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1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction?
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Commercial or promotional speech has no substantial motive for truth-telling, nor does it represent a *political* or *philosophical* position protected by the first amendment, but on the contrary is essentially advertising, paid for because of its power to raise sales and awareness of a product. For these reasons, speech about drugs, which when issuing from manufacturers or representatives of manufacturers, always aims to create positive reactions to the drugs, is highly compromised in essence and in principle, and cannot logically or philosophically be given the exact same protection as the speech of citizens that is fully protected by the first amendment.
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5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard?
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Consumer confusion might be the desired result of a bad-faith compliance by drug manufacturers, so that they could argue for the position of not being required to issue warnings at all. But surely there are simple ways of giving consumers *some* accurate information disclaiming announced benefits or safety.
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