Merck Settles Off-Label Pink Eye Drug Charges for $5.9 Million
Merck & Co. has agreed to pay $5.9 million to settle a federal lawsuit claiming a former subsidiary promoted its pink eye drug for off-label uses.
The suit, United States of America v. Inspire Pharmaceuticals, maintains the company received FDA approval for AzaSite for pink eye treatment in April 2007. Inspire marketed the drug to pediatricians, but when sales were slower than expected, changed its campaign to market unapproved anti-inflammatory effects for the treatment of blepharitis, an inflammation along the edge of the eyelid.
Prescription claims for AzaSite were submitted to federal healthcare programs for payment even though the anti-inflammatory effects weren’t demonstrated by clinical data, documents filed in the U.S. District Court for the Southern District of New York show. The government’s complaint notes that proper treatment for blepharitis is good hygiene and use of eyelid scrubs, not prescription medicine.
In a 2011 warning letter, the FDA cited Inspire for making unsubstantiated claims that AzaSite maintained therapeutic concentrations in ocular tissues for up to five days after the last dosage. The company’s marketing materials also omitted information about warnings and precautions noted in the product labeling.
The U.S. government will get $4.9 million of the settlement, with the remainder going to several states.
Merck spokeswoman Lainie Keller says company is pleased to move forward. The drugmaker purchased Inspire in May 2011, after the alleged misconduct occurred, and sold it to Akorn in 2013. — John Bechtel