A pharmaceutical company scored a major victory over the Food and Drug Administration (FDA) in district court in Amarin v. FDA, claiming the First Amendment allowed it to promote a drug’s off-label use because its claims were truthful and not misleading.
Marc Scheineson, co-leader of Alston & Bird’s Food, Drug & Device/FDA Practice, notes that this verdict could put pressure on the FDA to deliver long-promised but not delivered guidance on off-label promotion.
The FDA could appeal to the Second Circuit to set up a review by the U.S. Supreme Court review, but the High Court has consistently held that truthful speech is protected by the First Amendment, Scheineson said.
Despite the FDA’s fear that companies could use this decision to promote off-label use and avoid the approval process, the agency “still has a big hammer with the false or misleading standard,” said Scheineson. The FDA’s Office of Prescription Drug Promotion, however, may be cautious with its warning letters and untitled letters, recognizing that the district court decision may add new layers of legal review for enforcement and strain the agency’s already stretched resources.
The agency’s Office of Inspector General (OIG) has “extracted billions” from pharmaceutical companies by turning off-label promotion allegations into False Claims Act (FCA) cases, said Scheineson. But the Amarin decision may provide a path for companies to mitigate FCA risks, as it may be difficult for the OIG to prosecute an FCA case if there is a disclaimer specifically telling a prescriber that the drug is not reimbursable.
The unique circumstances of this case will keep manufacturers conservative until the FDA offers clarity, said Scheineson. Amarin brought its study to the FDA first, but the FDA is “good at shredding the design” of a study it hasn’t seen beforehand.
Marc Scheineson, co-leader of Alston & Bird’s Food, Drug & Device/FDA Practice, notes that this verdict could put pressure on the FDA to deliver long-promised but not delivered guidance on off-label promotion.
The FDA could appeal to the Second Circuit to set up a review by the U.S. Supreme Court review, but the High Court has consistently held that truthful speech is protected by the First Amendment, Scheineson said.
Despite the FDA’s fear that companies could use this decision to promote off-label use and avoid the approval process, the agency “still has a big hammer with the false or misleading standard,” said Scheineson. The FDA’s Office of Prescription Drug Promotion, however, may be cautious with its warning letters and untitled letters, recognizing that the district court decision may add new layers of legal review for enforcement and strain the agency’s already stretched resources.
The agency’s Office of Inspector General (OIG) has “extracted billions” from pharmaceutical companies by turning off-label promotion allegations into False Claims Act (FCA) cases, said Scheineson. But the Amarin decision may provide a path for companies to mitigate FCA risks, as it may be difficult for the OIG to prosecute an FCA case if there is a disclaimer specifically telling a prescriber that the drug is not reimbursable.
The unique circumstances of this case will keep manufacturers conservative until the FDA offers clarity, said Scheineson. Amarin brought its study to the FDA first, but the FDA is “good at shredding the design” of a study it hasn’t seen beforehand.