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POLITICO PRO – FDA user fee authorization faces unusual challenges

POLITICO PRO – FDA user fee authorization faces unusual challenges

Reauthorization of the FDA user fee programs is usually one of the surest bets on the congressional agenda. But not this year.


These crucial agreements with drug and device makers, which provide about half of the FDA’s annual budget, are facing unusual obstacles ahead of a fall deadline for approval. And without congressional action, these programs would sunset on Sept. 30, resulting in hundreds of layoffs at FDA.

Work on renewing the five-year user fee agreements is already moving at a much slower pace than previous reauthorizations, largely because it’s taking a back seat to Republicans’ complex efforts to repeal and replace Obamacare.


Another complication is that for the first time in 25 years, work on reauthorization is spanning two presidencies — the Obama administration reached initial agreements with industry last summer, and now it’s up to the Trump administration to finalize them. President Donald Trump, who hasn’t yet named a nominee to lead the FDA, has signaled he may radically deregulate the agency, which could complicate the reauthorization process.


The other elephant in the room is how much the FDA bill will get swept up into the national debate on drug pricing. If Democrats press the issue, the left could risk jeopardizing the typically bipartisan process behind the must-pass FDA funding bill.


“There is not only concerns about what the Republicans would do, but also concerns about how drug pricing enters into this and are Democrats going to use this as a vehicle for talking about drug pricing,” said Rep. Diana DeGette (D-Colo.) earlier this month.


The House Energy and Commerce Committee announced Thursday it will start its user fee hearings next week, but the Senate HELP Committee has not said when it will begin its public work. Because of the busy health care agenda and early delays in the process, the committees are expected to hold fewer hearings on the user fee programs this year.


By comparison, at this time during the last reauthorization effort in 2012, hearings on the user fees had already taken place. Both the Senate and House, had their first hearings in July 2011, more than a year ahead of the deadline for reauthorization.


Congress must review four user fee agreements for brand drug makers, generic drugs, biosimilars and medical devices, with the expectation they will eventually be packaged into one bill.


JC Scott, the chief advocacy officer for the medical device lobby AdvaMed, said Hill staffers want to move more quickly on user fee legislation, but there have been few signs of concrete progress.


“Some of the pressure is just finding the bandwidth on the committees’ schedule to get comfortable with the terms of the agreement,” Scott said.


Action on the Hill was also delayed in the first weeks of the Trump administration, which initially barred FDA officials from meeting with members or staffers. That resulted in the FDA canceling some meetings on user fees. HHS told POLITICO this week that the FDA is now meeting with Capitol Hill on a variety of topics, but would not specify if that includes user fees.


While FDA observers are concerned about the lack of progress, they say they’re not totally worried yet.


“Compared to five years ago, it’s a little bit behind schedule, but I don’t think there is reason to be alarmed at this point,” said Jeff Allen, president of Friends of Cancer Research. But, he added, “given the magnitude of what rides on these deadlines, I think everyone is going to be watching the clock a little bit about how much should be done at certain points.”


There’s also concerns among some in the industry that Republicans won’t simply rubber stamp initial agreements negotiated by the Obama administration.


One drug industry executive said some Republicans believe that the FDA hasn’t spent user fee funds as efficiently and effectively as they would like. Some Republicans already worry the agency is too dependent on industry funding.


There’s already concern that the initial medical device user fee agreement has nearly doubled to $1 billion, said Cynthia Bens, vice president of public policy at the Alliance for Agency Research.


Industry is also wary that Trump could use these agreements to push a broader agenda to deregulate the FDA in a way that drug makers oppose. For instance, Vice President Mike Pence has expressed particular interest in pursuing a national “right-to-try” law that would allow terminally ill patients to request access to experimental medicines.


Republicans are also interested in writing a new regulatory scheme on lab-developed tests to counter recent FDA efforts to assert greater authority over these devices. Republicans don’t want the FDA to make it harder to develop and sells these devices in the United States.


Movement on these issues could throw the user fee process into controversial territory.


“It’s the perfect storm with Trump so clearly wanting to make changes to FDA,” a drug lobbyist said.


Lobbyists say Republicans want to give some deference to the Trump administration to review the agreements, but FDA and industry sources are adamant that they are committed to keeping the underlying agreements made with the Obama administration.


Scrutiny by the Trump administration or Republicans would “blow things up when they are fully baked,” one drug industry lobbyist said. It would be “playing with fire” to open up the agreements and would not help the drug industry or the administration to “have FDA in chaos,” the lobbyist added.


Both Senate and House majority committee leaders on the bill said they are committed to conducting oversight of the user fee programs to improve accountability, while still keeping the timeline in check.


“The committee will be holding multiple hearings on the user fee agreements so members better understand the various improvements FDA has made since the programs were last authorized, as well as to identify and fix outstanding concerns and inefficiencies before moving forward,” said a spokesperson for the Energy and Commerce Committee.…