Recent reports from the United States Food and Drug Administration (FDA) have shown that only 28% of manufacturing for active pharmaceutical ingredients occurs within the nation. While international collaboration on commerce and health are not uncommon, the recent COVID-19 coronavirus pandemic has introduced concerns on whether the country should remain reliant on external supply chains.
United States Senator Chris Coons even stated that domestic medical manufacturing should become the new focus as global supplies become scarce amid the virus. He also emphasized the importance of a federal office for pandemic preparation. What exactly is the situation for domestic production of pharmaceuticals, and what changes should be made?
In the past, American medicines were produced domestically, but manufacturing has recently shifted to other countries. The FDA has measured about a 10% decrease from 2013 to 2019 in domestic facilities according to a study by Boston University and the Massachusetts Institute of Technology.
For instance, Abbott Laboratories, a company that operated from the 90s to the 2000s, had shut down several plants within the nation to outsource the labor elsewhere.
Reasons for this general trend include different tax policies, cheaper labor, or lower environmental laws. Many medical businesses have merged and purchased other companies as well, contributing to the move.
COVID-19 presents a significant issue with global supply chains, pharmaceutical ones included. The need for social distancing can interrupt work schedules, and the increased demand for supplies can cut into inventory.
Most important, there’s a chance that exports may require restriction or even a complete stall. In these cases, it will be difficult to obtain the medication and supplies necessary to fight the virus.
Experts agree that moving manufacturing back to American soil will be expensive and time-consuming. Figures have ranged into the billions of dollars and usually involve a couple decades at least.
Additionally, there are genuine reasons to have overseas manufacturing in some cases. During pandemics, a company can shift its operations from one nation to another in case infections plague one facility.
The government-led Biomedical Advanced Research and Development Authority (BARDA) may spearhead new developments and vaccines for COVID-19. Congress allocated $3.5 billion toward the organization earlier this year, a significant increase from previous fundings.
Among its activities are projects to fund research into experimental products and building domestic networks of production facilities. It also focuses on contributing to the National Pharmaceutical Stockpile, the United States’ national inventory of essential medical supplies, antibiotics, and vaccines.
BARDA has begun supporting Johnson & Johnson and Moderna in their efforts to not only develop a vaccine but also scale up manufacturing to accommodate the millions of doses necessary.
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