Myth Six: FDA guidance is flexible and subject to interpretation

The FDA does not regulate the practice of medicine, so what is their place in the discussion of orthobiologics? Their guidance is to the industry, never directly to clinicians. You begin to cross the barrier if you are selling a device–the FDA has clear jurisdiction here.

“The FDA regulates marketing and promotion of drugs, not the practice of medicine. The FDA writes the rules, and they will tell you what they mean. There’s no room for interpretation. If you’re unsure, you can get in front of them for guidance in compliance,” Andrew stated. “If you enter the world of industry, and you don’t get clearance, then the FDA will respond, which could lead to serious charges.”

Play the video to learn when the FDA comes into play.

Myth Five: The cellular content of bone marrow declines uniformly with age.

With this discussion, you’ll learn about how marrow degrades, which is not uniformly. At youth, all your marrow will respond. As you age, your spine and hip can respond in much the same way. Andrew said, “Mechanically transplanting rich marrow compensates for the decline that happens with age. Bone marrow donors are also accepted up to the age of 60. Looking at some research on the topic, we find that there is not a strong correlation between age and the amount of marrow.”

View the video for more clarity on the subject.