Regulatory Roundup: John Taylor to Serve as Acting Principal Deputy Commissioner after Joshua Sharfstein's Departure, and more.

Jan 06, 2011
By PharmTech Editors

According to the FDA Press Office on Jan. 5, 2010, John Taylor, counselor to the commissioner, has been asked to serve as the acting principal deputy commissioner for the next 60 days. It was reported earlier this week that Joshua Sharfstein, principal deputy commissioner under Margaret Hamburg, was leaving the agency to work for the state of Maryland as secretary of health. Dr. Hamburg issued a memo on the subject today.

The US Pharmacopeia (USP) released proposals for universal standards to guide the content, language, format, and appearance of prescription drug labels. USP is seeking comments from pharmacists and other healthcare professionals for the newly proposed General Chapter <17> Prescription Container Labeling. Comments are due Mar. 31, 2011. The development of the proposed standards was led by the Institute of Medicine (IOM) and aim to “improve health literacy in the United States by bringing together government, industry, associations, and other groups to advance practical strategies that can be implemented to maximize patient comprehension of health information,” according to the USP notice. The core components of the standard proposals include labeling prescriptions in a patient-centered manner; emphasizing instructions and other important information; giving explicit instructions, including the purpose for use; improving readability; and limiting auxiliary information.