The Regulatory Landscape of Orthobiologics - If I’m confused, you must be too

Orthobiologics, including platelet rich plasma (PRP), bone marrow aspirate concentrate (BMAC), microfragmented adipose tissue (MFAT), and more have gained popularity in recent years as treatments for various musculoskeletal conditions. However, the unclear regulatory landscape for these product s has led to much confusion for doctors, regulators, legislators, and even judges. The Food and Drug Administration classifies some of these as blood products requiring no regulation, while others are classified as drugs, requiring preclinical trials, pharmacology/toxiciy studies, Investigational New Drug (IND) approvals for human clinical trials, and finally biologic license applications (BLA) prior to marketing. Another layer of confusion stems from the multipronged enforcement of these by the United States Food and Drug Administration (FDA), Federal Trade Commision (FTC), state and federal courts, and individual state medical licensing boards. Physiatrists need to understand these differences in order to protect patients from harm, remain compliant with state and federal regulations, avoid large financial penalties, and maintain their medical licences. This session aims to A) sort through the history of orthobiologic regulation in the United States, B) clarify the current set of regulations, and C) address ongoing areas of confusion. The basic science, pathophysiology, technical aspects and treatment efficacy of these procedures will not be addressed as it is outside the scope of this session.