Richard L. Jackson is the founder and CEO of Jackson Healthcare, the parent company of USAntibiotics.
The United States leads the world in pharmaceutical innovation. But it is less successful in manufacturing generic versions of the very same lifesaving medicines it invented, often leaving Americans’ treatment dependent on foreign companies whose drug formulations and processes undergo little regulatory scrutiny. Lower-cost generics now represent 9 out of 10 prescriptions filled in America, yet the vast majority are made overseas.
After America’s last remaining manufacturer of the widely used antibiotics amoxicillin and amoxicillin-clavulanate filed for bankruptcy in 2020, my company bought and refurbished the plant for $38 million — and it looked like the worst decision in my 40-year career in health care. Since reviving production of these and other penicillin-class antibiotics, USAntibiotics has been fighting heavily subsidized foreign drugmakers to compete and survive while providing the level of quality American patients deserve.
Now the U.S. government is finally taking decisive action to support domestic manufacturers of critical generic medicines.
In June, the Food and Drug Administration announced a pilot program to expedite the typically year-long review of medicines when they aligned with national priorities. On Dec. 9, Augmentin XR, one of the most reliably effective extended-release antibiotics ever developed, was announced as the first drug approved for sale under the accelerated FDA framework. Its imminent return to pharmacy shelves marks the first time since 2011 the drug has been manufactured domestically, and credit for this goes largely to President Donald Trump. Beyond the FDA pilot program, his administration has elevated supply chain security to a national priority and pushed federal agencies to move with urgency when essential products faced risk.
Why should this be a federal priority? Antibiotics such as amoxicillin — and Augmentin, which combines amoxicillin with clavulanate to reduce antibiotic resistance — form the backbone of modern medicine. These bacteria-killing drugs treat community-acquired pneumonia and acute bacterial sinusitis in adults and children. They treat the ear infections and cases of strep throat that send millions of children to pediatricians each year. Without these drugs, routine surgeries become high-risk procedures, minor infections can turn deadly and cancer patients undergoing chemotherapy face life-threatening complications.
Furthermore, unlike conventional antibiotic formulations requiring three daily doses, the extended-release (XR) version of Augmentin requires only two. Clinical research demonstrates that patients on twice-daily regimens are significantly more likely to complete their antibiotic courses than those on three-times-daily schedules. Better adherence means better outcomes.
When a drug’s patent expires, generic versions mean that prices fall and access expands. That is, until overseas competition becomes so great that U.S. domestic manufacturers are forced to discontinue production. After decades of this pressure, the manufacturing of generic drugs’ key starter materials, active pharmaceutical ingredients and finished doses became almost entirely consolidated in China and India, leaving the U.S. exposed to disruptions from geopolitics, export controls, quality lapses and capacity constraints.
The staggering quality gap between domestic and foreign-manufactured drugs should concern every American. U.S. federal inspectors visited fewer than one-third of Chinese and Indian pharmaceutical facilities in fiscal 2024. Among those they did inspect, which is permitted only after advance notice, Indian plants recorded a higher rate of serious manufacturing violations, at 13 percent. Inspectors have found workers walking barefoot through supposedly sterile facilities, cats and lizards roaming freely and bacteria-contaminated samples. A 2025 study found that Indian-made generics were 54 percent more likely to cause severe adverse events than American-made drugs.
In 2020, USAntibiotics made a deliberate decision to invest in bringing essential antibiotic manufacturing back to American soil and under American safety oversight. That required long-term capital in an extremely low-margin business. But the FDA’s fast-track pathway is helping to make that investment more viable by shortening the time to market. In manufacturing, time and scale matter. Faster, predictable approvals reduce carrying costs, stabilize production planning and make domestic supply competitive over time.
Of course, one product will not fix the system. But Augmentin XR’s return is likely to be the first of many important drug releases built on three principles: expanding fast-track FDA pathways for priority drugs; using drug acquisitions for the Strategic National Stockpile and other federal programs to reward domestic manufacturing, reliability and quality over lowest price; and making long-term demand commitments to stabilize essential generics.
If the United States wants patients to have reliable access to essential medicines, it must be capable of making them at home. Trump was right to elevate domestic manufacturing and supply-chain security as national priorities. The FDA’s fast-track approval of Augmentin XR shows this strategy can work in practice.
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