US FDA's Hiring: First Phase Of Cures Implementation Will Focus On Senior Staff
Executive Summary
Workforce report to Congress, mandated by 21st Century Cures Act, details FDA's plans for implementing its new authorities provided by the law.
As the US FDA is preparing to face a slew of senior staffers reaching full retirement eligibility in the coming years, the agency's first point of implementation of hiring authorities from the 21st Century Cures Act will focus on supervisory and executive positions across the medical product centers.
Compounding FDA's ability to staff leadership positions within the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH) and the Center for Veterinary Medicine (CVM) is the private sector's ability to pay higher average salaries, coupled with the increased responsibilities of senior roles, the agency said of its workforce in a report to Congress dated May 21.
"Interviews with FDA leaders indicate that supervisory positions are particularly difficult to fill," the report states. "One of the reasons cited is that FDA is not able to pay salaries to supervisors that make it attractive to take on the additional responsibilities of being a manager."
Senior leadership positions will remain in the spotlight over the next few years, as roughly 50% of these staffers will be eligible to retire.
With the new hiring authorities granted by the Cures Act, however, FDA Commissioner Scott Gottlieb has remained confident that the agency will be able to cope with the upcoming retirements. (Also see "US FDA Hiring For Senior Staff Vacancies Boosted By Cures Act, Pilot Program – Gottlieb" - Pink Sheet, 7 May, 2018.)
The Cures Act specifically provides FDA with the flexibility for the hiring of individuals for certain scientific, technical and professional positions, and also the ability to establish a new pay authority to more effectively compete with the private sector. (Also see "The Freeze Thaws: US FDA Allowed To Hire Staff For Cures, User Fee Activity" - Pink Sheet, 22 Mar, 2017.)
Increased hiring authorities, FDA explains in the report, are essential to keep up with the agency's increasing regulatory responsibilities. For instance, the agency estimates it will need to add roughly 200 new staff to implement the Cures Act's requirements in areas such as regenerative medicine, the qualification of biomarkers, novel clinical trial designs, and the use of real-world evidence. (See sidebar for related story.)
The agency made its first new hires under the Cures act in early 2018, one of which was Patrizia Cavazzoni as deputy director for operations in CDER. (Also see "New CDER No. 2 May Impact FDA's Safety Monitoring Aspirations" - Pink Sheet, 17 Apr, 2018.) More hires are expected in the coming months, FDA noted in the report.
FDA's report to Congress also discusses the agency's hiring initiative, which includes a pilot project aimed at filling 140 vacancies in CDER and CBER. (Also see "US FDA Hiring Initiative Aims To Get Scientific Staff More Involved In Recruitment" - Pink Sheet, 17 Jul, 2017.) and (Also see "US FDA Staff Slams Agency Hiring Policies In Report Ahead Of Public Meeting" - Pink Sheet, 24 Nov, 2017.)
Although the initiative will take time, FDA officials believe that the agency's efforts "will begin to show measurable results in the near future," according to the agency. The report is mandated by the Cures Act, which requires that FDA issue a report to Congress on the agency's workforce planning within 18 months of the law's enactment.
An 'Alternative Pay Structure'
With the Cures Act, FDA has been working to phase in an "Alternative Pay Structure" (APS) designed to "balance the flexibility provided by Cures with policies and procedures to facilitate consistency," the report states.
The agency first identified 38 occupations that fit the law's statutory parameters with regard to the hiring of "scientific, technical, or professional positions that support the development, review, and regulation of medical products." FDA then created a pay structure of nine different "bands," which was partially on the General Services (GS) scale, according to the report.
"The Agency is in the process of completing policies and procedures to guide the placement of employees within these bands based on the type and relative complexity of different positions," FDA says. "The band structure, and accompanying policies, will facilitate consistency within individual Centers and across FDA."
Executive and supervisory positions within the 38 identified occupations across the medical product centers will be the focus of the first phase.
The next phase of implementation, the report states, will focus on "mission-critical positions," which include toxicologists, pharmacists and veterinarians. According to FDA, these positions have the largest gaps between government and private sector pay. (See chart below).
A Strategy To Fill Senior Positions?
The agency says is developing a proactive workforce succession plan to address the cliff of upcoming retirements. Details, however, remain sparse, as it appears the agency is still sorting out the specifics of the plan.
"FDA is developing workforce and succession planning strategies to help the Agency become proactive in identifying projected workforce gaps to reduce the need for reactive hiring," the report states.
"To address these issues, FDA is developing succession management strategies that will shape FDA's future leadership cadre," the agency adds. "FDA is improving its strategic human capital practices; continuing to promote an inclusive and fair work environment; and developing a talented, diverse, and engaged executive cadre needed to fulfill its mission."
But even with the Cures Act's new authorities, the agency suggested challenges competing with the private sector for senior leadership positions will remain.
"The pay disparity with market salaries grows as positions increase in responsibility in the leadership chain at FDA," the report states. "At the Senior Executive Service (SES) level, candidates from the private sector often report that their current salaries are well above the $400,000 Cures HR salary cap."
Gottlieb Lauds New Authorities, But Are They Sufficient?
Gottlieb has made no secret about his support for the hiring authorities, as he has touted their benefits on multiple occasions.
The commissioner, however, raised concerns in the report that certain agency staffers may not fit within the statutory language pertaining to the hiring authorities. Since the Cures Act specifically applies scientific, technical, and professional positions related to the regulation of medical products, certain other centers may be disadvantaged, he says.
For example, Gottlieb says, statisticians situated in the Center for Tobacco Products (CTP) or the Center for Food Safety and Applied Nutrition (CFSAN) – who may work across the agency's centers – cannot be hired under the Cures Act's authorities since their centers do not support the regulation of medical products.
"This would put them in a different pay structure than a person with similar skills and responsibilities who might be situated in a different FDA Center," Gottlieb writes.
The commissioner added that FDA welcomes the opportunity to continue to work with Congress to address the agency's hiring authorities.
FDA's 21st Century Cures Workforce Planning Report to Congress