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Off-Label Ads For AzaSite End in $6 Million Fine

Off-Label Ads For AzaSite End in $6 Million Fine

June 18, 2015 — Inspire Pharmaceuticals had agreed to a $5.9 million settlement to resolve claims that its prescription pink-eye drug AzaSite was illegally promoted “off-label” for other eye diseases.

AzaSite is an eye drop product that contains azithromycin, an antibiotic.

According to the Justice Department lawsuit (PDF), AzaSite was promoted for blepharitis, an often chronic inflammatory disease of the eyelids caused by clogged oil glands near the base of the eyelashes. However, AzaSite is only FDA-approved for bacterial conjunctivitis (pink-eye), an infection of mucous membranes inside the eyelids.

Prosecutors said AzaSite was promoted “off-label” from 2008 until May 2011, when Inspire Pharmaceuticals was acquired by Merck & Co., according to Reuters.

The problem is that blepharitis is normally treated with good hygiene and the use of eyelid scrubs — not antibiotics. When doctors are misled into prescribing a medication that patients do not actually need, the patient can suffer from devastating side effects like allergic reactions and vision loss.

According to the lawsuit:

“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 government also accused Inspire Pharmaceuticals of defrauding federal healthcare programs by causing doctors to prescribe AzaSite for unapproved uses, costing millions of dollars in false claims. The accusations against the drug-maker first surfaced in 2010, when a whistleblower filed a lawsuit under the False Claims Act.

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