By Megan R. Wilson

Listen to this briefing

• Regulators tease crackdown on drug ads: The Trump administration wants more rules for pharma ads, but details are scant so far.
• A sunscreen revolution?: The newly released MAHA report signals potential momentum for efforts to bring new types of sunscreen to the market.
• Susan Monarez heads to the Hill: The former head of the CDC will testify before the Senate health panel in an oversight hearing next Wednesday.

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Good afternoon and welcome to the Health Brief newsletter. I’m Megan Wilson, and I’m your host on this rainy Wednesday afternoon. Do you have any tips or scoops? Did you get a letter from the FDA about your pharmaceutical advertising? If so, I want to hear from you.

I’m at megan.wilson@washpost.com or on Signal at megan.434.

A QUICK CORRECTION:

Yesterday’s edition of the newsletter mistakenly attributed a post about the FDA’s “green list” on X to Hims, the telehealth company. However, the X post was made by Hims House, an unaffiliated group of investors who support the company. Your host regrets the error.

Federal regulators are threatening to tighten rules around drug advertisements directed at consumers. (Elise Amendola/AP)

	The Lead Brief

The biggest splash in Washington was the much-anticipated release of the Make America Healthy Again report and the rippling announcements made in its wake. My colleague Rachel Roubein in the Washington Post newsroom has the full rundown of the report for you, so make sure to check that out. But let’s unpack some of this.

First, the massive pill bottle in the room: The Trump administration’s plan to crack down on the pharmaceutical industry’s TV and digital advertising of its products— released Tuesday evening — was one of the first more specific shots at the industry following the release of the report earlier in the day, but many questions remain.

The Food and Drug Administration announced it would be acting on a directive signed by President Donald Trump and taking drug advertising rules back to the ’90s, rolling back a policy change made in 1997 that eased the requirements for ads directed to consumers and set off the flood of ads for medicines that’ve now become ubiquitous.

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The FDA also said it had sent out about 100 cease-and-desist letters to drug companies with “deceptive” ads and thousands more letters asking companies to remove “misleading ads.”

The moves could put several sectors in the crosshairs, such as:

• Drugmakers spent $10 billion last year to advertise their products directly to consumers through print, digital, TV and social media ads, one industry analysis showed, with about half spent on television advertisements — and the numbers are only increasing.
• Telehealth platforms that advertise their services and offer patients medicines such as compounded versions of GLP-1 weight loss drugs.
• Influencers on social media who have partnerships or sponsorships with pharmaceutical companies.

Further, if drug companies pull back on ad spending, broadcast corporations and platforms that receive the advertising cash could begin to push back.

What’s Next

But there’s still a lot we don’t know: The companies targeted, however, aren’t named. A spokesperson for the Department of Health and Human Services said the agency can’t comment about the recipients, because the letters represent “an open compliance matter.”

As of right now, the lobbyists for pharmaceutical companies I’m talking to are still trying to figure out what it all means — and how to react.

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PhRMA, the trade association representing large drug companies, said that direct-to-consumer advertising “provides patients with important fact-based, useful and accessible information about potential treatment options” and that its members are “committed to responsible, accurate advertising.”

→ The administration said it plans carry out the changes through the rulemaking process, which means this is going to be a drawn-out battle. This formal process involves soliciting and reviewing comments before implementation from those affected, which can take months or years.

There have been several bills introduced in Congress to limit pharmaceutical advertising, so it will be interesting to see how lawmakers weigh in during this process. Courts have also routinely upheld pharmaceutical advertising as free speech, so this could become a legal flash point, depending on how the rules are written.

	Under the Radar

The MAHA report also says the FDA “will promote innovation in the sunscreen market, and improve regulatory processes for over-the-counter sunscreen, which has fallen behind other countries.”

→ The FDA hasn’t approved a new type of sunscreen in more than 25 years, leading to frustration from lawmakers, health providers, patient groups and sunscreen manufacturers and complaints about the bureaucratic hurdles. There’s a renewed push in Congress to lower the barriers for market entry for new sunscreen formulations that some advocates hope gains traction.

The Public Access to SunScreens Coalition — formed more than a decade ago by patient groups, providers, public health groups and companies like including Kenvue and Beiersdorf — has been pushing to modernize the process and bring the U.S. in line with many other countries.

“The language in the MAHA report is significant because it’s a very public statement from the administration that they want to see a new pathway, or an improved pathway, to market for sunscreens in the U.S.,” said Michael Werner, who represents the coalition and co-leads Holland & Knight’s health care and life sciences team.

He said the focus is on those congressional efforts to overhaul the system at the FDA, which could be passed as part of the update to the Over-the-Counter Monograph Drug User Fee Program — known as OMUFA — that lawmakers tackle every five years.

Agency Alert

Former top health officials Susan Monarez and Debra Houry will testify before the Senate Health, Education, Labor and Pensions Committee next week as part of a series of hearings the panel is having on oversight of Robert F. Kennedy Jr.’s stewardship of HHS, Chair Bill Cassidy (R-Louisiana) announced.

→ The hearings come as Kennedy has been receiving increasing scrutiny from outside HHS. On Wednesday, the American Academy of Family Physicians urged Trump to “reconsider Secretary Kennedy’s ability to serve.”

Monarez was fired as head of the Centers for Disease Control and Prevention amid a clash with Kennedy over vaccines, and Houry, the CDC’s former chief medical officer, resigned in protest shortly after. They’ll be talking about their experiences at the agency before their departures.

The Post’s Dan Diamond has the write-up, includes all the context for the hearing to help you preview for the event next week.

→ Cassidy’s office has billed the hearing as part of “delivering President Trump’s mission to restore radical transparency” at the CDC.

Cassidy, who has emerged as a vocal critic of Kennedy’s decisions involving vaccines, said he’s planning to invite current officials at HHS to future hearings and allow them to respond.

What We’re Reading

ICYMI from The Washington Post’s David Ovalle: “How to get a coronavirus vaccine and who’s eligible amid limited access”

“Kennedy commission child health report ignores gun violence, the leading cause of child death,” reports Corinne Purtill at the Los Angeles Times

Education Secretary Linda McMahon and Kennedy wrote an op-ed for The Washington Post: “Children need natural sources of mental health.”