Teva subpoenaed in marketing of Copaxone, Azilect

Teva Pharmaceutical Industries, a global leader in the manufacture of generic and specialty drugs, is cooperating with a federal investigation into possible violations of the False Claims Act.

Last month, the U.S. attorney in New York City sent Teva a civil investigative demand requesting information and documents from 2006 until the present concerning the company's sales, marketing and promotional tactics for multiple sclerosis drug Copaxone and Parkinson's disease treatment Azilect. Teva is cooperating with the subpoena, according to its annual report filed Monday with the Securities and Exchange Commission (PDF). No other details were made public.

Under the False Claims Act, a qui tam complaint can be made by a whistle-blower who alleges that a company has violated provisions of the law. Among other practices, the act prohibits illegal kickbacks and off-label marketing of drugs.

In 2012, GlaxoSmithKline agreed to pay $3 billion and plead guilty to criminal charges in what was described at the time as the largest healthcare fraud case in U.S. history. Charges stemmed from the pharmaceutical company's branding, safety disclosures and price reporting of several drugs, including off-label marketing of antidepressants Paxil and Wellbutrin and failing to report safety data to the Food and Drug Administration for its diabetes drug Avandia.

In prosecuting a company under the False Claims Act, the federal government can seek to recover up to three times the amount of damages, plus a civil penalty of up to $11,000 for each false claim. But it can take several years for such an investigation to be resolved, according to notes contained in Teva's annual report.

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