision that "as the Supreme Court, and now the Second Circuit, have recently affirmed, speech by biopharmaceutical companies is protected by the First Amendment, and any policy that restricts speech by biopharmaceutical companies, while allowing others to freely engage in similar speech, is subject to heightened constitutional scrutiny."

An FDA spokeswoman declined comment. A Justice Department spokesman said the government had not decided on its next legal step, including a Supreme Court appeal.

Because the decision, for now, directly impacts only the Second Circuit states of New York, Connecticut, and Vermont, manufacturers are unlikely to change tactics, said Virginia Gibson, a former federal attorney involved in prosecuting drug companies and now a partner in the Philadelphia office of Hogan Lovells, which represents some drug companies.

Judge Debra Ann Livingston, who dissented in the appeals court verdict, argued that there are situations where speech is properly restricted and that the FDA rules are exceptions created because of profit-driven drug companies and their salespeople.

In writing that "the majority calls into question the very foundations of our century-old system of drug regulation," and runs contrary to previous Supreme Court decisions about that regulatory issue, Livingston invoked Abby and Martha Brewster, the killer sisters in Arsenic and Old Lace. Livingston wrote that just because it was legal to consume arsenic doesn't mean statements in the play by Abby and Martha about their intent to murder lonely bachelors with arsenic would be deemed acceptable and unusable as evidence against them.

Livingston, who was appointed to the appeals court by President George W. Bush, noted that insider-trading rules restrict speech, with the "intended use" of the regulation being fairness for all stock-market traders.

Livingston referenced a 19th-century company run by the Hamlin brothers of Elgin, Ill., who peddled a potion that supposedly contained alcohol, sassafras, and turpentine, among other ingredients.

The brothers claimed it was good - internally or externally - for rheumatic pain, sore muscles, pneumonia, cancer, diphtheria, earache, toothache, headache, and hydrophobia, according to a book published on elginhistory.com. Judge Kenesaw Mountain Landis, who later gained fame as the first Major League Baseball commissioner, fined the Hamlin brothers $200 for false advertising in 1916.

"The concept of 'intended uses' largely defines the scope of the FDA's regulatory authority," Livingston wrote. "To put the matter in practical terms: It is because of the 'intended uses' principle that hardware stores are generally free to sell bottles of turpentine but may not label those bottles, 'Hamlin's Wizard Oil: There is no Sore it will Not Heal, No Pain it will not Subdue.' "