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April 05, 2007
FDA Recommends PDUFA Renewal
On March 23, the FDA recommended to Congress that the Prescription Drug User Fee Act, first passed in 1992, be renewed. The Act requires that manufacturers of prescription drugs pay a fee, which supplements the FDA's funding for the review of submitted NDAs and post-marketing safety surveillance. The recommendation for renewal comes with a recommendation to increase the fees by $87.4 million, to a total of $392.8 million. The increase in funding will continue the original mission of the PDUFA, while increasing safety monitoring through, amongst other things, the review of direct-to-consumer advertising.
The increased oversight and review that comes from renewal of the PDUFA may have several consequences for the practice. First of all, it has the potential to expedite review and bring many new medications to the market. Also, the increased safety review may result in more medications being pulled from the market. It is the responsibility of pharmacists to continue to monitor these developments and educate patients accordingly.
For more information, visit http://www.fda.gov/bbs/topics/NEWS/2007/NEW01592.html
Posted by kwiatkg at April 5, 2007 04:01 PM