Inspire Pharmaceuticals, Inc. has agreed to pay $5.9 million to state and federal governments over misleading marketing claims it made about AzaSite, a drug approved to treat pink eye. According to a press release issued by U.S. Attorney’s Office for the Southern District of New York, the settlement resolved civil fraud claims alleging that the company marketed AzaSite for non-FDA approved uses for financial gain. The company made admissions as to its conduct as part of the settlement. The case stems from whisltleblower allegations filed under the False Claims Act.
“As demonstrated by today’s settlement, we are committed to ensuring that drug companies do not undermine the FDA’s approval process by deliberately marketing drugs for uses that are unsupported by substantial evidence or clinical experience, while profiting at taxpayers’ expense.” said Manhattan U.S. Attorney Preet Bharara, according to the DOJ press release.
AzaSite was approved to treat bacterial conjunctivitis, more commonly known as pink eye. According to the complaint, Inspire began marketing the drug for blepharitis, a different eye condition involving inflamamtion of the eyelids. The company engaged in marketing strategies that emphasized the anti-inflammatory properties of AzaSite, despite a lack of substantial evidence and clinical experience to support these claims. Additionally, Inspire geared its marketing towards doctors that are likely to treat blepharitis as opposed to pediatricians and primary care physicians.
The FDA sent a letter to Inspire in April 2011 criticizing an advertisement that emphasized anti-inflammatory properties. The agency said the ad was “false or misleading because it broadens the indication, makes unsubstantiated claims, and omits and minimizes important risks associated with the use of AzaSite.”
As a result of Inspire’s misleading and unsubstantiated marketing claims about the anti-inflammatory properties of AzaSite, doctors prescribed the drug for uses not covered by federal healthcare programs. This caused federal healthcare programs to pay millions in false claims. Under the settlement, the company admitted that it engaged in a marketing campaign to expand the use of AzaSite for uses not approved by the FDA beginning in January 2008. The company also admitted that AzaSite was prescribed for blepharitis, resulting in false claims being submitted to federal healthcare programs.
HHS-OIG Special Agent in Charge Scott J. Lampert said “Marketing pharmaceuticals for other than FDA approved uses by making misleading statements can expose patients to questionable drug treatments while asking taxpayers to pick up the Medicare bill. Investigations of such misconduct will continue to be a priority for this office.” according to the release.