Jenkins defends approvable letters
A recent controversy about the FDA ducking its legal obligation to approve new drugs on time by issuing "approvable" letters is just silly, said FDA director of new drugs John Jenkins. He was also annoyed by the media's slowness to educate themselves.
An “approvable” letter allows the sponsor to submit additional information for FDA consideration, leading some to say the agency is more risk-averse in the wake of the Vioxx withdrawal.
Jenkins said at the Drug Information Association's annual meeting in Philadelphia in June that public comments on these letters “is really a kind of silly way of looking at data and very short-lived numbers.”