•Ads must not be directed at people under 18 through the selection of media or the context in which they appear

In my opinion, it is the responsibility of the company that markets the drug in question not to undermine, refute, or publicly challenge the black box warning once the FDA has made a decision to require this warning. It is the FDA's scientific judgment, not that of the pharmaceutical company, that should be the final word in making the decision about whether or not a black box warning is required and what the black box warning should state. If the company refutes the black box warning publicly once it has been required, then it is essentially thumbing its nose at the FDA and substituting its own scientific judgment for that of the agency.

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