By Rita Cook
WASHINGTON, D.C. – As of August 21, President Donald Trump has signed 192 Executive Orders during his second term.
Three of those orders signed this term are related to America’s pharmaceutical independence.
He also signed two additional EO’s during his first term with a nod toward pharmaceutical issues.
His most recent EO on the topic “Ensures American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve.”
Coined SAPIR the idea is to ensure the United States has the appropriate critical drug components, which means a resilient domestic supply chain for essential medicines.
The Order directs the Department of Health and Human Services to develop a list of approximately 26 critical drugs vital to national health and security. From there the task is to ready the SAPIR repository to receive and maintain the Active Pharmaceutical Ingredients (APIs) used to make these critical drugs.
The Order also focuses on the necessity of a six-month supply of these critical APIs, with a preference for obtaining domestically manufactured APIs if possible and placing them in the SAPIR.
The Order references an updated 2022 list too, which named 86 essential medicines, with a plan to obtain and store a six-month API supply for these drugs.
According to the EO only about 10% of APIs for U.S. prescription drugs are manufactured domestically, leaving the nation vulnerable to foreign supply chain disruptions.
“The Biden Administration failed to advance domestic production or fill the SAPIR, despite spending billions on supply chain initiatives,” the EO stated. “Overreliance on foreign, sometimes adversarial, nations for Key Starting Materials (the materials used to make APIs) and APIs risks shortages of essential medicines.”
The National Library of Medicine Reported in 2020 the “The U.S. capacity to manufacture key essential medications has diminished.”
The report went on to note that the extent of U.S. reliance on foreign sources of medications was largely unknown, but that pharmacists did not have a reliable way to determine the country of origin (i.e., source), capacity, or geographic location of pharmaceutical manufacturers, limiting its ability to anticipate challenges or mitigate risks to the U.S.’s drug supply.
It has been widely known for some time the dominant source for the U.S.’s generic drug and API supply is China and India. India is the major source for finished generic drugs and China is the largest supplier of essential APIs, which are the raw materials for medications.
The Atlantic Council, a nonpartisan organization that encourages US leadership and engagement in the world said in 2023 “Chinese firms have become major suppliers of US pharmaceuticals. Since 2020, US imports of Chinese pharmaceuticals have grown by 485 percent, going from $2.1B in 2020 to $10.3B in 2022.”
Georgia Representative Earl L. “Buddy” Carter said Trump’s EO is a step in advancing key priorities in the area of pharmaceutical supply.
Carter is the chair of the American-Made Medicines Caucus and directs the Office of the Assistant Secretary for Preparedness and Response (ASPR), within the Department of Health and Human Services.
“This is a win for public health and national defense,” Carter said. “With this EO, we are reducing America’s reliance on foreign, sometimes adversarial, nations, and ensuring access to affordable, American-made drugs.”
The EO stated “President Trump has consistently prioritized policies to secure America’s pharmaceutical independence and ensure access to affordable, domestically produced drugs.”
To that end the EO highlighted in 2020 he the president signed an Executive Order directing his Administration to increase domestic procurement of Essential Medicines, Medical Countermeasures, and Critical Inputs, as well as identify supply chain vulnerabilities.
That year he also created SAPIR to stockpile APIs, laying the foundation for pharmaceutical resilience.
In May of this year, Pres. Trump signed an EO to remove regulatory barriers and facilitate the restoration of a robust domestic manufacturing base for prescription drugs, including key ingredients and materials necessary to manufacture prescription drugs. A second EO signed in May was to implement most-favored-nation drug pricing to lower the prices Americans pay. He later sent letters to 17 pharmaceutical companies to encourage competitive pricing and domestic production.
Rita Cook is a world traveler and writer/editor who specializes in writing on travel, auto, crime and politics. A correspondent for Texas Metro News, she has published 11 books and has also produced low-budget films.
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