Temple Retires; Bumpus Leaves FDA
Following 52 years of service at CDER, senior advisor for clinical science Bob Temple has retired effective 12/31. Additionally, effective 12/31 FDA principal deputy commissioner Namandjé Bumpus, the agency’s second-in-command, has left the agency in advance of the new incoming presidential administration. Temple joins CDER deputy director for regulatory programs Doug Throckmorton, who is retiring this month (see earlier story) after 27 years at FDA, in putting a dent in the agency’s institutional knowledge. Coincidence or not, there has been speculation that some FDA employees may be seeking the exit door based on anticipated disruptions from the incoming administration (see earlier story).
Temple has had a long fascination with the design and conduct of clinical trials, and he has written extensively on this, including the choice of control group, evaluation and interpretation of active control, dose-response, and those using enrichment designs to help improve efficiency, according to an agency bio.
He joined CDER in 1972 as a medical officer in the Division of Metabolic and Endocrine Drug Products and later became the director of the Division of Cardio-Renal Drug Products. In 1995, Temple was promoted to the Office of Drug Evaluation I and oversaw cardiovascular and renal, neurology, and psychiatry drug products, and he simultaneously served as the Center’s deputy director for the next 23 years.
In a 2022 restructuring move under CDER director Patrizia Cavazzoni, Temple’s deputy Center director title was removed and he was retitled senior advisor for clinical science within her immediate office. In this capacity, he served as the Center executive-level leader on the clinical evaluation of drugs and related scientific and policy matters. A CDER spokesman told us at the time that his role was to provide advice and counsel to the Center director and higher-level agency officials; leadership in the advancement of policies and guidances related to the clinical evaluation of drugs; and advance understanding of FDA’s responsibilities for enforcing standards and regulations.”
In an unusual move, CDER’s announcement included this recognition statement from now-retired and former CDER director Janet Woodcock:
“Bob, congratulations on your incredible career at FDA. In the first several decades of your service, you and a small band of collaborators basically invented the regulatory standards for clinical evidence generation: how to interpret the adequate and well controlled trials requirement of the FD&C Act. And as more drugs got approved, you drove the non-inferiority protocols so needed when making comparisons to active agents. I’m not sure anyone else was thinking about that at the time. Your contributions made a huge difference in medical practice and in people’s lives.
“And of course, as those things were worked out, other challenges arose. You were instrumental in helping devise the use of accelerated approval, as well as the policies around a single trial with confirmatory evidence. And always, your wise counsel and incredible clinical intuition provided guidance to all of us. Your wisdom will surely be missed, but your legacy will remain.”
Regarding Bumpus, she would have remained FDA’s senior leader and acting commissioner after Califf departs later this month until a new commissioner is confirmed by the Senate. President-elect Donald Trump previously nominated Johns Hopkins surgeon and public policy researcher Marty Makary (see earlier story) as FDA commissioner. Makary was selected to correct FDA’s course, according to Trump, who says the agency has “lost the trust of Americans, and lost sight of its primary goal as a regulator.”
Bumpus was named principal deputy commissioner earlier this year, replacing Woodcock after she retired. She was named chief scientist 6/2022 after serving as E.K. Marshall and Thomas H. Maren Professor and chair of the Department of Pharmacology and Molecular Sciences at Johns Hopkins University School of Medicine. Previously, Bumpus was associate dean for basic research at the same school. “Bumpus’ research has focused on drug metabolism, pharmacogenetics, bioanalytical chemistry, and infectious disease pharmacology,” her bio says on the agency’s Web site.
An email from Califf recognized Bumpus for helping to plan and manage FDA’s recent reorganization, which he described as the largest in the agency’s history. Bumpus also led efforts to modernize the FDA’s laboratories and expanded the role of the chief scientist’s office, Califf said.