A Major GLP-1 Drug Shortage Is Over. Some Patients Aren’t Celebrating

The End of a Long-Running Shortage Brings Mixed Reactions

October 9, 2024

A significant milestone in the medical world was achieved recently with the removal of Mounjaro and Zepbound, two popular glucagon-like peptide 1 (GLP-1) medications, from the FDA's drug shortage list. This development should bring relief to many patients who have been struggling with the scarcity of these essential treatments. However, the relief is not universal, as many patients are turning to compounded versions of these GLP-1 medications, which raises concerns about safety and regulatory compliance.

The Shortage: A Brief History

The shortage of GLP-1 medications, particularly Mounjaro (tirzepatide injection) and Zepbound (tirzepatide injection), has been a long-standing issue. These medications are crucial for managing diabetes and obesity, and their scarcity has left many patients in a precarious position. The shortage was attributed to increased demand and supply chain disruptions.

FDA's Decision: A Milestone

The U.S. Food and Drug Administration (FDA) has confirmed that the shortage of these medications has been resolved. This news was welcomed by many, but it also highlights the complexities of the pharmaceutical supply chain and the challenges patients face in accessing essential treatments.

FDA Clarifies Policies for Compounders

The FDA has emphasized its policies regarding compounders, reminding them that making copies of FDA-approved drugs is strictly regulated. Compounded drugs, unlike FDA-approved ones, do not undergo the rigorous review process required for safety, effectiveness, and quality. However, there are exemptions under sections 503A and 503B of the Federal Food, Drug, and Cosmetic (FD&C) Act for certain compounding.

• Section 503A: This section restricts compounding of drugs that are essentially copies of commercially available drugs. When a drug is no longer in shortage, it is generally considered commercially available, and compounding is only permissible in limited amounts.
• Section 503B: This section restricts outsourcing facilities from making compounded drugs that are essentially copies of FDA-approved drugs. The compounded drug may not be identical or nearly identical to an FDA-approved drug unless the approved drug is on the FDA's drug shortage list.

Compounded Versions: A Growing Concern

Many patients have turned to compounded versions of GLP-1 medications due to the shortage. While these compounded versions may seem like a convenient solution, they raise significant concerns about safety and regulatory compliance.

What Are Compounded Drugs?

Compounded drugs are medications that are not FDA-approved but are created by a pharmacist or physician to meet a specific patient's needs. Unlike FDA-approved drugs, compounded drugs do not undergo the same level of testing for safety and efficacy. They are often made in small batches and may not have the same quality control measures as FDA-approved drugs.

Risks Associated with Compounded Drugs

The use of compounded GLP-1 medications poses several risks:

• Regulatory Compliance: Compounded drugs are not held to the same standards as FDA-approved drugs. This lack of regulation increases the risk of contamination or incorrect dosing.
• Safety Concerns: Without rigorous testing, there is no guarantee that these medications are safe for long-term use.
• Effectiveness: The efficacy of compounded versions may vary significantly from FDA-approved medications, potentially leading to suboptimal treatment outcomes.

Patients' Perspectives

The resolution of the shortage is a mixed bag for patients. While some may finally have access to their prescribed treatments, others are left to navigate the complex world of compounded medications.

The High Cost of FDA-Approved Drugs

One of the significant barriers to accessing FDA-approved GLP-1 medications is the high cost. Mounjaro, for instance, costs $1,069 per month without insurance, making it unaffordable for many patients. Compounded versions, although potentially cheaper, come with their own set of risks.

The Need for Transparency

The FDA has emphasized the importance of transparency in the pharmaceutical supply chain. As patients navigate this complex landscape, it is crucial for healthcare providers and manufacturers to be transparent about the origin and quality of the medications they prescribe.

The FDA’s Response

The FDA has been actively working with manufacturers to resolve the current shortages of GLP-1 medications. As shortages resolve, the agency closely monitors the situation to ensure an adequate supply. Before determining that a shortage is resolved, the FDA considers various factors, including:

• Manufacturer's Ability: The company's ability to meet current and historical demand.
• Stock Levels: The amount of the drug in stock.
• Affected Market Share: The impact on the market share.
• Alternate Manufacturers: The ability of other manufacturers to cover the demand.
• Market Stabilization: Confirmed market stabilization.

Conclusion

The resolution of the GLP-1 medication shortage is a significant development in the medical world. However, it also highlights the complexities and challenges patients face in accessing essential treatments. While FDA-approved medications offer a high level of safety and efficacy, compounded versions raise significant concerns. As patients continue to navigate this landscape, it is crucial for healthcare providers, manufacturers, and regulatory bodies to prioritize transparency, safety, and regulatory compliance.

For the latest information on drug shortages, visit the FDA’s Drug Shortages Database.

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References:

• FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
• FDA removes Lilly’s Mounjaro and Zepbound from its shortage list
• GLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Shortage List
• The end of a shortage of popular weight-loss drugs may mean many aren't celebrating
• A Major GLP-1 Drug Shortage Is Over. Some Patients Aren’t Celebrating.