The battle over blockbuster weight loss medications is intensifying, and patients are finding themselves caught in the middle. The Food and Drug Administration recently announced the end of the shortage of Eli Lilly’s tirzepatide, used for diabetes and obesity. This move signaled to compounders that they can no longer produce copycat versions of the drug without official agency approval.
In response, Lilly has taken action against compounders by sending hundreds of cease-and-desist letters, urging them to stop making their versions of the medication. Despite the FDA’s declaration that the shortage has ended, pharmacies are still struggling to stock Lilly’s treatment. Even if available, many patients cannot afford the branded drugs, which can cost over $1,000 a month and may not be covered by insurance.
The discontinuation of compounded tirzepatide poses a significant risk to individuals who have found success with this treatment for obesity. These patients now face uncertainty in accessing both compounded and branded versions of the drug, potentially leading to health risks if they abruptly stop taking tirzepatide. Weight regain and the return of previously addressed conditions such as high blood pressure and high blood sugar are possible consequences.
Some patients have expressed intentions to stockpile and ration compounded supplies, which could lead to health risks if used beyond expiration dates. Additionally, the use of counterfeit drugs and unregulated “research chemicals” poses further dangers. As the availability of tirzepatide remains uncertain, patients may turn to unsafe alternatives, risking their health in the process.
While the FDA’s statement suggested intermittent localized supply disruptions as the drug moves through the supply chain, pharmacies across the country continue to report difficulties in obtaining the treatment. Patients may also face financial barriers in accessing the branded drugs, as many insurance plans do not cover obesity medications or have strict approval processes.
Lilly’s introduction of discounted vials for Zepbound may not significantly improve accessibility, as the lower-priced vials only offer starter doses and are limited to patients paying out of pocket. Despite the risks associated with compounded drugs, some patients are willing to accept these risks to access necessary medication. However, the lack of standardized regulation for compounding pharmacies raises concerns about the level of care provided to patients.
As the debate over branded versus compounded medications continues, the ultimate goal should be to make authorized medicines more affordable and accessible to all patients who need them. Balancing the need for innovation with affordability is crucial in ensuring that patients receive the care and treatments they require without facing financial burdens or health risks.
