Trade, Red Tape Make U.S.-Produced Drugs a ‘Massive Undertaking’



Shira Stein and Jacquie Lee | Bloomberg Law

The Trump administration’s effort to manufacture more medical products in the U.S. will take several federal agencies, years of jumping through regulatory hoops, and hundreds of millions of dollars, lawyers, lobbyists, and policy analysts say.

Health-care providers have struggled to get the drugs or equipment they need during the pandemic because so many of those drugs are made overseas. Researchers and lawmakers have decried that foreign reliance for years, but the public outcry over equipment shortages during the Covid-19 pandemic may finally lead to lasting change, industry analysts say.

President Donald Trump has prepared an executive order to bolster domestic manufacturing of the essential drugs and devices that were in short supply during the pandemic. The administration awarded a $354 million contract to a generic drugmaker to get it to begin that process.

But to undo over 30 years of offshoring would take years and substantial political clout. Trade deals might need to be renegotiated, and manufacturers need to be convinced they can keep plants financially afloat on U.S. soil.

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