A recent TV ad for a heart medication showed a patient enjoying whale-watching, football games, and nature trips with his grandchildren. While the scenes looked appealing, the FDA’s Center for Drug Evaluation and Research called them “false or misleading.” The ad didn’t accurately reflect what patients with a rare heart condition could realistically expect from the drug, Amvuttra, based on clinical trials. The FDA asked the drugmaker, Alnylam Pharmaceuticals, to correct the misleading claims. This was one of several enforcement actions the FDA announced this month to protect patients from inaccurate direct-to-consumer (DTC) advertising. The agency plans to send thousands of letters, including about 100 cease-and-desist orders, to companies urging them to fix misleading ads. The FDA’s new approach aims to align U.S. drug advertising with global standards and pre-1997 U.S. rules, which required full side effect disclosures. Now, companies must list all side effects in ads, not just the most serious ones. The FDA also plans to strengthen enforcement of existing DTC marketing rules, which have been loosely monitored, and expand oversight to social media. FDA Commissioner Dr. Martin Makary noted that pharmaceutical advertising spending has surged nearly 800% since 1997, often driving demand for medications that may not be suitable for patients. Industry experts agree with the FDA’s goals. Jon Roffman, head of global biopharma at ZS Associates, said the changes align with pharma companies’ efforts to provide fair and balanced information. However, requiring full side effect disclosures in TV ads—where most DTC spending occurs—could be challenging. Roffman estimates that including all safety details could extend ads by four or five minutes, making them less engaging and more expensive. If the FDA doesn’t offer flexibility, companies may shift away from TV ads and explore other marketing methods. Despite these challenges, drugmakers won’t abandon DTC advertising, which has proven effective. Studies show that people who see ads for cholesterol-lowering drugs are 16% to 20% more likely to be diagnosed with high cholesterol. Roffman believes DTC ads help patients get necessary information. To avoid penalties, companies must ensure their ads accurately represent their products. Past enforcement actions have resulted in hefty fines for violations. Companies should review their current ads, make necessary changes, and prepare for stricter oversight. Roffman expects more innovation in advertising, such as unbranded ads focusing on diseases rather than specific drugs, and increased use of social media and telehealth platforms. The key message is for pharma companies to stay adaptable as regulations evolve.