Botox 'off-label' promotion questioned

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Allergan said it has received a subpoena for documents related to the promotion of Botox.

The subpoena from the Department of Justice, US Attorney's Office for the Northern District of Georgia, broadly requests Allergan documents regarding promotional, educational and other activities. According to Allergan, the inquiry involves questions regarding alleged off-label promotion of the anti-wrinkle injection 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. 

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