FDA can better monitor quality production of domestic versus foreign firms. Ongoing shortages of critical medicines, many linked to supply chain disruptions due to the COVID-19 pandemic, continue to generate calls to shift production of drugs and pharmaceutical ingredients from foreign nations to the United States. The globalization of the biopharmaceutical industry during the past 30 years has encouraged production of drugs, particularly generic medicines and APIs, in regions offering cheap labor and less restrictive environmental and other regulations. Now the White House and some members of Congress look to “on shore” drug production to better ensure reliable access to vital medicines now produced overseas. An example of how the Trump Administration’s “Buy American” campaign could apply to pharmaceuticals is the announcement on May 19, 2020 of an initial $354 million, four-year award to Phlow Corp. by the Biomedical Advanced Research and Development Authority (BARDA) to boost US production for both the ingredients and finished dosage forms of certain drugs experiencing supply shortages (1). Peter Navarro, director of the White House Office of Trade and Manufacturing Policy, made clear that a prime objective is to reduce US reliance on foreign manufacturing and supply chains for “our most important medicines and active pharmaceutical ingredients,” to avoid placing “Americans’ health, safety, and national security at grave risk” (2). A main question about the BARDA award, which can rise to $801 million over 10 years, is whether the investment can ensure access to high-quality, made-in-the-USA drugs at affordable prices without the large government subsidy. It’s well documented how production of APIs and generic drugs moved to India and China and other regions in the 1980s to reduce costs. One result has been ongoing product shortages, many related to quality manufacturing issues, as firms at home and abroad delayed improvements and modernization of facilities and accepted ingredients with limited quality assurance…

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• Manufacturing

• Pharmaceutical Technology

• 7/1/2020

• Article