The U.S. Department of Health and Human Services is expected to propose new rules requiring pharmaceutical companies to include more complete safety information directly in television and radio advertisements, rather than directing consumers to external sources such as websites or brochures. The proposal could significantly reshape the direct-to-consumer pharmaceutical advertising landscape and increase costs for drugmakers. Experts caution that the changes could significantly increase the length and complexity of pharmaceutical advertisements, making them less practical and more costly to produce and broadcast.
Dominick DiSabatino, a partner on Sheppard’s life sciences team, said the administration faces a complex regulatory balancing act as it develops the rule. He noted that several factors are influencing policymakers and suggested the government may seek an approach that increases disclosure requirements while avoiding an outright elimination of pharmaceutical advertising. DiSabatino also observed that adopting a formal rule would represent a stronger and more consequential regulatory step than simply issuing updated guidance.
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