The US Food and Drug Administration’s efforts to increase its scientific and medical staff by 10 percent this year will include several new hires with pharmacogenomics and genomics expertise, including a new associate director of genomics in the Office of Clinical Pharmacology.
The hiring drive at the agency began in April after Congress enabled the initiative by approving increased appropriations, and the Office of Personnel Management gave the FDA direct-hire authority to make on-the-spot offers.
Direct-hire authority is an appointing authority OPM can give to federal agencies for filling vacancies “when a critical hiring need or severe shortage of candidates exists,” the FDA said in a statement.
The hiring initiative allows the agency to bring on board 1,317 new employees. The FDA currently has 1,005 new staffers and plans to add 158 more by Sept. 28. An additional 160 candidates have accepted job offers and are awaiting security clearances, an FDA spokesperson told Pharmacogenomics Reporter.
Of these new hires, several individuals joining the FDA’s Office of Clinical Pharmacology have training in phamacogenomcis. The agency plans to hire more employees with PGx knowledge in an effort to bolster the FDA’s genomics expertise.
“We have hired a new director of the genomics group in my office to replace Felix Frueh,” Lawrence Lesko, director of FDA’s Office of Clinical Pharmacology, told Pharmacogenomics Reporter last week. Although Lesko held off on naming Frueh’s replacement until the agency’s own announcement is issued, he noted that the new director will start his post on Oct. 15.
Frueh, who left his post as associate director of genomics in May to join Medco as the VP of personalized medicine R&D, previously told Pharmacogenomics Reporter that the FDA’s internal assessments had revealed that genomics expertise at the agency was lacking [see PGx Reporter 01-03-2007].
In addition to Frueh’s replacement, the FDA hired a new reviewer in genomics in August. Mike Pacanowski comes to the FDA from the University of Florida’s Center for Pharmacogenomics where he was a cardiovascular pharmacogenomics fellow, and will focus on oncology and cardiovascular medicine at the Office of Clinical Pharmacology.
Pacanowski and other new hires at the Office of Clinical Pharmacology will collaborate with the Office of New Drugs and the Office of Surveillance and Epidemiology at the Center for Drug Evaluation and Research to identify new pharmacogenomics opportunities for investigational new drugs and new drug applications. In addition, they will be attending educational opportunity program meetings to interface with industry on pharmacogenomics efforts.
The effort to hire new individuals at the agency with genomics and pharmacogenomics expertise “reflects the growing activity in clinical applications of genomics for drug safety, dosing, and efficacy,” Lesko said.
A year ago, the FDA, along with a collection of industry and academic partners, launched the Serious Adverse Events Consortium, a public/private collaborative effort to identify genetic markers that might be used to identify patients at high risk for adverse reactions to particular drugs [see PGx Reporter 10-03-2007].
Lesko noted that that agency intends to hire at least two more individuals with pharmacogenomics expertise in the Center of Pharmacology after October 2008.
According to Lesko, the effort to hire new employees at the agency with genomics and pharmacogenomics expertise “reflects the growing activity in clinical applications of genomics for drug safety, dosing, and efficacy.
“We continue to look at new opportunities to relabel previously-approved drugs with PGx information to improve the safety and benefits of drugs,” he said.
In August 2007, the FDA updated labeling recommendations for warfarin, stressing that people with variations of the genes CYP2C9 and VKORC1 may respond differently to the drug. And just two months ago, the FDA added a new boxed warning in labeling for the HIV drug abacavir stating that “patients who carry the HLA-B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir,” and issued a statement advising healthcare officials to “discontinue [abacavir] as soon as a hypersensitivity reaction is suspected.”
The agency has long been looking into updating tamoxifen’s label with pharmacogenomic data also.
Lesko said the Office of Clinical Pharmacology is “actively interviewing candidates with clinical PGx experience and training right now,” and that the agency expects to make new hires in PGx in 2009 “in proportion to the increase in work in this area.”
The agency is looking for skills that include clinical experience in medicine and understanding in pharmacogenomics so that employees may address issues of drug efficacy, safety, and dosing both in pre- and post-approval settings.
According to an FDA spokesperson, more than 850 of the 1,005 new hires who have already joined the agency have scientific and medical backgrounds, including chemists, biologists, pharmacologists, medical officers, consumer safety officers, statisticians, general health scientists, and microbiologists.
Of the 1,317 total hires, 770 are new positions and 547 are backfills. CDER will see the largest influx of new employees, filling 444 new positions and 219 replacements.
“We have a good mix of employees from other federal agencies and industry,” the FDA spokesperson said.
The new hires will be funded partly by expanded appropriations by Congress and partly by user fees. The agency’s budget is about $2.2 billion a year, with some 77 percent coming from taxpayers and the rest from industry user fees.
“FDA has been able to hire in the past; however, the additional legislation enables us to hire the staff needed to meet the legislative mandates,” the agency spokesperson said.
FDA currently employs 10,144 individuals. Of this number, 2,131 full time-equivalent positions will be funded by user fees when the current fiscal year wraps up at the end of the month.
“At the end of this hiring initiative [on] Sept. 30, FDA intends to have approximately 11,000 total employees on board,” the FDA spokesperson said. Approximately 500 of the 1,317 new hires will be filled with user fees, and no funding from other programs will be diverted to fill these new spots.
“This is the largest expansion done agency wide since the counter terrorism hiring initiative following the Sept. 11, 2001, terror attacks,” the spokesperson noted.