OrthogenRx on FDA’s Ambiguity on Hyaluronic Acid

OrthogenRx on FDA’s Ambiguity on Hyaluronic Acid

MPO's Sean Fenske speaks with Mike Daley of OrthogenRx about the role HA plays in alleviating knee pain and the challenges with the FDA over it.

By Sean Fenske, Editor-in-Chief03.02.21
In this episode of Medtech Matters, a podcast focused on the medical device manufacturing industry and the factors impacting it, we speak with Mike Daley, CEO of OrthogenRx. He speaks on the benefits of hyaluronic acid (HA) to address osteoarthritis as an alternative to pain medications and surgical replacement. The FDA, however, has recently changed its oversight of HA and is now treating it as if it were a drug instead of a device. Specifically, the following questions are addressed.

  • Your company offers a hyaluronic acid treatment for osteoarthritis. Can you provide a brief explanation of that technology?
  • For 20 years, hyaluronic acid was treated as a device by the FDA. Then in 2018, the agency questioned that classification and indicated it might be a drug? What impact does that have on a company like yours?
  • Did the FDA give a reason for their change in thinking?
  • Has there been any new decisions on this since the agency questioned the classification in 2018?
  • More and more combination products are emerging and those that interact with the body or breakdown and deliver a pharmaceutical agent. What could the FDA’s actions with regard to hyaluronic acid mean for companies of those types of products?

Listen to this episode and see what you think of the FDA’s revised stance on this technology. If you’d like to share thoughts, ask questions, or suggest a future participant for Medtech Matters, please reach out to me at sfenske@rodmanmedia.com.

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