Introduction
If there would be a drug of the decade, it would have to be semaglutide brand Ozempic. That’s because of its capacity to regulate blood sugar levels and promote weight loss.
Despite these therapeutic benefits, it still has a number of problems. The clamor for Ozempic has led to a massive shortage issue, making it inaccessible for those who need it. Some manufacturers are also turning to compounded but unsafe versions of the drug to bridge the supply gap.
With all these issues, could a semaglutide ban be possible? This article explores its regulatory standing with the FDA and factors influencing a potential prohibition.
What is semaglutide?
Before we dive into the challenges surrounding semaglutide, we must understand what it is and how it works.
Semaglutide is a glucagon-like peptide-1 receptor agonist, which mimics the actions of a hormone, GLP-1. Whenever we finish eating and blood glucose is high, the drug triggers insulin release to reduce blood sugar levels.
Another effect of the drug is that it slows down digestion, making you feel fuller for longer. As a result, people on semaglutide tend to lose weight as they don’t think about food as much.
Oral and subcutaneous semaglutide
Apart from Ozempic, it shares the active ingredient semaglutide with its two other sister brands, Wegovy and Rybelsus. Ozempic and Rybelsus both treat people with type 2 diabetes, while Rybelsus helps treat people with obesity.
Both Ozempic and Wegovy come in injectable dosing pens and you administer them subcutaneously or under the skin. You take Rybelsus, meanwhile, orally as it is in tablet format.
Eligibility
Not just anyone can take semaglutide. People must meet certain diagnostic criteria before they can receive a prescription for it.
For Ozempic and Rybelsus, you must have type 2 diabetes and cardiovascular disease. Meanwhile, for Wegovy, you must have a BMI of 27 or greater with one weight-related condition. It is also applicable to those with a BMI of 30 or greater.
Despite these criteria, many healthcare professionals prescribe Ozempic off-label even to those without type 2 diabetes. This is a possible contributor to the drug’s current shortage crisis.
Safety and efficacy
With the positive outcomes of several clinical trials, Ozempic, Wegovy, and Rybelsus received their respective approvals from the US FDA. The following are highlights from the research that proves semaglutide’s safety, efficacy, and tolerability in patients.
In the STEP 5 trial, researchers looked at the two-year effects of semaglutide in adults overweight or with obesity. Participants lost an average of 15 percent of their body weight with semaglutide. Meanwhile, those in the placebo group lost approximately 2.6 percent of their body weight.
Participants taking the drug also had reductions in their waistline circumference as well as in their systolic blood pressure. Participants in the semaglutide group also experienced better diastolic blood pressure, blood sugar levels, total cholesterol, and triglycerides.
Another study revealed semaglutide users lost more body fat than body mass and ate less due to a weaker appetite. They had better control of eating and fewer food cravings, especially for greasy foods.
Semaglutide and the US FDA
Amid its supply issue and the abundance of compounded semaglutide in the market, how does semaglutide stand with the FDA? Let’s take a step back to review its FDA approval history.
FDA Approvals
Based on evidence from seven clinical trials on treating type 2 diabetes, the FDA approved Ozempic in December 2017. In 2018, Novo Nordisk started another clinical trial with semaglutide to test its weight loss effects. In 2019, the FDA approved Rybelsus.
In 2021, the FDA approved Wegovy. A 2022 review found that semaglutide was more effective as an anti-obesity treatment than other earlier anti-obesity drugs.
Supply issues
Towards the latter part of 2023, there was a major shortage in Wegovy and Ozempic amid the clamor for the drugs. The shortage problem will likely persist for several more years.
Novo Nordisk admitted a “short-term stock-out” of Wegovy in the US through December due to demand surpassing supply capacities.
Currently, semaglutide is sold in the following countries: Australia, Canada, France, Germany, Japan, Netherlands, Switzerland, the US, and the UK.
Compounded semaglutide
Because semaglutide and weight loss drugs are pricey, some use compounded forms to save money and enjoy the same benefits. These compounded versions still contain the active ingredient but with the addition of other ingredients, such as vitamins.
The FDA has approved some drugstores to custom-mix variations of semaglutide and its competitor active ingredients tirzepatide and dulaglutide. However, a supply issue affected these in 2022. There have also been reports citing adverse effects from the compounded versions. Novo Nordisk and Eli Lilly have also reported impurities in the compounded medications.
In October 2023, there were reports of counterfeit Ozempic pens on sale in Europe, reportedly containing insulin. People who fell for the pens suffered from hypoglycemia and seizures. In December 2023, the FDA issued a warning about similar fake Ozempic pens being sold in the US.
It’s vital to remain vigilant and wary of merchants selling semaglutide through non-state-approved means.
Existing and potential bans
In 2023, Germany’s drug approval authority BfArM considered stopping Ozempic exports as the demand caused a shortage, despite Wegovy’s launch. According to Reuters, several European countries have already banned Ozempic.
Speaking to Spiegel magazine, BfArM President Karl Broich shared, “We are currently in talks with lawmakers about what we will do if the current measures and the public messages don’t show an effect. We would then think about imposing an export ban so that enough remains in the country for the patients that need it.”
Also in 2023, Belgium temporarily banned Ozempic prescriptions for weight loss until summer 2024, due to a shortage of supply.
Salt forms of semaglutide
In January 2024, the FDA announced medications containing semaglutide targeted to patients with type 2 diabetes and obesity.
The bureau noted that whenever a drug is in short supply, it allows compounded versions as long as it meets FDA requirements. Drugs compounded in an outsourcing facility must meet good manufacturing practice (CGMP) requirements. Meanwhile, those compounded by a doctor or a licensed pharmacist in a state-licensed pharmacy. As a general rule, manufacturers must make semaglutide in sanitary conditions.
The announcement added that the FDA had received several reports of compounded semaglutide’s side effects. It reminded patients to not take a compounded drug if an approved drug is available. The FDA also clarified that it does not review compounded versions of medicines for safety, efficacy, or quality.
The FDA has also received reports compounders would use salt forms of semaglutide, such as semaglutide sodium and semaglutide acetate. These are different ingredients than those in the approved semaglutide brands. It also cautioned healthcare providers considering working with compounders that their semaglutide products might contain salt forms of semaglutide.
“The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements for types of active ingredients that can be compounded,” read the FDA’s statement.
The FDA has caught illegal semaglutide online and has issued warning letters to stop these potentially counterfeit products. Additionally, the FDA is also investigating counterfeit Ozempic in the US.
To patients, it reminded them to only get a prescription from a state-licensed pharmacy in the US.
Discontinuing medicines
Drugmakers may discontinue medicines for different reasons, from safety and efficacy concerns, to market factors, supply chain problems, and regulatory issues. A drug may have serious adverse reactions, low market demand, shortages, or failure to meet new safety and efficacy standards.
More semaglutide manufacturers in 2032
Patients may have better access to semaglutide as the patent of its drug manufacturer, Novo Nordisk, will end in 2032. Until then, it has the privilege of dictating the drug’s price, according to non-profit Institute for Clinical and Economic Review. When the patent ends, other drugmakers can produce generic versions of semaglutide at lower prices.
Conclusion
Will semaglutide be banned? There is no guarantee that semaglutide will not face the risk of getting banned in the US or in additional countries. Currently, though, authorities have halted the sale of Ozempic in certain countries due to its scarcity.
The US FDA continues to be vigilant as it continues to receive reports on the adverse effects of potentially counterfeit semaglutide. It is also constantly monitoring the illegal sale of semaglutide online.
Authorities encourage consumers to report any adverse effects from compounded semaglutide and to seek approved versions of drugs when available. Healthcare providers, meanwhile, to be wary of working with compounders to acquire semaglutide products. These may contain salt forms of semaglutide, which has not been tested for safety and efficacy.
Glossary of terms:
- GLP-1: Glucagon-like peptide-1 is a gut-based hormone involved in the secretion of insulin to lower blood sugar levels typically elevated after meals.
- GLP-1 Ra: Glucagon-like peptide-1 receptor agonists mimic GLP-1 in the production of insulin to control blood sugar levels.
- BfArM (Federal Institute for Drugs and Medical Devices)
