Healthy Skepticism Library item: 15122

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Goldstein J.
Feds Look to Extend Off-Label Marketing Streak With J&J
The Wall Street Journal Blog 2009 Feb 20
http://blogs.wsj.com/health/2009/02/20/feds-look-to-extend-off-label-marketing-streak-with-jj/

Full text:

The Justice Department has been on a roll lately, charging companies with marketing their drugs for unapproved uses. The effort continued yesterday, as the feds joined two whistleblower lawsuits alleging that Johnson & Johnson marketed its heart-failure drug Natrecor for uses that hadn’t been approved by FDA. The WSJ has the story.

Typically in cases like this, the DOJ seeks to recover damages based on the argument that off-label marketing led doctors to prescribe a drug for patients covered by public insurance programs such as Medicare. State attorneys general often join in. (Doctors are allowed to prescribe drugs for any reason they see fit, but companies may only market drugs for approved uses.)

A lot of money can be at stake in such cases. Just a few weeks ago, Pfizer took a $2.3 billion charge linked to a government probe of its marketing of the painkiller Bextra. Also last month, GlaxoSmithKline said it was taking a $400 million charge related to a DOJ investigation of “marketing and promotional practices” for several products.

Eli Lilly paid $1.4 billion in a recent settlement over its antipsychotic Zyprexa. And, a few months back, Cephalon said it was paying $444 million to settle long-running state and federal probes of its sales and marketing practices.

As for the cases involving J&J, a company spokesman told the WSJ the company has “reviewed the allegations thoroughly and will be prepared to address them through the courts.”