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In Reply: Dr Shein highlights the complexity of DTCA's impact on public health and hence the difficulty of crafting an appropriate regulatory and legal response. In particular, there is substantial face validity to his concern that advertisements can mislead patients or subtly alter their preferences in ways that cannot be overcome through subsequent discussions with their intermediaries. There is ample reason to closely monitor changes in physicians' ability to steer patients to appropriate treatments and to reconsider the learned intermediary rule if future studies demonstrate that the assumptions on which it is based are no longer true.

Many of Shein's concerns, however, are not well addressed by a change in failure-to-warn doctrine. They go to the more fundamental issue of whether DTCA should be permitted at all—a question, as we noted, that has constitutional implications. We share Shein's concern about misleading advertisements, but that problem is more readily remediable through . . . [Full Text of this Article]

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