What the #@%$ is a PDUFA?

Working in healthcare marketing there is no shortage of acronyms. One that comes up often is PDUFA usually pronounced as Pa-doof-a. It stands for the Prescription Drug User Fee Act. Its a law that was passed by the United States Congress in 1992 which allows the FDA to charge a fee to drug manufacturers to pay for the drug approval process. The fee to drug manufacturers is usually over 1 million dollars, but the fee enables the FDA to have the appropriate staff and facilities to review new drug applications in a timely fashion. This act is designed to not only help the FDA get the job done, but to help patients who are waiting for life saving drugs, get access to them sooner. It also helps drug manufactures who have invested millions of dollars in research and development create a plan to appropriately bring a drug to market without having to guess when the FDA will get around to approving it. The act is designed to help out on all sides, and has mostly been well received, but has come under some scrutiny by law makers and politicians over the power of the FDA.

PDUFA dates are deadlines for the FDA to approve new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted 6 months to review the drug. These time frames begin on the date that an NDA (New Drug Application) is submitted.

This is just a quick summary for all the information on PDUFA and more, go to the official FDA site: www.fda.gov/Drugs/DevelopmentApprovalProcess

Here’s a great info graphic video breakdown on how it all works. This was put out in the spring of 2012 to raise PDUFA awareness so congress would renew the act…


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