|
In what has been described as disappointing news to some herb and dietary supplement industry leaders, the Food and Drug Administration announced in May that Susan J. Walker, MD is now the new Director of the FDA’s Division of Dermatology and Dental Products, Office of Drug Evaluation III, in the Office of New Drugs, at the Center for Drug Evaluation and Research (CDER).
The move is a major shift in focus and locus for Dr. Walker, who, since September 2003 has been the Director of the Division of Dietary Supplement Programs in the Office of Nutritional Products, Labeling, and Dietary Supplements at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN). By moving from CFSAN to CDER, Dr. Walker leaves the dietary supplement and food area of FDA and resumes activities in the dental and dermatological drug evaluation side of the Agency, where she previously spent 7 years, as medical officer and later as medical team leader.
Dr. Walker has a background in dermatology. According to an email sent to CDER staff by John K. Jenkins, MD, she received her medical degree from the Uniformed Services University of the Health Sciences School of Medicine (USUHS) in 1981. Dr. Walker completed a surgical internship at the Naval Hospital in Oakland, CA, and a Dermatology Residency at the Naval Hospital in San Diego, CA. Prior to coming to FDA in 1995, she was Chief, Dermatology Section, at the VA Northern California in Martinez, CA, and coordinator of the dermatology residency program there. 1
While working in CFSAN Dr. Walker focused on the “interpretation, implementation and enforcement of the Dietary Supplement Health and Education Act (DSHEA), directing the development of guidance for the industry, publication of FDA initiatives, and managing the review and response to structure/function claims and new dietary ingredient notifications.” 1 In May 2005, Dr. Walker was the recipient of an HHS Secretary’s Award for Distinguished Service for her outstanding performance developing the final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids and for handling related enforcement and defensive litigation matters. 1
Dr. Walker became known as an approachable, responsive, reasonable and rational interpreter of FDA policy, especially with respect to the Agency’s attempts to provide regulations and guidance in the enforcement of DSHEA.
In an e-mail to colleagues, dietary supplement industry leader Loren Israelsen, executive director of the United Natural Products Alliance, an industry trade group, wrote, “Personally, I regard this as unwelcome news, as Dr. Walker was a good friend and colleague. She was both realistic and practical with respect to implementation of DSHEA and how to collaborate with industry.” 2
It is not clear at this time who will replace Dr. Walker at CFSAN and/or whether her departure may signal the leaving of other CFSAN officers who have been working in the area of dietary supplement regulation.
-Mark Blumenthal
References
1. Jenkins JK. Selection of New Division Director, Division of Dermatology and Dental Products [e-mail]. May 12, 2006.
2. Israelsen LD. LDI e-News Update / Dr. Susan Walker. May10, 2006.
|