June 13, 2024
Chain Disruptions Anticipated

Supply Chain Disruptions Anticipated if FDA Removes Ineffective Decongestant

A recent study conducted by researchers from the University of Pittsburgh School of Medicine has revealed that phenylephrine continues to be the most widely purchased nasal decongestant, despite concerns over its lack of effectiveness. The findings, published in JAMA, indicate that there may be significant disruptions in the supply chain if the Food and Drug Administration (FDA) decides to remove oral phenylephrine from the market, as suggested by an FDA advisory panel in 2023.

The researchers analyzed the purchasing patterns of phenylephrine and pseudoephedrine—the only two FDA-approved nasal decongestants—by major retail outlets and pharmacies. Between 2012 and 2021, American pharmacies bought 19.8 billion units of phenylephrine products, compared to 13.2 billion units of pseudoephedrine products.

Interestingly, pseudoephedrine is typically sold as a standalone product, while phenylephrine is often combined with other drugs and packaged as multi-symptom products. If the FDA proceeds with the advisory panel’s recommendation, the majority of multi-symptom products will be removed from the market, leaving few pseudoephedrine-based alternatives available.

Lead author Timothy Anderson, M.D., M.A.S., emphasized the need for ongoing reforms in the over-the-counter drug review process. Anderson, who is a primary care physician, health services researcher, and assistant professor of medicine at Pitt, stated that the FDA should hold over-the-counter drugs to the same standard of effectiveness as prescription drugs. He also highlighted the importance of establishing a comparable pathway for monitoring the risks and efficacy of over-the-counter drugs, similar to the post-approval monitoring process for prescription drugs. However, Anderson noted that this would require a substantial investment in infrastructure to expand capacity.

The study’s other authors included Katie J. Suda, Pharm.D., M.S., and Walid F. Gellad, M.D., M.P.H., both from Pitt, as well as Mina Tadrous, Pharm.D., Ph.D., from the University of Toronto.

This study sheds light on the potential consequences of removing a popular but ineffective nasal decongestant from the market. With millions of units of phenylephrine products being purchased each year, any disruptions in the supply chain could impact both consumers and healthcare providers. As the FDA considers the advisory panel’s recommendation, careful consideration must be given to mitigating the challenges associated with supply chain disruptions and ensuring that effective alternatives are available to meet the needs of those who rely on nasal decongestants. Continued research and reforms in the over-the-counter drug review process will be essential in achieving these goals and maintaining the availability of safe and effective products.

1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it