Healthy Skepticism Library item: 15346

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: Journal Article

Tanne JH.
US justice department sues company for off-label promotion of antidepressants for children.
BMJ 2009 Mar 25; 338:b1222:
http://www.bmj.com/cgi/content/extract/338/mar25_3/b1222?papetoc

Abstract:

The United States Department of Justice filed a civil complaint last month against Forest Laboratories in a district court in Massachusetts, alleging that the company violated the federal False Claims Act.

The department’s complaint says that the company marketed its antidepressants citalopram (marketed in the US as Celexa) and escitalopram oxalate (Lexapro) for use in children when the drugs were not approved for such use, that the company paid inducements to doctors to promote use of the drugs in children, that the company failed to disclose a study showing that Celexa was not effective in children, and that the government was defrauded of millions of dollars because federal health insurance programmes such as Medicaid paid for prescriptions for the drugs that were not covered by off-label paediatric use.

Under the statute, the justice department says, “the government can recover treble damages and $5500 [£3800; 4000] to $11 000 for each . . .

Keywords:
Antidepressive Agents/therapeutic use* Child Citalopram/therapeutic use* Drug Approval Drug Industry/legislation & jurisprudence* Humans Massachusetts