As rates of obesity have increased over the last 20 years, demand for medicines to treat obesity has soared, resulting in shortages of critical ingredients needed to manufacture these drugs. These treatments – called GLP-1s – help manage type 2 diabetes and effectively promote weight loss. Fortunately, the Food and Drug Administration (FDA) recently announced that the two-year-long shortage of semaglutide – the main ingredient in popular weight loss drugs Ozempic and Wegovy – has been resolved. Although compounding pharmacies play an important role in the health system during drug shortages – producing additional supply of medicines that would otherwise only be available as a commercial product from a drug manufacturer – the resolution of this shortage presents an opportunity to reassess the safety and regulatory compliance of these pharmacies so that we may continue to ensure patient access without compromising FDA’s rigorous safety standards.
The FDA rigorously regulates the pharmaceutical industry to ensure that a product is safe for use, and that it has the ingredients and strength it claims to have. In 2013, in response to a meningitis outbreak at the New England Compounding Center that sickened nearly 800 people and killed more than 100, the FDA was given more authority to regulate the manufacturing and distribution of drugs, including those prepared by compounding pharmacies because many of these facilities are not required to follow FDA regulations and have less stringent guidelines for quality assurance.
As pharmacists, we recognize the important role of compounding pharmacies for increasing access to critical medicines during a shortage, but we remain concerned about entities trying to continue this practice when a shortage ends, putting patient safety at risk. Moreover, some compounding facilities are promoting that they can provide GLP-1s and other drugs for a lower cost than the manufacturer.
During the Super Bowl, which was watched by 123 million people, one company aired a commercial portraying the U.S. obesity problem and claiming Americans could not afford weight-loss medicines because of a greedy healthcare system. The company promoted its own compounded products as a lower-cost alternative for patients. While this message may be viewed as a solution to reduce costs and improve access to GLP-1s, it also blatantly bypasses the regulatory safeguards that protect patients.
Pharmaceutical manufacturers undergo significant testing before a drug is approved by the FDA and introduced to the market. The FDA’s regulations are among the most stringent in the world and help to ensure that medicines available to patients are both safe and effective. Allowing compounding pharmacies free rein over what products they can create by subverting FDA regulations and oversight threatens patient safety and compromises patient and provider trust in medications.
Pharmacists are among the most trusted healthcare professionals, especially in places with limited access to healthcare, such as rural communities. However, we are concerned that large, profit-motivated compound pharmacies will bypass existing standards that protect Americans, undermining public trust in our profession and potentially resulting in public harm. The cost of medications is an undeniable problem in need of thoughtful solutions, but compounding pharmacies are not the answer to the high cost of medications.