October 30, 2014
On October 27, 2014, the Society of Nuclear Medicine and Molecular Imaging (SNMMI) hosted a broad stakeholder meeting in Linthicum Heights, Md. The society brought in more than 40 experts from the field of nuclear medicine and molecular imaging to discuss the current regulatory climate. Represented at the meeting were leaders from the U.S. Food and Drug Administration (FDA), Centers for Medicare and Medicaid Services (CMS), National Cancer Institute (NCI), National Institutes of Health (NIH), Nuclear Regulatory Commission (NRC), industry and specialty societies.
Dwaine Rieves, MD, who retired from FDA in 2013 and has extensive experience in drug and biological product development, diagnostic imaging drug development, and regulatory strategies, moderated the meeting and challenged the group to think about what possibilities may exist for the creation of new approval pathways for new and non-proprietary radiotracers.
SNMMI Vice President-Elect Sally Schwarz, MS, RPh, BCNP, spoke about the work of SNMMI’s FDA Task Force, the group responsible for planning the meeting and strategizing how to create a more efficient and timely approval process. Brief presentations were also given by Louis Marzella, MD, PhD, FDA’s director in the Center for Drug Evaluation and Research, Office of New Drugs; John McInnes, MD, JD, CMS’s director in the Division of Outpatient Care; and Paula Jacobs, PhD, NCI’s associate director in the Division of Cancer Treatment and Diagnosis.
Meeting participants split into four breakout groups and discussed market/commercialization barriers, strategies to improve the current approval process, possible new pathways and outcome measures for both the FDA and CMS. Participants felt that certain challenges in the current regulatory process exist due to varying definitions of efficacy and clinical benefit/utility between FDA and CMS. Individuals felt that clearly defining these terms would reduce ambiguity for all stakeholders involved in the drug development process.
The society is developing a detailed white paper, scheduled to be released in the coming months, which will identify outcomes of each breakout group, action items, recommendations and strategies that SNMMI will implement.