The Southern District of New York recently decided in favor of drug manufacturer Amarin Pharma, Inc., in a dispute with the U.S. Food and Drug Administration, ruling that the company may engage in truthful and non-misleading speech about off-label uses of its approved drug, Vascepa, without the threat of a misbranding action under the Federal Food, Drug, and Cosmetic Act.
“A decision on a preliminary injunction can be enough” to lead the FDA to drop the case, said Marc Scheineson, Alston & Bird partner and head of the firm’s Food and Drug Law Practice. “In prior cases that are similar to this one, it has been enough” because the ruling indicates that Amarin “is likely to prevail on the merits of the case.… That’s normally been enough for the FDA.”
A former associate commissioner for legislative affairs at the FDA, Scheineson said he would be “very surprised if the agency appeals,” adding that while “commercial free speech rights are not as strong as individual free speech rights,” the ruling made clear that companies with “products that are lawfully marketed have the right to speak about [off-label uses] truthfully and as long as they are not misleading.”
Said Scheineson: “Doctors are able to prescribe drugs for off-label uses.”
Even if the decision is “likely to stay and be good law” as it comes from a “well-established and influential court, I don’t think the floodgates will open,” he said, pointing to the potential dangers with both product liability litigators and the HHS Office of Inspector General, which has gotten “billions of dollars from companies that promoted off-label” uses that were reimbursed by Medicare or Medicaid.
As for Medicare or Medicaid reimbursement, “it still isn’t clear” what OIG will do, so it’s likely that “companies will continue to be conservative and careful about making off-label claims,” said Scheineson. “Fewer FDA warning letters will be issued” because those will likely be “pushed back to the FDA’s Office of Chief Counsel for review.”
Scheineson noted that “this is a landmark case because the court spent so much time – 71 pages – going through specific language” and that it can be used “as a roadmap or a textbook on how companies should promote” off-label uses of their products and avoid running afoul of the FDA.
“A decision on a preliminary injunction can be enough” to lead the FDA to drop the case, said Marc Scheineson, Alston & Bird partner and head of the firm’s Food and Drug Law Practice. “In prior cases that are similar to this one, it has been enough” because the ruling indicates that Amarin “is likely to prevail on the merits of the case.… That’s normally been enough for the FDA.”
A former associate commissioner for legislative affairs at the FDA, Scheineson said he would be “very surprised if the agency appeals,” adding that while “commercial free speech rights are not as strong as individual free speech rights,” the ruling made clear that companies with “products that are lawfully marketed have the right to speak about [off-label uses] truthfully and as long as they are not misleading.”
Said Scheineson: “Doctors are able to prescribe drugs for off-label uses.”
Even if the decision is “likely to stay and be good law” as it comes from a “well-established and influential court, I don’t think the floodgates will open,” he said, pointing to the potential dangers with both product liability litigators and the HHS Office of Inspector General, which has gotten “billions of dollars from companies that promoted off-label” uses that were reimbursed by Medicare or Medicaid.
As for Medicare or Medicaid reimbursement, “it still isn’t clear” what OIG will do, so it’s likely that “companies will continue to be conservative and careful about making off-label claims,” said Scheineson. “Fewer FDA warning letters will be issued” because those will likely be “pushed back to the FDA’s Office of Chief Counsel for review.”
Scheineson noted that “this is a landmark case because the court spent so much time – 71 pages – going through specific language” and that it can be used “as a roadmap or a textbook on how companies should promote” off-label uses of their products and avoid running afoul of the FDA.