FDA Approving More Novel Drugs Without Advisory Committee Review
The Center for Drug Evaluation and Research is becoming more comfortable approving new molecular entities and novel biologics without first seeking the views of its outside experts. In 2011, 13 of the 30 novel therapeutics cleared did not undergo advisory committee scrutiny beforehand.
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The Food & Drug Administration is approving the first products under the new PDUVA V review process. The Program, as it is known, gives FDA an extra two months with an application in exchange for additional meetings for sponsors. It’s designed to help reduce the number of late-cycle “surprises.” There have been a few hiccups, but so far, it appears to be doing just that.
FDA has signaled that it will re-form its Pharmacy Compounding Drugs Advisory Committee, which was dissolved in 2002, as it deals with an ongoing meningitis outbreak related to compounded steroid injections. 2012 proved to be another busy year for the Oncologic Drugs Advisory Committee, but the full drug safety/risk management panel saw a significantly lighter workload than in recent years.
The 11-member staff CDER devotes to drug shortages is moving to the Office of the Center Director and will report to Deputy Director for Regulatory Programs Doug Throckmorton.