The Trump administration has made a sizable effort to increase domestic manufacturing of medicines. While FDA inspections are critical for patient safety, the time it takes to inspect and approve new facilities has been sped up. It is puzzling, then, that ingredients entering the U.S. from China and India, without inspection by the Food and Drug Administration.
Compounded drugs are allowed when there is a legitimate shortage or when a patient cannot take the regular FDA-approved medicine, such as they cant swallow a pill so a syrup is made for them in the pharmacy.
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GLP-1s, the popular medication for people with obesity, were briefly in short supply due to a high degree of demand when they were first approved for use. Online pharmacies offering compounded medicines stepped in, often using deceptive advertising, to grab millions of consumers. They also used ingredients from un-inspected Chinese and Indian facilities that would never be allowed for a legitimate drug company.
Due to the billions of dollars invested by FDA-approved U.S. manufacturers in legitimate GLP-1 drugs, the GLP-1 shortage is now over. But still, the FDA is allowing hundreds of thousands of people to continue to take unapproved, un-inspected compounded medicines produced in countries where the manufacturing facilities are not held to the same standard as those in the U.S.
People taking these compounded medicines often dont know where they come from, or that the FDA has raised safety concerns about them albeit without acting to block them. The FDA clearly has the power to block un-inspected imports, but it chooses to let foreign companies flood the U.S. market with questionable and often impure ingredients, putting American manufacturing facilities at a disadvantage and patients at risk.
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The U.S. is a world leader in complex manufacturing, including medicines. Branded medicines are the newer drugs that are often used for complex, life-altering diseases such as cancer or neurological conditions, so quality is paramount. Americas reliable and efficient manufacturing facilities produce more than half of all branded medicines used in the country. But this leadership is at risk.
U.S. facilities face a higher degree of regulation and inspection relative to manufacturers in China or India, and workers are paid far less, so their production costs are lower. The FDA allows these foreign-manufactured GLP-1 drug ingredients into the U.S., helping foreign manufacturers dominate in the U.S. market.
Manufacturing capacity in the U.S. is increasing, with companies spending billions on capacity. When drugs are manufactured in the U.S. the drug companies that invested millions in clinical trials and getting the drug approved can have greater confidence that the medicines will be produced safely, reliability and with purity. Biopharmaceutical companies have recently announced $158 billion in new investments to build manufacturing capacity in the U.S., including in Florida.
If the U.S. continues to allow foreign, unapproved, and un-inspected drug ingredients into the U.S., the effort to retain and expand U.S. leadership in the manufacturing of complex medicines will be a waste. Drug companies wont invest in developing drugs and producing them safely in the U.S. if they have to compete with foreign, unregulated manufacturers who have invested nothing in drug development.
The U.S. government already has the legal authority to block ingredients from entering the country. It is time to stop giving a handout to China and India and make the effort to support American manufacturers by blocking illegal imports of medicines.
About the author:
Tom Gaitens is the former State Director of FreedomWorks and a longtime Government Affairs consultant. Regular contributor to the Ed Dean Show on WBOB on Public Affairs and Government Policy.
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