By Dr. Kate Scannell, Syndicted Columnist
First published in Print: 12/08/2012
Until recently, the law of the land firmly held that once the Food and Drug Administration (FDA) approved a drug, doctors could prescribe it as they saw fit -- but the drugmakers could market the drug only for the FDA-approved indications as specified on the drug's so-called "label." Indeed, it was illegal for drug sales reps to even mention, let alone promote, the use of a drug for conditions that were "off label."
But Monday, a federal appeals court wrote a new script that could pose far-reaching side effects on U.S. drug regulation and patient safety. In a 2-1 decision, the judges of the 2nd U.S. Circuit Court of Appeals ruled that a pharmaceutical salesman's First Amendment rights of free speech had been violated when he was convicted in 2009 for promoting off-label drug use. His conviction was overturned, and the pharmaceutical industry celebrated.
As a doctor and a patient, I think this ruling was a big mistake. It jeopardizes drug regulation in the public interest, and it allows drug companies to have an even louder say in how medicine is practiced. It upholds and defends the free speech of a commercially motivated drug salesperson as though it were an abstraction, without considering the real risk of real harm to actual patients.
But like yelling "fire" in a crowded theater, shouting out a drug's name in a busy clinic filled with harried physicians and vulnerable patients can cause mortal harm. Read More
First published in Print: 12/08/2012
Until recently, the law of the land firmly held that once the Food and Drug Administration (FDA) approved a drug, doctors could prescribe it as they saw fit -- but the drugmakers could market the drug only for the FDA-approved indications as specified on the drug's so-called "label." Indeed, it was illegal for drug sales reps to even mention, let alone promote, the use of a drug for conditions that were "off label."
But Monday, a federal appeals court wrote a new script that could pose far-reaching side effects on U.S. drug regulation and patient safety. In a 2-1 decision, the judges of the 2nd U.S. Circuit Court of Appeals ruled that a pharmaceutical salesman's First Amendment rights of free speech had been violated when he was convicted in 2009 for promoting off-label drug use. His conviction was overturned, and the pharmaceutical industry celebrated.
As a doctor and a patient, I think this ruling was a big mistake. It jeopardizes drug regulation in the public interest, and it allows drug companies to have an even louder say in how medicine is practiced. It upholds and defends the free speech of a commercially motivated drug salesperson as though it were an abstraction, without considering the real risk of real harm to actual patients.
But like yelling "fire" in a crowded theater, shouting out a drug's name in a busy clinic filled with harried physicians and vulnerable patients can cause mortal harm. Read More