ISTA Pharmaceuticals: The Sales Buckets Behind Xibrom

The ISTA Xibrom settlement included a $15 million civil agreement resolving allegations that off-label promotion and kickbacks caused false claims to government health care programs. A sales representative’s complaint described the campaign from inside: uses sorted into sales categories, salespeople coached to win prescriptions, and a manager’s written instruction connecting the pitch to the representative’s bonus. The medical message had a sales target attached.

The Justice Department announced the resolution on May 24, 2013. This pharmaceutical fraud case reaches from the training room to the physician’s office and then to the government-paid prescription.

What Is Considered Off-Label Promotion?

Off-label promotion markets a drug for uses outside its FDA-approved labeling. Xibrom was a nonsteroidal anti-inflammatory eye drug approved to treat pain and inflammation after cataract surgery. The government described employees promoting it after Lasik and glaucoma surgery and for the prevention and treatment of cystoid macular edema between 2005 and 2010.

In the pharmaceutical business, the approved use is part of the product being sold, alongside its strength, dosage form and presentation. For Xibrom, the commercial opportunity described in the complaint was to expand the occasions on which an ophthalmologist would prescribe the same drug. The sales campaign reached before surgery, beyond cataract surgery and into promises of better results.

The civil allegation connected that off-label promotion to government reimbursement. The government said ISTA promoted uses that federal healthcare programs did not cover and caused claims for those uses to be submitted. The prescription was where the sales campaign became a bill to taxpayers.

How the Xibrom Promotion Worked

The whistleblower alleged that ISTA built off-label uses into its sales training, field expectations and compensation. The complaint’s account of a February 2007 sales meeting describes five categories the company called “buckets”: cystoid macular edema, preoperative use, postoperative uses beyond the approved cataract indication, better surgical results, and high-risk patients such as people with diabetes.

A district manager’s field contact report allegedly told the representative how to turn those categories into business:

The complaint also described district expectations that representatives carry with them, reinforcing the same categories and encouraging preoperative instruction sheets. A sales employee could encounter the alleged campaign in a meeting, a customer simulation, a field review and a manager’s email. The repeated instructions put management behind the pitch.

A Weak Study Became a Rehearsed Answer

The complaint alleged that ISTA trained representatives to promote a study of Xibrom for cystoid macular edema despite knowing its results were not statistically significant. New representatives allegedly received flashcards to memorize the results, and the whistleblower described being drilled on the study during training.

When a physician challenged the evidence, the complaint alleged, the company had an answer ready:

A physician’s objection to the evidence became another response for the representative to rehearse.

Getting Into the Patient’s Surgery Kit

The complaint alleged that representatives used their budgets to print preoperative instruction sheets so physicians could more easily prescribe Xibrom before surgery. The whistleblower said a district manager commended that spending as a way to grow the business.

The campaign also sought a place inside competitors’ surgical kits. According to the complaint, Alcon and Allergan supplied packs containing eye drops, eye patches and other products for patients after cataract surgery. ISTA’s sales booklet allegedly instructed representatives to secure a physician’s commitment and then work with the surgical coordinator to place one-milliliter Xibrom samples in the kits.

The alleged sales instruction followed the product into the materials the practice handed to the patient. A representative or surgical coordinator could recognize the arrangement without attending the meeting where management set the strategy.

The Justice Department also described continuing medical education programs used to promote unapproved uses and postoperative instruction sheets paid for by employees. It reported that management told some employees not to put certain physician interactions in writing or leave certain printed materials in physicians’ offices. The complaint’s written instructions make that effort to limit the paper trail particularly striking.

How Do Pharmaceutical Kickbacks Work?

Pharmaceutical kickbacks work by offering a benefit to influence prescribing. In its Xibrom account, the Justice Department described employees providing physicians with free Vitrase, another ISTA product, to induce Xibrom prescriptions.

The government’s description of the physician inducements also included sponsorship of an event for a nonprofit associated with a physician, a golf outing, wine tasting, paid consulting or speaker arrangements, and honoraria for advisory meetings intended as marketing opportunities.

Those pharmaceutical kickbacks reached doctors through product supplies, events and paid roles. The alleged commercial return was the same: prescriptions that sent patients to pharmacies for Xibrom, including prescriptions paid by federal programs.

A later ophthalmic case shows another way free product can buy future business. In the EyePoint case, the government alleged that reimbursement promises and excessive free DEXYCU samples induced ambulatory surgery facilities to purchase and dispense the drug. The whistleblower’s complaint alleged that samples covered procedures for patients whose insurance did not reimburse the product, while encouraging further purchases for government-insured patients. The benefit to the practice helped sell the next prescription.

How Xibrom Prescriptions Became Medicare and Medicaid Claims

The sales representative’s complaint alleged that these uses had neither FDA approval nor support in the medical references Medicare and Medicaid relied on for coverage. It further alleged that ISTA’s promotion caused medical personnel and pharmacists to submit prescriptions for payment through Medicare and Medicaid. The doctor’s decision and the pharmacy’s claim connected the manufacturer’s sales effort to public money.

The ISTA civil settlement resolved two qui tam cases. The sales representative brought the complaint describing the training, field reports and surgical kits. A partnership brought the other case.

How Much Money Do Pharmaceutical Whistleblowers Get for Exposing Fraud?

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. In ISTA’s case, the Justice Department announced that the sales representative would receive approximately $2.5 million from the federal share of the civil recovery.

The representative’s account shows the value of an insider who knows how the sales instructions reached the field. For pharmaceutical whistleblowers, a manager’s critique or a customer-training booklet may explain the purpose behind prescribing patterns that someone outside the business can only see in totals.

What the Resolution Changed Inside the Company

Bausch+Lomb, which acquired ISTA in June 2012, agreed to controls that addressed the same commercial channels. Sales and marketing personnel were to have no role in final educational-grant decisions. Sales agents were to discuss uses consistent with approved labeling and direct requests about unapproved uses to Medical Affairs.

The parent also agreed to prohibit inducements for prescriptions paid by federal programs. Education funding, the response to a physician’s question and payments to prescribers all appeared in the required controls.

You Know What the Sales Instructions Meant

If you recognize the coaching, sample arrangements or physician payments behind a drug’s sales, speak with our whistleblower experts. We build the case around the company’s instructions, prescriptions and government payments, and bring in pharmaceutical fraud whistleblower lawyers who understand promotion and kickback cases. We stay beside you through the case, with your knowledge of the sales operation at its center.