From the FDA Law blog: Congress May Let FDA Regulate the Practice of Medicine

Regulatory News,

This article raises concerns about a provision in the Appropriations Bill before the US Congress. a section on “Bans of Devices for One or More Intended Uses.”
"This provision would have serious implications. Firstly, the proposed provision, should it pass, would allow FDA to ban a device in a way it has never been allowed to, ultimately giving the Agency authority to dictate the practice of medicine. Secondly, the proposed provision would be implemented with no scrutiny, public input, or public hearing. Yet this provision could potentially have far-reaching consequences. Even if FDA has infrequently used its banning authority, nothing would stop FDA from seeking to use this power much more extensively in the future. Giving FDA the power to ban off-label uses could preclude patient access to off-label therapies that FDA objects to even though their physicians deem the treatment essential. Thirdly, this provision erodes a bedrock principle: FDA does not have the power to regulate the practice of medicine."

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