Eric Brodsky

About Eric Brodsky

Board-certified Internal Medicine physician with over two decades of prescription drug labeling, regulatory, and clinical experience, including over 20 years at the U.S. Food and Drug Administration (FDA). Recognized as FDA’s U.S. Prescribing Information (USPI) expert with a proven record of shaping prescription drug labeling policy across the Center for Drug Evaluation and Research (CDER)’s 24 prescription drug review divisions in the Office of New Drugs (OND). As the Associate Director of the Labeling Policy Team in OND since 2015, selected accomplishments include:• Reviewed and developed over 750 USPI across all therapeutic areas in the 24 prescription drug review divisions.• Gave over 35 public and 250 internal presentations about prescription drug labeling.• Authored or co-authored 15 FDA guidances. • Established and maintained OND’s labeling review program. • Led implementation of the Physician Labeling Rule.• Provided oversight of CDER-regulated USPI quality.• Developed and updated prescription drug labeling resources for external stakeholders and internal CDER staff.• Provided expert responses to questions from FDA colleagues, industry, academia, reporters, interest groups, HCPs, Congress, other federal agencies, and foreign drug regulatory agencies about U.S. prescription drug labeling.

Experience

1. Director, Labeling Policy Team, Office of New Drugs, Cder, Fda (Associate Director in Ond)

   FDA

   May 2015 — Present · Silver Spring, MD, US

   Oversaw CDER’s implementation of U.S. Prescribing Information (USPI) regulations and guidances to help ensure the USPI for CDER-regulated human prescription drugs―including biologics―met regulatory labeling requirements, was consistent with labeling guidances, was clinically meaningful, and was communicated clearly to health care professionals.• Provided expert USPI recommendations to each of CDER/OND’s 24 prescription drug review divisions.• Authored or co-authored 15 FDA labeling guidances and provided critical input to the creation of over 50 additional FDA guidances and CDER Manual of Policies and Procedures; and reviewed and commented on all CDER-authored guidances prior to publication to ensure that their content was consistent with labeling regulations, guidances, and CDER policies.• As FDA’s USPI expert, gave 35 public labeling presentations; organized three two-day CDER Prescription Drug Labeling Conferences, and gave over 250 labeling presentations to FDA staff in the last 10 years.• Established the OND labeling review program in 2012 and trained and mentored these labeling reviewers within the prescription drug review divisions since the program’s inception.• Led/co-led major labeling initiatives including required and voluntary PLR implementation and PLLR implementation. • Developed and updated prescription drug labeling resources for external stakeholders and internal CDER staff.• Provided oversight of CDER-regulated USPI quality.• Developed product quality information in the USPI policy, and carton and container labeling policy.• Provided major contributions to the creation of “Medication Guides: Patient Medication Information” proposed rule, and the development of patient labeling resources including patient Instructions for Use guidance.

Education

• Massachusetts Institute of Technology

  Bachelor of Science - BS, Molecular Biology

• Tufts University School of Medicine

  Doctor of Medicine - MD