Novartis Vaccines and TOBI: Marketing Beyond the Approved Patient Population

In the Novartis Vaccines TOBI settlement, Novartis Vaccines & Diagnostics Inc. and Novartis Pharmaceuticals Corporation agreed to pay $72.5 million to resolve civil False Claims Act allegations over off-label promotion of the inhaled antibiotic. The government alleged that the marketing reached people with diseases other than cystic fibrosis and cystic-fibrosis patients outside the approved patient population. For someone who worked on the brand, that second allegation is the important one: a sales campaign can stay inside the disease and still reach beyond the patients the drug was approved to treat.

The Department of Justice announced the settlement on May 4, 2010. Chiron Corporation marketed TOBI before Novartis. Three former Chiron employees brought the pharmaceutical fraud case over the promotion and resulting government claims. Taxpayers, the government alleged, were footing the bill for the expanded market.

What Is Considered Off-Label Promotion?

Off-label promotion includes marketing a drug beyond its approved use or patient population. In the TOBI case, the government alleged both: promotion for other diseases and promotion for cystic-fibrosis patients who did not meet the FDA-approved indication’s parameters and for whom TOBI was not a medically accepted use.

The Food and Drug Administration had approved TOBI to treat certain cystic-fibrosis patients. The word certain carries the distinction. A disease name describes a broad market. The approved indication identifies the patients within it. A campaign described simply as cystic-fibrosis marketing can conceal the very difference that matters to the allegation.

That is a familiar commercial boundary in pharmaceuticals. Manufacturers sell a product with a particular approval, label, strength, dosage form and route of administration. Product approval and the population targeted by a sales campaign need to be compared at that level. An employee who knows which patients a presentation describes may recognize a change that disappears in a report showing only sales of the brand.

A Narrow Indication Can Become a Much Larger Sales Market

The government’s separate Protonix allegations against Wyeth illustrate how much a disease label can leave out. Protonix was approved for short-term treatment of erosive esophagitis, a condition associated with gastroesophageal reflux disease that required an invasive endoscopy to diagnose. The government alleged that Wyeth promoted it for all gastroesophageal reflux disease, a much more common condition that could be diagnosed without that procedure.

That comparison makes the TOBI distinction easier to see. Expanding the promoted market can mean moving to an entirely different disease, or widening the group within a familiar one. The useful comparison is between the approved indication and the patients the company encouraged prescribers to reach.

How TOBI Promotion Reached Government Claims

The government alleged that Chiron, and then Novartis, caused false claims to federal healthcare programs through TOBI promotion. A manufacturer can be responsible under the False Claims Act for causing a false bill, even when a pharmacy, physician or facility sends it. The sales pitch and the payment request can come from different businesses.

The TOBI announcement specifically alleged promotion beyond the approved parameters for patients for whom the drug was not a medically accepted use. The allegation joined the company’s marketing decisions to the public money spent on the resulting claims.

The Patient’s Use Can Disappear at the Pharmacy

A dispensing record may identify the drug without capturing its indication. A May 2018 Managed Care article on indication-specific pricing quoted this explanation of the information gap:

The article examined pricing arrangements that depend on knowing why a drug was used. Its observation also explains an evidence problem in a population-based promotion case. The product name on a pharmacy transaction may leave the central question unanswered: which patients received it for which use?

Chiron, Then Novartis

The alleged conduct ran from January 1, 2001 through July 31, 2006. The Justice Department identified Chiron Corporation as the predecessor and described Chiron’s marketing followed by Novartis’s marketing. Novartis Vaccines & Diagnostics and Novartis Pharmaceuticals were the companies that agreed to resolve the civil allegations.

We place the message, the people responsible for it and the decisions about the promoted population with the company involved at the time. Someone who worked at Chiron may know how the campaign began. Someone who worked on the brand later may know what continued or changed.

The former Chiron employees brought a qui tam case under the False Claims Act. Their role fits a broader finding from Public Citizen’s study, Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010, published in 2010. The study found that whistleblower cases accounted for 59% of federal pharmaceutical settlements from 2001 through 2010. Its account emphasized former employees’ role in bringing company conduct to light.

An insider supplies the business context behind the transaction: what the company wanted a prescriber to do, how it communicated that objective and who knew which patients the campaign would reach.

The TOBI Settlement and Whistleblower Reward

The announced agreement allocated $43.5 million to the United States to resolve the federal claims and $29 million to states to resolve their claims. The Justice Department announced that the former employees would receive a combined $7.8 million whistleblower reward from the federal share.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. The TOBI case shows the role of employees who know the product’s commercial history and can explain the promotion behind the claims.

What an Insider Can See Across the Records

In a case about promotion beyond an approved patient population, the valuable detail is the connection between the intended audience and the patients whose treatment reached government claims. Sales, medical affairs and reimbursement employees may see different parts of that connection.

The government’s TOBI allegation joined those pieces: a broader promoted population, uses outside the approved parameters and resulting false claims. Your knowledge of the campaign may explain the connection between a brand strategy and the public money it drew.

You Know Which Patients the Campaign Targeted

If you saw a drug’s sales campaign reach beyond its approved patient population, speak to one of our whistleblower experts about who the campaign really targeted. We build the case with you and bring in pharmaceutical fraud whistleblower lawyers who understand the connection between marketing, patient use and government reimbursement. We stay beside you as your knowledge of the brand becomes the foundation of your strongest pharmaceutical whistleblower case.