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Innovative Procedures vs. FDA Approval

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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 …”

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