Inspire Pharmaceuticals, a specialty pharmaceutical company with its principal place of business in Lake Forest, Illinois, has reached a settlement agreement of $5.9 million with the US Department of Justice (DOJ). The settlement money will go to the United States and various state governments. According to the US District Attorney’s press release, Inspire admitted to starting a marketing campaign in 2008 to broaden the customer base for AzaSite by focusing on, among other things, AzaSite’s claimed anti-inflammatory effects, which were not approved by the Food and Drug Administration (FDA), and were not demonstrated by substantial evidence or substantial clinical experience. INSPIRE further admitted that AzaSite was prescribed for blepharitis, and that claims to treat blepharitis were submitted to federal healthcare programs for payment. This case was initially brought forward by a whistleblower in 2010 under the qui tam provisions of the False Claims Act. The United States quickly intervened, taking over the case.
On April 27, 2007, the FDA approved AzaSite to treat bacterial conjunctivitis, more commonly known as pink eye. Inspire Pharmaceutical’s initial advertising for the product was geared toward treating children with pink eye. Its advertisements prominently displayed a child and emphasized the ease of administering AzaSite with only nine drops. The product was also marketed to pediatricians and primary care physicians. From 2008 until 2011, Inspire encouraged physicians to use AzaSite to treat blepharitis, a condition characterized by inflammation of the eyelids, in an attempt to generate more revenue. The FDA had not approved AzaSite to treat this condition. The marketing strategy of the product changed, now highlighting the anti-inflammatory characteristics of AzaSite. A child was no longer included in the advertisements and Inspire reduced its marketing toward pediatricians and primary care physicians. Instead, Inspire began marketing the product to doctors who were likely to treat blepharitis. This caused doctors to prescribe AzaSite for uses not covered by federal healthcare programs, resulting in federal healthcare programs paying millions of dollars in false claims.
According to the DOJ, the FDA sent a letter to Inspire on April 14, 2011 informing the company that its advertisements misleadingly suggested that AzaSite had anti-inflammatory effects, even though this had not been demonstrated by substantial evidence or clinical experience. The FDA informed Inspire that its advertisement was false or misleading because it broadened the indication, made unsubstantiated claims, and omitted and minimized important risks associated with the use of AzaSite. The Government also claimed that Inspire trained its sales forces on the purported anti-inflammatory effects of AzaSite and advised its sales force that every call needed to emphasize, among other things, the purported anti-inflammatory properties of AzaSite. Inspire Pharmaceuticals gave its sales force marketing material targeting blepharitis, and had a nationwide speaker program geared toward promoting AzaSite to treat blepharitis. INSPIRE did this to drive prescriptions for the non-FDA approved treatment of blepharitis.
The present off-label promotion case is similar to ones that were litigated against Pfizer by Greene LLP. The firm filed the first ever off-label promotion case involving the drug Neurontin. The case settled in 2004 for $430 million. A more similar case to the present one, litigated by Greene LLP as well, involved the drug Detrol. Pfizer settled with the US government for $14.5 million, resolving the False Claims Act allegations that the company illegally marketed a drug for purposes that were not approved by the FDA. Detrol was approved for the treatment of overactive bladder. However, Pfizer marketed the product for use in male patients suffering from benign prostatic hypertrophy and several allied conditions, all of which were not an approved use of the drug by the FDA. This case resolved the last of a group of ten qui tam suits filed against Pfizer. The other nine suits were settled or dismissed in 2009 as part of the government’s global resolution with Pfizer, under which the company agreed to pay $2.3 billion dollars to resolve civil claims and criminal charges regarding multiple drugs, according to the DOJ.
Manhattan US Attorney, Preet Bharara, said that the Government will continue to ensure that drug companies do not illegally make claims that are not supported by the FDA. The Government will go after pharmaceutical companies, which market drugs that have not been supported by clinical experience or substantial evidence. Whistleblowers continue to be very helpful in uncovering government defrauding schemes. They help protect taxpayer’s funds and maintain the integrity of the federal healthcare programs. The Government will continue to go after companies who have violated the False Claims Act.
The Department of Justice press release can be found here.