Regulatory Roundup: Sundlof Resigns as FDA's Head of Food Safety; and More

May 13, 2010
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Sundlof Resigns as FDA's Head of Food Safety; and More

Stephen F. Sundlof stepped down last week from his position as head of food safety at the US Food and Drug Administration. According to a letter posted on the FDA website from FDA Commissioner Margaret Hamburg and Deputy Commissioner for Foods Michael R. Taylor, Sundlof has accepted a two-year assignment with the Virginia–Maryland Regional College of Veterinary Medicine. Michael Landa, the current Deputy Director for Regulatory Affairs at the Center of Food Safety and Applied Nutrition, will serve as Acting Director. Roberta Wagner and Donald Kraemer, who have extensive experience at FDA, will serve as Acting Deputy Directors.

FDA is conducting a safety review of commonly used prostate cancer drugs, according to a May 3 agency press release. Specifically, gonadotropin-releasing hormone (GnRH) agonists have been associated with a small increased risk for diabetes, heart attack, stroke, and sudden death in men, says the release. Drugs in this class are marketed under the brand names Eligard (sanofi-aventis, Bridgewater, NJ), Lupron (Abbott Laboratories, Abbott Park, IL), Synarel (Pfizer, New York), Trelstar (Watson Pharmaceuticals, Corona, CA), Vantas (Endo Pharmaceuticals, Ford, PA), Viadur (Bayer Pharmaceuticals, Wayne, NJ), and Zoladex (AstraZeneca, Wilmington, DE). Several generic products in this class are also available.

Earlier this week, a US Pharmacopeia advisory panel issued a set of recommendations to bring consistency to prescription labeling and, ultimately, to help avoid patient confusion. The panel’s recommendations included organizing the label in a patient-centered manner, simplifying language, using explicit text to describe dosage and interval instructions, including purpose for use, improving readability, providing labeling in the patient’s preferred language, including supplemental information, and standardizing direction to patients. Full details on these recommendations are on the USP website. USP will consider the recommendations as it develops a new general chapter on prescription container labeling, which is expected in a few months.