Speaker: Be compliant with FDA biologic product regulations to ‘stay out of trouble’
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NASHVILLE, Tenn. — A presenter, here, suggested ways that orthopedic surgeons can avoid being scrutinized by the FDA for orthobiologics use.
During the Biologic Association Annual Summit, held in conjunction with the American Orthopaedic Society for Sports Medicine and Arthroscopy Association of North America Combined Meeting, Joanne Halbrecht, MD, discussed FDA [human cells, tissues, or cellular or tissue-based products] HCT/P regulations and in-office harvesting of adipose and bone marrow aspirate concentrate (BMAC).
The discretionary period for enforcement of certain biologics in the FDA act that regulates HCT/Ps ended on May 31, 2021, she said. The act provides the FDA with the authority to establish regulatory requirements for marketing and use of HCT/Ps.
To stay out of trouble, Halbrecht recommended removing any references to stem cell therapy from the practice's website, advertising or social media and not list conditions treated because this can only be done for on-label use and there are no orthobiologics approved for orthopedic pathology.
Autologous orthobiologic products that are not more than minimally manipulated can, however, be harvested in the office without the need for sedation. Halbrecht described the techniques for adipose and BMAC products. Physicians should be aware that use of these products is nonhomologous, which is "similar to off-label use of a drug," she said.
“Minimal manipulation does not alter the original relevant characteristics to the tissue’s repair or replacement,” Halbrecht said, urging physicians to be compliant with FDA regulations.
“Don’t use illegal products. Use and market orthobiologics in a legal, safe and ethical manner. The FDA is definitely watching you. Adipose and BMAC that is not more than minimally manipulated can be harvested in the office. Don’t advertise your off-label use. Show that there’s evidence for the clinical use for that off-label use; and it requires proper staffing and equipment,” Halbrecht said.
Editor's Note: The article was updated on July 13, 2021 with clarified information and quotes from the presenter.
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