Will the FDA's Settlement with a Tiny, One-Drug Company Open the Door to Off-Label Marketing for Big Pharma?

Will the FDA's Settlement with a Tiny, One-Drug Company Open the Door to Off-Label Marketing for Big Pharma?

In recent years, numerous Big Pharma companies have been fined hundreds of millions and even billions of dollars for "off-label marketing" - promoting uses for its drugs that have not been ruled "safe and effective" by the FDA. Restrictions on what drug companies can say to promote their products don't restrict what physicians can prescribe. Doctors can use FDA approved drugs any way they want to. The issue is only about what manufacturers can say, or not say, to promote their products. If the FDA's recent loss in court to a tiny, one-drug company has the snowballing effect many observers expect, it could soon lift the lid for the pharmaceutical industry's eager marketers. Several years ago, tiny Ireland-based Amarin Pharma, Inc. decided that it must expand the market for its one and only drug or risk declining share values and investor wrath. The company's prescription-based derivative of fish oil, called Vascepa, is FDA-approved only for patients with very high triglyceride levels. Amarin applied to the FDA to expand its on-label use to patients with somewhat lower triglycerides with heart disease and who are taking cholesterol-lowering statin drugs. The company conducted several trials and provided convincing evidence of benefits. Eventually, based on other considerations, the FDA disapproved the application. Impressed with its own research, and believing physicians should know about it too, Amarin decided it must find a way to legally tell doctors about the positive findings of its drug trials.

David vs Goliath

In an action that some observers say will surely permeate all of pharma, Amarin sued the FDA in federal court for violating its "free speech" rights guaranteed under the First Amendment. In June 2014, before the trial began, the FDA revealed how desperate it was to get Amarin to quit the case, and told the company it could go ahead and talk about its product. But Amarin wasn't having any of it, and proceeded to court. And in August, Judge Paul Engelmayer, U.S. District Court for the Southern District of New York, handed down "one of the most significant rulings concerning First Amendment protection for a pharmaceutical manufacturer's off-label promotion of an otherwise approved drug," according to the FDA Law Blog. Judge Engelmayer granted a motion for "preliminary injunction" against the FDA and in favor of Amarin. Surprising legal experts, the judge defended the merits of Amarin's First Amendment claims for free speech in its marketing. The ruling also allows Amarin to submit marketing materials to the FDA for approval, but only if it wants to. The injunction rendered the FDA powerless to stop Amarin until a final determination of the merits of the case could be decided. The agency's only recourse was to appeal the court's decision. "Citing the First Amendment," Roger Cergel wrote in MedPage Today, "the judge's ruling said Amarin - and presumably every other pharmaceutical company - can say anything to physicians as long as it's truthful, without prior approval from the government."

Which way will the FDA go?

For nearly eight months, industry watchers have waited to see whether the FDA would appeal or concede. Obviously, the preliminary injunction was seen as a potentially massive erosion of the FDA's essential control over drug use, labeling and marketing. Last week, the FDA confirmed it will not appeal Judge Engelmayer's decision. It announced that Amarin can discuss its drug trial results with doctors, providing it drops its case against the FDA. "It is important to note," the FDA said, "that this settlement is specific to this particular case and situation, and does not signify a position on the First Amendment and commercial speech." However, the court's landmark decision had already prompted another company, Pacira, to ask a federal court to do the same for its pain drug Exparel. Back in 2014, the FDA warned the New Jersey company to stop promoting Exparel for uses not listed on its label. But the company claims its label doesn't actually limit the drug to specific surgeries, and that they should be allowed to point that out to doctors.

Where does it all end?

Writing in a JAMA Internal Medicine article, Yale law professor Amy Kapczynski, JD, said that the Amarin decision could unleash a flood of misleading marketing to physicians and replace drug regulators with judges who lack the training and tools to evaluate drug claims. At some point, she said, the agency will need to take the issue of off-label marketing to the Supreme Court "or lose a key aspect of its regulatory authority by a thousand cuts." Dr. Jerry Avorn, Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women's Hospital, was equally disturbed. Writing in Health Affairs Blog, Dr. Avorn said "the real issue is whether we as a society feel that there is something special about human illness and its treatment that warrants a different legal status than promotional statements made about refrigerators. "The rampant forces of commercial free speech zealotry that are working in the service of corporate empowerment are likely to win this battle. Paradoxically, patients' rights to the best possible medical care will be diminished in the process," Dr. Avorn added.

The bottom line

Here at Novus, we've witnessed many arguments between the forces of "more drugs" vs "less drugs" - particularly concerning opioids and other psychoactive drugs. We hope that the current "free speech" movement among pharma companies won't contribute in any way to undercut the recent positive federal guidelines calling for greater restraint in opioid prescribing.

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