The FDA approval process and patient safety

The FDA approval process is important for patient safety and cell therapy research

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In 2017, the Food and Drug Administration gave for-profit stem cell clinics three years to engage the regulatory approval process to establish the safety and efficacy of their investigational products. An analysis from leading bioethicist Leigh Turner, Ph.D., has found more of these businesses in the US today than in 2017. Many of these clinics claim their stem cell therapy treatments can cure diseases from Parkinson’s Disease to diabetic foot ulcers without demonstrated clinical evidence to back up the claims. 

The FDA approval process for a new significant risk product is arduous and takes time, often many years of research and testing for a product to be approved. Processes and regulations evaluate whether a new product’s benefits outweigh its risks. The more risk involved in a new drug or device and the condition it aims to treat, the more time and consideration is required before approval and public access. 

Stem cell clinics that cut regulatory corners by offering unapproved medical procedures or products could negatively impact patients. According to Pew, “Providers of unapproved treatments are unlikely to report patient harm to regulators or disclose such cases through public reporting.” Some of these adverse events linked to treatments administered outside of FDA-approved clinical trials include infections, permanent disabilities, and even death. 

Cellular therapy has real potential to treat a wide range of diseases. However, the actions of these clinics undermine public confidence in the field of regenerative medicine as a whole. Potential patients may be less willing to participate in FDA-approved clinical trials as a result of the confusion, which can make recruiting difficult, and slow progress for researchers testing cell therapies. The noise around stem cell clinics can drown out cell therapy research.

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