By Toni Clarke
WASHINGTON (Reuters) - The retirement of Dr. Janet Woodcock as head of the Food and Drug Administration's pharmaceutical division is at least a year away, but the industry she regulates is already bracing for her departure.
The following is a list of possible candidates to replace Woodcock, drawn from interviews with some two-dozen people inside and outside the FDA who have worked with Woodcock and are familiar with the demands of the job.
Dr. Rachel Sherman, Associate Director of Medical Policy at the FDA's Center for Drug Evaluation and Research (CDER).
Considered a Woodcock protege and possible front-runner, Sherman oversees the regulation of prescription drug promotion and advertising, as well as policy on biosimilars. In addition, she directed management of the FDA's Critical Path initiative - which was launched in 2004 to increase innovation in the way medical products are developed. The initiative is widely considered one of Woodcock's major achievements.
Dr. Richard Moscicki, Deputy Center Director for Science Operations at CDER.
Moscicki joined the FDA in February as one of Woodcock's top deputies. Previously he was senior vice president and head of clinical development at the biotechnology company Genzyme Corp, which was acquired by Sanofi SA in 2011. At Genzyme, Moscicki was responsible for worldwide regulatory and pharmacovigilance, or drug safety, matters as well as all aspects of clinical research and medical affairs.
Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH)
Shuren, a neurologist and lawyer, is Woodcock's counterpart in the medical device division. He held various policy and planning positions within the FDA before becoming CDRH director in 2010, including acting deputy commissioner for policy, planning and budget.
Dr. Karen Midthun, director of the Center for Biologics Evaluation and Research (CBER)
The center is responsible for overseeing the safety and effectiveness of biological products including vaccines, blood and blood products, and cellular, tissue and gene therapies - treatments that are often at the cutting edge of science. Midthun was previously deputy director of CBER. She joined the FDA in 1993.
Dr. Richard Pazdur, Director of the Office of Hematology and Oncology Products.
Known as the FDA's "Cancer Czar," Pazdur is a highly-respected oncologist who spent many years at the MD Anderson Cancer Center. He joined the FDA in 1999 and took over the oncology products office in 2005. He is known for mentoring young reviewers and is well-known to the pharmaceutical industry.
Dr. Edward Cox, director of the Office of Antimicrobial Products.
Cox, an infectious disease specialist, was appointed director of the antimicrobial office in 2007. He is in charge of some of the biggest health matters facing the FDA, including antibiotic resistance as well as HIV, hepatitis and other viral infections.
Dr. Jonca Bull, Director of the Office of Minority Health.
Bull, an ophthalmologist, joined the FDA in 1994, serving in a variety of roles before going to the cancer drug company Genentech in 2006 as director of clinical regulatory policy. In 2008 she joined Swiss drugmaker Novartis AG as vice president of U.S. regulatory policy, returning to the FDA last year.
Dr. Robert Meyer, Director of the Virginia Center for Translational and Regulatory Sciences at the University of Virginia's School of Medicine.
Meyer, a pulmonologist and critical care specialist, spent 13 years at the FDA, eventually overseeing the office in charge of reviewing pulmonary, metabolic and rheumatology drugs, as well as anesthetics. He left in 2007 to become a vice president at Merck & Co, and joined the University of Virginia in March this year.
(Reporting by Toni Clarke; Editing by Grant McCool)
- Food and Drug Administration