Industry Lauds, Worries About FDA Hiring Going Forward
Executive Summary
Pfizer's Honig says that as the US FDA adds more employees or fills vacant positions, focus needs to be on training.
Sponsors may have to be mindful of an oncoming skills gap that could arise as the US FDA's hiring binge continues.
It is no secret that the agency has hundreds of openings across the executive and rank-and-file levels that need to be filled. And while it likely would be considered an overall positive development should those positions be filled and the drug center operate at full capacity, there may be some drawbacks.
Peter Honig, Pfizer Inc. senior VP and head of worldwide safety and regulatory, and former director of CDER's Office of Drug Safety, said during the Informa's FDA-CMS Summit that the focus on hiring is good, but that staff also needs to be adequately trained.
"Quantity does not equal quality," he said. "Getting the bodies in place is important, but getting the right people and the right training for these folks is absolutely essential otherwise we're going to be in trouble."
Indeed, drug review may be described as part art as well as science. The agency's flexibility in clinical trial requirements or in judging efficacy often is not a black-or-white decision. Reviewers learn to understand the "art" portion of the process through experience. With new reviewers joining FDA and some experienced reviewers and senior leaders leaving, the lack of institutional knowledge may create problems for sponsors.
There was a net addition of 90 full-time equivalents in 2017 to the new drugs program. Patrick Frey, Office of New Drugs chief of staff, said among the 2018 priorities for the office will be filling another 160 slots, he said.
Center for Drug Evaluation and Research Director Janet Woodcock also said during the conference that she hoped to start bringing in new staff as part of its new authority granted in the 2016 21st Century Cures Act.
FDA improved its scores in the annual Best Places to Work among federal agencies, which may help recruitment efforts. (See sidebar.)
The Cures legislation allowed FDA to offer salaries outside the federal schedule to attract expertise. (Also see "The Freeze Thaws: US FDA Allowed To Hire Staff For Cures, User Fee Activity" - Pink Sheet, 22 Mar, 2017.)
FDA also has created a hiring pilot program to improve recruiting and retention. (Also see "US FDA Hiring Initiative Aims To Get Scientific Staff More Involved In Recruitment" - Pink Sheet, 17 Jul, 2017.)
Inconsistency Can Stem From Hiring
The downside of calls for FDA to add more employees is that inconsistency can develop as the new reviewers complete training and begin looking at applications.
The generics Industry raised a similar concern during the agency's massive hiring binge following the launch of the ANDA user fee program.
FDA added hundreds of reviewers and other staffers to better handle its generic drug workload. Once new employees were onboarded, several metrics improved. But there also were complaints about consistency among the staff, including among refuse-to-receive decisions. (Also see "ANDA Refuse-to-Receive Challenges Become More Common – And More Successful" - Pink Sheet, 20 Jul, 2015.)
FDA announced more changes intended to improve generic drug assessment consistency and streamline business practices in January. (Also see "FDA Ends ANDA 'Reviews' To Streamline Approval Process" - Pink Sheet, 3 Jan, 2018.)
'Second Level Innovators' Needed, Honig Says
While the prospects seem better for attracting new talent, there also are concerns about the leaders that have left.
Ned Braunstein, Regeneron Pharmaceuticals Inc. senior VP of regulatory affairs and pharmacovigilance, said during the conference that the void created when John Jenkins retired as OND director in early 2017 is significant.
"In order for [employees] to feel comfortable with change, they have to feel they have the management support and the management investment in that change otherwise people are hesitant," he said. "I think that gap and the void is really taking a toll."
Woodcock became acting OND director when Jenkins left. (Also see "Jenkins' Retirement From US FDA Was Several Years In The Making" - Pink Sheet, 6 Dec, 2016.) A new OND deputy director, Peter Stein, also began at the agency shortly before Jenkins' departure. (Also see "Merck R&D Exec Jumps To US FDA As Office Of New Drugs Deputy Director" - Pink Sheet, 8 Nov, 2016.) And OND began a reorganization, which could change internal structures and practices. (Also see "US FDA Drug Office Reform: 'Everything' Is On The Table" - Pink Sheet, 15 Nov, 2017.)
Honig also said that Woodcock needs to develop another generation of leaders within CDER.
"[Woodcock] needs to create that second-level cadre of innovators that feel comfortable in working within the regulations, which I always felt are intrinsically flexible," Honig said. "You need to be creative in how you regulate."
Gottlieb has discussed streamlining FDA's internal promotion process, in part because a new generation of career agency staff eventually must take leadership posts. (Also see "Gottlieb: The Next Janet Woodcock Is Waiting To Be Discovered At FDA" - Pink Sheet, 9 Nov, 2017.)
Is Hiring Leading To More Appeals?
Honig also wondered whether FDA's problems with recruiting and retention are manifesting in formal appeals and dispute resolutions. He said it appears based on conversations that dispute resolutions have increased.
"In talking to my colleagues and friends, I sense that there's more than there have been in the past," he said. "This to me is a failure of the system that everything winds up being pushed to the OND director or the center director for disputes. And maybe it goes to the issues of not getting clear feedback or rationale as to why they disagree with things … but again, it probably boils down to capacity and capabilities."
Indeed, the number of formal appeals that were accepted by FDA jumped more than 41% from fiscal year 2016 to FY 2017. The total included prescription drug- and generic drug user fee-related appeals. (See chart.)
FDA said the increase between FY 2016 and FY 2017 in accepted appeals was due to growth in GDUFA-related dispute resolution requests, which more than doubled.
"Our assumption is that the increase in GDUFA-related [formal dispute resolution requests] could be due to increasing familiarity among ANDA sponsors of the formal appeal option available to them, however, at this time we do not have any data to support this conclusion," the agency explained.
Honig told the Pink Sheet that "having experienced and well-trained staff in leadership positions who possess hard competencies, as well as the leadership skills such as listening, negotiation, influencing etc., can really make a difference when there are tough internal decisions as well as at the interface with regulated industry.”
"In my experience, some disputes could be avoided if industry felt that they had the opportunity to interact and make their case to a receptive audience or at least an audience that was willing to have a dialog and take legitimate scientific disagreements under consideration,” he said. "Increasing FDA workload and capacity constraints can limit such opportunities."
Sponsors have been using dispute resolution in part to better understand their path forward. (Also see "If At First You Don’t Succeed, Try Dispute Resolution" - Pink Sheet, 9 Dec, 2013.)