Tag Archives: drug manufacturers

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  As we noted, on June 8, 2015, … Continue Reading

FDA Sued By Drug Manufacturer Over Constitutional Right To Discuss Off-Label Uses

This post was written by Evelien Verpeet The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do … Continue Reading

D.C. Circuit Decision Upholds DOD Rule, Potentially Leaving Pharmaceutical Manufacturers on the Hook for Refunds

In a recent decision, the D.C. Circuit upheld a Department of Defense ("DOD") rule that will require drug manufacturers to provide partial refunds on some prescription drugs, dating back to 2008. The rule that was in question in the case imposes a cap on the retail price of drugs and requires manufacturers to refund the difference between the retail price and the discounted rate of the pharmaceutical drug benefits the DOD provides through TRICARE.… Continue Reading
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