Allergan subpoenaed over Botox promotion materials

Share this article:

Allergan said it has received a subpoena for documents related to the promotion of its anti-wrinkle injection Botox.
 
The subpoena from the Department of Justice (DOJ), US Attorney's Office for the Northern District of Georgia, broadly requests Allergan documents regarding promotional, educational and other activities.

According to Allergan, the nature of the inquiry involves questions regarding alleged off-label promotion of the drug for the treatment of headache.
 
Allergan is currently in Phase III studies, investigating the use of Botox as a treatment for headache, however the drug is not currently approved by the FDA for this use.

Doctors may use their discretion in prescribing drugs for off-label uses however it is illegal for manufacturers to promote their products for indications not approved by the FDA.

Allergan said in a statement 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.

The Botox-maker said it will fully cooperate with the DOJ to satisfactorily address “any and all” questions regarding the matter.

In 2007, Botox sales were $1.2 billion, representing about one-third of Allergan's total $3.9 billion in sales. Professional advertising for Botox is handled by Pacific Communications.

Share this article:
You must be a registered member of MMM to post a comment.

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...