Lawyers: Device Rider In Omnibus Lets FDA Oversee Practice Of Medicine

By Beth Wang / December 23, 2022 at 1:38 PM
Congress’ year-end spending deal states that FDA has authority to ban a medical device for one or more intended uses, potentially including off-label uses -- a move drug and device lawyers say has “far-reaching consequences” by essentially giving the agency power to regulate the practice of medicine. They view the provision as a sea change that could lay a precedent for FDA to also block patient access to off-label uses of prescription drugs. “[T]his provision erodes a bedrock principle: FDA...

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