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Scott Gottlieb, M.D., has ended the hiring freeze President Donald Trump imposed on the FDA. The action means FDA commissioner Gottlieb can fill vacancies to shape an agency capable of enacting his plans for how safety and efficacy information are gathered during development.

Trump imposed the hiring freeze on the FDA and other federal agencies after taking office earlier this year. But last month the president gave agencies the option to resume hiring provided they set out a plan for trimming their headcounts and costs by the end of June. Gottlieb has taken Trump up on this offer, positioning him to start taking on the staff he needs to achieve the objectives he has set for his tenure as commissioner.

Gottlieb shared more details of his goals at a hearing of the House appropriations subcommittee. The commissioner’s comments covered how, while the FDA may not get faster under his leadership, he does want the agency to become more efficient in how it builds a picture of the safety and efficacy of experimental medicines.

“Review times are very short and the agency is very efficient. I think the question we need to be asking is … do we have tools, are we asking the right scientific questions to make sure that that part of the process isn’t just efficient but [that] we’re learning all we can about both the safety and efficacy of products in the development process. That’s where I’d like to focus attention,” Gottlieb said.

What this means in practice remains to be seen and will depend, in part, on how much money the agency is given. With the hearing taking place shortly after Trump unveiled his budget, the stage was set for an uncomfortable morning for Gottlieb. But, in keeping with his interactions with Congress to date, Gottlieb breezed through the encounter, diffusing the one question on the topic by saying he “wasn’t involved in the formulation of the budget.”

While Gottlieb sidestepped the question about whether budget cuts are short sighted, he made no attempt to defend Trump’s proposed last minute rebalancing in how the FDA is funded. Instead, Gottlieb took the opportunity to talk up his willingness to push for adequate funding of the agency.

“I’m going to do everything I can to work with the administration … to make sure that the agency has the resources it needs,” he said.

The hearing provided Gottlieb with another opportunity to hit the talking points that have defined his early weeks in the job. Gottlieb’s plans to tackle opioid addiction, drug pricing and facilitate innovation all got a run out during the meeting.

By Nick Paul Taylor

Source: Fierce Biotech