Regulatory and Ethical Aspects of Orthobiologic Therapies.

Orthobiologic therapies show significant promise to improve outcomes for patients with musculoskeletal pathology. There are considerable research efforts to develop strategies that seek to modulate the biological environment to promote tissue regeneration and healing and/or provide symptomatic relief. However, the regulatory pathways overseeing the clinical translation of these therapies are complex, with considerable worldwide variation. The introduction of novel biologic treatments into clinical practice raises several ethical dilemmas. In this review, we describe the process for seeking approval for biologic therapies in the United States, Europe, and Japan. We highlight a number of ethical issues raised by the clinical translation of these treatments, including the design of clinical trials, monitoring outcomes, biobanking, "off-label" use, engagement with the public, marketing of unproven therapies, and scientific integrity.
Competing Interests: One or more of the authors has declared the following potential conflict of interest or source of funding: This work was supported by the Orthoregeneration Network. J.C. has received education payments from Arthrex and Smith & Nephew; consulting fees from DePuy, Linvatec, and Smith & Nephew; speaking fees from Linvatec; and hospitality payments from Medical Device Business Services, Medwest, and Stryker. N.S.P. has received research support from Zimmer Biomet Holdings and RegenLab. R.M.F. has received grant support from Arthrex, education payments from Arthrex and Smith & Nephew, nonconsulting fees from Arthrex, and hospitality payments from Joint Restoration Foundation. J.H. has received education payments from Gemini Mountain. B.M. has received speaking fees from Arthrex and consulting fees from Arthrex, Biomarin Pharmaceutical, DePuy, and Exactech. J.L.D. has received grant support from Terumo BCT; consulting fees from Arthrex, Bioventus, DePuy, RTI Surgical, and Zimmer; and nonconsulting fees from Arthrex. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.
(© The Author(s) 2022.)