 |
Hello, and welcome to Andy’s Take.
Recently the Food and Drug Administration developed a new draft guidance document for the medical industry for drug eluting vascular stents - a mechanical device, which holds a blood vessel open, and also slowly delivers a drug that inhibits scar-forming cells.
My Take on this action is that it not only emphasizes the value of collaboration within FDA, but more importantly, it previews the future challenge of regulating medical products that are not only combined, but are truly integrated in their function – integrated like your lap-top computer that combines parts and pieces such as a hard drive, microprocessors, and software, to yield a system where the components work together to create a product that benefits you.
In the future, integrated medical products will be even more complex and more common. For instance, with the introduction of nanotechnology, one might imagine a device like the drug eluting stent with nano-components that would also monitor gene expression of the scar-forming cells while informing other components to time-release the precise amount of a drug for the optimal balance of healing. This device would integrate the properties of diagnostic monitoring, mechanical support and drug delivery.
This is one example of an early chapter in the story of science and technology making “smart” medical products a reality. But regulatory agencies like FDA are not aligned for this new reality and I believe we must change just as the products are changing. FDA must work in an interdisciplinary and coordinated way to create a well-defined regulatory pathway that enables us to assure the benefits and risks that are associated with each element in these products as well as with the entire product itself.
Science and technology are leading us to a future in which the science fiction of the past will be a reality of the future. Science and technology must lead FDA into that future as the world’s premier regulatory agency for medical solutions – solutions that will benefit the lives of you and your family.
Look forward to sharing with you my next Andy’s Take.
Andy
Andrew C. von Eschenbach, M.D.
Commissioner of Food and Drugs
|
|
