Axios Live: Safety concerns fuel push for compounded GLP-1 oversight
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Rep. Rudy Yakym (R-Ind.) and Axios' Stef Kight in conversation at an Axios Live event. Photo: Ralph Alswang for Axios
WASHINGTON – The Safe Drugs Act would establish new safeguards for compounded GLP-1 drugs, said Rep. Rudy Yakym (R-Ind.) at an Axios event.
Why it matters: Mass-compounded GLP-1 drugs are cheaper alternatives to blockbuster medications like Wegovy and Ozempic, but those copycat versions are not FDA-approved.
Axios' Stef Kight and Brock Turner hosted conversations with Yakym, Rep. Nikki Budzinski (D-Ill.) and Scott Kahan, director of the National Center for Weight and Wellness. The July 22 event was sponsored by the Partnership for Safe Medicines.
State of play: Compounded GLP-1s were permitted during an FDA-declared shortage of branded weight-loss drugs. After the shortage ended, the FDA banned the copycat drugs early last year, but some compounders and telemedicine companies continued selling them.
What they're saying: "Americans expect that when they take a medication, the medication they're taking is going to be safe," said Yakym, who co-introduced the bipartisan bill.
Yes, but: Kahan said telemedicine has "real value" in expanding obesity care because relatively few physicians specialize in treating obesity.
- He cautioned, however, that some for-profit models prescribe compounded GLP-1s based on online questionnaires with limited physician oversight or patient monitoring.
Zoom out: Drug affordability remains a major issue. The Trump administration is promoting discounted branded GLP-1s through TrumpRX, but Budzinski is skeptical.
- "It's very unclear what kind of real savings there is in it," she said. "There's a total lack of transparency around what is provided, what's being offered."
- She said Congress has bipartisan interest in lowering drug costs but argued TrumpRX doesn't address the "root of the issues."
- The administration has touted its "most favored nation" drug pricing deals as one of its biggest accomplishments. However, Yakym said he wants more details around the agreements before deciding whether Congress should codify the policy. "Right now we've got 17 or 18 separate negotiated agreements that are kind of in a bit of a lockbox that we don't know all the details to."
Content from the sponsor's segment:
In a View From the Top conversation, Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, said compounded GLP-1s pose a huge patient safety risk because of the lack of safety standards.
- "There's so many patients – hundreds of thousands of patients – who are taking these medicines, and what they don't realize is that they are not FDA-approved," said Safdar.
Go deeper: Watch the full event.
