FDA Finally Concedes It Must Accept More Risk In Order To Spur Innovation

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, stated that the FDA’s risk-averse behavior must change and FDA must be willing to take bigger safety risks to promote innovation and overall patient benefit. Shuren describes the state of innovation in the U.S. today as itself “a patient in the ICU, with multiple organ system failure.”

Shuren said that the FDA has long had a “cultural problem” of looking at risks and benefits from a regulator’s perspective rather than from the view of a patient or doctor. He said a newly finalized risk-benefit framework, which takes into account the seriousness of the illness being treated and whether any other treatments exist, should help.

The following are three key ways the FDA aims to be a driver of innovation:

1. Adjusting Premarket Risk Analysis. Under the new risk-benefit framework for Premarket Approval and De Novo classifications of devices, devices that were previously considered too risky may now be considered acceptable for the market when the FDA considers the severity of the disease, the availability of alternative treatment or diagnostic options, and whether the technology is novel technology addressing unmet medical need.
2. Implementing Postmarket Surveillance. FDA’s new national medical device postmarket surveillance plan aims to facilitate medical device innovation by monitoring the products for continued safety and effectiveness after they are in use, rather than before approval, to accurately characterize information about real-world device performance, including the clinical benefits and risks of marketed devices.
3. Increasing Collaboration with Partners. FDA has improved communication with CMS to help CMS make coverage decisions about new medical devices more quickly. Now, CMS is able to issue a decision about whether a device will be covered under Medicare or Medicaid before the FDA issues a final decision about the device’s approval. Furthermore, FDA is establishing an “innovation consortium” that will include the FDA, industry, researchers and other stakeholders to discuss funding and data and to share expertise and critiques.