FDA’s Center for Drug Evaluation & Research Director Janet Woodcock, MD, can sum up the agency’s recruitment and hiring challenge in a single sentence: “It’s really hard to talk people into taking a couple hundred thousand dollar pay cut to come work for the government, even though what we do is fascinating.”

That, in a nutshell, is the uphill battle that Woodcock faces in filling the 600 open spots within CDER: It doesn’t always pay (much) to work at FDA. And while she acknowledges that open positions are “inevitable” at any federal agency, the loss of key senior managers at FDA in recent years puts significant pressure on an agency that has been tasked with multiple new programs and authorities.

“With people being assigned leads on major initiatives and programs, every time we lose an executive, there’s a hole, and we have to figure out somebody else to do that,” Woodcock said during her opening keynote address at The RPM Report’s FDA/CMS Summit for Biopharma Executives on December 11. “We’re struggling to run the HR process. It takes a lot of time for our staff to recruit people in, and we have multiple open executive positions.”

To illustrate that point, Woodcock organized her presentation as a list of 50 priorities for the center, and identified a senior manager as a lead for most of them. “Improve staffing” rounded out a list of a dozen “front burner priorities” for CDER.

Staffing issues was also a prominent feature raised by Office of New Drugs Director John Jenkins, MD, at the FDA/CMS Summit. While Jenkins has discussed staffing challenges in the past, one difference in this year’s remarks was the specific challenge of making government salaries an attractive proposition for medical experts that otherwise would be very well compensated in the private sector.

“We are really hampered by the federal hiring system: pay freezes, pay caps [and] a very outdated pay system that we try to operate under,” Jenkins acknowledged. “All these adversely impact on our ability to recruit and retain the staff we need.”

Woodcock pointed specifically to the challenge of hiring qualified neurologists as medical reviewers in the Division of Neurology Products. “I was told by [the division] that we have a terrible time hiring neurologists, because the starting salary of a newly-minted neurologist in private practice is more than what I make. So, there’s not much of a career path,” she joked.

There are real implications for industry when FDA cannot attract qualified experts. For example, the Division of Neurology Products is working on final guidance documents on early Alzheimer’s disease and Duchenne muscular dystrophy—very different areas that are nevertheless the subject of intense interest from outside the agency. ([A#2014500092])

Neither Woodcock nor Jenkins offered solutions to the staffing shortages, and it is not at all obvious where a solution might lie. After all, government salaries aren’t specific to FDA, and in a climate of strict discretionary spending limits it seems unlikely that Congress would authorize dramatic pay raises for federal employees.

So far, the staffing shortages do not seem to have impacted CDER’s ability to push forward its highest-priority initiatives, and the agency continues to meet or exceed its review times for new drugs and biologics. But as FDA and industry head into Prescription Drug User Fee Act VI negotiations, the issue is likely to become more troublesome.

After all, it will be hard to discuss appropriate goals for new or user fees when FDA can’t hire staff to meet the obligations of the old agreement.

Still Not Enough Staff

The Office of New Drugs, which houses all CDER’s review divisions, has seen some progress in hiring over the last few years. OND currently has 959 full-time equivalents on staff, compared to 916 FTEs at the start of FY 2013 on October 1, 2012. (See Exhibit 1.)

In terms of sheer numbers, that’s a big improvement over the years before FDA won direct hiring procedures from the Department of Health & Human Services. Direct hiring – plus some extra cash from Congress – gave the agency the authority to hire hundreds of new staff for and grow CDER by one-third in 2008. By the time that process was halfway completed, the Office of New Drugs had added more than 100 new employees, bringing the total base to more than 700 individuals. Also see "Reinforcements At Last: CDER Hiring Process Well Underway" - Pink Sheet, 1 June, 2008.

The Office of New Drugs is now 250 FTEs above the 2008 staffing levels. But at the same time, the office was asked to do a lot more work under PDUFA reauthorizations and Congressional legislation – and it didn’t always come with new funding.

“We have new expectations added all the time,” Jenkins said at the FDA/CMS Summit, listing as examples Breakthrough Therapies, an abbreviated pathway for biosimilars, patient-focused drug development, antibiotic incentives under the GAIN Act, development of a benefit-risk framework, the new generic drug user fee program and priority review vouchers. “The list goes on and on and on.”

So while CDER is markedly bigger than it used to be, the center still has its work cut out for it. At the Office of New Drugs, “we’ve had a little bit of success in gaining staffing, but we are still over 75 people below our authorized ceiling” of 1,058 full-time equivalents, Jenkins said. “And the overall ceiling is nowhere near the actual level we need to do all this work.”

Indeed, few of the drug review offices within the Office of New Drugs are at their FY 2015 ceiling, and some (like ODE II and the oncology office) are under the hiring line by more than 20 staffers. ODE III, it is worth noting, is currently four individuals over the ceiling office, but it won’t stay that way for long. Divisions “have been allowed to go slightly over their official ceiling since we are early in the new fiscal year and will get back down to official ceiling due to anticipated losses during the year,” FDA said.

Even a big hiring campaign isn’t the perfect solution. The hiring frenzy in 2008, for example, infused CDER divisions with new – but relatively inexperienced – reviewers. Also see "CDER's Generational Shift: Many New Reviewers With Little Experience" - Pink Sheet, 1 December, 2009. For an agency that relies heavily on institutional knowledge, the full impact of those hires is probably only now being realized – and only if those individuals haven’t since left the agency for more lucrative employment.

The average salary of an FDA staffer isn’t the only thing hampering the recruitment process. Simply put, there are fewer perks to being a government employee than working in the private sector. Budget restraints have led to very restrictive travel schedules for FDA staff, and CDER’s new White Oak campus is bursting at the seams. Employees report limited access to parking and staffers needing to double up on offices, a cohabitation structure referred to by some as “bunk beds.” Also see "CDER's Generational Shift: Many New Reviewers With Little Experience" - Pink Sheet, 1 December, 2009.

Loss of CDER Senior Officials

But where CDER may be struggling the most is at the senior management level as long-time officials leave for retirement or more lucrative positions in the private sector. Those departures underscore CDER’s aging workforce at the top – and the impact that the loss of institutional knowledge has on an agency that depends so heavily on a handful of top officials that have spent their careers working at FDA.

Even Woodcock was the focus of speculation a year ago that she might be retiring (a rumor reignited by her acceptance of a recent lifetime achievement award from the Institute for Safe Medication Practices). Woodcock has denied those rumors, and there are no indications that she is thinking about leaving FDA. But CDER has lost some key high-level officials in recent years.

Rachel Sherman left as Office of Medical Policy director for a consulting job at Greenleaf Health LLC, and Deborah Autor moved from FDA’s global head of regulatory operations and policy to Mylan NV Keith Webber, the former head of the Office of Pharmaceutical Science, left FDA to take a job with Perrigo Co. PLC. More recently, Jesse Goodman, FDA’s chief scientist, took a position at Georgetown University.

At other times, a new public health crisis requires experienced management attention, leaving Woodcock scrambling to find a senior official at the center to address it. For example, Jane Axelrad, CDER’s head of the Office of Regulatory Policy, moved over to handle FDA’s increased efforts in the pharmacy compounding area, including implementing provisions in the Drug Quality & Security Act. ([A#2014500006])

FDA has taken some steps to address the staffing shortage. Woodcock recently tapped Richard Moscicki, CDER deputy director for science operations, to spearhead a recruitment campaign of senior industry executives from outside the agency. Moscicki is uniquely capable of making a case for FDA; he was recruited to his current position from Genzyme Corp. in 2013. Also see "CDER Taps Genzyme Exec As Deputy Director For Science Operations" - Pink Sheet, 13 February, 2013.

But even Moscicki acknowledges FDA’s uphill battle. In an interview with “The Pink Sheet” last year, he said the federal hiring process is slow and hurts the agency’s ability to recruit outsiders, who likely give up or find other employment by the time the process is over. Moscicki’s hiring process, for example, took about a year to complete, compared to six or eight weeks in the private sector. ([A#00140324010])

Once hired, there is a culture shock for managers that come to the federal government from industry – and it’s not just the pay level. Moscicki said it took him a year on the job to feel comfortable at the agency.

“There’s a culture...of empowerment at certain levels, which sometimes leads to a greater difficulty in creating organizational alignment, but I think that that’s part-and-parcel of the regulatory network that requires such empowerment,” he said. “And learning how to manage within that is a different skill set, I think, sometimes than in the more straight-forward tools and alignment that you have in the private sector.”

Staffing Shortages at the Office of New Drugs

Exhibit 1

Office

Division

FY 2015 Ceiling

On Board as of 12/14/14

OND Immediate Office

Director Staff

5

3

Rare Diseases

6

5

Safety Policy & Research

7

6

Learning & Career Development

6

5

Study Endpoints & Labeling Development Staff

19

15

Regulatory Affairs

10

10

Guidance Policy Team

8

6

Pharmacology/Toxicology

5

4

Program Management & Analysis

37

34

Total

108

93

Office of Drug Evaluation I

Immediate Office

4

3

Cardiovascular/Renal

51

50

Neurology

59

57

Psychiatry

53

49

Total

167

159

Office of Drug Evaluation II

Immediate Office

5

3

Metabolism & Endocrinology

69

61

Pulmonary, Allergy & Rheumatology

63

53

Anesthetics, Analgesia & Addiction

54

49

Total

191

166

Office of Drug Evaluation III

Immediate Office

5

5

Bone, Reproductive & Urology

48

57

Gastroenterology & Inborn Errors

51

45

Dermatology & Dental

35

36

Total

139

143

Office of Antimicrobial Products

Immediate Office

7

7

Anti-Infective Products

48

47

Anti-Viral Products

56

57

Transplant & Ophthalmology

30

37

Total

141

138

Office of Drug Evaluation IV

Immediate Office

8

4

Nonprescription Drug Products

50

40

Medical Imaging

29

29

Pediatric & Maternal Health

29

25

Total

116

99

Office of Hematology & Oncology Products

Immediate Office

17

12

Oncology Products (DOP 1)

36

34

Oncology Products (DOP 2)

58

45

Hematology Products

50

44

Hematology Oncology Toxicology

27

26

Total

188

161

OND TOTAL

1,050

959

The Food & Drug Administration

Show Me The Money: FDA Recruitment Efforts Challenged By Government Salaries

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