|FDA's Janet Woodcock|
Pharma marketers are closely watching Amarin's ($AMRN) lawsuit demanding the right to talk up the off-label uses for its cardiovascular drug Vascepa. After all, if the legal attack against FDA regulations succeeds, that gives credence to drugmakers' free speech argument--and could open up new worlds of drug promotion.
The FDA knows this. And it's fighting back, if obliquely. Agency official Janet Woodcock wrote Amarin this week to say, a., the company should have talked to the FDA rather than rushing off to the courthouse to sue; and b., most of the marketing moves Amarin wants to make are kosher already.
"FDA does not have concerns with much of the information you proposed to communicate," wrote Woodcock, director of the agency's Center for Drug Evaluation and Research (as quoted by Reuters).
Amarin has been struggling to gain traction for Vascepa, a fish oil-derived pill that competes with GlaxoSmithKline's ($GSK) newly generic Lovaza. Right now, Vascepa is approved only for lowering extremely high triglyceride levels, an indication much narrower than Amarin had hoped for. The company has so far failed to persuade the FDA to broaden Vascepa's approval to patients with high triglycerides at high risk of coronary artery disease--a much larger population.
Naturally, Amarin wants access to those patients. And it's prohibited under current FDA rules from touting Vascepa for that hoped-for indication.
But it can talk about research in those patients, Woodcock wrote in the letter, filed with a federal court in New York. Amarin can discuss articles published in medical journals or data from clinical trials, she wrote.
"FDA would not consider the dissemination of most of that information to be false or misleading, and we do not intend to rely on it as evidence that Vascepa is intended for a use that would render Vascepa an unapproved new drug or misbranded," the letter states.
Amarin's lawsuit is full of grandiose First Amendment talk, claiming that FDA restrictions violate the company's constitutional rights. The company isn't the first to use that argument, either. And since the U.S. Supreme Court upheld one sales rep's right to discuss off-label drug uses--as protected free speech, so long as it's truthful--the FDA has been saying it's open to the argument.
At least up to a point. The agency is working on new guidelines for pharma's distribution of off-label information about its drugs, including journal articles and other data on unapproved uses. But in addition to the pressure from drugmakers that want to discuss off-label use, some consumer watchdogs and other groups are urging the FDA to hold the line. After all, unapproved uses aren't approved for a reason.
If Amarin's free speech argument were to succeed in court, then the company might be able to take credit for blazing a trail for its larger competitors--and circumventing the FDA's own efforts to loosen up on off-label chatter. "This is a precedent-setting lawsuit that seeks to break new ground on the rights of free speech," a company executive recently wrote in a letter to its doctor-speakers. No wonder the FDA is trying to nip that in the bud.
- read the Reuters news