Eight Products Enter US FDA’s Opioid Challenge
After spending the past six months receiving and reviewing hundreds of product applications, US FDA has decided to select eight promising devices and diagnostics to help tackle the opioid crisis.
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In one of his last public appearances as US FDA commissioner, Scott Gottlieb identified new opioid-alternative medtech products in the regulatory pipeline that provide distraction therapy and thermal management for pain relief. The agency chief also pointed to old-school devices that provide localized delivery of analgesic drugs as effective opioid-substitute or opioid-reducing devices.
US Secretary of Health & Human Services Alex Azar discussed the move toward value-based health care, as well as HHS’s role in disaster response, as part of an annual "State of the Department" speech. The speech is tied to the release of HHS’s annual report.
In a statement to the Medicare Payment Advisory Commission, the medtech industry group bemoans the lack of consideration for medical device alternatives to opioids in treating pain management. The group says the commission should factor in such alternative treatments, per the SUPPORT Act, in their recommendations to Congress in March.