Bob Rappaport

In 1994, after four years on the faculty at George Washington, he joined the neurology division at the FDA’s Center for Drug Evaluation and Research, where he spent the first few years developing expertise in drug regulatory science, drug product development, and clinical trial design and analysis. In 1998, Dr. Rappaport was asked to become a team leader in the FDA division responsible for the analgesic, anesthetic, and addiction drug products, an opportunity well suited to his long-standing interest in improving pain management. He was promoted to Deputy Division Director later that year and Division Director three years later. He remained in that position until he retired from FDA in October of 2014.

As director of the Division of Anesthesia, Analgesia, and Addiction Products, Dr. Rappaport led a large team of physicians, scientists, and regulatory project managers to oversee the investigation, development, approval, continued safety, and safe use of drug products to treat pain and addiction disorders, as well as drug products used in the setting of clinical anesthesia. During his 12 years as division director, he was responsible for numerous innovations and important initiatives. He was an advocate for the development of novel analgesic, anesthetic, and addiction drug products throughout his tenure, and instituted new standards for the study of these drugs. He has also been an active member of the IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) consensus group since its inception. In 2010 he worked within FDA to build the ACTTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks) public-private-partnership, which was initially designed to advance the field of analgesic drug development by improving analgesic clinical study design, conduct, and analysis. This highly successful initiative was later expanded to include improving the study and development of anesthetics and drugs to treat addiction and peripheral neuropathy. Dr. Rappaport was centrally involved with the FDA’s continued efforts to encourage and assist in the development of abuse-deterrent opioid formulations, and with his staff he completed an updated guidance for the pharmaceutical industry on the development of analgesic drug products.

Dr. Rappaport established a second public-private partnership called SmartTots (Strategies for Mitigating Anesthesia-Related neuroToxicity in Tots), which was developed to address the need for extensive clinical and preclinical research on the potential for neurotoxicity to occur when children are exposed to anesthetic and sedation drugs. SmartTots has been a key effort in the promotion of increased attention to and funding for research related to this critically important public health concern.

In 2013, Dr. Rappaport received FDA’s Lifetime Achievement Award for his contributions to the anesthesia, analgesia, and addiction fields by accelerating the discovery and development of new drugs with improved efficacy and safety. In May of 2015, Dr. Rappaport received the 2015 John and Emma Bonica Public Service Award from the American Pain Society. The Bonica Award recognizes distinguished contributions to the field of pain through public education, dissemination of information, public service, or other efforts that further knowledge about pain.

At MMS, Dr. Rappaport supports and advises clients on scientific and policy issues; he also guides and reviews work from internal MMS scientists as they draft regulatory submissions and other documents, including briefing documents.

Suggested For You

perspectives

January 21st, 2025

REMS Modifications and Revisions: A Retrospective from the Past 12 Months

regulatory intelligence

January 17th, 2025

The FDA’s AI Guidance and its Seven Steps into the Future of Drug Development

regulatory intelligence

January 17th, 2025

New FDA Protocol Deviation Guidance:  Planning for the Things That Don’t Go According to Plan

perspectives

January 9th, 2025

How to Create Efficiencies When Creating Simultaneous NDA and MAA Submissions for the FDA and EMA

perspectives

January 2nd, 2025

Informed Consent in Clinical Research: Understanding its Significance and Sponsor Obligations

perspectives

December 17th, 2024

Oncology Drug Development: Webinar Learnings on the Use of Expedited Pathways and Oncology Center of Excellence Programs

perspectives

December 11th, 2024

Why Emerging Biotech Companies are Increasingly Turning to Specialized Data CROs

regulatory intelligence

December 4th, 2024

FDA Issues Detailed Guidance on Development of Gene Therapy Products

news

December 4th, 2024

AI in Pharma and Innovative Leadership Were on Display at the Biennial MMS Scientific Symposium

perspectives

November 26th, 2024

Finding GRASEland: Navigating the New Regulatory Path for Grandfathered OTC Drugs 

perspectives

November 21st, 2024

Essential Nonclinical Strategies for Cell and Gene Therapy (CGT) Success

news

November 19th, 2024

MMS Recognized as a Top Workplace by Detroit Free Press and USA Today Network for the Fourth Consecutive Year