The already agreed-to user fee agreements between FDA and industry could face setbacks under the incoming Trump administration.

Speaking at the FDA/CMS Summit in Washington, DC last week, Kay Holcombe, senior vice president for science policy at the Biotechnology Innovation Organization (BIO), said she's concerned that the user fee agreements, which were negotiated under the Obama Administration, will be reviewed by a new Congress and new administration, each of which might take issue with them as they stand and look to begin negotiations anew.

"This raises the specter of re-litigating all of these agreements, and in particular this PDUFA VI agreement," Holcombe said. "In 2016, we have this unique situation where all of the work on negotiating PDUFA has been done in this administration—the administration of President Obama. The administration has agreed to all the commitments that are in the commitment letter for PDUFA VI, but the administration that made those agreements is leaving before Congress receives the agreement and acts on the agreement," Holcombe said.

In the past, only two other iterations of PDUFA, PDUFA I in 1992 and PDUFA V in 2012, were negotiated in an election year. However, in both cases the acts were passed by Congress and signed into law before the election took place.

"Does this new administration have a commitment to sign off on this agreement? Or will this new administration come in and decide that there are some things about this agreement they don't like?" Holcombe asked.

Starting the negotiations over, Holcombe said, would be a "daunting" task, especially given the timeframes. If the agreements were to stall and not be approved by 30 September 2017, FDA could end up losing millions in user fees from industry and face layoffs.

"It's a big deal if we start over, and it's a big deal if this doesn't happen in time," Holcombe said.

However, Holcombe tempered her worries a bit, noting that the pure complexity of renegotiating the agreements could deter the new administration from seeking to.

"My gut tells me that because of the complicated situation and difficulty of starting over on this, that reasonable people will not want to do it. It would be my hope that even though people might be scratching their heads a bit that they will let this move forward," she said.

Federal Hiring Concerns

Another potential issue, Holcombe said, would be how a federal hiring freeze under the Trump administration could impact FDA's ability to hire staff for its drug review program.

As part of the PDUFA VI agreement, FDA has committed to hiring another 200 full-time employees, as well as to hire a contractor to help it fill hundreds of current vacancies.

"The individuals who are hired under PDUFA are paid for with PDUFA funds. They are not paid for out of money that comes to FDA in its appropriation or out of the treasury directly, so these are people whose salaries do not rely on government funds," she said.

In previous situations where government agencies closed due to appropriation negotiations, user fee-funded employees were able to return to work at FDA. However, Holcombe said she does not know whether the same principle would apply to hiring new employees during such a freeze.