Insights

On September 9, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (HHS) issued a news release announcing an “aggressive[]” “crackdown” on direct-to-consumer pharmaceutical advertising. This release came on the heels of a Presidential Memorandum President Trump issued the same day directing HHS to “ensure transparency and accuracy in direct-to-consumer prescription drug advertisements,” and the FDA to “take action to enforce legal requirements that advertisements for prescription drugs be truthful and not misleading.”

The Food and Drug Administration (FDA) has published revised draft guidelines in the Federal Register on promotional labeling and advertising considerations for the biologic and biosimilar industry, updating guidance from 2020. The quick revisions emphasize the fast-changing and rapidly growing nature of this industry.

In late December, the FDA released a guidance document that provides clarity for small businesses marketing direct-to-consumer (DTC) drug products on television or radio.  The Q&A followed the FDA’s November 2023 Final Rule amending DTC advertising regulations for prescription drugs. 

Companies worldwide are entering new product lines to address the COVID-19 pandemic, venturing into masks, ventilators, sanitizers, and other equipment and devices. With this move comes new legal challenges and opportunities for profit and prudent risk management. This webinar will share learnings on how savvy companies are making the most of their product pivots.