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It is a web that is not easily untangled. Within the legal realm, the subject lies at the intersection of First Amendment law and food and drug law. And within food and drug law, one comes up against many of the most difficult and divisive issues of the daymdash;issues such as off-label prescribing, direct-to-consumer marketing, and regulation of the pharmaceutical industry. Despite these difficulties, this is an issue that must be addressed. There are a number of reasons for its importance. First, there are ethical concerns relating to informed consent.

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