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Pink Sheet – The Freeze Thaws: US FDA Allowed To Hire Staff For Cures, User Fee Activity

Pink Sheet – The Freeze Thaws: US FDA Allowed To Hire Staff For Cures, User Fee Activity

Executive Summary

White House allowed agency to hire some new employees, but lawmakers remain concerned about federal hiring freeze’s effect on FDA.

The US FDA apparently is reaping the benefits of an exemption to President Trump’s federal hiring freeze. And while the number of new hires has yet to be revealed, it appears several new job types will be created.


Agency officials have been given the authority to fill positions that are necessary to meet mandates in the 2016 21st Century Cures Act and user fee programs, Center for Drug Evaluation and Research Director Janet Woodcock said.


Cures bill co-sponsor Rep. Fred Upton, R-Mich., asked Woodcock for details on the authorized hiring during a March 22 hearing by House Energy and Commerce Subcommittee for Health, but she said she was not in a position to discuss it.


Upton and other lawmakers have formally asked OMB about the freeze’s effect on FDA, Cures and user fee programs, but had not received a response. (Also see “US FDA May Find Relief From Trump’s Hiring Freeze” – Pink Sheet, 1 Feb, 2017.)


CDER Director Woodcock warns that incentivizing ANDA development with breakthrough-style approach could have unintended consequences, such as more citizen petitions designed to delay generic availability.

Woodcock reiterated after the hearing that she could not talk about how many people FDA had been authorized to hire and did not know the exact number anyway. The White House also did not respond to a question on the number of positions FDA could fill.


The day before, Woodcock told the Senate Health, Education, Labor and Pensions Committee that FDA was working through hiring issues with the administration.


The House hearing topic was the prescription drug user fee program reauthorization, but also included a discussion of potentially expanding the breakthrough therapy program to generic drugs. (See sidebar for related story).

FDA Recruiting Outside Comfort Zone

Woodcock told Upton that Cures-related programs will require a number of scientists, including some that FDA usually does not recruit.


The agency will need to hire social scientists who can help with patient-focused drug development efforts, such as creating patient-reported outcomes measures, she said. Woodcock also said FDA will be looking for scientists who can work with so-called “big data” and analyze real-world evidence.


“We’ve already had multiple outside parties approach us who are using real-world evidence in different ways, and they want to collaborate with us and we are working with them, some of them in the Oncology Center of Excellence,” she said. “We will need data scientists of that sort.”


The Cures legislation included a number of enhancements to the biomarker qualification process, and encouraged a greater use of real-world evidence. (Also see “The Evolution Of 21st Century Cures Legislation” – Pink Sheet, 29 Nov, 2016.)


Maybe more importantly, the bill gave FDA an infusion of additional funds to help pay for the mandates in the bill. (Also see “US FDA Getting More Money Up Front Under Cures Bill Revisions” – Pink Sheet, 30 Nov, 2016.)


FDA also has been granted authorization from the White House to hire some user fee-related positions.


Woodcock said the breakthrough therapies program will require additional hires in specific areas, particularly rare diseases.


“We have very focused needs in specific places for specific kinds of scientists,” she said.


As part of the prescription drug user fee reauthorization, the agency also has committed to integrating rare disease staff into the review divisions so orphan product applications obtain more streamlined and predictable reviews. (Also see “Rare Disease Integration Into FDA Reviews Will Grow Under PDUFA VI” – Pink Sheet, 18 Jul, 2016.)

Bipartisan Concern About Freeze

Trump announced the hiring freeze shortly after taking office. (Also see “A Burning FDA Hiring Freeze Question: What About User Fee-Supported Staff?” – Pink Sheet, 24 Jan, 2017.) FDA’s exemption seemed possible since guidelines indicated the freeze did not apply in cases where statutory mandates would be violated, as well as when public safety may be at stake. (Also see “FDA Gets Broad Exemptions From Federal Hiring Freeze In HHS Memo” – Pink Sheet, 9 Feb, 2017.)


Still, a number of lawmakers and stakeholders have announced their concern about the hiring freeze’s potential effect on FDA.


Jeff Allen, president and CEO of the Friends of Cancer Research, said during the House hearing that the hiring freeze, as well as budget uncertainty, places the new Oncology Center of Excellence “and so many other transformational opportunities at significant risk.”


The center of excellence allows staff from various product centers to work together to push oncology treatments through the review process faster. (Also see “Cures Bill Authorizes ‘Intercenter Institutes,’ But Will US FDA Create Them?” – Pink Sheet, 28 Nov, 2016.)


HELP Committee Chairman Sen. Lamar Alexander, R-Tenn., said of the freeze during the March 21 hearing: “That’s a problem. That needs to be lifted as soon as it can be.”


Sen. Elizabeth Warren, D-Mass., also said during the hearing that “the whole point of these user fees is that it’s supposed to add positions to do drug and device review, not plug holes that are created by a hiring freeze.”


Interestingly, Warren and other Democrats used the HELP Committee’s user fee hearing to complain about Affordable Care Act repeal and replace efforts. (Also see “FDA User Fee Hearing Hijacked By US Health Care Reform Arguments” – Pink Sheet, 21 Mar, 2017.)


Stakeholders also have warned that Trump’s budget plan for FDA could threaten its hiring abilities. (Also see “Trump’s Budget Outline Threatens User Fee Agreements” – Pink Sheet, 16 Mar, 2017.)

Even With Exemption, Hiring Will Be Tough

But even though the agency may now have the ability to add some new employees, it still may be difficult to actually fill the positions.


FDA has hundreds of openings at the moment, including some at the senior executive level. Because of the federal salary schedule and its lengthy hiring process, the agency often has trouble recruiting and filling positions.


In PDUFA VI, the agency and industry agreed to employ outside consultants to help improve hiring, as well as add 230 FTEs and devote more than $66.5m in user fee dollars to the effort. (Also see “FDA’s Breakthrough Workload Will Be Eased By Hiring Reviewers With PDUFA VI Funds” – Pink Sheet, 20 Jul, 2016.)


Cures also included a provision allowing FDA to depart from the federal salary schedule if necessary to land personnel. (Also see “CDER’s 50 Open Leadership Posts Could Be Bigger Hiring Challenges After Trump Freeze” – Pink Sheet, 2 Feb, 2017.)…