Biotech Values

[DewDiligence]

Re: Federal preemption

>Keep in mind that many of the cases brought are about the label - the theory being that the drug company "failed to warn" of the risks. Yet, the drug companies are prohibited from describing risks differently than the label - they can neither warn of greater nor lesser risks.<

There’s a fallacy* in this argument: In most cases, the FDA would gladly agree to adding a warning to a product label that was proposed by the sponsoring company.

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*There is no footnote, but I thought having an asterisk would make my point sound more professional.