A federal court ruled on Friday that the U.S. Food and Drug Administration (FDA) could not stop a drug company from marketing the unapproved uses of one of its products.
In a case seen to have a potential implications on the ability of the FDA to regulate drug marketing, U.S. District Judge Paul Engelmayer allowed Bedminster, New Jersey-based biopharmaceutical company Amarin Corp. to market its fish oil Vascepa drug for off-label use.
The company filed a suit against FDA citing violation of the First Amendment. Engelmayer said that stopping the pharmaceutical company from telling doctors about the unapproved uses of its drug would violate the protection of free speech.
"Although recognizing that the FDA's policies advanced a substantial government interest in requiring manufacturers to submit supplemental applications for new drug uses, the court held the FDA's restrictions on such speech were more extensive than necessary, and thus breached the First Amendment," the district judge wrote.
Drug companies have collectively been fined billions of dollars as a consequence of promoting drugs for their unapproved uses. The decision could have implications in the drug industry albeit lawyers said that they anticipate the FDA to appeal.
Pharmaceutical manufacturers are also likely to remain cautious with openly promoting products for their unapproved uses although Amarin, which sells Vascepa for the treatment of extremely high levels of triglycerides, a type of fat found in the blood, said that it now plans to promote the use of the drug for those who have lower levels of triglycerides, a use that health regulators refused to approve.
The judge ruled it unconstitutional for the FDA to impose restrictions on off-label marketing for the drug when Amarin could back up its promotional claims with evidence.
The agency attempted to prohibit the drug company from promoting that Vascepa could benefit those with "persistently high triglycerides," because the drug is only green-lighted for "very high triglycerides" level.
Although doctors can use approved drugs in ways that are not approved by the FDA with so-called off-label use of drugs actually being common, the government has long prohibited and considered it illegal for pharmaceutical companies to promote off-label uses.
"This lawsuit is based on the principle that better informed physicians will make better treatment decisions for their patients," said Amarin President and Chief Executive Officer John Thero. "Amarin will now be able to communicate efficacy data from ANCHOR and other relevant study results to these physicians and to others in the medical community in the context of appropriate disclaimers."
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