Drug Ads, Abilify & FDA Approval

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By Admin on August 03, 2009 3:02 PM

The onslaught of advertisements for Abilify as a treatment for depression exemplify the lucrative bounty of winning FDA approval to use a drug in a different manner than its originally intended purpose. The ability to promote Abilify for use with depression has brought its maker (Bristol-Myers Squibb) huge new revenues. FDA approval could also have paved the way for ads that border on deceptive, and many patients unnecessarily taking a drug that can have intense side effects.

An Abilify ad was recently featured on Consumer Reports' AdWatch. In the words of Consumer Reports, "[w]e chose Abilify for this seventh edition of our AdWatch series because, frankly, the ad scares us."

What is Consumer Reports' beef with the ad? Basically, that it makes Abilify sound like an anti-depressant, which it is not. It is an anti-psychotic which in 2007 the FDA approved for corollary use with patients on an anti-depressant. Consumer Reports also takes issue with the impression left by the ad -- that patients should try it if an anti-depressant alone hasn't worked.

According to Consumer Reports, the first anti-depressant tried often does not work on a patient. However, adjusting type, dosage and other treatment options may prove much less risky than prescribing Abilify, which comes with risk of more dangerous side effects.

Abilify serves as the perfect counter example to the recent Zyprexa story. There, Zyprexa's maker (Eli Lilly) paid $1.42 billion to settle civil claims and a federal criminal probe over it's marketing of the drug for unapproved uses. Doctors can at times prescribe a drug for a use which the FDA has not officially approved. (This is called "off-label use.") As explained in an earlier post, however, drug companies cannot market a drug for uses unapproved by the FDA.

Zyprexa did not receive FDA approval for uses associated with the elderly or helping them sleep, but Eli Lilly marketed such uses to the hilt. Result: big money loss for Lilly.

Abilify did receive FDA approval for use as corollary to fight depression. (Incidentally the customer base for depression uses dwarfs the customer base for Abilify's originally intended patients -- those suffering from schizophrenia or bi-polar disorder).

And market Abilify for its newly approved use it did. According to Consumer Reports, Bristol-Myers spent around $100 million marketing Abilify in 2008. Sales of the drug (which costs much more than most anti-depressants) reportedly increased approximately 33%.