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Pink Sheet – 100% User Fees: A 'Bad Idea' That May Be Inevitable

Pink Sheet – 100% User Fees: A 'Bad Idea' That May Be Inevitable

Executive Summary

The Trump Administration isn’t likely to drop the idea of having user fees pay the full cost of reviews. The pharmaceutical industry can afford higher fees, but industry officials worry about the perception if reviews are fully funded.

“Bad idea.”


That is how Amgen SVP-Global Regulatory Affairs & Safety Steven Galson characterized the Trump Administration proposal to increase user fees to cover the full cost of product reviews. Galson, the former head of the US FDA’s Center for Drug Evaluation & Research, was asked about the proposal during the Prevision Policy/Friends of Cancer Research Biopharma Congress Nov. 14.


President Trump called for a doubling of user fees to fully fund reviews in his budget request for fiscal 2018; it was not enacted as part of the user fee reauthorization this year, but it could re-emerge in future appropriations bills. (See sidebar.)


Galson made very clear that he doesn’t like the idea. “The public needs some ownership of what is going on,” he said. The current model “achieves some important celestial balance that’s working at FDA. I just don’t think that’s wise public policy.”


Other industry panelists agreed. “It’s not the money,” Merck SVP-Global Regulatory Affairs and Clinical Safety Sandra Milligan said. “It’s the balance.”


Having industry fully fund reviews would only fuel the perception of conflicts of interest, she said. “It would certainly be a stronger lightening rod I think for public opinion if it was 100% funded by us. I don’t think we could do anything right at that point.”


But don’t look for the Trump Administration to drop the idea – and, for that matter, don’t assume that it won’t happen no matter who is running the negotiations for the next user fee reauthorization in 2022.


Office of Management & Budget Associate Director for Health Programs Joe Grogan made clear during his remarks at the Biopharma Congress that Trump isn’t likely to drop the idea, describing it as an example of the President’s willingness to take on “sacred cows.” (See sidebar.)


Grogan described the goal as driven by budgetary necessity. “We’re out of money. We’re spending a ton of money that we don’t have every year,” he said. “We have to look to places maybe that we don’t want to, to find money.” The President “wanted to spark a debate about should premarket review be funded by industry completely,” Grogan said. “It wasn’t all the safety functions and it wasn’t the entire agency. It was this particular function of it.


Moreover, Grogan argued, the trend in user fees makes it all but inevitable that industry will end up paying the full cost of reviews. “Look at the trend line. We’re at like 72% now,” he said. “I guarantee it goes up and four and a half years from now we’ll be above where we are now. I think it’s a debate we should have about the level of taxpayer support for the review process.”


Grogan made clear that the White House is happy with the user fee reauthorization as it stands. “Congress made a decision to pass a clean PDUFA. I think it’s a great PDUFA package, probably the best one I’ve ever seen, and industry and FDA should be congratulated on it.” That said, “I do think we need to talk about the level of industry support for FDA.”…