FDA Policy/General

DTC Ads Kennedy’s Next Target?

President Donald J. Trump and his HHS secretary, Robert F. Kennedy, Jr., reportedly are considering ways to make it more expensive for drug companies to use direct-to-consumer (DTC) advertising. Bloomberg News reports they are considering not allowing companies to deduct their DTC ads as a business expense. They also are said to be looking at requiring a more extensive “major statement” of adverse effects in each ad, making them more expensive to produce and air.

The news service says the policy discussions within the administration follow the 6/12 introduction by Sens. Bernie Sanders (I-VT) and Angus King (I-ME) of the End Prescription Drug Ads Now Act to ban DTC ads across television, radio, print, digital platforms, and social media.

A ban on DTC ads was a feature of Kennedy’s failed 2024 bid for president before he withdrew to join the Trump campaign.

Past efforts to ban such ads fell to court rulings that the ads enjoy First Amendment speech protection. Presumably, Kennedy’s plan would attempt to end-run that objection by allowing the ads but making them so expensive that companies would decide not to run them.

In 2023, FDA issued a Final Rule setting five standards that it said drug marketers should follow to ensure that the major statement is clear, conspicuous, and neutral.

Bloomberg says that shortly after the 2024 presidential election, research firm Intron Health identified a potential ban on DTC ads as “the biggest imminent threat from RFK and the new Trump administration.”

The researchers said the return-on-investment on drug ads can range from 100% to 500%, depending on the drug. Companies, Intron said, would almost certainly see a decline in drug sales, even as they saved money on marketing.

In the first quarter of 2025, TV ad spending was up 30% over the same period last year, Bloomberg reports.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome