Despite recent reports that may have suggested the agency is eyeing suicidality studies for drugs across the board, one FDA official says that just isn’t happening.

“That’s simply not true,” John Jenkins, who heads the FDA’s Office of New Drugs, tells The In Vivo Blog. “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.”

Although the agency is investigating Merck’s Singulair, for instance, not every new asthma or allergy drug will be similarly scrutinized. The FDA is “still evaluating (Singulair) 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.”

“We have to be careful not to over-generalize this and suggest that every trial has to have a specific rating scale for suicidality,” he tells In Vivo. “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.”