Michael Okun, MD: Systemic Issues With Approving Neurological Devices for Rare Diseases


The executive director of the Norman Fixel Institute for Neurological Diseases discussed the issues within the current system that prevent approvals for neurologic devices for rare diseases.

"On the industry side, people should be given a legal break. Not a pass, but there should be breaks and incentives for them to make these devices available which can end up being life changing innovations for these various disorders. If we don’t do that, we’re going to be in trouble or just sitting on a lot of technology that can’t actually get out to these people with rare diseases.”

Traditionally, a drug in development will have a normal streamlined path, making its way through multiple phases of study before being submitted to the FDA with the financial help of a pharmaceutical company or industry leader. Neurological devices for patients with rare diseases do not benefit from the same process. Despite showing efficacy in clinical trials, industry partners may remain hesitant to invest their money due to the costs required to develop and maintain these devices, limitations of profit, or legal liability.

The outdated system that benefits traditional drugs for the masses and not neurological devices for rare diseases, was highlighted in a recent paper by Michael Okun, MD, and James Giordano, PhD. In the viewpoint, the 2 authors lay out multiple problems that lie within the outdated system, including the issues with insurance companies supporting costs, humanitarian device exemptions slowly being phased out, and changing the perception about investing for the greater good of the patients who need it and not the financial outcomes that result from it.

Okun, the executive direct of the Normal Fixel Institute for Neurological Diseases, and Adelaide Lackner Professor and chair of neurology at the University of Florida, also serves as the medical director of the Parkinson’s Foundation. In an interview with NeurologyLive, he explains where the disconnect is for devices for rare diseases, and why they do not benefit from the same system as traditional drugs.

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