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New FDA commissioner passes on defending president's budget proposal during House appropriations subcommittee hearing. With Congress disinclined to reopen user fee negotiations, Gottlieb instead focuses on his priorities for agency.

New FDA commissioner passes on defending Trump 

 

After several lawmakers had declared the Trump administration's budget proposal dead on arrival, US FDA Commissioner Scott Gottlieb danced around the subject of user fees in his first congressional testimony has head of the agency.

 

Speaking before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies May 25, Gottlieb did not address the major recalibration of user fees proposed in the president's budget. The Trump proposal would cut FDA budgetary authority by 31%, while hiking user fee funding by 68%. (Also see "FDA Safety Initiatives Could Suffer Under Trump's Budget Proposal" - Pink Sheet, 23 May, 2017.)

 

Subcommittee Chairman Rep. Robert Aderholt, R-Ala., and Ranking Member Rep. Sanford Bishop, D-Ga., both put the official kibosh on any notion reopening the user fee reauthorizations.

 

"I give someone credit for coming up with a very creative proposal," Aderholt said. "But the legislation before Congress reflects agreements that take up to two years to work out."

 

Bishop noted that the user fee agreements "are very far along in the legislative process," adding that it is "doubtful" that FDA and stakeholders would be able to renegotiate a new agreement in time before the current set of agreements expire.

 

Rep. Rosa DeLauro, D-Conn., also put it bluntly when she told Gottlieb that the proposal to sharply increase user fee funding is "quite frankly not going to happen."

 

Gottlieb, however, passed on his many opportunities to defend the president's budget proposal. He instead spent much of his time speaking informing lawmakers of his plans to foster a more competitive marketplace for generic drugs. (See sidebar for related story.)

The commissioner additionally discussed issues such as the 21st Century Cures Act, which Gottlieb said the agency would use as a guide in evaluating whether the proper regulatory science is in place to help make medical product development more efficient. Lawmakers also questioned Gottlieb on issues such as food safety and tobacco rules, to which Gottlieb often admitted he was still learning about and pledged to follow up at a later time.

 

In a response to DeLauro about food safety, he noted that he "was not involved in the formulation of the budget," and that he would work with the administration and Congress "to make sure the agency has the resources it needs to fulfill its mission."

 

Although Gottlieb did not offer a direct critique of his boss' proposal, his evasiveness on the user fee agreements, as well as the distancing of himself from the formulation of the budget, suggest that he might be less than enthusiastic about the president's proposal.

 

 

Hiring Freeze Lifted

Gottlieb also announced at the hearing that the hiring freeze was lifted at FDA Thursday morning. Although FDA was expected to have broad exemptions from the hiring freeze, it was unclear whether all user fee-funded positions would be in the clear. (Also see "FDA Gets Broad Exemptions From Federal Hiring Freeze In HHS Memo" - Pink Sheet, 9 Feb, 2017.)

 

Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander, R-Tenn., praised the lifting of the hiring freeze in that it allows the agency to fulfill the hiring provisions set forth in the 21st Century Cures Act.

 

“We asked the Food and Drug Administration last year to tell us the single most important thing we could do to help move safe drugs and devices more quickly into patients’ medicine cabinets and doctors’ offices. And they said it was to allow them to hire talented people and pay them more competitively,” Alexander said in a statement.

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