Senior FDA Official Dr. Julie Beitz Joins Hyman, Phelps & McNamara, P.C. as Principal Drug Regulatory Expert

Hyman, Phelps & McNamara, P.C. (“HP&M”), the largest FDA-dedicated law firm, is pleased to announce that Julie Beitz, M.D. has joined the firm as a Principal Drug Regulatory Expert.

Dr. Beitz served in leadership positions in FDA’s Center for Drug Evaluation and Research for nearly three decades.  She is an oncologist/hematologist and at the time she retired from FDA on July 29, 2023, she was the Director of the CDER Office of Immunology and Inflammation (OII) in the Office of New Drugs (OND).

Dr. Beitz was selected by FDA to be the inaugural Director of OII in March 2020 as part of the CDER OND reorganization.  In this position, she had primary oversight for actions taken by the following review divisions:

• Division of Dermatology and Dentistry
• Division of Gastroenterology
• Division of Hepatology and Nutrition
• Division of Rheumatology and Transplant Medicine
• Division of Pulmonology, Allergy and Critical Care
• Division of Pharmacology/Toxicology – Immunology and Inflammation

Prior to the March 2020 creation of OII, Dr. Beitz for 14 years was Director of the Office of Drug Evaluation III (ODE 3) in OND where she oversaw the Division of Gastroenterology and Inborn Errors of Metabolism, the Division of Dermatology and Dental Products, and the Division of Bone, Reproductive and Urology Products.

Other key drug leadership positions that Dr. Beitz served in at FDA include Acting Deputy Director for Clinical Sciences of OND, Director of the Division of Drug Risk Evaluation in the Office of Surveillance and Epidemiology and Acting Deputy Director and Clinical Team Leader in the Division of Oncology Drug Products.

Dr. Beitz earned a Bachelor of Arts (summa cum laude and honors in chemistry) from Barnard College, Columbia University, and a Doctor of Medicine from the College of Physicians and Surgeons, Columbia University.  She completed her residency and a fellowship in medical oncology/hematology at Brown University, Roger Williams Medical Center, and Brown University Affiliated Hospitals.

As a Principal Drug Regulatory Expert, Dr. Beitz joins HP&M’s Drug Development Team, which is comprised of attorneys and regulatory experts who assist companies on a range of drug and biological product legal, regulatory, and policy issues.  Dr. Beitz will be joining fellow former FDA Office Director Dr. Ellis Unger who joined HP&M in February 2022.  “I know Dr. Beitz well from our days as Office Directors at FDA, and I am delighted she is joining Hyman Phelps & McNamara! She made major, and lasting, contributions to public health at FDA. I always found her to be immensely thoughtful, knowledgeable, and insightful, and I am confident our clients will appreciate her approach,” said Dr. Unger.

“HP&M has long respected Dr. Beitz and enjoyed a professional working relationship with her during her distinguished FDA career.  We are thrilled that she is joining the firm and will add her expertise to our already exceptional Drug Development Team,” said JP Ellison, HP&M’s Managing Director.

Drug development attorney Frank Sasinowski commented: “For 20 years I have brought therapies that were needed by patients before Dr. Beitz and her colleagues in OII and ODE 3 and for that long I have admired and respected her sound scientific judgment and regulatory acumen.  Consequently, you can imagine how honored I am that Dr. Beitz would join her former OND Office Director Dr. Ellis Unger and our long-established HP&M drug development regulatory team to assist sponsors and patients in collaboratively working with FDA to bring critical new therapies to those in need.”