Tuesday, May 06, 2008

Setting the Record Straight on Suicidality

FDA Office of New Drugs Director John Jenkins wants to correct a misperception about testing requirements for psychiatric adverse events. Contrary to reports by certain media outlets, FDA is not putting in place a blanket request for suicidality studies.

“That’s simply not true,” Jenkins says. Rather, “it’s being done in a targeted manner, wherever it seems to be appropriate based on what we’ve seen from other products in the class, the pharmacology of the drug itself, or other studies of that same drug.”

Granted, the potential for certain drugs to cause mood disorders or suicidal thoughts has been in the news lately—especially given FDA’s recently aired concerns with potential psychiatric risk profile of Merck’s Singulair, a popular asthma/allergy medicine. But that’s not to say that FDA is changing the game for all drugs across all classes.

In the case of Singulair, FDA is “still evaluating the case reports that are coming in from spontaneous reporting,” Jenkins says. “We’re not systematically asking every sponsor of an anti-asthmatic drug or an allergic rhinitis drug to include suicidality as part of their targeted assessments.”

To do otherwise would not be scientifically sound, Jenkins says. “We have to be careful not to over-generalize this and suggest that every trial has to have a specific rating scale for suicidality. You could start taking that to its logical extreme and have every trial have a rating scale for every possible adverse reaction, even though there may not be a reason prospectively to specifically be concerned in that setting.”

For certain drug classes, however, FDA has upped the ante and is asking manufacturers to either prospectively or retrospectively test for psychiatric adverse events. For more information—and for an interview with FDA’s Jenkins—you can check out the latest issue of The RPM Report online; non-subscribers can sign up for a free trial to access the story.

But here's the good news: there are FDA-sanctioned ways to test for psychiatric adverse events. So even for companies that are being asked to test for depression and suicidality, at least there's a process to get some clarity and predictability into the process.

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