Botox maker fined $600 million for health claims; pleads guilty to criminal charge

Botox may ease wrinkles, but a $600 million government fine today of its manufacturer Allergan is making clear it's not a legal remedy for headaches, pains and juvenile cerebral palsy.

The Justice Department today came down hard on Allergan for making such claims, announcing a settlement that has Allergan pleading guilty to one misdemeanor criminal count of promoting Botox for off-label use as well as civil charges. Of the $600 million, $375 million is a criminal fine and the rest is a civil settlement that will be split with some state attorneys general, who in 2008 had sued the company.

"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," Sally Yates, U.S. Attorney for the Northern District of Georgia, said in a statement.

The Justice Department and the Food and Drug Administration under the Obama administration have taken a dim view of Big Pharma attempts at maximizing profits by promoting drugs for uses they have not been approved for. The Botox case is the latest example.