Endo reaches settlement with DOJ over Lidoderm claims

Hartunian: Prove efficacy “by science, not by sales pitches”
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.

You must be a registered member of MMM to post a comment.

Email Newsletters

What does going "beyond the pill" actually mean? At MM&M's recent inaugural spring conference, audience members heard from real-world companies that are managing the organizational, technological, and promotional challenges inherent in this transition, such as partnering with health neophytes, harnessing technologies that allow deeper engagement with patients, and adopting a new commercial mindset to serve, not sell. Download here.

A wave of more effective anti-cancer drugs has set the oncology world on fire with enthusiasm. While many hail this as a new era, an equally vocal faction questions the money spent for the value gained. This medical and commercial trend report for marketers of anti-cancer modalities touches on many of the latest shifts that have expedited product launches and otherwise impacted promotion and reimbursement of these drugs. Click here.