A Win for Off-Label Promotion

The U.S. Food and Drug Administration (FDA) has decided not to appeal a ruling in August that allowed Amarin Corporation the right to promote icosapent ethyl (Vascepa) for off-label uses as long as all statements that it makes are true, according to a Reuters report.

“This lawsuit was based on the principle that better informed physicians will make better treatment decisions for their patients,” John Thero, president and chief executive officer of Amarin, said in a statement in August. “Many physicians are aware of the efficacy data included in FDA-approved labeling for Vascepa, but are not aware of efficacy data from the ANCHOR study of Vascepa.”

Click here to read more about this history of this case.

What does this case mean for other drug companies?

For Pacira, that meant filing a lawsuit in September against the FDA to allow the company to promote bupivacaine liposome injectable suspension (Exparel), a pain medication approved for bunionectomies and hemorrhoidectomies, on a wider scale, according to a Reuters report.

Others are sure to follow suit.

Click here to read more about off-label use.

--Stephanie Vaccaro

References:

1. Reuters. FDA to allow Amarin to promote fish oil pill for off-label use. www.reuters.com. 2016 Mar 8.

2. Pierson B. Pacira sues FDA over pain drug marketing restrictions. www.pharmacylearningnetwork.com. 2015 Sep 9.