FDA's No Comment On Budget Plans Leaves Awkward Void

When asked about the effect of Trump's potential cuts to FDA, agency officials are not allowed to discuss it, creating more uncertainty about the budget and user fee process.

Sen. Elizabeth Warren, D-Mass., probably was looking to skewer the White House for its budget blueprint that appears to cut taxpayer money from FDA and increase user fee revenue.

The March 21 Senate Health, Education, Labor and Pensions Committee hearing was on FDA user fee programs, but already had ventured into other areas, like criticizing Republicans for not scheduling a hearing on the upcoming Affordable Care Act repeal and replace legislation.

Warren asked Center for Drug Evaluation and Research Director Janet Woodcock if cuts to FDA funding would make the agency's job easier or tougher.

But instead of confirming that less money could affect FDA's activities, all Woodcock would say was: "I'm not in a position to discuss budgetary matters at this time."

It created a somewhat awkward moment and Warren seemed a little surprised. She reminded Woodcock that she was not asking about budget specifics and asked whether budget cuts were a good idea. But Woodcock gave a similar answer.

"Again, I'm not able to comment," she said.

FDA officials usually are not allowed to advocate for or against legislation if the White House has not issued a position or given permission, but can provide technical assistance. The "no-comments" from Woodcock and others suggest the White House has not released them to talk about the budget just yet.

However, not speaking about the impact of budget changes may create more uncertainty for FDA as it enters the user fee renewal process, which itself throws several policy issues in the air. The result could be more worrying among FDA staff about the agency's future than usual. Agency leaders already have been forced to address staff concerns following Trump's election. (Also see "Woodcock Tries To Calm US FDA Staff Fears About Trump" - Pink Sheet, 21 Dec, 2016.)

Most other subjects were on the table during the Senate hearing, as well as a House Energy and Commerce Subcommittee on Health user fee hearing the following day, although when it came to FDA's exemption to the federal hiring freeze, Woodcock was reluctant to give specifics. (Also see "The Freeze Thaws: US FDA Allowed To Hire Staff For Cures, User Fee Activity" - Pink Sheet, 22 Mar, 2017.)

User Fee Worst Case Is OK To Discuss

The stated topic of both congressional hearings, user fee programs, was one where Woodcock was not afraid to discuss potential changes.

Woodcock described what would happen if they were not reauthorized during the March 22 hearing. The questions seemed intent on illustrating the importance of the prescription drug, generic drug, biosimilar and medical device user fee programs to FDA's budget and the services the agency offers.

Woodcock said that if there was no progress on reauthorization of PDUFA, the agency later this year would have to initiate activities to wind down the program, which likely would include telling thousands of employees they could be laid off. And if the Oct. 1 deadline to renew the programs was missed, FDA would begin letting people go.

"What we'd expect is the productivity would slow down as we approach the brink tremendously," Woodcock told Rep. Tony Cardenas, D-Calif. "Our people are heavily recruited into other jobs and … they aren't paid as much as the private sector. And so I would expect we would start to lose people very early, who would leave before they got their notice."

Neither FDA nor lawmakers likely believe the nightmare scenario will occur, but FDA in that case was willing to remind lawmakers of the implications of their inaction.

However, when it applies to the effect of Trump's upcoming budget request, the agency was not willing, or allowed, to engage in similar discussions.

"Unfortunately, we can't speak to the budgetary implications of that," Center for Biologics Evaluation and Research Director Peter Marks told Sen. Tim Kaine, D-Va., in response to a question about the effect of cuts to NIH's budget during the Senate hearing.

Trump's budget blueprint included a proposed 17.9% cut to the Health and Human Services Department from the fiscal year 2017 level, but did not give specific details about plans for FDA. It did say that the White House wanted to increase FDA user fee revenue, suggesting the existing user fee reauthorization agreements may need to be changed. (Also see "Trump's Budget Outline Threatens User Fee Agreements" - Pink Sheet, 16 Mar, 2017.)

Marks did acknowledge that there is a connection between NIH funding and innovation, but otherwise would not comment on the effect of cuts on innovation.

"I'm sorry I can't speak to it," he said.

Kaine was irritated by the unwillingness of FDA staff to answer his questions about the budget.

"I'm just troubled by the witnesses' unwillingness to offer professional opinions," he said. "We do call professional witnesses before a committee with the thought they would give us their best expertise and I find it impossible to believe that the individuals do not have an opinion on the question of whether the funding of research has a connection to medical innovation, whether the cutting of research funding would as a general matter reduce innovation."

Sen. Lamar Alexander, R-Tenn., who chairs the Senate HELP Committee, interjected that he thought they were answering as they had been told.

"Military officers have a different role and give different answers and the non-military officers always are in a tough spot presented with questions like that because they've been instructed by the Office of Management and Budget not to answer the questions," he said. "Maybe it should be different, but that's been the tradition throughout both, well, all of the administrations I know."

Sen. Al Franken, D-Minn., responded to the question for Kaine: "The answer is yes, reduction in NIH funding would have a reduction in innovation."

What Is Effect On Appropriations Process?

After the Senate hearing, Woodcock refused to say why she could not comment on the budget, or confirm that she was refusing to comment at OMB direction.

But hers and other FDA officials' refusal to discuss the Trump budget, at least for now, could hurt not only the appropriations process, but advocates' efforts to avoid the proposed cuts.

A more detailed White House budget request is expected in May. In the meantime, advocates likely will be pushing lawmakers to avoid cutting FDA's non-user fee funds, especially given that the user fee reauthorization agreements already have been completed and likely cannot be reopened to create more fee revenue.

Even if Trump's budget request is not realistic, as the Alliance for a Stronger FDA has said, a lack of acknowledgement from FDA of that fact may be concerning.

Usually, the president's budget request serves as the starting point for budget negotiations. An unusually low figure may make it harder for stakeholders to push the number much higher. (Also see "FDA Budget Request Is Flat For Drugs, Pressuring Stakeholders" - Pink Sheet, 15 Feb, 2016.)