Speaker: Biologic use, promotional material need to be in alignment with on label use
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Key takeaways:
- Biologic products need to be minimally manipulated and used in a homologous fashion.
- Promotional and marketing materials of biologic products must be “on label.”
LAS VEGAS — As the business of biologic products has continued to grow, scrutiny from the FDA and other federal authorities on the use and promotion of biologics has also increased, according to a speaker.
Although the FDA provides physicians with guidance on the use of biologics, Scott P. Bruder, MD, PhD, noted the agency does not regulate the practice of medicine.
“Too many physicians believe that the FDA regulates how you practice medicine. They do not,” Bruder said in his presentation during the combined Arthroscopy Association of North America and Biologic Association Specialty Day at the American Academy of Orthopaedic Surgeons Annual Meeting. “They regulate how sponsor companies make products available.”
Part of the FDA guidance includes products that are “eligible for FDA exemption if they are minimally manipulated and used in a homologous fashion,” according to Bruder.
“You cannot use a bone to recreate a cartilage and call that homologous use, for example,” he said.
Bruder noted orthopedic surgeons can convert an exam room into a laboratory and prepare platelet-rich plasma and bone marrow aspirate concentrate properly without any repercussions. However, the FDA and federal authorities consider culture-expanded cells or isolating and delivering fragments of complex cell populations as activities of a biologic manufacturing facility, which requires a biologic license. Surgeons can only use certain biologic products through an FDA registration study and only on patients enrolled in the study, Bruder said.
In addition, he said promotional and marketing materials of biologic products have been under scrutiny of the FDA and Federal Trade Commission and must be “on label.”
“It does not matter if Mrs. Jones could barely get off the couch before you treated her and now, she climbs Mount Everest. If you put her on your website saying that, you are subject to some serious scrutiny and possible prosecution. That is not consistent with the labeling,” Bruder said.
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Bruder SP. Update on regulatory status: How to stay out of jail. Presented at: American Academy of Orthopaedic Surgeons Annual Meeting. March 7-11, 2023; Las Vegas.
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