User fee hiring: CBER on track while CDER lags

Quarterly data released by the US Food and Drug Administration (FDA) show discrepant hiring patterns for staff at the agency’s drug and biologics centers under the Prescription Drug User Fee Act (PDUFA VII) and Biosimilar User Fee Act (BsUFA III) for the first half of FY 2023.

While the Center for Biologics Evaluation and Research (CBER) has achieved 57% of its full year hiring goal under PDUFA, the Center for Drug Evaluation and Research (CDER) is further behind and has filled 34% of the positions it aims to fill this year by the end of the second quarter. CBER’s goal is to hire 132 full time equivalents (FTEs) in FY 2023, while CDER’s goal is to hire 77 FTEs by the end of the fiscal year.

When combined, the two centers are almost halfway, or 49%, of the way toward achieving their hiring goal.

CDER is further behind on hiring for the BsUFA III program; the agency has filled just 4 of the 14 (29%) positions it aims to hire this fiscal year.

The agency has agreed to certain hiring goals under the terms of both PDUFA VII and BsUFA III and has committed to reporting quarterly updates on the progress made in its hiring goals throughout the programs, which run from FY 2023-2027.

When asked to comment on these trends, FDA told Focus that “both Centers are on track to meet their FY 2023 goals.”

FDA attributed CBER’s better hiring numbers to “more advanced hiring prior to FY 2023 than CDER due to their specific hiring goals.” FDA said that some of its hiring for positions within CBER included some PDUFA VII hiring completed prior to FY 2023.

The agency said CDER “continues to utilize available hiring incentives and flexibilities to recruit candidates to the extent possible.”

Trends not unusual

Observers discussed these hiring trends with Regulatory Focus and said these recruitment patterns are not unusual.

“FDA has always had a hard time meeting its hiring goals, which is often compounded by higher-than-expected exits,” said Robert Pollock, a senior advisor with Lachman Consultants. “Meeting those goals means competing with much higher salaries than industry and one other problem is getting people to move to the Bethesda/DC area.”

Pollock noted that another deterrent is the long process it takes to hire and onboard talent. He said “the other issue is that the runway for hiring is rather long, between interview, locating the right person for the job and then actually getting them on board can take months. The government also loses potential hires because of that long runway. They can’t be waiting forever to get a job, and during the wait something better might pop up.”

He added that the overall goal completion of 49% of the year’s hiring goal across the two centers is “really not that bad.”

Anna Abram, a senior advisor at Akin Gump Strauss Hauer & Feld LLP, indicated these hiring trends may be indicative of the nature of the work at CDER.

Abram noted that “there may be something more challenging in the CDER context and then it becomes a more granular question; is there a particular scientific area in which they are encountering a little bit more challenge in hiring than they anticipated? Another way to look at it, will they make it up in Q3?”

She added that “the hiring goals are an integral and arguably a launching pad for the agency’s work … I don’t think the agency would agree to something that they do not think they could achieve.”

CBER Director Peter Marks recently said the agency is still struggling to fill positions, especially since the kind of staff they are looking for are in high demand in the private sector. (RELATED: CBER chief discusses hiring and retention challenges brought on by remote work, Regulatory Focus 6 April 2023)

Quarterly hiring update

User fee hiring: CBER on track while CDER lags

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