Healthy Skepticism Library item: 12975

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

Girion L.
Botox maker under investigation
Los Angeles Times 2008 Mar 5
http://www.latimes.com/business/la-fi-botox5mar05,1,3879300.story

Full text:

The Department of Justice has launched an inquiry into the wrinkle smoother’s alleged promotion for medical uses.

The U.S. Department of Justice is looking at Allergan Inc.‘s promotion of its blockbuster wrinkle drug Botox for medical uses, but investors didn’t seem too worried about the news Tuesday.

Allergan shares closed at $57.38, down $1.28 or 2.2% on word that the Irvine company received a subpoena from the U.S. Attorney’s Office for the Northern District of Georgia demanding documents regarding its promotional and educational practices involving the use of the botulinum toxin-based drug for medical problems.

The company said it understood that the inquiry involved questions about the alleged use of Botox for the treatment of headaches.

Allergan is engaged in advanced clinical studies investigating the use of Botox for headaches. But the company does not have Food and Drug Administration approval to market the drug for that particular use.

Because the FDA has approved Botox for a number of other medical problems, physicians may use their discretion to prescribe it for headaches, a so-called off-label use.

The inquiry appeared to be focused on whether Allergan was promoting the drug to treat headaches without FDA approval for such marketing.

Allergan said that its policy was to promote its products “only in a manner consistent with the FDA-approved product labeling,” as well as with all laws and regulations.

Since its first U.S. approval in 1989, Botox has been used to treat a variety of often serious medical conditions, including crossed eyes, uncontrollable blinking and cervical dystonia. In all, it is approved for 20 different uses in 70 countries.

Botox is, by far, Allergan’s No. 1 seller, with annual revenue of more than $1 billion.

lisa.girion@latimes.com