Concerning new reports reveal that the drug shortage in the U.S. has reached its highest level since the American Society of Health-System Pharmacists began tracking data. In total, 323 medicines are now in short supply.
However, the problem is about to get worse because of government regulations on an entirely different issue. Counterintuitive measures from the Environmental Protection Agency (EPA) are set to effectively ban the domestic production of chemicals that are used in the process of manufacturing vital prescription drugs and vaccines.
Shortly after Congress amended the Toxic Substances Control Act (TSCA) in 2016, the EPA began the rulemaking process on 10 chemicals currently in use in the United States using a broad and overreaching definition of “unreasonable risk.” Now, the EPA is expected to release a final rule on methylene chloride under TSCA.
Methylene chloride has several applications, including in the process of manufacturing hundreds of medicines and vaccines like those that treat Hepatitis B and HIV infections, mental illnesses and epilepsy, heart failure and high blood pressure, and high cholesterol.
If this rule goes into effect, it will exacerbate the drug shortage by bringing domestic manufacturing to a halt while making our supply chains more reliant on foreign nations like China for pharmaceuticals. This runs in direct contradiction to the Biden administration’s “Investing in America” agenda, which aims to onshore supply chains critical to our economy and security.
For example, methylene chloride is used to make hollow fiber cartridges which are used in the manufacture of monoclonal antibodies and vaccines, including the COVID-19, HPV, Hepatitis B, and flu vaccines, as well as therapies for arthritis, migraines, osteoporosis, and autoimmune diseases. In a letter to the EPA, the company that produces these cartridges wrote their product is used in at least 190 human therapeutics and vaccines. Their supply is so essential that the U.S. Department of Health and Human Services and the Defense Department awarded the company funding to expand its manufacturing capacity here in the U.S.
The biggest winner with this new EPA rule will be China, which has grown to be the largestchemical producer in the world and the top exporter of methylene chloride.
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