PDA Letter Article

2023 PDA Quality & Regulations Conference

by Patrick Costello, AbbVie Pharmaceuticals, and Vinny Browning, Amgen (Co-Chairs)

During the pandemic, we all had to adapt; industry, supply chain and global regulators all implemented initiatives to keep medicines flowing. While we have seen the value that regulatory flexibility has brought to ensuring access to COVID-19 medicines and offset shortages, data demonstrates that miss forecasting, oversales and good practice (GxP) issues remain the main causal factor of shortages, which is an issue the industry needs to address; an issue that is impacting our patients!

2023 PDA Quality & Regulations Conference

Antwerp, Belgium

7-8 November, 2023

An example of where we have seen improvements in this space comes from the FDA. The United States (U.S.) FDA has collectively worked with the industry to better understand how to ensure drug supplies and prevent drug shortages. To do this, since 2013, the FDA has published an annual report to the U.S. Congress that describes each year’s drug shortages. This annual report summarizes the major actions the FDA has taken to prevent or help mitigate drug shortages in the United States. The FDA does this because they understand how drug shortages present a significant public health threat. Due to this, the FDA sees more manufacturers notifying the FDA earlier than in the past, allowing the FDA and the firm time to work with manufacturers and other stakeholders to identify ways to maintain treatment options and prevent a shortage. Consequently, because of the efforts in 2022, 222 drug shortages were prevented.

As a result of this important dialogue in our industry around drug shortages, the theme of this year’s 2023 PDA Europe Quality and Regulations Conference in Antwerp, Belgium November 7 – 8, will be “Building Supply Chain Resilience: A Holistic Perspective.” The conference will focus on gaining a better understanding of the industry's best practices for drug shortages, their management and building supply chain resilience. As well as obtaining a perspective on drug shortages from our regulators from the Danish Medicines Agency, the Health Product Regulatory Agency (HPRA), the FDA, the Israel Ministry of Health and more.

At the conference, we will listen to the industry's experts describe how they have approached drug shortages in a workshop-style meeting that will facilitate dialogue between regulators, industry, speakers and participants. We hope to see you there, and we look forward to continuing this important conversation to advance our industry into the future and look for ways to ensure all patients get the drugs they need!

About the Author

Patrick CostelloPatrick Costello, PhD, is the Director of Quality Assurance at AbbVie Pharmaceuticals Ireland. Costello has spent the last 22 years working in the pharmaceutical industry, initially as a regulator with the HPRA, followed by 4.5 years at the European Medicines Agency. He had varying roles at these agencies, from assessor, inspector and associated management roles. His most recent appointment with AbbVie Inc. is where he manages a team responsible for GxP reporting of significant events to global regulators, management review, quality metrics and data analytics. Costello has been on the PDA Europe Quality and Regulations Planning Committee for the last three years, Co-Chair in 2022 and again Co-Chair for our 2023 with Vinny Browning meeting.

Vinny BrowningVinny Browning, III, is Amgen in Singapore's Executive Director Quality Site Head. He has spent the last 25 years in the biotechnology industry, working on over 75 commercial and clinical products. Browning has worked across functions, from a Bench Analyst in quality control to a Site Head in Operations in Abingdon, United Kingdom, to a Global Commercial Attributes Sciences Executive in Process Development, and most recently, as the Quality Assurance Lead for two drug substance plants and site operations in Puerto Rico. Browning has been on the PDA Europe Quality and Regulations Planning Committee for the last several years, was the Co-Chair for 2021-2022 and, once again, the Co-Chair for our 2023 meeting with Costello.