FDA Regulations and Their Impact

Introduction

Progress of biologics in orthopaedic surgery, or orthobiologics, currently faces a delicate balance involving providers sprinting to apply clinically and profit on unproven technologies and the marathon of technology development through translational medicine. Weighing the balance is the orthopedic community and government regulatory bodies, while aspiring to move the front lines of patient care forward in a safe and ethical manner. While early promising development of orthobiologics was in the hands of basic scientists, the next steps of translation require patient care and have stumbled upon regulatory hurdles and early clinical shortcomings, i.e., technologies not performing as well in clinical trials as they performed in laboratory and animal studies. These hurdles and shortcomings are part of the developmental process and should not be cause for concern. To overcome the hurdles, clinicians and scientists must develop a deeper understanding not only of cellular/molecular mechanisms but also of the entire development process, which requires regulation. One can consider the study and understanding of FDA regulation a lot like understanding the rules of a sport. Rules have been made, precedent has been set, and we as clinicians should understand how to use the rules to not only judge emerging technologies but also sort out how to use them in our clinical practice and clinical trials. As clinicians, we should consider ourselves the referees in this game, at times getting yelled at by industry on one sideline and our patients on the other. The more we know, the better we will perform at translational medicine and the more we can stay out of trouble from regulatory bodies and/or malpractice risk when treating our patients.

Orthobiologics to an orthopedic clinician represent any naturally derived product, which can be used to improve the biology of healing in an orthopaedic intervention, including procedures in clinic such as joint injections and surgical procedures in the operating room. To the Federal Food and Drug Association (FDA), biological products are a subset of drugs and “biological” refers to those medical products that are derived from living material, as opposed to chemically synthesized. The FDA does not consider everything that clinicians consider orthobiologics as biological products. However, the FDA applies the Federal Food, Drug and Cosmetic Act (FDC Act) for the monitoring and regulation of many orthobiologics especially those involving cells.

Monitoring and regulation of orthobiologics is a double edge sword, important for patient safety and proof of worth on one side but stifling to progress at times on the other. Loose regulation encourages clinical experimentation, but raises concerns for patient safety, and does not force products to prove their value before clinicians set prices, market, and use them for patient treatments. Although rigid regulation stifles progress, it ensures patient safety and forces technologies to prove themselves through a developmental process. The latter requires a significant investment of time and money but produces clear indications and evidence for care. Although there is not currently an answer (or agreement) to how much freedom or regulation should be established in the development of biologics, the following will be a discussion regarding where we are today, how we got here, and where are we headed.