Utilizing an executive order to launch a National Biotechnology and Biomanufacturing Initiative, the Biden Administration aims to “drive biomedical innovation that supports the health of all Americans.” This move by the White House not only recognizes the importance of the biotech industry but will put in place a strong framework to promote domestic biomanufacturing products. This is just the news that the industry, across the country and in New York, need.
Despite having one of the most complex and innovative biotech industries in the world, where research and development thrive, much of the manufacturing of these discoveries has moved overseas. This not only has left the United States vulnerable to supply-chain issues as witnessed during the Covid pandemic, but emboldened countries like China to fill the void and leverage that power over our country. Moving back to more domestic production and support of the biotech industry will be crucial to the economic success of the United States in decades to come.
While the Biden move is an excellent first step, there”™s more to do. Congress needs to act before the end of the year to pass legislation that will solidify this commitment to retaining America”™s status as the world”™s biotech leader. The MADE (Manufacturing API, Drugs, and Excipients) in America Act (H.R. 3927/S. 2082) will bring much needed legislative incentives to the biopharmaceutical sector. It will help eliminate some of the risk that pharma companies are forced to deal with as part of their business model and help move innovations forward at a more rapid pace. Covid highlighted many of these issues, including issues with API ”” active pharmaceutical ingredients ”” the main ingredient in a pharmaceutical treatment that makes it effective for treating a medical issue. The MADE Act contains several common-sense strategies contained in this legislation to achieve these goals, These include changes to federal Food and Drug Administration protocols that will allow for advanced review of manufacturing technologies before being applied to a specific medication.
Additionally, the bill would require the FDA”™s Drug Shortages team to coordinate with FDA and manufacturers to resolve potential manufacturing risks before a shortage were to impact patients. The legislation also will have the FDA streamline the inspection processes with other countries to eliminate redundancies and red tape.
This all simply makes sense. As our world continues to evolve, the U.S. needs to remain the dominant leader in prescription drug research, development and manufacturing.
Reliance on other nations is simply not sustainable and puts our country at risk for shortages far worse than we experienced during the pandemic and months that followed. I urge our New York congressional delegation to get behind this bipartisan legislation, and for Congress to work swiftly to pass this into law.
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