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Drug Shortages: Looking Forward with Regulator Insight

ISPE Drug Shortages Initiative Core Team
Drug Shortages: Looking Forward with Regulator Insight

During 2020, the pressure points of the COVID-19 pandemic challenged us to broaden our thinking and change our practices. Adjustments were made at a global scale and more people were immersed in the experience of dealing with a crisis than ever before. This generated a spotlight on pharmaceutical supply chain practices. Patients and regulators were increasingly asking: what are best practices for business continuity planning to prevent drug shortages? what do companies do to prepare for these events to ensure continued supply?

As the pandemic evolved, introduction and supply of therapies and vaccines for COVID-19 were not the only products which required careful attention. It has been and continues to be critical to ensure uninterrupted supply for all essential drug products that address serious medical conditions and support emergency health care. With this increased intensity on ensuring continuous supply, questions emerged about how to do this best and excellent discussions were held to reflect on how we can do better. Two ISPE forums underscored elements of these important topics from the regulatory perspective and included additional context and discussions from industry experts: one held during the 2020 ISPE Europe Annual Conference, with representation from several health authorities (AEMPS, AIFA, ANSM, MHRA, USFDA, and WHO), and others during the 2020 ISPE Annual Meeting & Expo with representation from FDA.

In both events, regulators emphasized the importance of health authority engagement and business continuity planning for prevention or mitigation of drug shortage events. Their comments suggested we could do more as an industry. Engagement, or increased engagement, with health authorities to prevent shortages should be considered by companies because their comments reflect potential openness to benefit/risk analysis for difficult supply challenges. This engagement may increase opportunities for health authority assistance for situations when appropriate regulatory actions could be made to prevent a drug shortage. Additional insight into good health authority engagement practices may be found in the ISPE article on this topic

The importance of business continuity planning for preventing drug shortages was equally a focus in these meeting forums. There was lively discussion on how we can continue this journey and some reflection on the developing requirements in certain markets to increase risk management practices. While improving upon practices for business continuity planning will strengthen any supply chain, expansion of requirements in this area should be carefully evaluated, as illustrated by a statement made by Gustavo Mendes Lima Santos, General Manager of Medicines and Biological Products, ANVISA,. He shared, “When everything is a priority, nothing is a priority.” Additional dialogue between industry and regulators to establish a balance between the investment in preventive measures and patient needs will help us develop best practices for business continuity planning that deliver the greatest benefit. Learn more on the multifaceted topic of business continuity planning for preventing drug shortages. 

During the 2020 ISPE Europe Annual Conference regulator panel discussion on drug shortages, thoughts were shared regarding challenges related to differing health authority definitions or lists for “essential” or “critical” medicines. Any harmonization of these definitions or lists presents an opportunity to focus business continuity planning practices because it is unsustainable to have a backup for every resource, activity, and component required for pharmaceutical manufacturing. Therefore, it was encouraging to see a constructive discussion with regulators on the potential issues and observe their interest in continuing the conversation. The interest in this potential future activity is a positive sign, given that national and regional health authorities are naturally focused on local challenges during the pandemic.

If we can capture the benefits of the learnings from the unprecedented events of 2020, we may be able to significantly improve the strength of our supply chains when we return to more “normal” conditions. Based on the output of the constructive and thought-provoking discussions with regulators in the second half of 2020, the ISPE Drug Shortage Initiative Team is looking to further advance progress for business continuity planning practices and health authority engagement in 2021. For more regulator input into these important and challenging topics, please continue to follow the ISPE Drug Shortages Initiative. If you would like to contribute to the work of this team, please contact us at regulatory@ispe.org.

Disclaimer

This is brief and informal synopsis of discussion among regulators from various countries and regulatory and other organizations during a panel dialogue at the 2020 ISPE Europe Annual Conference and 2020 ISPE Annual Meeting & Expo. It has not been vetted by any agency or regulator and does not represent official guidance or policy of the regulatory agencies and organizations cited in this article.


ISPE Drug Shortages Initiative Core Team

Diane L. Hustead
Director, Regulatory Affairs
Merck & Co., Inc.
Chair
James Canterbury
Principal, Consulting
Ernst & Young LLP
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Dawn Culp
VP Regulatory Affairs
Hikma
Nasir Egal
Vice President, Global Quality
Sanofi
Ylva Ek
Chief Quality Officer (CQO)
KeyPlants AB
Melissa Figgins
Executive Director
Quality Executive Partners
Erin Fox, Pharm D
Senior Director, Drug Information & Support Services
University of Utah Health
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Karen Hirshfield, RPh
Director, Enterprise Regulatory Compliance
Johnson & Johnson
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Drishya Nair
LifeSciences Advisory Consultant
Ernst & Young
Terrance Ocheltree, PhD, RPh
Head Regulatory and Quality Assurance
Corium International Mfg Group
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Mukul Shukla
Managing Director
EY
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Deborah Tolomeo, PhD, JD
External Collaborations
Genentech Inc
Sumanth Venugopal
Partner
PricewaterhouseCoopers LLP