Roughly half a year after introducing the new regulatory pathway, the FDA has greenlit the first drug under its ultra-speedy—and controversial—Commissioner's National Priority Voucher (CNPV) pilot review program.
The inaugural approval under the program has gone to USAntibiotics and its domestically manufactured extended-release antibiotic, Augmentin XR, the FDA said in a Dec. 9 press release. As was the elevator pitch for the CNPV program, the FDA noted in its announcement that it completed its review of the “in just two months,” which the agency said marks “a major reduction of the review timeline for this type of application.”
The CNPV program, which was first unveiled in June, is dispensing a limited number of abbreviated review vouchers to companies whose goals are “aligned with U.S. national priorities,” the regulator said earlier this summer. A company that cashes in a national priority voucher can expect an application review timeline of just one to two months, versus the 10 to 12 months the agency typically requires for a standard drug review, the FDA has said.
The agency has handed out 15 vouchers under the CNPV program so far.
In its approval announcement, the FDA noted that USAntibiotics’ Augmentin XR application “demonstrated clear alignment with the CNPV program’s national health priorities by strengthening the U.S. drug supply chain through enhanced domestic manufacturing capacity at a U.S. facility.” The approval is also expected to help counter antibiotic shortages in the country, the FDA said.
There are some questions hovering over this CNPV approval, however.
GSK received FDA approval for Augmentin XR in 2002, but the drug was later discontinued, according to FDA records. USAntibiotics, the current owner of the med's marketing rights, received FDA approval (PDF) for an Augmentin XR filing back in 2022, with a pair of label updates following in 2024. It's not immediately clear what exactly the FDA approved with its CNPV voucher.
As of publication, the Department of Health and Human Services (HHS) and USAntibiotics have not responded to requests for comment.
Meanwhile, restoring the U.S.' drug manufacturing base has been a major facet of the second Trump administration’s healthcare policy this year, most prominently seen in the use of tariffs to push the industry into making local production investments.
Regarding the significance of the Augmentin XR nod, the FDA highlighted “[i]ncreasing antibiotic shortages over the past two decades” in the U.S., which it blamed in large part on vulnerable drug ingredient supply chains and “unexpected spikes in clinical demand.”
The CNPV award was heralded as a major boon for USAntibiotics earlier this year, with the company noting in October that it is the U.S.’ only domestic manufacturer of the prolific antibiotic drugs amoxicillin and amoxicillin clavulanate, also known as Amoxil and Augmentin, respectively.
Critically, the CNPV distinction—and now, approval—come several years after USAntibiotics took a chance on reopening a production plant in Bristol, Tennessee, which had slipped into bankruptcy and ceased operations in 2020. At the time of the plant’s reopening in 2021, USAntibiotics noted that the facility could produce and store “[e]very dose of Amoxicillin that will be needed in the United States over the next five years … supplying the entire U.S. strategic stockpile.”
"This voucher validates what we've known since reopening our Bristol, Tennessee facility in 2021: domestic pharmaceutical manufacturing capacity is a national security imperative, not a luxury," Patrick Cashman, USAntibiotics’ president, said in a statement on the receipt of the voucher in October.
"If our doors close, it would take half a decade and hundreds of millions of dollars to rebuild this capability from scratch,” he continued. “That's five years in which America would be completely reliant on adversarial nations for the most prescribed antibiotic in the country.”
Thus far, national priority vouchers have been awarded to 15 drugmakers, including major names like Merck KGaA, Regeneron, Sanofi, Novo Nordisk and Eli Lilly.
Late last month, Novo said that it would cash in its voucher to secure a one- to two-month review of a higher-dose version of its obesity blockbuster, Wegovy (semaglutide). That tees up a potential approval for high-dose Wegovy alongside an expected green light for an oral version of the GLP-1 drug, which the FDA is expected to weigh in on before the end of the year.
While it’s still early days for CNPV, the program hasn’t been without its detractors.
In late November, a pair of lawmakers—Democratic New Jersey Rep. Frank Pallone Jr. and Independent Vermont Sen. Bernie Sanders—expressed “deep concerns” over the regulatory pathway, arguing that the pilot program could “enable corruption by creating a new, lucrative gift for drugmakers and allies politically favored by President Trump.”
Aside from concerns about corruption and potential political favoritism, Pallone and Sanders warned that the program could lead to “rushed reviews,” which could in turn undermine public confidence in the FDA’s decisions and potentially put public health at risk.
At the time, a spokesperson for the HHS said the FDA would respond directly to the lawmakers. “The National Priority Voucher program strengthens [the] FDA’s ability to accelerate [the] development of products that meet urgent public health needs,” the spokesperson added.