FDA's Prescription Drug User Fee for Applications requiring Clinical Data

Since 1992 the FDA fees have gone up, and doubled from $2M in 2017 to $4M for 2024

This data is for simply for those researching the FDA and Big Pharma….I needed to place this research data somewhere!

We know that our regulators make their money from Big Pharma fees. The FDA has been increasing their fees up every year since the 1992 Prescription Drug User Fee Act (PDUFA) was passed.

But what are the other reprocussions of these exporbitant fees? How can a small company or a product that can’t be patented, like Vitamin C, be able to afford FDA’'s fees if a clinical trial was necessary- as seems to be demanded by the Evidence Based Medicine crowd.

Today I went through the archives and documented the fee which have been charged by the FDA for applications that required clinical data and ploted this.

You will notice that the fees have doubled from 2017 ~$2 million to 2024 ~$4 million! Why did they drop in 2017¹…I’ve not looked into, but it was a significant drop.

Graph of the fee’s that a drug (or vaccine) manufacturer is required to pay to the FDA for a product that requires clinical data assessment.

There are additional fees for non-clinical data. This is a snapshot of just one fee, and revenue stream for the FDA.

Most data links gathered from archives - HERE

I couldn’t find the data for 2002, but did note this following information which likely affected the fee (which I don’t have time to dig into further.)

“Recognizing the necessity of reauthorizing PDUFA before the end of FY 2002 to assure continuity of operations, Congress enacted the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which includes the Prescription Drug User Fee Amendments of 2002 (PDUFA III) reauthorizing user fees through FY 2007. The President signed PDUFA III into law on June 12, 2002”²

It would appear that every 5 years a "reauthorization of the Prescription Drug User Fee Act (PDUFA) is granted by the President which is intended to provide the “FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.”³

These reauthorisations allow the FDA to increase their fees. Following the Prescription Drug User Fee Act of 1992 (PDUFA) the first extension appears to have been granted in 1998.⁴

PDF

From 1992-1997 “the agency reduced, by about 40%, the length of time it required to review new drug and biologic license applications, without compromising review soundness and quality”⁵

PDUFA VII Information Technology and Bioinformatics Goals and Progress

Wow, so I went looking for the current PDUFA (its VII) …and it appears they are rolling “technology” and “modernization” into the fees!

So if the FDA are going to “Leverage Cloud Technology to Progress Regulatory Digital Transformation” and “Digital Health Technologies (DHTs) for Drug Development and Review” - wouldn’t technology theoretically make assessment cheaper? Or does it just cut out those companies that cannot meet the new demands of the FDA?

Does this action help the FDA work with the United Nations to integrate drug regulation into a one-world regulation scheme?

Is there a Plan for a Global Regulator??

Several years back I came across the World Health Organisation’s Access 2030 program (started in 2016, possibly as early as 2014), and to me it appears to be a plan to roll all drug regulation into one global body - sold as the need to help 3rd world countries. It certainly appears they are working their way towards this with the collaboration set up between Australia-Singapore-Swiss-Canada-UK with their Accesss Consortium ⁶ (interesting name!).

Be on the lookout for Access 2030!

Helping you do your own research!

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1. https://web.archive.org/web/20170629010406/https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm

2. https://web.archive.org/web/20061020030343/http://www.fda.gov/oc/PDUFA/default.ht

3. https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vi-fiscal-years-2018-2022

4. https://web.archive.org/web/20061009113054/http://www.fda.gov/oc/PDUFA/5yrplan.html

5. https://web.archive.org/web/20060622024952if_/http://www.fda.gov:80/oc/pdufa2/5yrplan/pdufa2.pdf

6. https://web.archive.org/web/20201101023413/https://www.tga.gov.au/australia-canada-singapore-switzerland-united-kingdom-access-consortium