Washington, DC [09/4/2020] – This week United States Senators Tina Smith (D-Minn.) and Elizabeth Warren (D-Mass.) told President Trump that his recent Executive Order to address the nation’s overreliance on foreign nations for key drug products is far too weak, and pressed him to support their legislation, which would arm the United States with the tools needed to adequately address this serious health and national security problem.
In a letter to Trump Wednesday, the two Senators said that while his Executive Order directs several federal agencies to prioritize the procurement of adequate supplies of U.S.-produced essential medicines, it does not require those agencies to create a definitive list of essential medicines. It also fails to require drug manufacturers to produce reports that are thorough enough to help federal officials understand – and fix – the weaknesses in the nation’s drug supply chain.
The letter also raises concerns that further deregulation at the Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) – the agencies responsible for the safe manufacture of the nation’s drug supply – may threaten production of safe and effective materials.
“Absent these meaningful actions, your Executive Order will not help address this legitimate national security and public health problem. We ask that you work with us and with other members of Congress on a bipartisan basis to pass legislation to help rectify the failures of your Executive Order and address the public health and national security risks posed by our overreliance on foreign drug producers,” wrote the Senators.
The Senators’ U.S. Pharmaceutical Supply Chain Defense and Enhancement Act would take a series of comprehensive steps that the Executive Order fails to put in place, like requiring the Biomedical Advanced Research and Development Authority to issue contracts to U.S.-based companies to promote the development of pharmaceutical products domestically, authorizing additional funds for agencies to procure domestically produced drugs and key starting materials, leveraging the federal government’s buying power to create a robust and sustainable market, and increasing transparency in the pharmaceutical supply chain by closing reporting requirement loopholes and providing additional resources to federal agencies.
Last year, a bipartisan congressional commission released a report highlighting the United States’ heavy reliance on imports of the essential medicines (and their ingredients) and detailing the potential national security and public health concerns it poses. The commission estimated that the United States imports 80 percent of the active pharmaceutical ingredients (APIs), the raw chemical components of drugs that are required to manufacture pharmaceutical products, used in domestic production of generic drugs and warned of the dangers of this overreliance.
Sens. Smith and Warren also asked President Trump to provide specific steps his Administration will take to end the country’s overreliance on foreign pharmaceutical products and urged him to work with them and other members of Congress on a bipartisan basis to pass legislation to help rectify the failures of his Executive Order and address the public health and national security risks posed by our overreliance on foreign drug producers.