Novo Nordisk Calls for FDA Action to Halt Compounded Versions of Semaglutide Drugs

What’s in today’s article?

• Why in News?
• Comparing Generic and Compounded Drugs
• Key Issues in Drug Compounding
• Proposed Solution to Address Issues with Drug Compounding

Why in News?

• Novo Nordisk, the Danish pharmaceutical giant behind the popular drugs Wegovy (for weight loss) and Ozempic (to treat type 2 diabetes in adults), has requested that the U.S. Food and Drug Administration (FDA) stops the compounding of semaglutide-based medications.
• The company argues that compounded versions, created to meet rising demand, may pose safety risks to patients.

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Comparing Generic and Compounded Drugs:

Key Issues in Drug Compounding:

• Limited regulations:
  • Under FDA guidelines, licensed pharmacists can legally compound medications to meet patient needs, particularly when branded versions are unavailable.
  • With Wegovy and Ozempic in high demand, compounding pharmacies have been formulating their own versions, prompting Novo Nordisk’s intervention.
  • American pharmaceutical firm Eli Lilly similarly sought to halt compounded versions of its drugs Mounjaro and Zepbound, intended for diabetes and obesity treatment.
  • The FDA has yet to issue a decision on either case.
    • Purity risks: Semaglutide’s intricate structure is challenging to replicate accurately. Hence, the compounded versions may lack precision, potentially compromising purity and stability.
• Risk of incorrect dosing:
  • The FDA-approved semaglutide is delivered through a single-use pen injector, ensuring precise dosage and clear usage instructions.
  • Compounded drugs, however, are often dispensed in multi-dose vials or syringes, raising the risk of incorrect dosing.
  • Reports cite patients accidentally overdosing, resulting in severe side effects like nausea and vomiting.
• Risking severe health issues:
  • Bioavailability – the degree to which the drug reaches the bloodstream – is crucial for semaglutide.
  • Without proper absorption, compounded versions may fail to provide the intended treatment effects, risking severe health issueslike heart disease, nerve damage, and kidney complications.
• Contamination risks:
  • Compounded semaglutide requires sterile facilities and precise handling to avoid contamination.
  • In recent years, the FDA has flagged sterility issues at compounding pharmacies, leading to significant recalls.

Proposed Solution to Address Issues with Drug Compounding:

• Adding Semaglutide to DDC list:
  • Novo Nordisk petitioned the FDA to place semaglutide on the Demonstrable Difficulties for Compounding (DDC) list, which would restrict its compounding when commercial options are available.
  • The FDA assesses drugs for the DDC list based on stability, bioavailability, dosage requirements, and sterility demands, all factors Novo Nordisk highlights in its case.

Q.1. What are generic drugs?

A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, colour, taste, and packaging.

Q.2. Who regulates generic drugs in India?

India’s regulatory landscape for generic drugs is governed by the Central Drugs Standard Control Organization (CDSCO), which operates under the Directorate General of Health Services, Ministry of Health and Family Welfare.

News: Why maker of ‘magic’ weightloss drug semaglutide wants copies banned