FDA may have the answer to its struggles finding and retaining top scientific talent inside its own walls.

Richard Pazdur, director of the Office of New Drugs’ Office of Hematology and Oncology Drug Products, does not seek more industry candidates, as FDA has focused on in recent years when looking for executive and other new hires.

Pazdur preys on potential recruits’ academic aspirations and has structured his teams in that mold. That has allowed him to attract the necessary scientific talent.

“I think it’s very important for the agency to think about recruiting people from academic medicine rather than industry,” he said Nov. 12 during the Biopharma Congress, sponsored by the Friends of Cancer Research and Prevision Policy.

FDA “needs to have that emphasis really because the science is changing and they have to be partners.”

The agency’s problems finding, as well as keeping, top talent are well-known.

The federal hiring system is extremely long and complicated, preventing FDA from hiring quickly, unlike industry. And it cannot pay the salaries that industry can afford, which often means its top recruits as well as its employees end up in industry.

“I always say to the people that we’re recruiting, when you go to a meeting, even though you’re right out of your fellowship, you’re representing the FDA and people want to hear from you. And that gives you some instant credibility here and take advantage of it,” Richard Pazdur, FDA

The problem results in a number of issues. Not only are there fewer bodies than needed to complete FDA’s work, but it becomes more difficult for the agency to stay abreast of new scientific discoveries and technology.

Pazdur said he realized that to keep up with emerging science he had to persuade potential new hires that FDA was just as interesting as an academic center.

“I said we do actually more academic work here at the FDA than most academic places,” Pazdur indicated during the panel discussion. “I’m talking about sitting down and really analyzing a problem. Sitting together with statisticians, the clinical pharmacologists, the pharm-tox people, the drug safety people, and discussing a problem and really having a thorough discussion of the pros and cons.”

In December 2014, the Center for Drug Evaluation and Research had 600 openings. Among the most severe examples of the agency’s problem is in the Division of Neurology Products, where agency efforts to recruit neurologists to be medical reviewers are hampered because starting salaries for neurologists in private practice are more than senior FDA officials make Also see "Show Me The Money: FDA Recruitment Efforts Challenged By Government Salaries" - Pink Sheet, 12 January, 2015..

Mixed Results On Retaining Outside Hires

In recent years, the agency has focused its searches on industry as well as academia to fill senior leadership positions ([A#00140324010]).

Results have been mixed.

FDA was able to entice former Genzyme Corp. executive Richard Moscicki to become CDER deputy center director for science operations Also see "CDER Taps Genzyme Exec As Deputy Director For Science Operations" - Pink Sheet, 13 February, 2013..

Robert Califf also was hired as deputy commissioner for medical products and tobacco in February after a distinguished career at Duke University.

He then was nominated to replace Margaret Hamburg as FDA commissioner, although concerns have been raised about his relationship to industry during his academic career ([A#00151123006]).

The agency also hired and quickly lost Gregory Geba, who left as Office of Generic Drugs director only eight months after arriving at FDA from Sanofi Also see "FDA Generics Director’s Departure Shows Why Chemistry Matters" - Pink Sheet, 18 March, 2013..

Stephen Spielberg had an industry and academic background when hired in 2011 as FDA’s deputy commissioner for medical products and tobacco, having worked for Merck & Co. Inc. and Johnson & Johnson, as well as at Children’s Mercy Hospital in Kansas City. But he left less than two years later for personal reasons Also see "Spielberg’s Replacement At FDA Also Will Have Strong Industry Ties" - Pink Sheet, 23 January, 2013..

Aspiring Commissioner Would Target Staffing

Hiring is gaining more attention as Califf moves toward confirmation.

Califf said in testimony submitted during his Senate confirmation hearing that his first priority as agency leader would be to “strengthen and better support FDA’s talented and dedicated workforce.”

“Sustaining the quality of FDA’s scientific workforce may be more important than any particular policy because it is our day-to-day decision making that protects the public without impeding technological progress,” Califf said in written testimony.

The Nov. 17 hearing also touched on a number of other issues, including a new approval pathway for combination products Also see "Califf Supports Combo Products Pathway At Confirmation Hearing" - Pink Sheet, 17 November, 2015..

Pazdur said during the conference that he wants to develop specialized skills within his staff.

“We’re trying to really develop people and their expertise,” he said.

“I always say to the people that we’re recruiting, when you go to a meeting, even though you’re right out of your fellowship, you’re representing the FDA and people want to hear from you. And that gives you some instant credibility here and take advantage of it.”

As part of the academic focus, Pazdur reorganized the Office of Hematology and Oncology Drug Products around disease types such as breast and lung cancer Also see "Oncology Drug Applications Migrate As Part Of FDA's Reorganization Of OOP" - Pink Sheet, 12 September, 2011..

FOCR also has proposed language for the Senate Innovation for Healthier Americans initiative that would reorganize the entire agency by therapeutic area (see related story, Also see "FDA Reorganization Advocates Seek Senate Boost For Disease-Oriented Structure" - Pink Sheet, 30 November, 2015.).

In addition, Hamburg initiated a realignment process in 2013 that will lead to more specialization within the Office of Regulatory Affairs, including having inspectors focus on specific product areas ([A#14150930003]).

PDUFA VI Talks Include Hiring Issues

FDA and industry are working on a hiring strategy during prescription drug user fee renewal discussions.

Minutes of an Oct. 13 PDUFA VI Reauthorization Steering Committee meeting indicate the agency gave a “high-level overview” of its current hiring challenges and its plan “to enhance targeted recruitment, onboarding and retention of scientific personnel.”

Industry supported it and FDA planned to provide more details on hiring efforts in the future, according to the minutes.

Hiring plans are expected to factor into decisions on adding more commitments to the PDUFA program. Industry representatives told the agency they need to understand current hiring and vacancies to discuss the impact of new commitments on workload.

FDA has added more than 1,000 new employees for the generic drug user fee program since it launched in 2012.

That total was more than the agency projected would be hired when GDUFA was negotiated and some of the positions may not be refilled when vacated once FDA’s ANDA workload is under control ([A#14150120003]).

Without another user fee-driven hiring project, FDA’s budget doesn't appear to allow for a dramatic expansion in employee count for drug review.

The agency’s fiscal year 2016 budget request asked for 822 additional full-time equivalents, but only 13 of them were for the human drugs program Also see "FDA Personnel Growth Looks To Have Plateaued For Drugs Program" - Pink Sheet, 16 February, 2015..

FDA Talent Hunt: Is Recruiting From Academia Better Than Industry?

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