The U.S. Food and Drug Administration chief counsel Elizabeth Dickinson announced a public meeting last month, that will be held this summer to address drug company concern that restrictions on what they can say about off-label use of drugs violate their First Amendment right to free speech.
Efforts by drug companies to change the rules gained steam after a 2012 decision from the Second Circuit Court of Appeals, which overturned the conviction of Alfred Caronia, a sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceuticals Inc. After Caronia was caught talking to physicians about various off-label uses of the narcolepsy drug Xyrem, the court said the First Amendment protected truthful and non-misleading off-label speech.
Under current rules, physicians are allowed to prescribe medicines off-label for whatever condition they want. But drug companies are not allowed to promote them for uses that have not been approved by the FDA. Now, pharmaceutical companies are citing the Caronia and similar rulings to pressure the FDA to let them talk more freely about off-label use.
"If you're a community physician it's hard to stay current," said Coleen Klasmeier, a partner at Sidley Austin LLP, which petitioned the on behalf of a coalition of pharmaceutical companies to "adequately justify and appropriately tailor its regulatory regime" in light of Caronia and similar rulings. This coalition, known as the Medical Information Working Group, includes Pfizer Inc, Sanofi, Novartis AG, Johnson & Johnson, Eli Lilly, and Co and GlaxoSmithKline Plc, among others.
At stake are billions of dollars in potential sales if manufacturers can persuade physicians to use their products for unapproved uses and a potentially significant weakening of the FDA's regulatory authority.
"If off-label marketing is allowed then drugs will come to be used for a wide variety of conditions for which there has not been developed evidence of safety and efficacy," said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. "You take away those checks and balances and it's the wild, wild west."