I recently attended the ISPE Annual Meeting, held October 29 through November 2, 2022 in Orlando, Florida. The conference had varied content in areas such as Digital Transformation, Manufacturing Trends, Regulatory and Quality, Supply Chain Optimization, and Therapy Innovations. The conference was well attended by both industry and regulators.
Although I found all of the sessions that I was able to attend compelling, I was particularly interested in a session that delved into drug shortages. We’ve all heard of supply chain shortages – remember trying to find toilet paper during the early stages of the COVID pandemic? Practically every day a new drug hits a shortage somewhere in the world. For example, the U.S. is currently experiencing a shortage of amoxicillin due to a surge in pediatric respiratory illness and potential supply chain issues.
The session outlined country‑specific requirements for reporting shortages or potential shortages. Over thirty countries have such requirements, meaning that when a company experiences a shortage or anticipates one, it must alert that country’s regulatory authority. These authorities then work to find solutions to resolve the shortages, including allowing import of products approved in other countries, allowing use of different dosage forms or strengths, and other options at regulatory discretion.
Valerie Jensen, Associate Director of the FDA’s Drug Shortage Staff, and Lisa Hedman, from WHO, talked about the importance of cooperation among regulators and the lessons learned during the pandemic. Of note is the role of WHO in helping to ensure that countries without purchasing power and leverage still have access to life saving medications, even in times of shortage.
It’s good to know that companies and regulators are working to minimize the impact of any shortages or potential shortages. I don’t think anyone was doing that when we all ran out of toilet paper!
If you are anticipating a shortage or have manufacturing issues that might result in shortages, contact Lachman Consultant Services at L.EvansOConnor@lachmanconsultants.com.
