White House Promotes US Pharmaceutical Manufacturing to Secure Access to Essential Medicines

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After a three-month review of vulnerabilities in the U.S. supply chain for products critical to national security, the Biden government launched a broad-based initiative to encourage domestic production of critical materials, including pharmaceuticals and their ingredients. The initiative calls on the Department of Health and Human Services (HHS) to create a public-private consortium for advanced pharmaceutical manufacturing to strengthen domestic competitiveness and supply chain resilience in this area (1).

A detailed report from the White House presents strategies for avoiding supply chain disruptions in several key industrial sectors. The overall goal is to provide US manufacturers with easy access to semiconductor chips, rare earth elements, and large-capacity batteries for electric vehicles, as well as pharmaceutical ingredients (2). Such gains will strengthen America’s economic and national security and address temporary supply chain challenges. The report acknowledges that US continued reliance on key pharmaceutical products and active ingredients from overseas has been fueled by pressures to cut costs, a situation that is leaving the medical supply chain vulnerable and warranting new approaches to support domestic manufacturing.

FDA Acting Commissioner Janet Woodcock welcomed the announcement, noting that the COVID-19 pandemic had demonstrated “how vulnerable the supply chain is” and that it is “essential to the United States’ national health and safety and economic prosperity.” States “is (3). The White House report recommends actions that have long been supported by Woodcock and other FDA officials, including increasing local pharmaceutical production, research and development to advance innovative manufacturing technologies, solid maturity of quality management to support reliable drug manufacturing and usage of data to improve the resilience of the supply chain.

Initially, the HHS consortium will select 50–100 critical drugs from the list of “essential drugs” drawn up by the FDA as part of an earlier federal initiative (4, 5). The aim is to advance the development of new platform technologies for the domestic production of active ingredients, especially for widespread generics. The initiative will be able to use $ 60 million from the American Rescue Plan to drive investments in advanced manufacturing technologies, such as systems with on-demand manufacturing capabilities, to increase the production of key drugs and ingredients.

The FDA expects to play a prominent role in promoting this and other supply chain resilience initiatives, and is working with other HHS agencies to develop another plan for developing and building long-term capacity for the US-based Develop manufacturing of consumables to combat future pandemics and biological threats (6). To increase the visibility of product sources across the pharmaceutical supply chain, HHS will seek legislative powers in two areas: the ability to track API sourcing and manufacturing by facility, and the requirement that all drugs sold in the US meet the API -Identify sources and finished dosage forms on the label.

The Supply Chain Safety report recognizes that the offshore shift of drug manufacturing, especially for generic active ingredient APIs, has cut U.S. costs by trillions of dollars over the past decade, but has left the American healthcare system vulnerable to a shortage of vital Has made medicines. Change is needed as the COVID-19 pandemic has highlighted the vital importance of a resilient US healthcare sector and the country’s ability to rapidly develop and strengthen the production of vital vaccines and medical products.

References

1. The White House, “FACT SHEET: Biden Harris Administration Announces Supply Chain Disruption Task Force to Resolve Short-Term Supply Chain Disruptions”June 8, 2021. The 2nd White House, Build resilient supply chains, revitalize American manufacturing and drive broad-based growth, 100-day executive order 14017 reviews, June 2021.
3. HHS, “Biden Administration recommends policy changes to secure the US pharmaceutical supply chain“, Press release, June 8, 2021.
4. FDA, “Executive Order 13944 List of Essential Medicines, Medical Countermeasures, and Critical Inputss “, www.FDA.gov, January 1, 2021.
5. FDA, “Essential Medicines and Biological Medicines, Medical Countermeasures, and Critical Submissions for the list described in Section 3 (c) of Executive Order 13944,“Www.FDA.gov.
6. FDA, Executive Order 14017 on America’s Supply Chains, www.FDA.gov, June 8, 2021.

About the author

Jill Wechsler is BioPharm Internationals Washington editor.

Item details

Pharmaceutical technology
vol. 45, No. 7
July 2021
Pages: 14–15

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When referring to this article, please cite it as J. Wechsler, “The White House Promotes US Pharmaceutical Manufacturing To Ensure Access To Essential Medicines.” Pharmaceutical technology, 45 (7) 2021.



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