How can off label utilization of biomedical product approved


Problem

From the paper "United States v. Caronia A Victory for Free Speech vs. Off Label Promotion - Policy & Medicine", discuss the following:

• Whether or not the Caronia ruling can impact patient safety and risk, while at the same time benefiting the drug/device manufacturers.

• How can off label utilization of biomedical products approved by FDA benefit, as well as potential harmful in patient responsiveness to these products?

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