U.S. Efforts to Bring Generic Drug Manufacturing Home Ramp Up. Will It Work?

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<p>The Trump administration is seeking information from drug companies about their ability to support domestic production of critical generic drugs that are currently largely sourced overseas, amid concerns about drug shortages and national security.</p>
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<p>Reliance on foreign manufacturers for medicines Americans depend on every day has come under greater scrutiny as the COVID-19 pandemic and ongoing geopolitical conflicts have exposed vulnerabilities in the pharmaceutical supply chain.</p>
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<p>On September 25, the Office of Management and Budget (OMB), a White House office that oversees federal spending, published a <a href="https://www.federalregister.gov/documents/2026/09/25/2026-19646/request-for-information-domestic-and-near-shore-manufacturing-of-essential-medicines-on-the-aspr-86">request for information</a> seeking market research on domestic and near-shore manufacturing capacity for 86 essential medicines, mostly generics. </p>
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<p>The administration says it aims to secure production of those drugs and their ingredients within 18 months.</p>
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<p>Drug manufacturers can participate voluntarily, and the request does not commit the government to action. OMB also wants the same information on domestic and near-shore production of the antibiotics amoxicillin and <a href="https://medshadow.org/conditions-treatments/antibiotics/the-unsettling-truth-about-ciprofloxacin-a-wonder-drugs-darker-side/">ciprofloxacin</a>, citing potential supply chain vulnerabilities.</p>
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<p>"There is a reason manufacturing has been moving overseas, and most of it is cost," said <a href="https://pharmacyservices.utah.edu/residency/drug-info-staff">Erin Fox, PharmD</a>, associate chief pharmacy officer at University of Utah Health and a national expert on drug shortages.</p>
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<p>That cost difference matters especially for <a href="https://medshadow.org/investigating-generics/investigating-generics-americas-overlooked-drug-crisis/">generic drugs</a>, which are sold at a fraction of the price of their brand-name counterparts and operate on thin profit margins.</p>
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<p>Under its request for information, the OMB is asking manufacturers in the pharmaceutical, chemical, and petrochemical industries about unused manufacturing capacity that could be brought online, as well as planned new capacity, at domestic or near-shore sites. The agency is seeking information on facilities that can produce finished doses, active ingredients, or starting materials for the 86 medicines that federal reviews have deemed essential. The OMB says responses may inform federal contracting and potential financial assistance, and is excluding companies controlled by China, Russia, Iran, or North Korea. </p>
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<p>Responses from manufacturers are due October 26. </p>
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<p>"This is a voluntary exercise. I'm not convinced generic suppliers will respond to this," Dr. Fox said. "I am fascinated to see if they get any answers."</p>
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<p>The Association for Accessible Medicines (AAM), an industry group that represents generic drug manufacturers and bulk ingredient suppliers, has <a href="https://accessiblemeds.org/resources/blog/quickest-route-us-essential-medicines-production-existing-and-idle-production-sites/">previously supported</a> reopening idle production facilities. It cites a 2022 survey by Anthony Sardella, an adjunct lecturer at Washington University in St. Louis's Olin Business School, which found that nearly half of the manufacturing capacity at 37 surveyed U.S. generic drug facilities was going unused.</p>
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<h2 class="wp-block-heading">Bringing Generic Drug Manufacturing Back to the U.S. Comes at a Cost</h2>
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<p>Generic and biosimilar medicines dominate the U.S. prescription drug market. In 2025, generics and biosimilars accounted for <a href="https://drugstorenews.com/aam-us-generic-biosimilar-medicines-saved-496b-2025">nearly 90% of prescriptions filled in the United States but only 12% of prescription drug spending</a>, according to AAM.</p>
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<p>The low prices that make generic drugs affordable can also make it difficult for manufacturers to justify the higher cost of producing them in the U.S.</p>
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<p>"We want more manufacturing in the U.S. but are [Americans] willing to <a href="https://medshadow.org/investigating-generics/investigating-generics-two-thirds-of-americans-would-pay-more-for-safer-drugs/">pay for it</a>?" Dr. Fox asks. "At the same time, we also keep hearing from the government that they want costs to be lower."</p>
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<p>The OMB’s initiative comes as the Trump administration is <a href="https://www.ropesgray.com/en/insights/alerts/2026/04/100-on-brand-us-imposes-new-tariffs-and-key-exemptions-on-patented-pharmaceuticals">imposing tariffs on certain drugs made overseas</a>. Imported patented pharmaceuticals and their ingredients can now face tariffs of up to 100%. While generic drugs are <a href="https://edition.cnn.com/2026/09/29/economy/trump-tariffs-drugmakers">largely exempt</a> for the time being, the president said in July that imported generics would remain tariff-free for just two years, <a href="https://www.usnews.com/news/us/articles/2026-07-21/trump-says-generic-drugs-to-face-no-us-tariffs-for-2-years-before-rates-of-100-and-200-later">after which they would face a 100% tariff, rising to 200% a year later</a>.</p>
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<h2 class="wp-block-heading">Reliance on Foreign Drug Manufacturing Raises Security Concerns</h2>
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<p>Concerns about overseas manufacturing go beyond whether the U.S. can actually produce more medicines domestically. Policymakers and public health experts have also warned that concentrating pharmaceutical production abroad leaves the U.S. vulnerable to supply disruptions.</p>
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<p><a href="https://healthpolicy.duke.edu/people/chan-harjivan">Chan Harjivan</a>, a visiting fellow at Duke University’s Margolis Institute for Health Policy and former White House health official, told the Senate Aging Committee earlier this year that “even if China never intentionally weaponizes medicines, the combination of geopolitical conflict risk and upstream concentration creates <a href="https://www.aging.senate.gov/imo/media/doc/0c8b8e82-fe72-daff-8137-d3a4ba88d7b2/Testimony_Harjivan%2003.11.26.pdf">a plausible national emergency scenario."</a></p>
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<p>One alternative to bringing all of that manufacturing back to the U.S. is “friendshoring.” Dr. Fox and others have proposed this approach, which would shift production of critical, lifesaving generic drugs away from higher-risk regions like China and toward geopolitical allies such as Canada, Mexico, and European countries.</p>
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