FDA's Annual Drug Approvals Dipped Slightly in 2025; PDUFA Reauthorization is an Opportunity for the U.S. to Get Back on the Right Track

According to the FDA's annual report released last month, the agency's Center for Drug Evaluation and Research (CDER) approved 46 novel prescription drugs in 2025 – slightly fewer than in recent years. While America's prescription drug approval process remains the global gold standard, maintaining this leadership position requires urgent attention from policymakers as competitive pressures from abroad intensify. 

The United States cannot afford complacency. China is pouring unprecedented resources into dominating the next generation of biomedical breakthroughs. As the bipartisan National Security Commission on Emerging Biotechnology warned Congress, without urgent regulatory corrections, China could overtake the U.S. in leadership within three years.  

A rational, well-functioning and pro-innovation regulatory environment is needed to accelerate medical breakthroughs, strengthen our innovation ecosystem, and ensure the United States continues to be the global leader in developing the next generation of life-savings treatments.  

Later this year, Congress is expected to begin the process of renewing the Prescription Drug User Fee Act (PDUFA). First enacted in 1992 in response to the urgent need for faster FDA drug reviews during the AIDS epidemic, PDUFA allowed the FDA to collect fees from pharmaceutical companies to hire additional scientific staff and modernize its review systems. This transformed the agency’s ability to evaluate safe and effective medicines, dramatically shortening approval timelines and accelerating patient access to lifesaving treatments.  

Without PDUFA, review times would likely lengthen significantly, therefore slowing innovation, delaying access critical therapies, and limiting predictability for developers working on the next generation of medical breakthroughs.  

To keep America at the forefront of drug development, policymakers should focus on critical areas including: 

• Speeding up the drug review process. The FDA should fully leverage efficiencies when reviewing multiple products arising from the same platform, modality or technological process. Platform-based technologies and novel modalities represent the future of medicine. America's regulatory framework must support, not hinder, U.S. leadership in these areas. Every month of unnecessary delay is time our global competitors gain ground. 

• Adopting more flexible pre-approval pathways. For promising U.S.-developed drugs with strong initial data packages addressing critical unmet public health needs, more flexible approval pathways paired with robust real-world evidence monitoring can get treatments to patients efficiently. This approach balances speed with safety, ensuring rigorous oversight while avoiding unnecessarily burdensome pre-approval requirements. 

• Expediting clinical trials by expanding U.S. platform trial networks for cancer, rare diseases and other therapeutic areas. Clinical trials are one of the costliest parts of drug development. Clinical trial networks can help drugs move through development more efficiently while generating robust evidence. Additionally, we should look at other reforms that reduce the time and cost of executing a clinical trial while also providing regulatory certainty. 

• Accelerating research & manufacturing infrastructure development. Initiatives like the FDA’s pre-check program, which aims to speed up the inspection process for new pharmaceutical manufacturing facilities, are a promising step in the right direction. Life sciences companies have committed to investing over $500 billion since the start of last year – regulatory processes must keep pace to rapidly scale our drug development infrastructure. 

The question policymakers are facing is straightforward: Will the epicenter of global medical innovation remain in the United States or will it shift overseas? 

PDUFA reauthorization offers Congress a chance to act decisively at a critical moment. By modernizing FDA processes, removing unnecessary barriers and enabling faster access to breakthrough treatments, policymakers can ensure America wins the race for the next generation of cures.