FDA Surrenders in Off-Label Promotion Fight

Game, set and match. The FDA has thrown in the Amarin towel and will not appeal a federal court ruling that Amarin Pharma, Inc. has the First Amendment right to tell physicians about off-label uses for their fish oil product, if the claims are “truthful and non-misleading.”

Medical device makers now have a clear roadmap for bringing truthful claims, not yet blessed by the FDA, to physicians about their devices.

In a settlement reached with the company on March 7, 2016, the FDA avoids another court loss that would have continued to damage the agency’s self-proclaimed right to require FDA blessing for all uses of a device or drug, regardless of the truthfulness of the claims.

Under the terms of the settlement, the FDA and the government have agreed to be bound by an August 7, 2015, judicial declaration that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa (icosapent ethyl) Capsules. Amarin’s expanded promotion of Vascepa, initiated following the August 2015 judicial declaration, continues as planned.

“We are pleased to announce this amicable resolution with and among the physician plaintiffs, FDA and the U.S. government and look forward to continuing to promote Vascepa in a truthful, non-misleading and responsible manner, ” stated John F. Thero, Amarin president and CEO. “With more truthful and non-misleading information readily available to healthcare professionals about the potential of Vascepa to improve cardiovascular health, this settlement serves the public interest by supporting informed medical decisions for tens of millions of patients with persistent high triglycerides.”

Other parts of the settlement include:

• Amarin bears the responsibility of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.
• The settlement terms are to be interpreted consistently with the August 7, 2015 opinion and order and are not to be construed to limit Amarin’s constitutional rights to free speech concerning Vascepa.
• FDA has agreed to provide Amarin with an optional preclearance provision through 2020 for new off-label claims.
• The parties have agreed to a dispute resolution provision designed to avoid future litigation on matters arising under the settlement order.
• The court would retain jurisdiction over the matter to ensure compliance with and resolve any future dispute arising from the settlement order.

Implications

Has tiny Amarin opened a Pandora’s box?

Recently, a federal jury acquitted Vascular Solutions and its CEO Howard Root of charges of off-label promotion of that company’s device for the treatment of varicose veins. In that case, the jury received instructions from the judge stating that truthful speech is a defense to FDA violations. These rulings, said Sanjay Kaul, M.D. of Cedars-Sinai Medical Center in Los Angeles, appear to “suggest that the federal government has abandoned the idea that truthful and non-misleading off-label promotion can be criminal.”

“Personally, I think this ruling while ‘legally’ and ‘constitutionally’ correct could potentially end up opening up a Pandora’s box that will likely burden the already stretched FDA with additional workload and detract from its mission of promoting innovation without compromising public safety, ” added Kaul, in an interview with tctmd.com.

In a client note on March 9, attorneys from King & Spalding note that the agreement is “not expressly limited to certain speakers at Amarin (e.g., those serving in scientific roles, as opposed to sales representatives); it is not expressly limited to a certain setting (e.g., a scientific setting as opposed to a promotional setting); and it is not expressly limited by the education or expertise of the recipient (e.g., to physicians and other health care professionals).

The agreement is only applicable to Amarin, but as the Vascular Solutions case shows, the truthful speech cat is out of the bag in courtrooms for all device and drug makers.

Your Roadmap

Should your sales reps start promoting truthful and non-misleading unapproved uses of your device? Consult your lawyers and consider it carefully before a competitor starts eating away at your indications.

Here’s what the King & Spalding lawyers advise—ask the FDA for a formal or informal advisory opinion. This allows the agency to make policy decisions on a one-off basis, such that the agency can act without needing to resolve larger policy issues. The agency can single out specific facts that distinguish a particular arrangement to protect a single proposed practice without necessarily setting a broader precedent or changing official FDA policy.

If you seek an FDA advisory opinion and the agency does not oblige, you can then proceed with filing a declaratory judgment action.

Finally, say the lawyers, “To the extent that seeking these types of advisory opinions becomes more common, it may also be difficult for FDA to articulate why other manufacturers should not receive the same prompt responses to which Amarin is entitled under the settlement agreement.”