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.

What’s in Today’s Article?

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

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 issues like 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.