• by Thom Forbes  @tforbes, May 8, 2015

Amarin, a small pharmaceutical firm based in Dublin, Ireland, that makes a fish-oil pill approved by the Food and Drug Administration to treat patients with high levels of triglycerides, and four physicians have filed a lawsuit in federal district court in New York seeking the right to discuss off-label uses of its drug with physicians based on its right to free speech under the First Amendment.

A ruling in its favor could have broad implications for pharmaceutical marketers who “have long argued they should have the right to talk to doctors about unapproved uses for their products, as long as they are being truthful,” writes Katie Thomas for the New York Times, pointing out that courts have sometimes agreed. 

“But the federal government still frowns on the practice and, in recent years, has fined drug companies billions of dollars for talking to doctors about so-called off-label uses for their medications,” Thomas reports.

The suit centers on Amarin’s Vascepa, which “was approved in 2012 to help reduce triglycerides levels in adult patients with severe hypertriglyceridemia, but was subsequently turned down by the FDA for reducing high levels of triglycerides in patients with heart disease who are taking statins,” reports Selina McKee for PharmaTimes Digital.

“The company is not seeking to actively market the drug to a wider population, but wants to be able to share with physicians relevant information that might be considered off-label promotion, including from a clinical trial … showing that Vascepa reduced triglycerides in patients with persistently high levels despite statin therapy,” McKee continues.

Amarin, whose U.S. operation is based in Bedminster, N.J., is represented by prominent free-speech lawyer Floyd Abrams of the New York law firm Cahill Gordon & Reindel and two other partners, Joel Kurtzberg and Michael Weiss. Among many honors he has received, Abrams was awarded the CUNY Graduate School of Journalism's Lifetime Achievement Award in 2011, the same year Yale Law School announced the formation of The Floyd Abrams Institute for Freedom of Expression.

“It’s a case which challenges the ability and the power of the FDA to limit speech and potentially punish it notwithstanding that the speech is both important in nature and has every aim of serving the public,” Abrams tells Forbes’ Matthew Herper, who points out that the attorney “is also representing tobacco companies in a case that challenges the FDA’s ability to require graphic labeling.”

The FDA had no immediate comment on the litigation.

“Even though doctors are free to prescribe medicines for any use, the FDA has long argued that off-label promotion may be evidence that a drug maker intended or attempted to sell misbranded medicines. The agency also maintains that off-label promotion effectively skirts the drug approval process,” reports Ed Silverman for the Wall Street Journal’s “Pharmalot” blog. “One consumer advocate agrees.”

“If companies can go directly to physicians with studies they believe support other uses, they would be no motivation to seek FDA approval for those purposes,” says Michael Carome, the director of Public Citizen Health Research Group.

“Amarin's hypothesis, shared by some physicians, is that lowering triglycerides reduces the risk of heart attack. The company is conducting a trial to evaluate whether that is the case. The results are expected in 2018,” Reuters’ Toni Clark reports. 

“The company had wanted in the meantime to market the pill simply as a triglyceride-lowering agent, but an FDA advisory panel recommended it not be approved for the broader population until the results of the trial were in. Last month the agency rejected the company's application, prompting the lawsuit.”

In other pharmaceutical news, Johnson & Johnson officially announced yesterday that it was creating a “first-of-its-kind” partnership with the NYU School of Medicine to create an independent third-party panel that will “review requests made to the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) for compassionate use of its investigational medicines.”

Arthur L. Caplan, a nationally known bioethicist “who has written extensively about the issue of experimental drug availability,” will oversee the panel, writes the New York Times’ Thomas in a scoop that led the print edition of the newspaper yesterday morning.

“J&J’s move comes amid growing support for the so-called ‘right to try’ movement in the U.S.,” reports PBS NewsHour’s Stephen Fee. Last year, Colorado became the first state to allow terminally ill patients to request experimental drugs without approval from the federal Food and Drug Administration.”

“‘The laws basically say, you know what? We’re tired of all these bureaucratic obstacles,’” Caplan told the PBS NewsHour last year. “We’re going to pass a law in our state that says, if you’re terminally ill, once it’s passed phase one — that tiny safety testing on a small number of people — you can get anything you want.’”

Thomas reports that J&J will fund the pilot program with payments going directly to NYU. Caplan, will not be paid, says he sees the experiment as “a chance to not just complain about what’s wrong, but maybe to suggest a way forward.”