Trump plan could make drug ad safety warnings even longer
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Illustration: Megan Robinson / Axios
Those disclaimers in TV drug ads could get longer if the Trump administration makes good on plans to require all safety risks to be disclosed in the ads instead of referring consumers to another source.
The big picture: The administration says the current practice of focusing on key risks is a loophole that needs to be closed amid a proliferation of direct-to-consumer drug ads.
- But some drug law experts contend that more detailed warnings — the kind of full product information found on drug labels in advertisements — could confuse consumers and stretch the ads to unrealistic lengths.
Driving the news: The administration plans to issue a proposal in December that would revise the so-called adequate provision requirement for product claims in drug ads.
- The move would track with a memorandum President Trump issued in September addressing transparency and accuracy in direct-to-consumer drug advertising.
- The administration said the envisioned change "does not constitute a ban or unreasonable imposition on DTC drug advertising" but would instead require complete safety information to help consumers make informed decisions.
- The notice was contained in the semi-annual Unified Agenda of Regulatory and Deregulatory Actions, a list of federal agencies' proposed rule changes.
Yes, but: Broadcast ads already contain a "major statement" of key risks. And in 2015 guidance on print drug ads, the Food and Drug Administration favored a brief summary of the most important risks over an exhaustive list, according to a post on the FDA Law Blog.
- In the post, attorneys at the law firm of Hyman, Phelps & McNamara questioned whether the change, if finalized, could effectively halt direct-to-consumer broadcast ads by making them so long that they're cost prohibitive.
Context: A 2024 federal transparency rule laid out new standards for direct-to-consumer ads to be more upfront about possible drug pitfalls, including having a clear main statement in which side effects and other risks are spelled out.
- Direct-to-consumer drug ads are banned in all other developed countries except New Zealand. They can influence whether consumers seek out more information about a drug, visit a doctor to discuss a product, or skip a doctor visit.
What we're watching: Whether the administration follows through on the notice of its plans, and whether the pharmaceutical industry pushes back.
