Amoxicillin/Clavulanate Potassium

iStock, hapabapa Rep. Jake Auchincloss of Massachusetts said the Commissioner’s National Priority Voucher program did not receive congressional backing. The FDA has also not yet made disclosures for eight senior reviewers, according to Auchincloss. The FDA’s Commissioner’s National Priority Voucher program could be on shaky legal ground, according to Rep. Jake Auchincloss (D-MA), who, in a letter to the agency, flagged the lack of transparency around how the scheme awards its tickets and approvals. “The public must have transparency about the ‘voucher’ program, under which drug approvals have been made almost wholly and in an unprecedented manner by the FDA’s political leadership,” Auchincloss wrote in his letter, according to a Tuesday report from the Associated Press . The program, he added, has been “shrouded in secrecy” because the regulator has failed to respond to several inquiries from Congress. Launched in June last year , the Commissioner’s National Priority Voucher program rewards companies that align with certain national priorities—such as lowering drug prices in accordance with the Most Favored Nation directive. The program aims to drastically shorten review times. Companies that use these vouchers can receive their regulatory verdicts within 1–2 months, as opposed to the usual 10–12 months. Such a scheme, however, did not receive congressional approval, Auchincloss pointed out in his letter, according to the AP . The representative also noted that the FDA hasn’t yet made public financial disclosures for eight senior officials who decide which drugs get awarded the Commissioner’s vouchers. Among the members of this high-level panel are Center for Biologics Evaluation and Research Director Vinay Prasad and Center for Drugs Evaluation and Research Director Tracy Beth Høeg. In a townhall meeting also on Tuesday, FDA officials assured employees that the final decision of whether or not an application gets approved still rests with the agency’s reviewers and scientists, not the political appointees in the voucher-granting group, according to reporting from STAT News . The FDA has so far handed out two batches of tickets under the CNPV program. The awardees include Sanofi’s type 1 diabetes drug Tzield, Regeneron’s gene therapy DB-OTO for congenital deafness, Eli Lilly’s obesity pill orforglipron and Vertex Pharmaceuticals and CRISPR Therapeutics’ sickle cell disease therapy Casgevy. In December 2025, the agency also awarded a voucher to Johnson & Johnson and was considering granting two to Merck —even though the companies had not applied for them. That same month, the agency granted its first CNPV approval , which went to GSK’s antibiotic Augmentin XR, a generic version of which is produced in the U.S. by manufacturer USAntibiotics. The FDA has yet to respond to Auchincloss’ letter, according to the AP . BioSpace has not been able to obtain a copy of Auchincloss’ letter. The representative is a member of the House subcommittee on health.

iStock, Sundry Photography The tickets could go to the lipid-lowering pill enlicitide decanoate and the antibody-drug conjugate sacituzumab tirumotecan, though a spokesperson for the HHS did not confirm the news. The FDA is considering giving Commissioner’s National Priority Vouchers to two investigational drugs from Merck, both with blockbuster potential, according to a Wednesday report from Reuters . After reviewing internal FDA documents, Reuters revealed that the cholesterol-lowering pill enlicitide decanoate and the antibody-drug conjugate (ADC) sacituzumab tirumotecan are each in the running for a priority voucher, which, if granted, would drastically reduce their respective review periods. Merck has yet to approval application for either of these molecules but the FDA expects a submission for enlicitide decanoate in April and sacituzumab tirumotecan in November of next year, according to Reuters . In a statement to Reuters , a spokesperson for the Department of Health and Human Services said that absent any official announcement from the FDA, reports regarding CNPV awards will remain speculative in nature. Enlicitide decanoate is an orally available blocker of the PCSK9 enzyme, working to reduce levels of low-density lipoprotein cholesterol (LDL-C). At the American Heart Association’s 2025 Scientific Sessions last month, the drug cut LDL-C concentrations by 55.8% versus placebo at 24 weeks. After Merck announced data showing enlicitide decanoate lowered cholesterol levels in two Phase III trials in June, BMO Capital Markets analysts wrote in a note to investors that the drug represented a “multi-billion dollar opportunity.” Meanwhile, Merck is developing sacituzumab tirumotecan for various oncology indications , including non-small cell lung cancer. Data from the Phase III OPtiTROP-Lung04 study, published in October in the New England Journal of Medicine , showed the ADC cut the risk of disease progression or death by 51% versus chemotherapy. Merck is also testing sacituzumab tirumotecan for breast, cervical, gastric, biliary tract, colorectal and pancreatic cancers. In November, Merck signed a $700 million funding agreement with Blackstone Life Sciences to develop the ADC. Jefferies analysts noted that the Blackstone deal indicated the molecule could reach $10 billion in sales, according to Reuters . The FDA rolled out the Commissioner’s National Priority Voucher program in June, looking to accelerate the approval process for drugs that satisfy certain federal priorities, such as lowering drug prices and boosting domestic manufacturing. These tickets shorten the regulatory review period from the usual 10–12 months to 1–2 months. Since the program’s launch, the FDA has handed out priority vouchers to 16 molecules, including Novo Nordisk’s weight-loss blockbuster Wegovy, Eli Lilly’s oral obesity candidate orforglipron and USAntibiotics’ antibiotic amoxicillin formulation Augmetin XR . Augmentin XR was approved earlier this month. Most recently, Johnson & Johnson earlier this week was granted a voucher—without even applying for it.