Ilisa Bernstein

  PhotoDr. Ilisa Bernstein is Director of Pharmacy Affairs in the Office of the Commissioner at the U.S. Food and Drug Administration (FDA). In this capacity, she advises on domestic and international issues related to the regulation of medical products, including drugs, biologics, dietary supplements, and medical devices, as well as pharmacy-related issues. In particular, she focuses on the U.S. drug distribution system, counterfeit drugs, drug importation, patient information, prescription and OTC drug labeling, drug safety, and Internet issues. She is the FDA's primary liaison with the pharmacy community. From 2003 to 2006, she was Senior Advisor for Regulatory Policy and from 1991 to 2002, she was a Senior Science Policy Advisor in the Office of the Commissioner. Bernstein has received numerous awards, including FDA's Award of Merit, the Secretary's Award for Distinguished Service two times, and received the Commissioner's Special Citation fourteen times for various projects. She is a co-author of the Pharmacy Law Digest! authored a chapter on "Legal and Regulatory Issues in Self-Care Pharmacy Practice" in the Handbook of Nonprescription Drugs! and a chapter on “Integrity of the U.S. Drug Supply" in the Handbook of Institutional Pharmacy Practice! and has published numerous journal articles. She was the Editor-in-Chief of Rx Ipsa Loquitur! the newsletter of the American Society for Pharmacy Law (ASPL) from 1999 to 2003. Previously, she served two terms on the Board of Directors for ASPL. Bernstein was also Co-Editor-in-Chief of the Pharmacy Law Annual! (1998-2000), an ASPL publication. She also served for three years on the U.S. Public Health Service Pharmacy Professional Advisory Committee, which advises the U.S. Surgeon General on pharmacy issues. Bernstein completed a post-doctoral residency at the National Institutes of Health, focusing on clinical and research pharmacokinetics. She received her Doctor of Pharmacy degree from the University of Michigan, College of Pharmacy and her Juris Doctor degree from the American University Washington College of Law.