Dive Brief:
- The Food and Drug Administration has cleared the first medicine under its new National Priority Voucher program, approving a U.S.-manufactured version of a decades-old antibiotic.
- GSK originally developed the drug, Augmentin XR, and won FDA approval for it in 2002. The British company then struck a deal in 2010 to sell its U.S. penicillin business, including its Augmentin franchise, to the generic drugmaker Dr. Reddy’s Laboratories. A Bristol, Tennessee, plant that was part of that deal is now operated by USAntibiotics, which won the priority voucher.
- FDA Commissioner Martin Makary trumpeted the approval as a boon for crucial supply chains of medications that often end up in shortages. The move “will strengthen domestic manufacturing and increase our national security,” Makary said in a statement Tuesday.
Dive Insight:
The Trump administration forged the National Priority Voucher system for medicines that address U.S. “national interests,” promising it would allow the FDA to evaluate new therapies in as little as one to two months, instead of the usual 10 months under the Prescription Drug User Fee Act.
The idea has drawn controversy, with Congressional Democrats arguing it has the potential to create “a new, lucrative gift for drugmakers and allies politically favored by President Trump.” Concerns about the initiative reportedly factored into the decision by Richard Pazdur, the FDA’s top drug reviewer, to retire from the agency just weeks after taking the job.
FDA officials issued the first round of vouchers in October to nine drugmakers, including USAntibiotics. The company is the only U.S. producer of amoxicillin and Augmentin and, like other manufacturers, has struggled in a market that desperately needs a steady supply of generic antibiotics yet pays very little for them.
In its press release touting the voucher win in October, USAntibiotics offered a dire warning. “If our doors close, it would take half a decade and hundreds of millions of dollars to rebuild this capability,” Patrick Cashman, the company’s president, said in the statement. “That’s five years in which America would be completely reliant on adversarial nations for the most prescribed antibiotic in the country.”
USAntibiotics rescued the Bristol facility in 2021 after it had been owned by Neopharma, which took it over from Dr. Reddy’s. As of 2024, Augmentin XR was listed on the FDA’s discontinued drug products list, but the agency that year cleared the way for another approval by making note that the medicine wasn’t withdrawn because of concerns about safety or effectiveness.
The FDA issued a second round of vouchers last month, a list that included two weight loss drugs. Novo Nordisk is using its voucher to seek approval of a higher-dose version of Wegovy, while Lilly is advancing an experimental pill called orforglipron. The vouchers were part of a larger deal on obesity drug pricing with the White House.
