Ireland-Based Drug Maker Reaches False Claims Act Settlement With U.S. Government

March 5, 2013 — Before a pharmaceutical can be approved under the Food, Drug and Cosmetic Act, its maker has to apply to the FDA and report all the intended uses for the product. It is illegal for pharmaceutical companies to market their drugs for any use that is not included in the initial drug application and approved by the FDA. This is called “off label” marketing and is a violation of the federal False Claims Act.

The False Claims Act Prohibits Drug Makers from Promoting Their Products for Unapproved Uses

Shire plc, a drug maker based in Ireland, has negotiated an agreement in principle to settle a civil investigation into the pharmaceutical company’s United States sales and marketing practices involving Attention Deficit Hyperactivity Disorder (ADHD) drugs. In 2009, the U.S. government subpoenaed documents concerning Shire’s Adderall XR, Daytrana, and Vyvanse medications.

At issue was whether Shire had engaged in off-label promotion of the drugs in violation of the federal False Claims Act.

Pharmaceutical Fraud Uncovered by Insider Employees

The federal False Claims Act allows informants to file whistleblower claims on the government’s behalf. Frequently, pharmaceutical sales representatives or other company insiders become aware of a drug maker’s attempts to market a product for off-label uses and blow the whistle. Under the False Claims Act’s qui tam provisions, government collaborators keep a portion of the government’s recovery.

The first thing potential tipsters need to do is become informed of their legal rights. The experienced lawyers at Waters & Kraus provide courageous informants with the legal representation they deserve. Contact us or call our whistleblower attorneys at 800.226.9880 to find out more about our pharmaceutical fraud practice and how we can help government collaborators.