Since a U.S. circuit court decided the First Amendment protected a pharma sales rep from off-label marketing charges, the free-speech arguments have multiplied in cases across the country, testing that Second Circuit decision in other regions.
PhRMA has jumped into a California False Claims Act case, with a friend-of-the-court brief defending Millennium Pharmaceuticals, Schering-Plough and Merck's right to talk up unapproved uses of the clot-fighting drug Integrilin.
While it was fighting a hostile takeover by Valeant Pharmaceuticals, Allergan found time to claim its free-speech rights in a dispute over eye-drug promotions. The U.S.-based drugmaker used a similar tactic back in 2009, in a lawsuit over its Botox marketing.
Studies have shown that cutting down on face time between pharmaceutical reps and healthcare providers can cut down on expensive brand prescribing. But now, new data suggest that scaling back rep visits can also lower off-label prescribing.
GlaxoSmithKline's latest penalty for improper marketing practices may seem little more than a slap on the hand--except that it's coming at the worst possible time for the embattled British drugmaker. GSK agreed to pay $105 million to settle charges in California, New York, Texas and more than 40 other states that it illegally promoted its asthma drug Advair and antidepressants Wellbutrin and Paxil.
Off-label marketing strikes again. Pfizer agreed to pay $325 million to wrap up claims that its Parke-Davis unit touted the epilepsy drug Neurontin for uses not approved by the FDA, costing healthcare payers millions in unnecessary spending.
FDA officials are having a rethink on free speech--and that could end with an about-face on off-label marketing.
What with key court decisions apparently backing First Amendment protections for drug promotions, the FDA has moved off-label communications to the top of its to-do list--and off-label marketing is a hot-button issue, what with the series of multibillion-dollar settlements with the U.S. Justice Department.
When Insys Therapeutics won approval for its new narcotic painkiller, Subsys, in 2012, few predicted the product would find much of a market, because the FDA limited its use to cancer patients who were already on powerful painkillers. But in 2013, the product raked in $96 million in sales, and the company's stock price quintupled to $25 a share.
For former Endo sales rep Peggy Ryan, the pivotal moment came about three years into her employment with the Malvern, PA-based company. She was at a national meeting, where the topic of discussion was how to distribute off-label studies in an unsolicited way, she says.