- Thursday, September 19, 2024

Compounding pharmacies that offer their own homebrew GLP-1 drugs are the new designer smoke shops: Illegal, unsafe, and popping up on every street corner in upper-income zip codes.

What? Your doctor won’t prescribe you Ozempic, Zepbound, Wegovy, or Mounjaro for off-label weight loss? No problem. If you’re willing to pay cash, there are plenty of compounding pharmacies ready to give you what you want. And plenty of websites too. The bad news is that the legality of their operations is questionable – as is the safety of what they’re manufacturing and selling.

“Unsafe” and “illegal” is a nasty health care double play. So, why isn’t the FDA doing more (beyond warnings on their own website) to shut these operations down? The short answer is that they don’t have the resources or the authority. Currently, the FDA can only target false or misleading posts by influencers or telehealth companies when they have an established financial relationship with the legitimate manufacturer of the drug and, in the age of social media and aggressive pharmaceutical compounding, that loophole has become an ever-expanding wormhole of dangerous behavior. The good news is that both Congress and the FDA recognize the problem and are taking action.

On the Congressional front, Sens. Dick Durbin (D/IL) and Mike Braun (R/IN) have crafted the “Protecting Patients from Deceptive Drug Ads Online Act” to crack down on deceptive or misleading online promotion of weight-loss and other prescription drugs by telehealth firms and social-media influencers who profit from their posts.

Unsurprisingly, body image-obsessed addicts of social media platforms have accelerated the demand for GLP-1 medicines. The Wall Street Journal reported that posts on platforms such as TikTok, YouTube and Instagram often omit information about difficult side effects and that some influencers and companies profit from the posts.

The Durbin/Braun bill would give the FDA the authority to send warning letters to both influencers and telehealth companies, regardless of whether they have financial ties to the drug’s manufacturer and follow up with fines for noncompliance. Ads that could be targeted under the law include posts that accrue a financial benefit to the influencer and contain false statements, omit facts or fail to disclose risks and side effects.

Telehealth is an important and growing post-pandemic development in healthcare delivery. But while still relatively new and largely unregulated, it also presents risks—not the least of which is the proliferation of misinformation. An important finesse for any regulatory action or legislation is to encourage the growth of responsible telehealth while constructing appropriate rules, regulations, and guardrails.

As to FDA initiatives, the agency has proposed a new rule that addresses what drugs should not be permitted for compounding. Per “Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding,” those criteria are “the formulation complexity, drug delivery mechanism complexity, dosage form complexity, complexity of achieving or assessing bioavailability, compounding process complexity, and complexity of physicochemical or analytical testing of the drug product or category of drug products.” GLP-1 medicines would meet all these enhanced standards.

The ballooning regulatory end-run to slimness also has serious systemic implications – such as slowing research into new and important uses for GLP-1 medicines. There’s mounting evidence that these medicines may potentially treat other serious conditions. That’s exciting, but such evidence is still anecdotal – and the plural of “anecdote” isn’t data.

To really dig into the scientific opportunities, the manufacturers of FDA-approved products will have to invest many millions into research and development. That’s where the good news is to be found. The bad news is that if the store-front and online snake oil salesmen hawking their knock-off products can continue their dangerous exponential growth, legitimate manufacturers may be dissuaded from undertaking these additional high-risk research programs.

After all, we can’t follow the science is there is no legitimate science to follow.

• Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest and a Visiting Professor at the University of Paris School of Medicine.

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