A. Anz (Gulf Breeze, US)

Presenter Of 1 Presentation

Extended Abstract (for invited Faculty only) Stem Cells

14.0.2 - What about Regulatory Approval?

Presentation Number
14.0.2
Presentation Topic
Stem Cells
Lecture Time
08:50 - 09:10
Session Type
Plenary Session
Corresponding Author

Abstract

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. 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. 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 to sort out how to use them in our clinical practice and clinical trials.

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 which are derived from living material, as opposed to chemically synthesized (1). 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. Though 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. (2)

Content

Progress of biologics in orthopaedic surgery faces a delicate balance of clinical application and technology development in the face of government regulations. While early development of orthobiologics was in the hands of basic scientists, the next steps will require the assistance of clinical researchers. Clinicians should understand how to use the governmental rules and regulations to judge emerging technologies and appropriately apply them to clinical practice and clinical trials. The Federal Food and Drug Association (FDA) is the United States governing body over the development and use of biologics in orthopaedic surgery. An understanding of the origin of the FDA and its current regulatory guidelines will help clinicians to avoid trouble from regulatory bodies and avoid malpractice risk when treating patients. This discussion of where we are today, how we got here, and where are we headed can be used to help further the work in the development and application of orthobiologics.

References

1 Frequently Asked Questions About Therapeutic Biological Products. In: Therapeutic Biologic Applications (BLA). 2017. Available at: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/ucm113522.htm. Accessed July 10, 2017.

2 Anz, A.W., & Pinegar, C.O. (2018). FDA regulations and their impact. In A. Mazzocca & A. Lindsay (Eds.), Biologics in orthopaedic surgery (pp 9-17). St. Louis, MO: Elsevier.

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Moderator Of 2 Sessions

Georgia Industry Satellite Symposium
Session Type
Industry Satellite Symposium
Date
06.10.2019
Time
11:30 - 12:15
Location
Georgia
Plaza B&C Free Paper Session
Session Type
Free Paper Session
Date
07.10.2019
Time
14:15 - 15:45
Location
Plaza B&C