Essential Drug Shortages and the FDA

by | Jul 7, 2021 | COVID-19, FDA, GMP, Medicine, MedTech, Pharmaceuticals, Regulatory

Patients who rely on a consistent supply of needed medication to sustain a normal life, such as insulin or heparin are significantly affected when shortages are experienced. Although patient health is the number one priority, a published 2019 study concluded that drug shortages are predominately accompanied by adverse economic, clinical, and humanistic outcomes to patients3. Stemming from drug shortages, patients and their families must shoulder the burden of financial obligations to receive medication. At the same time, these patients must fight through new challenges brought on by changes to clinical operations that were once consistently utilized. Since the peak of 250 new drug shortages in 2011, the FDA has been able to regularly maintain an average of just below 50 new drug shortages year after year since 2013, with a total of just 43 in 20202.

In 2020, new drug shortages in the US have decreased due to the FDA’s use of enforcement discretion1. This led to a consistent supply of critical medical products throughout the entire COVID-19 pandemic. The FDA recently published Drug Shortages for Calendar Year 2020, to summarize the agencies’ actions in helping reduce or eliminate drug shortages during the challenging year in public health. When the FDA claims they “leveraged all its regulatory tools” to increase patient access to critically needed medications, what do they mean? The Center for Drug Evaluation and Research (CDER), a division of the FDA, was responsible for practically every vital decision2. Specifically, they fast-tracked reviews for over 100 original Abbreviated New Drug Applications (ANDA) for treating patients with COVID-19, along with ramping up assessments of 150+ ANDA supplements to streamline manufacturing capacity for COVID-19 therapeutic biologics. Additionally, CDER utilized regulatory flexibility and appropriate discretion in 45 cases to increase supplies of heparin, albuterol, etomidate, midazolam, propofol, and more for the proper treatment of patients with COVID-19. Furthermore, the FDA with help from their CDER division issued six guidance documents regarding temporary enforcement discretion for the compounding of drugs required to treat hospitalized COVID-19 patients2.

Although the FDA made necessary actions resulting in a sufficient supply of critical medication during a world health crisis, they claim in the report, “ongoing work is needed to gain better insight into the supply chain”1. The pandemic sparked instantaneous adjustments and invaluable learning opportunities to carry out optimal methods to minimize drug shortages, which the FDA is keenly aware of as time moves forward. Published reports from the FDA such as the Drug Shortages for Calendar Year 2020 give insurmountable insight into the trend of regulatory bodies. At EMMA International, a major focus is to remain up-to-date with FDA standards so that every client receives current guidance on all relevant quality and regulatory needs. Make sure to give us a call at 248-987-4497 or email us at info@emmainternational.com to learn more about how EMMA International can take the stress out of quality and regulatory compliance!

  1. FDA (2021) Drug Shortages for Calendar Year 2020. Retrieved on 7 July 2021 from: https://www.fda.gov/media/150409/download
  2. Joanne S. Eglovitch (2021) FDA focuses efforts made to avert drug shortages in 2020. Retrieved on 7 July 2021 from: https://www.raps.org/news-and-articles/news-articles/2021/6/fda-focuses-on-efforts-made-to-avert-drug-shortage?utm_source=MagnetMail&utm_medium=Email%20&utm_campaign=RF%20Today%20%7C%2030%20June%202021
  3. PLoS One (2019) The impacts of medication shortages on patient outcome: A scoping review. Retrieved on 7 July 2021 from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6499468/

Zach Nies

Zach Nies

Quality Engineer (Co-Op) - Mr. Nies has experience in combination products, pharmaceuticals, and FDA compliance for many life science industries. He has experience with many different elements of quality and regulatory compliance. Mr. Nies is completing a Bachelor of Engineer degree in Biomedical Engineering from Wayne State University.

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