Wednesday, November 20, 2013

An Exception to the FDA’s Drug Approval Policies?

Princeton University has asked the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration) FDA for special one-time approval to treat Princeton students with a vaccine not yet approved in the U.S., according to university officials. The vaccine, called Bexsero, is currently used in Europe (but not the U.S.) to treat a particular type of meningitis bacterium known as serogroup B.

The request was prompted by an unusual outbreak of serogroup B meningitis on the Princeton campus. Seven students have contracted the disease so far, but fortunately none has died. Unlike most strains of bacteria that can cause meningitis, this particular strain can be transmitted fairly easily. Princeton students have been advised not to share drinks and to avoid kissing. (?)

In the event that FDA approval is granted (which is likely) the vaccine will be available for free by early December to Princeton undergraduate students, graduate students living in dorms, and students with specific health problems. At the moment, the vaccine’s use at Princeton is considered by the FDA to be a one-time exception to its policies. However, perhaps this incident will cause the FDA to consider fast-tracking its approval process for this particular vaccine, because at the moment there are no FDA-approved vaccines to treat this particular strain.

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