September: Botox maker pleads guilty for promoting drug for headache; October: FDA approves that same use

by Ben Vernia | October 16th, 2010

What a difference a month makes. Allergan announced on October 15 that the FDA had approved the company’s drug Botox for treating migraine headaches in patients who experience suffer from migraines 15 or more days per month. Just a month and a half ago, however (on September 1), Allergan paid $600 million and dropped its First Amendment case against the FDA for promoting Botox for – yes, headaches.

DOJ’s press release then argued that the company had “little” evidence of safety and efficacy for the off-label uses for which it promoted Botox:

“The FDA had approved therapeutic uses of Botox for only four rare conditions, yet Allergan made it a top corporate priority to maximize sales of far more lucrative off-label uses that were not approved by FDA,” said Sally Yates, U.S. Attorney for the Northern District of Georgia. “Allergan further demanded tremendous growth in these off-label sales year after year, even when there was little clinical evidence that these uses were effective. The FDA approval process ensures that pharmaceutical companies market their medications for uses that are proven to be safe and effective, and this case demonstrates that companies that fail to comply with these rules face criminal prosecution and stiff penalties.”

That assertion sounds a bit hollow now.

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