It was a good play.
When Pfizer's (NYSE: PFE) epilepsy drug Lyrica was included in a list of 11 drugs that might need a black-box warning, company executives said it wasn't so. They argued that Lyrica is different and doesn't deserve a warning. In a $10 billion market, being the only one without a warning label probably would have been a significant advantage.
Well here's a shocker for you: The Food and Drug Administration convened an advisory panel to go over the safety issues, and the outcome was actually positive for drug companies -- that is, those other than Pfizer.
On Thursday, an advisory panel said that the FDA's worries about epilepsy drugs, like GlaxoSmithKline's (NYSE: GSK) Lamictal and Cephalon's (Nasdaq: CEPH) Gabitril, are much ado about nothing. Or, more precisely, much ado about a little. Those on the committee did think there was evidence that the drugs may be causing suicidal tendencies, but decided the issue isn't serious enough to merit adding that black-box warning on the label.
The FDA still gets to make the ultimate decision -- it doesn't have to follow the panel's recommendation -- so it's anyone's guess how this will turn out. Maybe Pfizer will get the advantage after all; that is, if Lyrica itself avoids the label.
In addition, the strong warning might not have hurt sales that much; the suicide rates are low enough that doctors would still likely view the benefits to their epilepsy patients as outweighing the risks. But the warning could have hurt drugs that are prescribed for other uses, such as Johnson & Johnson's (NYSE: JNJ) Topamax and Abbott Labs' (NYSE: ABT) Depakote. Those are approved to treat migraine headaches.
We're in the middle of the highly safety-conscious FDA's crackdown on side effects, and I don't think investors should expect it to let up anytime soon. Call me cynical, but the good news for drugmakers is that if this keeps up, we'll end up with every drug covered in strong warning labels, and patients and their doctors eventually just ignoring them.
And Pfizer's sales would be no worse than they are now.
More Foolishness on warnings about side effects:
Want to make money in up, down, and rollercoaster markets? Find out how. Claim your private invitation to a breakthrough new service from Motley Fool Co-founder David Gardner and team. Simply enter your email below.
Terms & Conditions
RSS Headlines
Fool UK