From Upcoming Treatments to Treatments Yet to Come
On Saturday, I graduate into yet another decade of my life’s journey. In this Blog, instead of looking back, I will look to the future.
The U.S. Food and Drug Administration plays a vital role in facilitating the development and availability of innovative medical products. Products such as cellular-derived therapies, including stem cell-based products, offer the potential to treat or even cure diseases such as osteoarthritis.
The agency intends to exercise enforcement discretion with respect to the FDA’s investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products on May 31, 2021. This compliance and enforcement discretion policy gave manufacturers time to determine if certain requirements apply to their products, and if an application is needed, to prepare and submit the appropriate application to the FDA.
They are now reaffirming the timing of the end of the compliance and enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies.
Despite all of the FDA’s efforts to engage the industry, there had continued to be broad marketing of these unapproved products for the treatment or cure of a wide range of diseases or medical conditions. Many of these unapproved products appear to be HCT/Ps that are regulated as drugs, devices and/or biological products subject to premarket approval requirements. The wide extent of the marketing of such unapproved products is evidenced by their inappropriate advertisement in various media and by the number of consumer complaints about them submitted to the FDA.
Regenerative medicine products are not without risk and are often marketed by clinics as being safe and effective for the treatment of a wide range of diseases or conditions, even though they haven’t been adequately studied in clinical trials. There is no room for manufacturers, clinics, or health care practitioners to place patients at risk through products that violate the law, by not having an IND in effect or an approved biologics license. The FDA oversight of cellular and related products has included taking compliance actions, including numerous warning and untitled letters, and pursuing enforcement action for serious violations of the law. I for one, welcome these actions.
I encourage the public and patients who are considering treatment with regenerative medicine products to work with me to learn about the treatments offered. Ask questions and understand the potential risks of treatment; I do not offer unapproved products. It is critical to only seek treatment using legally marketed products, or, for unapproved products, to enroll in our clinical trials under FDA oversight. The public can visit the FDA’s website to find out if a particular regenerative medicine product is approved.
I am committed to helping advance the development of safe and effective regenerative medicine products, including stem cell-based products, to benefit individuals in need. As an Evidence-Based Cellular Orthopedic practice, I look forward to working with you. To schedule an office visit, call (312) 475-1893.