Inspire Pharmaceuticals Pays $5.9M to Settle Misleading AzaSite Marketing Claims

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, comments that civil fraud claims against Inspire Pharmaceuticals have been settled by the United States government. The claims, which were filed under the False Claims Act, alleged that Inspire made misleading claims about its drug AzaSite and promoted it for uses not approved by the U.S. Food and Drug Administration (FDA). According to an announcement by the U.S. Attorney's Office for the Southern District of New York, Inspire has agreed to pay $5.9 million to federal and state governments and also made admissions as to its conduct. The settlement was approved by U.S. District Judge Loretta A. Preska on June 15, 2015.

The FDA has only approved AzaSite for bacterial conjunctivitis, more commonly known as pink eye. However, allegations indicate that Inspire marketed the drug off-label for blepharitis, a different condition involving inflammation of the eyelids. According to the complaint, Inspire shifted its marketing for Azasite from 2008 through May 2011 to misleadingly focus on its supposed anti-inflammatory treatments. These claims were not supported by substantial evidence or clinical experience and caused doctors to prescribe Azasite for uses not covered by federal healthcare programs, according to the Department of Justice (DOJ) release. Off-label marketing of Azasite for blepharitis resulted in false claims being submitted. As part of the settlement, Inspire admitted to starting a marketing campaign intended to expand the use of Azasite despite lack of substantial evidence. The company also admitted that claims were submitted to federal healthcare programs as a result of AzaSite being used to treat blepharitis off-label. ( http://www.justice.gov/usao-sdny/pr/manhattan-us-a... )

Parker Waichman and commends the settlement. ““When pharmaceutical companies make misleading claims about their products, it is harmful to patients and costly for taxpayers,” said Gary Falkowitz, Managing Attorney at the firm.

Parker Waichman supports efforts to protect whistleblowers and offers free case evaluations and anonymity when a company, such as a government entity, consumer product manufacturer, medical device maker, or pharmaceutical company, is suspected of committing fraudulent activities. Contact Parker Waichman LLP at the firm's Whistleblower page at yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).