“Although recognizing that the FDA’s policies advanced a substantial government interest in requiring manufacturers to submit supplemental applications for new drug uses”, the district judge wrote in his opinion, “the court held the FDA’s restrictions on such speech were more extensive than necessary, and thus breached the First Amendment”.
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The FDA has 60 days to appeal the ruling.
Amarin Corporation plc (ADR) (NASDAQ:AMRN) announced a United States District Court has ruled that Amarin may promote to healthcare professionals certain uses of Amarin’slead product, Vascepa(icosapent ethyl) capsules, that are not covered by current FDA-approved labeling for the drug so long as the promotion is truthful and non-misleading.
Drugmakers are not allowed to advertise drugs for “off-label” uses, or those that have not been cleared by the FDA as safe and effective. In the trial, the product was tested on patients having quit high levels of triglycerides after statin therapy.
An FDA spokeswoman declined to comment on the decision. A 2012 decision in that circuit set a similar precedent, overturning the conviction of a pharmaceutical salesperson who engaged in off-label promotion. Amarin had sought to sell the drug to people with lower levels of triglycerides.
Courts have considered First Amendment protection for off-label marketing before. The agency essentially said that it did not take issue with numerous company’s plans and that it would have permitted them if the company had consulted regulators before filing its lawsuit.
Amarin wanted to provide doctors with clinical trial data that didn’t directly pertain to the approved uses of its Vascepa prescription fish-oil pill.
“This lawsuit is based on the principle that better informed physicians will make better treatment decisions for their patients”, saidJohn F. Thero, President and Chief Executive Officer.
When Amarin was unable to persuade the FDA to broaden Vascepa’s approval to patients with high triglycerides at high risk of coronary artery disease-a much larger population-it sued the agency to allow it to tell doctors that it did lower blood lipids and that research shows that can be good for patients with heart disease.
All could have been resolved in a matter of weeks, according to Loss, with no hassle, but if the company insists to “strut and think they accomplished a great achievement by beating the FDA in court, they’re free to do it.”.
Vascepa is a prescription strength form of an omega-3 fatty acid found in wild fish.
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Shares of Amarin surged 21% to $2.49 following the ruling.
