A judge’s ruling allowing one drugmaker to engage in off-label promotion upends longstanding taboos about what is permissible to market beyond the FDA-approved label, but companies still need to proceed carefully if they want to exploit the legal opening to pursue similar claims.  

The ruling in question permits Amarin to legally share truthful, scientific data that demonstrates that its prescription fish-oil drug, Vascepa, can lower triglyceride levels in patients with less severe hypertriglyceridemia.

The FDA approved Vascepa in 2013 as a treatment for patients with severely high triglyceride levels, a condition that affects about 4 million people in the US. Amarin had sought out a broader indication that would have allowed it to market Vascepa to a patient population that is ten times bigger, a move that would have differentiated the drug from competitors and most likely boosted sales.   

When the FDA declined to approve the drug as a therapy for patients with elevated triglyceride levels, a less severe form of the condition, Amarin sued, alleging that the agency violated its First Amendment rights and contending that the information it wants to provide to physicians is mostly derived from an FDA-approved study and from FDA materials.

“At this stage, the court’s judgment is to err on the side of caution, meaning in favor of giving doctors more, not less, information,” the judge wrote in his decision.  

Still, the closely watched ruling, while a setback for FDA and a win for Amarin, doesn’t give drugmakers free rein to communicate any off-label information they want to physicians or patients.

What it does do is create a legal pathway that other pharma companies can mimic by first ensuring they have collected truthful scientific data, then seeking permission from the FDA to communicate that data and finally taking their case to the US Court of Appeals Second Circuit as the final option.

“The procedure is out there,” said Jim Beck, a lawyer with Reed Smith.

There are lingering questions left to be answered, including whether the FDA will appeal the judge’s decision. The deadline for appeal is in early October.  

“It’s one ruling and one case in New York,” said Albert Cacozza Jr., a partner at law firm Ropes & Gray, one of the firms representing the Medical Information Working Group, which was hired to advance the drug industry’s agenda in Washington. “The smoke hasn’t cleared yet.”

One area in which the Amarin ruling cast doubt and requires further clarification involves the FDA’s longstanding rule of limiting “scientific exchange” to some healthcare providers but banning promotional communication by sales reps and paid media, observed John Kamp, executive director of the Coalition for Healthcare Communication.

In a communiqué to coalition members following the ruling, Kamp said that the MIWG, along with the trade group PhRMA, submitted various requests to the FDA for clearer definitions of scientific exchange and that, as the standard for allowable marketing evolves, these requests “offer clues to the next stage” of what is permissible.

“Industry is warned not to change its off-label policies based only on this decision,” Kamp wrote. “However, it is clear that the era of bans on truthful off-label marketing is coming to an end.”

The lingering ambiguity won’t stop Amarin from moving forward with plans to promote Vascepa for people with elevated triglyceride levels. The company said it plans to begin marketing use of the drug in this patient population “as soon as possible.” An Amarin spokesperson declined to comment on upcoming promotional activities.

The prescription fish-oil market is a competitive one. Amarin’s Vascepa, which was approved in 2013, is a relative newcomer to the market. GlaxoSmithKline brought the first prescription fish-oil drug, Lovaza, to market in 2005. The drug reached blockbuster sales status before it lost patent protection in 2013; Teva received approval for a generic last year.

AbbVie and AstraZeneca also market fish-oil drugs for patients with severe hypertriglyceridemia. AstraZeneca launched its drug, Epanova, in late 2014.

There are some differentiating factors among the handful of generic and branded prescription fish-oil drugs sold in the US. Amarin is unique is that it has data that further differentiates it from competitors, said Akiva Felt, an analyst for Oppenheimer & Co. Still, the availability of that data has done little to change the prescribing habits of physicians.

“GSK did a really good job building this market,” Felt said. “But in a big primary-care market, it’s hard to shift doctors.”

The vast majority of prescriptions for prescription fish-oil drugs are already written for off-label indications, with an estimated 75% of Lovaza’s prescriptions used in an off-label capacity. The ruling and Amarin’s subsequent marketing activities “should move the needle a little bit,” Felt said.

Amarin, which has one FDA-approved product, Vascepa, reported $54.2 million in revenue in 2014, up from $26.3 million in 2013, but the company’s sales are notably lower than the other players in the prescription fish-oil market, a position that may have prodded the company into taking legal action to support its promotional activities.

Beyond the relatively small prescription fish-oil market, though, the case has been closely watched. Industry leaders such as Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Johnson & Johnson and PhRMA filed amicus briefs in support of Amarin.

Floyd Abrams, a partner at Cahill Gordon & Reindel and Amarin’s counsel, described the case as the “first decision that clearly and unequivocally rebuffs the government’s view that off-label promotion can be prosecuted even if it is truthful and non-misleading.”

It also fits neatly into a broader narrative calling for changes to longstanding rules limiting what drug information pharma companies can promote to patients and to physicians.

The ruling in the Amarin case was largely based on a 2013 decision in the same Second Circuit court that vacated the conviction of Alfred Caronia, a former pharma sales rep who gave truthful off-label information about a narcolepsy drug to physicians. Additionally, the 21st Century Cures Act, passed by the House in July, includes a provision that would allow pharma companies to share off-label economic data with payers.

Off-label pharmaceutical marketing is often synonymous with problematic marketing of drugs for off-label indications that is done solely to boost corporate profits and has caused patient harm in some cases. Dozens of drugmakers have paid billions of dollars to settle lawsuits claiming they engaged in off-label marketing of their drugs.

Sources say Amarin’s case for off-label marketing is different in its make-up than the off-label marketing cases brought by the government in recent years.

“I don’t think it’s going to open the floodgates to irresponsible off-label promotion,” said Dr. Daniel Carlat, a drug marketing expert and associate clinical professor of psychiatry at the Tufts University School of Medicine. “Companies are still going to have to be really cautious about what their sales reps say.”

Still, the case may raise questions about what constitutes truthful off-label marketing. Small clinical studies that are not well controlled that show a drug is effective for treating a particular condition or patient population may be held up as scientific data that is truthful and is not misleading. “That may be more likely to happen with a decision like this,” Carlat said.