CDER’s 50 Open Leadership Posts Could Be Bigger Hiring Challenges After Trump Freeze

President Trump’s hiring freeze on civilian employees will exacerbate the Center for Drugs Evaluation & Research’s existing difficulties in recruiting and retaining qualified individuals. CDER is currently 591 positions under the hiring ceiling, include 50 open positions within CDER management.

The federal hiring freeze implemented by the Trump Administration adds another challenge to the ongoing struggle by FDA’s Center for Drug Evaluation & Research to recruit and retain qualified individuals to fill both open executive leadership positions and vacancies within its drug review teams.

While CDER’s recruitment challenges are longstanding and well-publicized by the 21^st Century Cures legislative discussion, the Jan. 23 hiring freeze on civilian employees will exacerbate the issue, at least temporarily. The number of CDER vacancies has hovered stubbornly around 600 FTEs – despite the fact that recruitment has been a top priority for CDER Director Janet Woodcock. The Trump freeze halts any efforts to fill those posts.

The freeze provides an opportunity to look at CDER’s recruitment challenges in a freeze-frame view. The center for drugs is currently 591 positions under the hiring ceiling, including 50 open positions within the senior management ranks. Of those, 18 are senior level positions and 32 are division director/deputy division director positions.

The recently established and centralized drug quality operations, CDER’s Office of Pharmaceutical Quality, may feel the effects of the hiring freeze more than other offices; OPQ has 10 open leadership positions, and four of its six sub-offices do not yet have in place a director or deputy director, according to information available on CDER’s website (last updated Sept. 30, 2016).

While an outlier in vacancies among CDER offices, OPQ is a representative illustration of the challenges FDA faces in recruiting top officials. OPQ was stood up more than two years old to great fanfare by CDER’s Woodcock, who stepped in to oversee the office until a permanent director (Michael Kopcha) could be named. (Also see "CDER Pharmaceutical Quality Office Gains Permanent Director" - Pink Sheet, 25 Sep, 2015.)

The fact that 25 months have passed since without CDER able to staff so many leadership positions speaks to the challenges the agency has in recruiting management-level talent.

Not 50 Empty Offices, Necessarily

It is important to note that the 50 open senior management positions do not necessarily translate into 50 empty offices. First, CDER counts all “acting” positions as vacancies; some acting division directors can be expected to assume their positions on a permanent basis, once the government hiring red tape is cleared.

Furthermore, most CDER offices have just a few vacancies each. In most cases where there is an opening, the sub-offices are staffed by either a director or a deputy director (the Office of Program and Strategic Analysis is one exception).

The Office of New Drugs, which houses the review teams that work directly on drug applications, is in relatively good shape at the division management level, with just two open deputy director positions at the Office of Drug Evaluation level (ODE I and III). OND, however, has one significant vacancy at the top of the organization; OND Director John Jenkins left the agency in January. (Also see "'Brilliant' and 'Steady' Jenkins Retiring From US FDA's Office of New Drugs" - Pink Sheet, 5 Dec, 2016.)

Jenkins joined Greenleaf Health as Principal of Drugs and Biologics, effective Feb. 1.

Woodcock has assumed the role of OND director since Jenkins’ departure. This role could stretch Woodcock and CDER thin during the period of trying to ensure that the PDUFA VI agreement gets through Congress against the cross-currents caused by the start-up of the Trump Administration. Some of the pressure on adding additional staff at OND may be tempered in the short-term by an anticipated review of the status and organization of it. That type of review seems likely – especially in the wake of the formation of the new Oncology Center for Excellence. (Also see "Oncology In 21^st Century Cures: Heading Toward A Two-FDA Solution?" - Pink Sheet, 10 Jan, 2017.)

PDUFA VI and ‘Cures’ At Risk

The long-term impact of the hiring freeze on FDA is unclear. It is possible the restrictions will be lifted by the Trump Administration. The White House Office of Management & Budget (OMB) has been directed by the Administration to prepare a long-term government reduction plan by April 23 (90 days from President Trump’s executive memo). FDA will remain without a forceful voice for staffing until a new permanent commissioner is confirmed.

It is also possible that the ban stays in place, and FDA is able to revise some workarounds. An updated implementation memo issued Jan. 31 by the OMB outlines some exemptions that could apply to FDA, including hires that address "national security" or "public safety responsibilities.” FDA may also be able to use internal career ladder promotions and reallocation of personnel to address workload issues. (Also see "US FDA May Find Relief From Trump's Hiring Freeze" - Pink Sheet, 1 Feb, 2017.)

In addition to day-to-day regulatory operations, the freeze has two major near-term consequences for FDA and industry:

1. Implementation of hiring provisions contained in the “21st Century Cures” Act, and
2. Upcoming reauthorization of the Prescription Drug User Fee Act.

The “21st Century Cures” Act included a number of provisions to ease FDA’s recruitment procedures, including raising salary caps and a streamlined hiring process. (Also see "Woodcock, Califf Give Thumbs Up To Certain 21^st Century Cures Provisions" - Pink Sheet, 14 Dec, 2016.) Those are now on hold under both the hiring freeze and an executive order on regulatory reform.

The freeze and the “two for one” regulatory reform may also have implications for PDUFA VI. The user fee agreement includes the hiring of 230 additional employees over the five-year period. Unless otherwise interpreted by OMB, those additional hires (in addition to the current vacancies) appear to fall within the federal hiring freeze. (Also see "A Burning FDA Hiring Freeze Question: What About User Fee-Supported Staff?" - Pink Sheet, 24 Jan, 2017.)

OMB’s initial guidance seems to reinforce the President’s assertion that the freeze applies to all executive departments and agencies (except military personnel), regardless of the source of funding. And the user fee agreement itself (in addition to agreed-to guidance documents with PDUFA VI) would be subject to the regulatory reform order, and require the removal of two regulations for each new one implemented.

When – or whether – the hiring freeze is lifted at FDA may depend in part on who Trump picks for commissioner. So far, four names have been floated, from the more traditional Republican pick (Scott Gottlieb) to more disrupter-style choices, like Silicon Valley executives James O’Neill and Balaji Srinivasan to author and ardent FDA critic Joe Gulfo. (Also see "Trump Meets With Two US FDA Commissioner Candidates; Third Still Lurking" - Pink Sheet, 12 Jan, 2017.)

An announcement on an FDA commissioner nominee could be in the near-term; President Trump told a group of pharmaceutical CEOs on Jan. 31 that he will be revealing a name soon. (Also see "Trump Promises Changes To 'A Lot Of Rules' At US FDA" - Pink Sheet, 31 Jan, 2017.)

That timing may depend to some degree on the Senate confirmation of HHS Secretary nominee Tom Price. His nomination cleared the Senate Finance Committee – with no Democrats present – on Feb. 1.

From the editors of the RPM Report