FDA Personnel Growth Could Have Plateaued For Drugs Program

Only a handful of new FTEs are requested in President Obama’s FY 2016 budget request for human drugs activities, suggesting that GDUFA and other related programs may have reached their critical mass of employees for now.

Any hope that FDA’s drug program hiring binge will continue appears to have been nixed. By fiscal 2016, it largely will be over.

In President Obama’s fiscal 2016 budget request, the agency asked for 822 more full-time equivalents than the level enacted by Congress for fiscal 2015. But the human drugs program only would receive an increase of 13 full-time equivalent employees over the fiscal 2015 enacted level.

The leveling off of FDA’s staffing needs in the human drugs program may signal that FDA is nearing its critical mass of human capital to meet its oversight needs after several years of expansion to deal with new mandates. Yet it does not appear FDA will stop hiring altogether in 2015, based on the number of existing positions that remain vacant.

FDA said the human drugs program needs 5,516 FTEs in fiscal 2016, a fractional increase from the 5,503 FTEs in the 2015 enacted budget. The biologics program would see about the same increase – the agency asked for 11 additional FTEs from the 2015 enacted level of 1,326 (see table below).

The miniscule increase for human drugs would represent a dramatic change from previous years. FDA increased its FTE count by 864 in the enacted 2015 budget compared to the previous fiscal year’s actual budget and added 362 additional FTEs in fiscal 2014 compared to 2013.

The biologics program did not see a similar rise in recent years. The 2015 enacted budget included seven more FTEs than 2014, but both totals, as well as the fiscal 2016 request, were less than the 2013 actual FTE level of 1,342.

The requested increases, FTE and budgetary, stand little chance of being enacted as is, given that Congress typically does not follow Obama’s funding proposals to the letter. But the agency’s request for an increase in budget authority may be received well by industry (Also see "User Fees Would Recede In Significance Under President’s Budget" - Pink Sheet, 2 Feb, 2015.).

FTEs Without User Fees

A glaring difference in the FTE request compared to past years is the number that would be supported by user fees.

For the human drugs program, which includes the brand and generic drug and biosimilar user fee programs, FDA requested two additional user-fee supported FTEs. The remaining 11 needed in 2016 would come from budget authority, according to the budget document. In 2015, the human drugs program received 788 additional FTEs that were supported by user fees compared to 2014. Another 76 additional FTEs came from budget authority in that period.

The two fee-supported positions to be added in fiscal 2016 would be funded by the proposed International Courier user fee, which likely will not be created. It has been requested for a number of years and largely ignored by appropriators (Also see "FDA Globalization Efforts Gain Traction Even As Budget Request Emphasizes Old Inspection Model" - Pink Sheet, 21 Feb, 2011.).

Generic drug user fees, a major source of new personnel since its launch in October 2012, are projected to add no additional FTEs for the human drugs program in 2016, according to the budget document. FDA requested 664 FTEs for center operations and 173 FTEs for field activities to be supported by GDUFA revenue, which was the same as the 2015 enacted level.

That would appear to signal that FDA intends to complete its GDUFA hiring plan on time this fiscal year. The agency wanted to hire more than 900 new employees across several offices to help deal with GDUFA-related responsibilities from 2013 through 2015.

FDA exceeded the hiring goal ahead of schedule, adding more than 1,000 new employees for GDUFA positions (Also see "GDUFA Success Story: FDA Exceeds Hiring Goals, Names OGD Director" - Pink Sheet, 15 Jan, 2015.).

FDA also said some of those positions may not be refilled if vacated after the agency gets a handle on the backlog of pending submissions (Also see "FDA’s Generic Drug Staff To Be Reduced When Workload Under Control" - Pink Sheet, 20 Jan, 2015.).

The agency also requested the same number of human drug program FTEs supported by prescription drug user fees in fiscal 2016 as were received in 2015: 2,400 for center operations and 48 for field activities. And that was after an increase of 298 PDUFA-supported FTEs for the center and two for the field in 2015, compared to the previous year.

FDA did not hire any staff for the human drugs program with biosimilar user fees in 2014, but added 59 for center operations and five for field activities in 2015, according to the budget document. BsUFA user fees also would not support any additional FTEs in 2016.

The biosimilar program is just beginning to grow. FDA recently completed its first advisory committee meeting for a 351(k) application. It was an overwhelming vote to recommend approval of Sandoz Inc.’s filgrastim, a biosimilar of Amgen Inc.’s Neupogen (Also see "Sandoz Makes First Biosimilar Review Look Easy; Will Future Sponsors Be As Lucky?" - Pink Sheet, 12 Jan, 2015.).

FDA’s second 351(k)-related advisory committee meeting will consider Celltrion Inc.’s infliximab, a biosimilar of Johnson & Johnson’s Remicade (Also see "Remicade Biosimilar Review: Where 351(k) Pathway Bumps Into Orphan Drug Rules" - Pink Sheet, 9 Feb, 2015.).

In addition, fees related to FDA’s new expanded oversight of compounding will not create additional FTEs in fiscal 2016. The revenue, projected at more than $660,000, would come from facilities registered as outsourcers under the 2013 Drug Quality and Security Act. The agency requested the same number of employees supported by the fee as 2015: one for the center and another for the field, according to the budget document.

Even though more FTEs were requested for human drugs field operations, that area was slated for some reductions in the 2016 budget request (Also see "FDA Field Operations Would Endure Reductions Under Budget" - Pink Sheet, 9 Feb, 2015.).

A Silver Lining

Although FDA may not be requesting many new FTEs in the fiscal 2016 budget, it still appears hiring will remain a focus.

The Center for Drug Evaluation and Research has hundreds of rank-and-file openings and has trouble filling them, in part because of the federal pay scale (Also see "Show Me The Money: FDA Recruitment Efforts Challenged By Government Salaries" - Pink Sheet, 12 Jan, 2015.).

The agency also has been trying to fill a number of senior management positions and anticipates more may open in the coming years (Also see "FDA Searches Small Industry Candidate Pool To Fill Executive Vacancies" - Pink Sheet, 24 Mar, 2014.). CDER recently began its formal search for a deputy director of the Office of Generic Drugs. Applications are due by Feb. 22, according to the job notice.

Still, the slowdown in overall staff growth may prove advantageous for FDA. The agency also said in the 2016 budget request that it needs to update the master plan for its White Oak headquarters to address the facility needs of a staff larger than anticipated when the original plan was written (Also see "FDA’s Rent Is Too Damn High: Consolidated Labs Cost More Than Off-Campus Space" - Pink Sheet, 9 Feb, 2015.).

FDA Full-Time Equivalent Employee Needs
Program	FY 2014 Actual	FY 2015 Enacted	FY 2016 Request	FY 2015-FY 2016 Difference
Human Drugs	4,639	5,503	5,516	13 (0.23%)
Biologics	1,319	1,326	1,337	11 (0.83%)
Foods	3,650	3,744	4,196	452 (12.1%)
Animal Drugs and Feed	837	854	906	52 (6.1%)
Devices and Radiological Health	2,087	2,086	2,135	49 (2.3%)
National Center for Toxicological Research	286	287	288	1 (0.35%)
Family Smoking and Tobacco Control Act	592	773	962	189 (24.5%)
FDA Headquarters	1,090	1,179	1,234	55 (4.7%)
Source: FDA congressional justification of President Obama’s FY 2016 budget request