In an article titled “A Bipartisan Case Against US FDA User Fees?” published in the Pink Sheet on July 11, 2022, Michael McCaughan discusses two of the no votes from senators on reauthorization of the user fee program. McCaughan writes that Senators Richard Burr and Bernie Sanders “expressed concern that the increasing fees contribute to higher drug prices.” He describes some of the other differences in the views of the two senators, but McCaughan’s bottom line is “the notion that the (relatively speaking) paltry price of an FDA review is a meaningful factor in the context of Big Pharma pricing decisions is almost laughable.”
Well, that may be somewhat true, but it seems that the real impact of the UFAs, including PDUFA, is raising costs and forcing some potential applicants with promising ideas out of the race to approval. Additionally, before 1992, when PDUFA, the first UFA, was passed, the FDA operated totally on appropriated funds. Remember, the genesis of the User Fee programs was the industry’s desire to speed drugs to market. Well, the UFA programs certainly have done that but, in doing so, have raised other serious recurring questions about the coziness of the FDA and industry in the game of approvals. While I have been mainly quiet about my views on the user fee programs (other than, perhaps, this post here – and I do think they have helped dramatically), maybe it *is* time to relook at how the FDA is funded.
Certainly, we have seen the government spend hundreds of billions, if not trillions, of dollars on response to the COVID pandemic and the subsequently declared public health emergency. The UFAs have brought many welcomed changes in the review process and have resulted in improved approval times as well as additional needed guidance from the Agency. The platforms are now in place and maybe charging the government with fully funding the FDA at current levels (plus the perhaps four billion dollars that would cover all of the current user fee program’s operating enhancements and personnel costs) would remove the criticism that industry is paying the freight for reviews. It would also end the five‑year reauthorization process that costs both the industry and the FDA time and money. In addition, it would lower the barrier to entry for some smaller firms that just can’t pay the fees to play in the FDA’s sandbox, and end the program fees that, in some cases, lead to product withdrawals because these fees (especially the PDUFA program fee) drain the profit out of smaller NDA products. Just a thought! There, I got it off my chest! Of course, there are many other points of view. What are your thoughts? I’d love the hear them.
