What is PDUFA?

 I used to have a much beloved co-worker who was not in healthcare, but upon hearing the term "PDUFA" – standing for the Prescription Drug User Fee Act – for the first time during a meeting, shouted out "What the hell is PDUFA?"  After that, PDUFA became his nickname.  Almost no one called him by his real name, everyone called him PDUFA.  

I regularly monitor the search terms people use when they use a search engine and land on Eye on FDA.  I like to see the most common uses and I also like to see the most uncommon uses.  Google Analytics shows you both.  Two of the most frequent search terms or phrases is as follows:

  • What is PDUFA?
  • What is a PDUFA date?
  • List of PDUFA dates

What is perhaps even more surprising is to see where some of these requests are coming from.  That is beyond our scope today, but I thought that the frequency of the search merited a special posting.  So if PDUFA is already well-known to you, you may want to stop here.  Or you may want to read on and kindly amend in the comments section any oversights I might have made.

What is PDUFA?  PDUFA, as noted above, stands for the Prescription Drug User Fee Act, originally passed in 1992.  In its most simple terms, the legislation authorized the FDA to begin collecting fees from drug sponsors that would be utilized to expand review staff so that new drugs could be reviewed more quickly.  The act has been periodically reviewed and expanded upon through reauthorizations and is currently in its fourth iteration.  

What is a PDUFA date?  The new system established set time periods for the FDA to review a new application, usually set at a 10-month period.  If a drug, however, gets a priority review designation, then the review time will be set at 6 months.  (A priority review is given to drugs that offer a significant new breakthrough in treatment, or offer a treatment where none or few exist, and can be given for a drug which treats a serious condition as well as those that treat less serious conditions).  The timing for the clock to tick begins when the company submits the new drug application to the FDA.  The date is a target for FDA, but the agency can, and many times does, announce a decision prior to the PDUFA date.  

List of PDUFA Dates.  While there are some companies that perform competitive intelligence and assemble PDUFA dates, and many investors will track PDUFA dates, there is no official "list" that is published by FDA.  That is because the filing of the new drug application and its contents are proprietary to the company that made the filing.  Many companies reveal the date of their filing by press release, while some do not – and there are various factors that go into that decision.  

It is also worth noting that a PDUFA date can be extended by the FDA.  This happens when the agency simply needs more time due to a circumstance in the consideration process – to peg down a risk management program or, more likely, to review new data.  

And, an alternative to this definition of a PDUFA date, of course, is going out to dinner and/or a movie with my friend PDUFA.  

Hopefully this brief and topline overview is helpful for the many, many people who each day enter search terms into search engines seeking some information on PDUFA.  And be careful asking out loud "What is PDUFA?"  It is a nickname that sticks.  

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2 Responses to What is PDUFA?

  1. Ssmedley says:

    Please clarify: PDUFA timing begins when the company submits the new drug application to the FDA – so is it the postmark date or receipt date by FDA? Thx.

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