Merck to Pay $5.9 Mln for Misleading Marketing of Pink Eye Drug: U.S.

By Nate Raymond

June 19, 2015

NEW YORK(Reuters) - Merck & Co Inc has agreed to pay $5.9 million to resolve claims that a former unit fraudulently promoted a drug used to treat pink eye for unapproved purposes, U.S. authorities announced on Wednesday.

Manhattan U.S. Attorney Preet Bharara said Inspire Pharmaceuticals, which Merck acquired in 2011 and later sold, promoted its drug AzaSite (azithromycin ophthalmic solution) to healthcare providers for uses the Food and Drug Administration had not approved as safe and effective.

While the FDA had approved AzaSite for treating bacterial conjunctivitis, Inspire sought more revenue by marketing the drug for the non-approved treatment of another eye condition, blepharitis, according to a lawsuit.

The lawsuit said that Inspire from 2008 through May 2011 misleadingly marketed to doctors purported anti-inflammatory properties of AzaSite that were not supported by substantial evidence or clinical experience.

The marketing caused doctors to prescribe AzaSite for uses not covered by federal healthcare programs, which paid millions of dollars in false claims, the lawsuit said.

As part of the settlement, which will go to the United States and various state governments, Inspire made several admissions related to its conduct, Bharara's office said.

Lainie Keller, a Merck spokeswoman, said the company was "glad to put this behind us," adding that the conduct at issue occurred prior to Merck acquiring Inspire, which it later sold to Akorn Inc in 2013.

The case was initiated in 2010 by a purported whistleblower, Jill DeGuzman, under the False Claims Act, and the United States subsequently intervened in it. DeGuzman's lawyer did not immediately respond to a request for comment.

The case is U.S. v. Inspire Pharmaceuticals Inc, U.S. District Court, Southern District of New York, No. 10-7450.

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