Just a few weeks after paying a $600 million to fine settle criminal charges that Botox was illegally marketed to treat headaches, Allergan (AGN) has won FDA approval to promote the med for treating chronic migraines. The move comes despite some chatter that Allergan’s off-label marketing machine and subsequent guilty plea might influence the FDA to withhold approval.
In a statement, however, the FDA notes that chronic migraines, which are defined as occuring most days of the month, are very debilitating. “This condition can greatly affect family, work, and social life, so it is important to have a variety of effective treatment options available,” says Rusty Katz, who heads the neurology products division in the FDA’s Center for Drug Evaluation and Research.
There is one caveat: there was no evidence to show Botox will successfully treat migraines that occur 14 days or less per month, or for other forms of headache. Ironically, the most common side effects reported by patients were neck pain and…headache, of all things. In any event, Botox - which rose to fame for eliminating wrinkles - can now be used to treat one’s head inside and out.
Nonetheless, the approval may underscore the argument that off-label marketing fines are a cost of doing business. Wall Street analysts have previously estimated that Botox sales just for treating migraines could reach $1 billion or more annually in a few years, quickly dwarfing the fine. Of course, Allergan shareholders would prefer to have the $600 million back in the corporate treasury, but Allergan execs have succeeded in priming the market.
In announcing the settlement, the feds said Allergan exploited an approved indication for cervical dystonia (CD) to grow off-label pain and headache sales. How? By developing a “CD/HA Initiative” as a “rescue strategy” in the event of negative results from its clinical trials. Allergan claimed CD was as “underdiagnosed” and docs could diagnose CD based on headache and pain symptoms, even when the doctor “doesn’t see any cervical dystonia” (read the charges and whistleblower lawsuits here).