Endo reaches settlement with DOJ over Lidoderm claims

Share this article:
Endo reaches settlement with DOJ over Lidoderm claims
Hartunian: Prove efficacy “by science, not by sales pitches”

Endo Pharmaceuticals became the latest drugmaker to ink an off-label marketing settlement, paying $192.7 million to resolve charges it promoted pain patch Lidoderm for unapproved uses.

According to a statement from the Justice Department, Endo sales managers instructed certain reps on how to “expand sales conversations” with doctors beyond post-herpetic neuralgia (PNH), Lidoderm's only FDA-approved use, and pushed promotion of the patch in workers' compensation clinics. “The safety and efficacy of drugs must be shown by science, not sales pitches,” said US Attorney for the Northern District of New York Richard Hartunian, in the statement.

The settlement is comprised of a deferred prosecution agreement to resolve a criminal charge, along with forfeiture of $20.8 million, plus civil false-claims settlements of $171.9 million.

Also as part of the settlement, Endo agreed to enter into a Corporate Integrity Agreement with the Department of Health and Human Services Office of Inspector General.

The settlement resolves three pending “whistleblower” suits. The total is less than in such recent settlements as Johnson & Johnson's $2.2-billion payout in November to resolve charges it improperly marketed anti-psychotics Risperdal and Invega as well as heart drug Natrecor. In 2012, Glaxo­SmithKline agreed to pay $3 billion—the largest such settlement ever—to clear up charges it promoted antidepressants Paxil and Wellbutrin for unindicated uses and withheld safety data on diabetes drug Avandia.

Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Leadership Exchange: How Do We Get Beyond the Pill?

Leadership Exchange: How Do We Get Beyond the ...

As its focus moves from manufacturing to service, pharma needs to partner with healthcare neophytes as well as established players. James Chase asks six experts to assess the risks and ...

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic ...

Read the complete August 2014 Digital Edition

Read the complete August 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.