Health

How Making GLP-1s Available Over the Counter Can Unlock Their Full Potential

Drugs like Ozempic might not only address obesity but also alcoholism, smoking, and drug addiction.

|

topicshealth | Photo: Munro/iStock
(Photo: Munro/iStock)

When the Food and Drug Administration (FDA) approved Byetta (exenatide) in 2005, doctors thought it was just approving the first glucagon-like peptide-1 (GLP-1) agonist to treat Type 2 diabetes. But this new drug class had the potential to treat a host of other problems.

GLP-1 agonists mimic the body's intrinsic GLP-1, a hormone that stimulates insulin release, suppresses the hormone glucagon, slows the muscles that move food through the intestinal tract, and decreases appetite. GLP-1s indirectly
cause weight loss by slowing the movement of food through the stomach and intestines, extending the feeling of fullness. Researchers soon discovered they also directly act on GLP-1 receptors in the brain to reduce appetite and cravings. During clinical trials and postapproval surveillance, clinicians noticed people on GLP-1s losing weight.

Clinicians began prescribing GLP-1s off-label—not for a purpose or in a dose the FDA specifically approved—soon after seeing the drug's weight loss effects. By 2014, the FDA approved the GLP-1 Type 2 diabetes drug Victoza (liraglutide) to treat obesity under a different brand name, Saxenda. Both brands contain the same drug but have different dosing instructions. Since then, other drug manufacturers have followed the same strategy.

The makers of the GLP-1 Ozempic(semaglutide) got the FDA to approve the same drug in a different dose under the name Wegovy to treat obesity. Later, the FDA permitted the makers of Mounjaro (tirzepatide) to market it for weight loss as Zepbound. Getting FDA approval for these rebranded products allows drugmakers to use existing patent laws to extend their exclusivity for the new indication—enabling them to charge higher prices. It also makes it easier for them to secure insurance coverage.

***

As clinicians and clinical researchers learned more about the direct effect that GLP-1s have on food cravings, they set out to find if they may help reduce cravings for other substances and perhaps even help people with substance-use disorders.

A 2023 study found that people using GLP-1 medications for weight loss also drank less alcohol. More recently, research co-authored by National Institute on Drug Abuse Director Nora Volkow suggested that GLP-1 agonists could help prevent relapse in those with alcohol-use disorder. Together, these findings suggest that the drugs may reduce alcohol cravings.

Volkow and colleagues published a study in 2024 suggesting GLP-1s might also reduce the desire to consume cannabis. There is anecdotal evidence they may even cut nicotine cravings.

There is emerging evidence that GLP-1s can similarly reduce cravings for opioids.
If so, GLP-1s can supplement or, in some
situations, replace methadone and buprenorphine, two proven medications for
opioid-use disorder. Even if they only work
in conjunction with methadone or buprenorphine, they might reduce patients' dose requirements and reliance on them.

Even more exciting, there is early evidence that GLP-1 might reduce cravings for stimulants such as cocaine and methamphetamine. Presently, there are no medications for stimulant-use disorders.

Some researchers are now looking into whether GLP-1s can reduce compulsive behavior, including compulsive gambling.

GLP-1s are not without risks. In addition to common side effects such as nausea and diarrhea, these drugs can occasionally cause pancreatic inflammation and, in very rare cases, are linked to a rare form of thyroid cancer in people with a genetic predisposition.

***

As I explain in my book Your Body, Your Health Care, in 1951 Congress gave the FDA exclusive power to decide which drugs manufacturers could sell over the counter (OTC) and which ones adults could only purchase with a prescription—a permission slip from a government-licensed health care provider. Before that law, manufacturers made those decisions. If they believed a drug was too complex or carried a high risk of misuse, they would choose to have it sold by prescription only, in part to protect themselves from liability.

If Congress removed the FDA's monopoly power to require prescriptions, it is possible that some 20 years after GLP-1s appeared on the market, competition from new brands will incentivize some makers of GLP-1 products to market them over the counter.

Ibuprofen carries the risks of kidney damage, hypertension, ulcers, and cardiovascular events. The FDA approved ibuprofen as a prescription drug in 1974. Ten years later it removed obstacles to people buying it over the counter. If adults are competent to buy and use ibuprofen with proper labeling instructions after 10 years, why can't they use GLP-1s with proper labeling instructions after 20 years?

Imagine how people would benefit
if they could buy GLP-1s over the counter. Drugs tend to be dramatically less expensive when they are available OTC. Prescription drugs usually carry higher price tags than do OTC products, mainly because insurance covers prescriptions but not OTC purchases. When people pay out of pocket, they look for better deals, which pressures companies to keep prices competitive. Once insurance takes over the cost, shoppers stop paying attention to price and drugmakers can charge the deeper-pocket third-party payers more without worrying about losing customers.

If people are worried they might be drinking too much alcohol, using too much cannabis, or addicted to opioids, meth, or cocaine, wouldn't it be great if they could simply buy a GLP-1 over the counter? This way they could, if GLP-1s' effects in these areas pan out, privately and discreetly reduce their substance use to a safer level without facing any stigma.

Until adults can get these drugs over the counter, removing the FDA's restrictions on compounding pharmacies can go a long way toward making GLP-1s less expensive. Under the Food, Drug, and Cosmetic Act of 1938 and its amendments, compounding pharmacists can make and sell products to consumers without needing FDA approval, as long as they use FDA-approved ingredients from licensed facilities. But the FDA prohibits pharmacies from creating drugs that "essentially copy" commercially available ones—though this restriction is lifted during critical product shortages.

After the FDA approved Wegovy for weight loss, demand for this and other GLP-1s soared, resulting in shortages of the FDA-approved brands. In late 2022, the FDA declared a shortage of Zepbound, Wegovy, and other GLP-1s and allowed compounding pharmacies to create essential copies. These pharmacies helped increase patient access to these effective drugs at significantly lower prices than the commercially manufactured versions.

In February 2025, the FDA announced that the shortage was "resolved." This means consumers will return to paying more for the commercially available product. The higher prices may force some people to stop taking the drug altogether. Compounding pharmacies are exploring alternatives, such as creating products with different doses or delivery systems than those used in commercially available drugs.

One way to improve the situation would be for Congress to remove FDA barriers to compounding pharmacies making products that are essentially copies of commercially available off-patent products.

Imagine a future where GLP-1s are readily accessible—through compounding pharmacies or OTC options—offering hope and healing to millions. For those battling obesity or substance-use disorders, these medications could become life-changing tools for reclaiming health and opportunity. Achieving that future will require bold policy decisions that lift needless restrictions and put transformative care within everyone's reach.

This article originally appeared in print under the headline "Unlocking the Full Potential of GLP-1s."