T.The Covid-19 pandemic has exposed serious flaws in the US medical supply chain. Excessive reliance on imported goods. Reinvigorating our domestic supply chains is an important step in protecting the health of Americans and our national security.
At the height of the Covid-19 pandemic, supply chain disruptions and export restrictions made it difficult, if not impossible, for hospitals to import critical materials ranging from N95 masks to life-saving drugs. China accounted for more than 85% of all US personal protective equipment (PPE) imports at the time — including N-95 and other disposable and non-disposable face masks, surgical drapes and surgical towels — Reducing PPE exports and vital supplies from markets around the world.
In the first year of the pandemic, 29 out of 40 critical drugs to treat Covid-19 patients were in short supply. A combination of factory closures, shipment delays and a dramatic increase in global demand for Covid-19 remedies has created a rapid shortage of essential medicines. Today, the Food and Drug Administration reports that more than 120 medicines are in short supply in the United States. This is about three times the pre-pandemic level.
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To better prepare the U.S. healthcare system for future pandemics, the Centers for Medicare and Medicaid Services recently finalized a proposed rule that would provide financial assistance to hospitals purchasing domestically produced N95 masks. That’s a step in the right direction. This will drive his PPE manufacturing domestically and cut off supplies for hospitals from abroad. This bottom-up approach is essential as the United States strives to increase domestic manufacturing capacity.
But the government should step up this initial effort by encouraging domestic production of more complex medical supplies such as medicines, ventilators and other life-saving devices.
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Pharmaceuticals are the logical central point of this work. The United States has long offshored too many of the essential medicines it needs. Strengthening American-made drug production supports high-paying jobs and protects the country from future supply chain disruptions, whether caused by pandemics, wars, or other unforeseen crises. This is the intent of the American Drug Act (S. 3991 and HR 7400) introduced into Congress earlier this year.
There is an alarming number of medicines in short supply these days. Antibiotics are 42% more likely to be in short supply in the United States than other types of drugs, according to a United States Pharmacopoeia analysis. The shortage of Adderall is so severe that many ADHD patients cannot fill their prescriptions. Last year, the decades-old chemotherapy drug fludarabine sold wholesale for $110. But now, due to shortages, prices have risen to $2,736.
A key factor driving these shortages and rising prices is our reliance on foreign manufacturing, which is overly dependent on facilities in China and India. According to Yanzhong Huang, senior fellow for global health at the Council on Foreign Relations, in early 2020, before the Covid-19 pandemic hit, Chinese pharmaceutical companies were selling US antibiotics, ibuprofen and hydrocortisone. was serving more than 90% of him. Acetaminophen and heparin.
Covid-19 has sounded alarm bells for American manufacturing, revealing a heavy reliance on imports for critical supplies ranging from semiconductors to life-saving medicines and medical devices. In light of the supply chain shock caused by Russia’s invasion of Ukraine and the looming specter of additional regional conflicts, it is imperative that the United States quickly onshore the manufacturing of as much of its medicines and supplies as possible.
This effort must be made across the pharmaceutical value chain, from easy-to-manufacture generics to complex biologics. One way the U.S. can protect itself from shocks in the pharmaceutical supply chain and boost domestic production is by supporting U.S. biosimilar manufacturers. Similar to generic versions of brand-name small molecule drugs, biosimilars are clinically relevant in their function as reference biologics such as insulin, hormones, and various drugs to treat cancer. There is no difference.
Biologics are very expensive to manufacture. On average, biosimilars cost 27% less to manufacture than brand-name reference biologics, helping to reduce costs for both patients and manufacturers. The RAND Corporation estimates that biosimilars could drive the cost of biologics used to treat serious diseases such as cancer and rheumatoid arthritis down to $38.4 billion from 2021 to 2025. I’m here.
The FDA has approved 39 biosimilar drugs — compared to 73 approved by the European Union — but only about a dozen are currently being produced in the United States. Providing support for hospital purchases of domestically produced biosimilars and other medicines will greatly spur further US-based manufacturing. Tax incentives to develop biosimilar manufacturing capacity are another approach Congress could take to encourage companies to develop and produce drugs here.
Another option is to expand use of the Strategic National Stockpile, America’s emergency cache of antibiotics, vaccines, chemical antidotes, antitoxins, PPE, and other critical medical supplies. Providing tax incentives to U.S. biosimilar manufacturers, provided they sell some of their biosimilars to the stockpile, ensuring a steady emergency supply of life-saving medicines and helping U.S. businesses Employment can be supported.
The American Made Pharmaceuticals Act gives Congress an opportunity for mission-critical bipartisan victories. Domestic manufacturing of medical supplies must be made a key priority, and we should look to pharmaceutical companies as leaders in that cause. By passing this law and boosting domestic production of biosimilars, other drugs, and other medical supplies, the United States will create high-paying jobs for its citizens and protect against future supply shocks from pandemics or war. , can reduce the cost of living. Save medical supplies for Americans.
Tony Paquin is President and CEO of iRemedy Healthcare. David Sanders is Vice President of Government Affairs and Policy at Coherus BioSciences and Executive Director of the Securing America’s Medicine and Supply Coalition. Members of this coalition include AmerisourceBergen, Amneal Pharmaceuticals, and Coherus BioSciences (all of whom manufacture biosimilars) and other pharmaceutical and medical companies. supply manufacturer. Both authors are on the board of directors of the federation.
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