Federal Ban on Ozempic Replicas

ozempic replica ban

Federal Government to Ban Compounded Replica Ozempic Amid Safety Concerns

The federal government will prohibit all compounding pharmacists from producing replica versions of diabetes drugs like Ozempic and Mounjaro, widely used off-label for weight loss, following a Four Corners investigation that exposed illegal manufacturing practices in Australia.

Investigation Findings

A video recorded by investigators from the Therapeutic Goods Authority (TGA) revealed that a facility in Western Sydney was producing these drugs under unsanitary conditions, using kitchen equipment and chemicals. The investigation found that these illegally manufactured drugs were being exported overseas.

Ongoing Drug Shortages

Global shortages of Ozempic are expected to continue into next year. The government has announced a four-month transition period for the industry before the ban takes effect.

Public Safety Concerns

The Four Corners investigation uncovered that a registered Australian pharmacist was running an international operation, manufacturing and exporting replica Ozempic to the United States. Patients who used medication from Total Compounding Pharmaceuticals (TCP) reported serious side effects, including nerve damage, rashes, vomiting blood, and bleeding gums, which they believe were linked to the compounded drugs.

Currently, Australian compounding pharmacists are allowed to reproduce brand-name drugs during shortages, but these replicas are not subjected to the same stringent safety checks. Federal health minister Mark Butler announced that this loophole will close in October, removing the exemption for compounding active ingredients in drugs like Ozempic.

Impact on Patients and the Industry

In Australia, an estimated 20,000 people use compounded weight loss medications, but the actual number may be higher. The TGA has already seized vials of unlawfully manufactured semaglutide from a Victorian pharmacy.

Minister Butler expressed concern that many patients using compounded versions of these drugs were unaware of the safety risks, which have also been highlighted by the FDA in the United States. He emphasized the lack of oversight in the manufacturing conditions and the ingredients used, as well as the absence of a formal system for reporting adverse events.

Filthy Manufacturing Conditions

The TGA provided footage showing the deplorable conditions in which TCP was allegedly producing replica Ozempic. The facility, filled with kitchen mixers and blenders, did not meet the standards expected for manufacturing injectable medications.

Regulatory and Industry Response

The announcement of the ban has garnered support from various health organizations, including the Pharmacy Board of Australia, Diabetes Australia, the Medical Board of Australia, and the RACGP. However, some pharmacy groups and telehealth companies, like Eucalyptus, opposed the ban, arguing it would deny thousands of Australians access to life-changing medication amid global shortages.

Addressing the Shortage

RACGP president Dr. Nicole Higgins acknowledged the shortage and the potential anxiety it might cause for patients using Ozempic off-label for weight loss. Minister Butler assured that the government is working with pharmaceutical companies to mitigate the impact of the ban. He stressed the importance of prioritizing diabetes patients for whom these drugs are approved under the PBS.

“We’ve already got a shortage of this medication for the people it was initially designed for, which is our [people with] type 2 diabetes. I expect that those shortages may be exacerbated, and it’s going to cause some anxiety for those who’ve been using Ozempic off-label,” Dr. Higgins said.

The TGA’s latest update indicates that the supply of Ozempic will remain limited throughout 2024 due to increased demand for weight loss, with Mounjaro also expected to be in short supply until at least September.

Moving Forward

Patients relying on compounded medications are advised to consult their GPs and healthcare teams for support during this transition. Minister Butler reiterated the government’s commitment to ensuring that diabetes patients have priority access to these essential medications.

The four-month transition period is intended to allow the industry to adapt while safeguarding public health by eliminating unsafe manufacturing practices.

Nestle $5 Pizza for Ozempic Users

ozempic and alcohol

Nestle Launches $5 Pizza for Ozempic Users

Nestle (NESN.S) is introducing a new $5 line of frozen pizzas and protein-enriched pastas in the United States, specifically designed for individuals taking weight-loss medications like Wegovy and Ozempic. These new products are tailored to meet the nutritional needs of those on GLP-1 agonists, drugs known for their appetite-suppressing effects.

Targeted Nutrition

Nestle, the world’s largest food company, which already sells popular brands like DiGiorno pizza and Stouffer’s meals, has developed these new offerings with higher levels of protein, iron, and calcium. Tom Moe, president of Nestle USA’s meal division, described the new brand, Vital Pursuit, as “food solutions” for people seeking the right nutrition to complement their use of weight-loss drugs. These meals are priced at $4.99 and under, slightly more than a DiGiorno four cheese personal pan pizza, which retails at $4.79 at Target.

Rapid Development

Nestle began developing companion products for GLP-1 drugs last year. “We moved real fast on this,” Moe said. Nestle CEO Mark Schneider noted in October that the company was closely monitoring the potential impact of these drugs on food product demand and was working on products to help mitigate “loss of lean muscle mass” in users.

Market Response

Despite concerns that appetite-suppressing drugs could reduce food company sales, executives at Nestle and other companies like Conagra (CAG.N) see an opportunity to market products such as beef jerky, popcorn, and frozen meals. Mondelez (MDLZ.O) also views its snack bars as fitting well into the diet of a GLP-1 patient.

Growing User Base

Goldman Sachs estimates that 10 million to 70 million U.S. consumers could be using GLP-1 drugs in the next four years. Nestle has engaged with individuals on these medications to develop suitable meals and will soon offer samples. The company first introduced the brand to Walmart (WMT.N) and plans to expand to other major retailers like Kroger (KR.N) and Target (TGT.N).

Addressing Protein Needs

People on GLP-1 medications risk losing lean muscle mass as they lose weight and often have reduced appetites. Dr. Ethan Lazarus, an obesity doctor in Colorado, emphasized the importance of ensuring adequate protein intake for these individuals. Lazarus, who has worked with GLP-1 drugmakers Eli Lilly (LLY.N) and Novo Nordisk (NOVOb.CO), noted the potential popularity of protein-rich, easy-to-digest foods.

Other Market Players

Nutrition company Herbalife (HLF.N) has also begun selling shake mixes and fiber supplements in bundles targeting people on GLP-1 drugs, with plans to expand these bundles to other markets, including South America. Meal kit provider Daily Harvest offers a GLP-1 companion food collection but has seen slow sales.

Vital Pursuit Details

Vital Pursuit meals will range from eight to 10 ounces (227 to 284 grams). Unlike the calorie-focused Lean Cuisine brand introduced in the 1980s, Vital Pursuit emphasizes higher fiber, protein, and other macronutrients.

By addressing the nutritional needs of people on weight-loss medications, Nestle aims to provide better dietary support for those seeking to maintain their health and muscle mass while using these popular drugs.