FDA cracks down on GLP-1 compounding claims

The FDA earlier this week issued nearly 60 warning letters to telehealth firms, med spas, and providers marketing compounded versions of blockbuster GLP-1 weight loss drugs, accusing them of misleadingly suggesting their products are equivalent to FDA-approved medications like Wegovy and Zepbound.

The letters, STAT's Katie Palmer writes, are part of a wider crackdown on drug promotion. They highlight claims about "same active ingredients" as deceptive, even as compounding trade groups insist such statements are technically true.

Regardless, experts say a reading of the letters indicates they are unlikely to reshape how patients interpret the booming online marketing of compounded GLP-1s, which often skirts traditional FDA advertising oversight.

FIRST OPINION

Why U.K. policy prompted a pharma freeze

The U.K.'s once world-class life sciences ecosystem is reeling as AstraZeneca, Merck, Eli Lilly, and Sanofi collectively pause billions in planned R&D investments. They cite an inhospitable business climate and collapsing drug pricing talks with the National Health Service, writes First Opinion contributor David Grainger, founding partner at Europe-based investment firm Medicxi Ventures.

Rising taxes, restrictive labor laws, and aggressive price negotiations — compounded by U.S. "most-favored nation" drug pricing pressure — are driving pharma away, with some companies already hiking U.K. prices two- to threefold. Unless Health Secretary Wes Streeting creates a more collaborative environment, analysts say Britain risks losing its hard-won edge in global drug innovation.

"Solving the pricing standoff (painful and difficult as it may be) would go some way to restoring corporate confidence in the U.K. as a destination for pharmaceutical investment," Grainger writes. "Much more challenging to overcome is the wider anti-business policy agenda of the current government. That seems unlikely to change, suggesting that worse may yet be to come for the U.K. life sciences innovation ecosystem."

podcast

Biotech M&A's quiet roll, and more

Are pharmaceutical companies pulling their money out of the U.K. beacuse of Trump? How is biotech M&A pacing this year? And what will vaccine advisers discuss at their closely watched meeting this week?

We discuss all that and more on this week's episode of "The Readout LOUD."

STAT's European correspondent Andrew Joseph calls in from the U.K. to the podcast to dissect why companies like Merck and GSK are putting their money elsewhere. We also discuss the Advisory Committee on Immunization Practices meeting and biotech M&A, including Roche's $3.5 billion acquisition of 89bio and its MASH drug, announced this week.

Listen here.

PHARMA

CDC backs Gilead's HIV prevention drug, as advocates push CVS for coverage

The Centers for Disease Control and Prevention yesterday recommended that a groundbreaking medicine from Gilead Sciences should be used for HIV prevention, as patient advocacy groups used the news to push CVS Health to reverse a recent decision not to cover the drug.

The Food and Drug Administration approved lenacapavir, which is marketed as Yeztugo, three months ago. But CVS Health, which runs the largest pharmacy benefits manager in the U.S., is so far not covering the medicine, although a source familiar with the situation told STAT's Ed Silverman that Gilead is negotiating with CVS.

In light of the CDC recommendation, 64 organizations wrote to CVS and called on the company to cover the Gilead medicine. "We urge you to reconsider this decision and cover Yeztugo without delay," they wrote.