It is 2021 and the United States Congress will soon convene to discuss PDUFA reauthorization.
During this time the Commissioner of the FDA will go before members of Congress to explain how it can
help the Agency to continue fulfilling its mission. Assuming the FDA has properly met its review
timelines while collecting user fees from industry, compose a 2-3 page letter to the FDA Commissioner
stating why you believe PDUFA should, or should not, be reauthorized. If you believe PDUFA should be
renewed, describe any improvements you believe should be made to the previous Act. Remember, the
FDA has dual, sometimes opposing responsibilities to protect consumer safety while providing the public
access to potentially life-saving treatment. You may write the letter from the perspective of a consumer, a
Regulatory Specialist working in industry, or an FDA employee. Background Information:
The Prescription Drug User Fee Act was initially authorized in 1992. In exchange for industry
user fees, the FDA agreed to follow deadlines imposed for drug review time among meeting other
performance standards. PDUFA was renewed in 1997, 2002, 2007, 2012, 2017. Over the past two
decades, annual user fees- which make up a large portion of FDA funding- have increased substantially as
the average drug review period has declined. However, debate continues whether PDUFA is directly
associated with the acceleration in NDA review times, and whether the decrease in average NDA review
time has compromised post-approval safety. Prompt:
In a letter to the FDA Commissioner, describe the reasons you believe PDUFA should be amended,
kept the same, or ended. Provide evidence to support your argument. Consider average drug approval
times in recent years, post-approval safety problems, and the amount of user fees collected by FDA.
Several websites you may find useful include:
https://www.fda.gov/forindustry/userfees/prescript…ucm446608.htm” class=”redactor-linkify-object”>https://www.fda.gov/forindustry/userfees/prescript…
https://www.phrma.org/advocacy/research-developmen…
https://www.fda.gov/forindustry/userfees/prescript…
There is no right or wrong answer. Evaluation will be based on justification of argument, clarity
of opinion, and proper citation and attribution of sources. PDUFA provisions aside from user fees and
review timelines may be used to support your argument.