Inspire Pharmaceuticals: The Sales Pitch Changed, the Approved Use Did Not

In the Inspire AzaSite blepharitis settlement, Inspire Pharmaceuticals agreed to pay $5,960,163 to the United States and state governments to resolve civil claims over allegedly misleading promotion of a pink-eye drug for inflamed eyelids. Inspire admitted that its advertising campaign promoted anti-inflammatory effects unsupported by substantial evidence or substantial clinical experience. For someone who worked on the sales message, the case connects familiar decisions about advertisements, target doctors and sales calls to the claims sent to government health care programs.

A whistleblower brought the pharmaceutical fraud case as a qui tam case under the False Claims Act, and the government joined it. The Justice Department announced the resolution on June 17, 2015.

AzaSite Was Approved for Bacterial Conjunctivitis

The Food and Drug Administration approved AzaSite for bacterial conjunctivitis, commonly called pink eye, on April 27, 2007. Blepharitis is a different condition involving inflammation of the eyelids. At the time of the campaign, AzaSite had no approval to treat it.

According to the government’s complaint, Inspire initially advertised the drug with a child pictured prominently and a pitch about the convenience of only nine drops. Its sales audience included pediatricians and primary care physicians likely to treat pink eye. The patient in the advertisement, the benefit being sold and the doctors being approached all fit the approved use.

Then the company changed the audience and the message.

What Is Considered Off-Label Promotion?

In the AzaSite case, off-label promotion meant encouraging doctors to prescribe the drug for blepharitis when its approval covered bacterial conjunctivitis. The government alleged that Inspire shifted its campaign toward that unapproved use beginning in 2008.

The change reached the advertising and the sales force together. According to the complaint, Inspire removed the child from its advertisements, substantially reduced its marketing to pediatricians and primary care physicians, and targeted doctors likely to treat blepharitis. The new message emphasized purported anti-inflammatory effects.

The government alleged that Inspire trained representatives on those effects and told them that every sales call needed to emphasize them. It supplied marketing materials targeting blepharitis and ran a nationwide speaker program geared toward promoting AzaSite for that condition.

An instruction for every call matters. It puts the message inside the company’s sales routine. For an employee, the training, promotional materials and choice of doctors explain how the campaign was supposed to work before a prescription ever reached a pharmacy.

The Food and Drug Administration challenged the advertising in a letter dated April 14, 2011. As the Justice Department described it, the agency said the advertisement suggested anti-inflammatory effects without adequate support, broadened the indication and omitted or minimized important risks. The government alleged that the misleading marketing ran through May of that year.

What Inspire Admitted About the Campaign

Inspire admitted that it began an advertising campaign in January 2008 designed to broaden AzaSite’s customer base by focusing on claimed anti-inflammatory effects. It admitted that those effects were not approved and had not been demonstrated by substantial evidence or substantial clinical experience.

The admission reached the payment side too. Inspire admitted that doctors prescribed AzaSite for blepharitis and that claims for treating that condition were submitted to federal healthcare programs for payment.

The government’s broader allegation connected that campaign to the bill: misleading promotion caused prescriptions for uses federal programs did not cover, resulting in millions of dollars in false claims. Taxpayers picked up the bill for the unsupported sales pitch, according to the government’s account.

How the Sales Message Reached the Government Bill

The reimbursement allegation followed a sequence: the company promoted blepharitis treatment, doctors prescribed AzaSite for it, and claims reached federal programs. The government alleged that the promoted use was not covered and that the campaign caused those claims.

That sequence reflects how the prescription-drug business works. The physical product travels from manufacturer to wholesaler to dispenser. A pharmacy or physician submits the reimbursement claim. The manufacturer can influence what gets prescribed before a different business sends the bill.

The condition being treated matters to that inquiry. In its May 2018 article, Indication-Specific Drug Pricing–Simple in Theory, Complex in Reality, Managed Care described a practical difficulty in identifying drug uses: an electronic medical record may contain the indication while the point-of-sale transaction when the drug is dispensed may not capture it.

An insider who knows why the company targeted particular doctors may supply a part of that connection that a dispensing record leaves out.

Here, the support behind the promotional claim was central. Inspire’s admission addressed the lack of substantial evidence or clinical experience for its advertised anti-inflammatory effects. That gives a sales or medical affairs employee a concrete comparison: what the company said about the drug and what it had to support the statement.

The Sales Instructions in Other Promotion Cases

Other cases show how a company can turn an unapproved use into an assigned sales objective. In a separate whistleblower complaint against ISTA Pharmaceuticals, the whistleblower alleged that the company divided off-label uses of Xibrom into sales categories called buckets. The complaint quoted a company instruction:

The alleged instruction tied the promoted use to the representative’s bonus. Inspire’s case puts a different instruction in view: the government alleged that the anti-inflammatory message belonged in every sales call.

AstraZeneca’s Seroquel settlement, announced in April 2010, resolved allegations that promotion of unapproved uses caused noncovered claims. The government also alleged that AstraZeneca paid doctors recruited as authors of company-prepared articles and used those publications in its promotion. The comparison is the route the message took: through sales calls and speakers in the Inspire allegations, and through paid physician authorship as well in the Seroquel allegations.

What an Insider Can Add

A pharmaceutical whistleblower may know who chose the target doctors, what representatives were trained to say and how a speaker program reinforced the campaign. AzaSite shows why that knowledge matters. The government’s account describes a coordinated change in advertising, physician targeting, training and promotional materials.

For a person in sales or medical affairs, those details may already be familiar from the work. The useful connection is between the internal commercial decision and the public claim for payment. We work with you to understand what your knowledge of that campaign adds and build the case around it.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Know How the Pitch Was Built

If you helped develop or deliver a drug’s sales message and know where it outran the evidence, speak to one of our whistleblower experts about how that campaign reached the government’s bill. We build your strongest pharmaceutical whistleblower case with you, bring in pharmaceutical whistleblower lawyers who understand promotion and reimbursement, and stay beside you throughout the case.