WASHINGTON—President Donald Trump signed an executive order on Aug. 13 to enhance American drug supply chain resilience by filling and maintaining the strategic reserve for essential pharmaceutical ingredients, with a preference for American-made ingredients—a move designed to push production away from dependency on China-made ingredients.
“Nearly two-in-five prescription finished drug products are made in the United States, including many of the essential medicines,” the president’s executive order stated. “However, when it comes to Active Pharmaceutical Ingredients (APIs), the biologically active components of finished drug products, only about 10 percent of the APIs by volume for the finished drug products used in the United States are made here.”
Trump ordered the rapid restocking of the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR), a program he created in his first term to stockpile APIs. He criticized the Biden administration for leaving the reserve nearly empty.
Under the new order, the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the Department of Health and Human Services has 30 days to identify what is estimated to be roughly 26 drugs considered critical to the nation’s health and security.
Within 120 days, the agency must prepare the existing Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) to begin receiving and storing these APIs.
The ASPR is directed to secure a six-month supply of the ingredients needed to produce critical drugs, prioritizing domestically manufactured sources, if possible.
The plan also includes a proposal and cost estimate for opening a second strategic reserve site within one year.
“Stockpiling APIs is advantageous as APIs are generally lower-cost and have longer shelf lives than the finished drug products they make,” according to the executive order. “Filling the SAPIR will also insulate the United States from the concentration of foreign, sometimes adversary, nations in the world-wide supply of the Key Starting Materials used to make APIs.”
The president’s order aims to encourage more domestic production of APIs.
‘Catastrophic Failure’
The U.S. generic drug supply chain still heavily relies on global production, with a significant portion of ingredients and raw materials sourced from China.
The pharmaceutical supply chain often involves a tiered production process, where core ingredients, known in the industry as key starting materials (KSMs), are produced in China and then transferred to countries such as India for the production of APIs. China is also the dominant producer of APIs. Some good-quality drugs and APIs are also produced in Ireland. Then, the finished product is sold to the United States.
After years of offshoring production to China and other countries, the United States lost the ability to produce many life-saving drugs, creating a national security threat, according to Rosemary Gibson, co-author of “China RX: Exposing the Risks of America’s Dependence on China for Medicine.”
“We have a system that is perfectly designed for catastrophic failure and significant loss of human life, and that has to change,” she told Jan Jekielek, host of Epoch TV’s “American Thought Leaders” in a May interview.
Gibson estimates that the United States relies on China for 95 percent of the core ingredients needed for generic drugs.
On April 1, the Trump administration launched what’s known as a Section 232 investigation to determine the national security implications of imports of pharmaceuticals and their ingredients.
On Aug. 5, the president told CNBC’s Squawk Box he will announce new tariffs on imported pharmaceuticals “within the next week or so,” with rates that could eventually climb to 250 percent.
Reprinted with permission from The Epoch Times by Emel Akan.
The opinions expressed by columnists are their own and do not necessarily represent the views of AMAC or AMAC Action.
start building new pharma plants in the U. S.
Trump’s plans will not only make us less vulnerable to the machinations of the CCP but also pave the way for more jobs in this country for our citizens!
Needed
Didn’t Biden and his corupt cronies also drain the strategic oil reserves? Sold them to China, correct?
Let’s start doing alot more stuff in the states and not be dependent on China or any other country!!
This should never have been allowed in the first place. How stupid does a person have to be to know that we need to produce our own medications? This is ridiculous. As a retired nurse, I cannot believe that the government and Big Pharma allowed this to happen.
How many of those Active Pharmaceutical Ingredients produced in China contain some type of poison or other ingredients not meant for human consumption? Honest question.
The key to this is rotation. All drugs have an expiration date. And where as most drugs can be effective after this date their potency is on the decline. So to keep from being wasteful we need to rotate these drugs with new drugs with a plan to use the old drugs before they expire. But it’s not as simple as it sounds. At some super secret locations this is dealt with effectively, and at some they’re not. Who’s in charge of these drugs and do they have a plan other that letting them set in a warehouse and expire. Then replacing them with new drugs and letting them set in a warehouse and expire….
Good, great, spend a billion to save a million, awesome……..rah, rah, rah,
NOW, where are those Epstein Files Donnie? Folks are calling you a pedophile, why don’t you prove them wrong?
They are wrong, right?