This article has been updated from a previous version, which incorrectly stated that Genomic Health had received a warning letter from the FDA. The company received a letter requesting a meeting with the FDA to discuss its Oncotype Dx test.
Steven Gutman, director of the Office of In Vitro Diagnostic Device Safety and Evaluation, will leave the US Food and Drug Administration by the end of the year for a post in academia, Pharmacogenomics Reporter has learned.
“I made the very difficult decision that it was time for a change,” Gutman told PGx Reporter this week.
Gutman said he plans to join the University of Central Florida in January, where he will be a professor of pathology and part of the founding faculty at the university’s new medical school.
“I will miss the people, the mission, and the fire of OIVD,” Gutman said. “It has been a lovely ride. I do hope to remain involved in personalized health care, both scientific and policy.”
The FDA has not yet announced who will replace Gutman.
In addition to his teaching post at UCF, Gutman said he also hopes to spend time writing and consulting.
Gutman, who has been at the agency for nearly 17 years, has been the top man at OIVD since November 2002 when the division was formed to consolidate all regulatory activities for in vitro diagnostics.
He joined the FDA’s Division of Clinical Laboratory Devices as a medical officer in 1992. A year later he was promoted to division director.
Gutman’s time at OIVD’s helm has been marked by a period of rapid industrial innovation in the area of genetic testing. Against this backdrop Gutman was responsible for guiding the regulation of constantly evolving and increasingly complex technologies, a task that proved controversial at times.
For instance, under Gutman’s tenure, OIVD released two draft guidances on the regulation of IVD multivariate index assays, its first in September 2006. Device manufacturers are eagerly awaiting OIVD’s final guidance on IVDMIAs, an area that has been a particularly contentious regulatory topic due to disagreement on whether the FDA has regulatory authority over IVDMIAs, a more complex subset of lab-developed tests.
Gutman’s OIVD has also taken a firm stance against genetic-test manufacturers who have failed to follow FDA’s regulations. Almost eight months before the FDA issued its first IVDMIA draft guidance, Genomic Health became the first in a slew of companies to attract the FDA's attention when it received a letter to meet with the agency to discuss its Oncotype DX test.
Most recently, Laboratory Corporation of America received a warning letter from OIVD that said its OvaSure test was “misbranded” and “adulterated.”
Before joining the FDA, Gutman spent a decade as a clinical pathologist and chief of laboratory services at the Buffalo VA Medical Center.