Mr. Speaker, the medical device legislation we are considering today is the product of lengthy, bipartisan negotiations. It is a good compromise bill. I appreciate the majority's willingness to work with us to ensure the legislation promotes timely access to medical devices without compromising FDA's ability to do its job, that is, to ensure medical products, both drugs and devices, are safe and effective for their intended uses and to make sure these products are promoted to the medical community and to the public in an accurate manner, and for the benefit of the FDA's general counsel, who has repeatedly questioned FDA's authority to regulate the advertising associated with drugs and devices. When I say promoted in an accurate manner, I mean accurate labeling and accurate balanced advertising. After all, a product is no longer safe and effective if it is being marketed as something it is not.
Editor's note · Context
Discussing the bipartisan medical device legislation and its implications for FDA regulation.
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