Innovative Procedures vs. FDA Approval

By /

centeno fda

This has been an interesting few weeks for our support of innovative therapies (much of medical innovation is led by physicians) vs. the FDA’s position on medical innovation (you can innovate only if you’re a big drug company). I’ve blogged on a recent analysis by KL Gates on the landmark nature of our FDA case in determining how the fledgling stem cell industry will evolve. Now comes yet another legal analysis from Law 360 on how the case (Centeno FDA) will impact how physicians are able to innovate for their patients. Here is the web link (you have to sign up for a free subscription to the site, we have no connection to this media group). The issue brought up by this legal site is one near and dear to our hearts-physicians drive much of the meaningful innovation in medicine. If you look at everything from In-vitro Fertilization (IVF), to open heart surgery, to many of today’s orthopedic procedures such as knee microfracture-these exist not because some big drug or device company decided to make an investment in an FDA approved clinical trial, but because some brave and innovative physician worked with a no-option patient to try and engineer a solution to their problem. The Law 360 article points this out with the following conclusion:

“What Will the Future Bring?

This case addresses an issue of first impression for the court and will likely have a revolutionary impact on a large number of innovators that are involved in developing and/or practicing these novel types of therapies. How will the court define the term “drug” underthe FDCA? How will FDA’s minimal manipulation criterion for HCT/Ps be defined? Will litigation regarding the interpretation of the other prongs of 21 C.F.R. § 1271.10(a) follow? How will the court define the practice of medicine that is left to regulation by the states alone? How broadly will the court construe “activities that substantially affect interstate commerce”? Will innovators be shut down and left with no ability or motivation to jump through the hoops required for them to continue practicing their products? Stay tuned …”

Join us for a free Regenexx webinar.

If you have questions or comments about this blog post, please email us at [email protected]

NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you.

Get Blog Updates by Email

By submitting the form, you are agreeing that you read and consent to our Privacy Policy. We may also contact you via email, phone, and other electronic means to communicate information about our products and services. We do not sell, or share your information to third party vendors.

Category: Latest News
Copyright © Regenexx 2021. All rights reserved.



9035 Wadsworth Pkwy #1000
Westminster, CO 80021


*DISCLAIMER: Like all medical procedures, Regenexx® Procedures have a success and failure rate. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else.

Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive.