Did you know that biopharmaceutical manufacturers must begin setting up the manufacturing supply chain for a medicine years before that medicine is even approved for use by patients? That’s a fact that is frequently overlooked by policymakers who are proposing drastic, mandated changes to pharmaceutical supply chains. Changes made to any supply chain require careful consideration and planning, as well as substantial engagement with FDA to obtain regulatory review and approval.
Fact: Building a new biopharmaceutical manufacturing facility can take 5 to 10 years, on average, before it is operational and can cost as much as $2 billion.
Biopharmaceutical manufacturers are committed to ensuring a safe, stable and secure supply chain, which requires a significant investment in time and resources to make sure that patients receive safe and effective medicines when they need them. As the R&D process progresses and researchers get closer to a potential successful treatment, companies must build the capacity to safely and efficiently manufacture sufficient quantities of that medicine for patients needing treatment, as well as developing plans for getting those medicines to patients. This includes, for example, contracting with various suppliers to ensure high-quality, reliable sourcing of certain materials used, ensuring the availability of the highly skilled labor force with the ability to manufacture the medicine, and maintaining the critical quality control and testing systems needed to protect patients.
At the same time, manufacturers have complex systems in place to avoid major disruptions in the supply chain. For example, they make sure they have back-up suppliers and facilities in different parts of the world in case of a natural disaster or emergency. That way if one facility experiences issues, another facility can quickly help out and prevent any major or long-term disruptions in the supply chain.
Over decades, biopharmaceutical manufacturers have carefully built these robust global supply chains to ensure patients in the United States and around the world have ongoing access to medicines. Biopharmaceutical companies invest significantly in the design and ongoing maintenance and modernization of manufacturing facilities and their quality systems, and these efforts have been successful in avoiding any major disruptions due to the COVID-19 pandemic.
We should continue to look for ways to encourage more manufacturing in the United States, but we must also recognize the complexities and potential disruptions of undermining carefully established and functioning manufacturing supply chains.
Nicole Longo Nicole is director of public affairs at PhRMA focusing on Medicare, 340B, importation and more. She previously worked for a D.C.-based public affairs firm where she assisted a wide range of clients with communications efforts on everything from trade policy to agriculture policy to health care policy. Outside the office, Nicole can be found trying new restaurants (usually Italian), taking an occasional barre class and cheering on the Cincinnati Bengals.