In September 2025, the FDA announced a sweeping enforcement push, issuing roughly 100 cease-and-desist notices and thousands of warning letters related to misleading direct-to-consumer drug promotion.¹⁰ The action followed a White House memorandum directing health officials to ensure ads present true “fair balance” between benefits and risks.¹¹
For context: in 2023, the agency issued a single warning letter related to promotional violations. In 2024, none.¹²
When the cop stops writing tickets, the billboards multiply.
The new enforcement wave targeted high-visibility placements. Hims & Hers drew scrutiny over a Super Bowl advertisement promoting compounded weight-loss drugs without adequate risk disclosure.¹³ Eli Lilly and Novo Nordisk received warnings related to promotional communications judged to minimize or omit serious side effects.¹⁴ These were not obscure cable spots. They were mainstream cultural events.
Regulators are not banning ads. They are trying to close gaps that allow benefit-forward narratives to float above proportional risk context.
Yet the deeper question remains unresolved.
If the defense of high American drug prices is that we subsidize global innovation, why does that innovation require mass persuasion?
Part of the answer lies on the other end of the spectrum—the miracles.
In 2019, researchers published in the New England Journal of Medicine the case of a child with Batten disease who received a customized antisense therapy—milasen—designed specifically for her genetic mutation.¹⁵ It was a triumph of precision medicine. It was also a glimpse of a future where treatments are engineered for individuals.
Boston Children’s Hospital has described the research costs for such individualized programs as averaging roughly $1.6 million per case—astonishingly low by pharmaceutical standards, yet still reliant on extraordinary coordination and philanthropic support.¹⁶
The contrast is jarring.
On one side: bespoke cures built in months for a single child.
On the other: primetime commercials for six-figure therapies aimed at viewers who may not know they’re candidates.
Both exist in the same system.
And that system prices not at cost, but at leverage.
Insurance insulates patients from immediate sticker shock. Premiums absorb the difference. The signal becomes simple:
Why not ask?
The danger is not that Americans are uniquely fragile. It is that we have built an economy in which attention functions as a clinical input.