FDA gets a new regulator

The Food and Drug Administration made an important new hire today, bringing in someone with deep and practical experience in the development of new drugs to a senior post in the agency’s drug center.

As FDA recruits more of its clinical review staff out of the ranks of medical practice and from academic postings, a declining proportion of the staff have meaningful experience in actually developing new drugs. Yet this sort of practical background can be invaluable to informing regulatory judgement, and giving the agency’s review staff a sense for which regulatory requirements can add to our understanding of a product’s safety and benefits. And those requirements that are unachievable (because the clinical trials can’t be enrolled or completed) and  simply serve to thwart investment and new product development.

Today’s announcement gives the agency substantial, practical experience at the top. The full announcement:

 

From: CDER Center Director
Sent: Tuesday, February 12, 2013 11:37 AM
To: FDA-CDER-wide
Subject: Richard Moscicki Selected as CDER Deputy Director

CDER Staff:

I am pleased to announce that Richard (Rich) A. Moscicki (Mo-shis-ke), M.D., a nationally recognized expert in clinical research and development, has been selected as deputy center director for science operations.

With CDER now over 4,000 employees, Dr. Moscicki, in his newly established role, will join Bob Temple, deputy director for clinical science, and Doug Throckmorton, deputy director for regulatory programs, in providing leadership and overall direction to Center activities to ensure that we accomplish our mission most effectively.

Dr. Moscicki currently serves as senior vice president (SVP), Head of Clinical Development at Genzyme Corporation. He joined Genzyme in 1992 as medical director and became the chief medical officer and SVP of biomedical and regulatory affairs in 1996 — holding that post until 2011.

Over the past two decades, Dr. Moscicki has been responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He is known to be inclusive in his management style and is credited with implementing solid business practices to sustain the company’s long-term operations.

As deputy director for science operations, Dr. Moscicki will share in executive direction of Center operations and provide leadership in overseeing the development, implementation, and direction of our programs.

Dr. Moscicki received his medical degree from Northwestern University Medical School. He is board certified in internal medicine, diagnostic and laboratory immunology, and allergy and immunology. He completed his residency with a focus on immunology, followed by a four-year fellowship at Massachusetts General Hospital (MGH) in immunology and immunopathology. He remains on staff at MGH and on the faculty ofHarvard Medical School.

His medical, academic, clinical, and regulatory knowledge and expertise – coupled with his strong leadership and organizational management qualifications – make him the ideal candidate for this important position.

Please join me in welcoming Dr. Moscicki. He respects the work that we do and is looking forward to bringing his skills and experience to our Center to assist us in advancing the Agency’s mission.

Janet Woodcock

 

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