AzaSite Drug-Maker Fined $6 Million for “Off-Label” Marketing

AzaSite Drug-Maker Fined $6 Million for "Off-Label" MarketingJune 18, 2015 — Inspire Pharmaceuticals musy pay $5.9 million to settle claims that AzaSite was illegally promoted for “off-label” (unapproved) uses.

AzaSite is an eye drop solution containing the antibiotic azithromycin. It is only approved for bacterial conjunctivitis (pink eye), a bacterial infection of the mucous membranes which line the inside of the eyelids.

The lawsuit (PDF) accuses drug-makers of illegally promoting AzaSite as an anti-inflammatory medication for blepharitis, an often chronic inflammation of the eyelids that occurs when tiny oil glands near the base of the eyelashes become clogged.

Reuters reports that the Justice Department accused Inspire Pharmaceuticals of promoting AzaSite for “off-label” (unapproved) uses from 2008 until May 2011, when the company was acquired by Merck & Co.

Furthermore, the FDA warned the company for promoting AzaSite with “false or misleading” ads that minimized risk information. According to the lawsuit:

“The standard of care for the treatment of blepharitis is good hygiene and the use of eyelid scrubs, and not prescription medication. Moreover, in April 2011, the FDA found that the purported anti-inflammatory effects of AzaSite that Inspire asserted in its then-current advertisement had ‘not been demonstrated by substantial evidence or substantial clinical experience.’”

The case began in 2010, when a whistleblower named Jill DeGuzman filed a complaint under the False Claims Act. Inspire Pharmaceuticals was accused of defrauding the government by causing doctors to prescribe AzaSite for uses that were not covered under federal healthcare programs, costing millions in false claims to Medicare, Medicaid, and other federal healthcare programs..

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