FDA Misses PDUFA Goal Dates for 11% of Novel Drug Approvals in 2023, Citing Inspection Challenges

Jessica Adams, a prominent voice in pharmaceutical discourse, recently sparked discussion with a tweet challenging the sole reliance on approval numbers to gauge the U.S. Food and Drug Administration's (FDA) performance. In her social media post on August 22, 2025, Adams asserted, > "Don't get me started on approvals as a metric of FDA performance. Give FDA props for reviewing applications like real referees." Her statement highlights a nuanced perspective on the agency's regulatory role.

The FDA's performance in drug approvals is often evaluated through metrics tied to the Prescription Drug User Fee Act (PDUFA), which mandates specific review timelines. Historically, the agency has demonstrated high efficiency, with 98% of novel drug approvals between 2013 and 2022 meeting or exceeding PDUFA goal dates. This framework aims to expedite access to new medicines while upholding stringent safety and efficacy standards.

However, a recent report on the Center for Drug Evaluation and Research's (CDER) 2023 novel drug approvals revealed a notable dip, with 11% of New Molecular Entities (NMEs) missing their PDUFA goal dates. The primary reason cited for these delays was issues with international inspections, particularly those hindered by COVID-19 related travel restrictions. This highlights how external factors can influence the very metrics often used to assess the agency's efficiency.

Adams's emphasis on the FDA acting "like real referees" underscores the critical importance of the agency's rigorous review process over mere approval speed. The FDA's role extends beyond simply processing applications; it involves meticulous scientific evaluation to ensure drug safety and effectiveness. This commitment is evident in initiatives like the quality metrics program, which seeks to assess manufacturing quality and prevent drug shortages, although it has faced industry pushback regarding implementation.

The debate surrounding FDA performance metrics reflects a broader challenge in balancing timely access to innovative treatments with unwavering regulatory oversight. While approval rates and PDUFA timelines offer valuable insights, they do not fully capture the depth of the FDA's diligence or the external complexities influencing its operations. The agency continuously strives to refine its processes, aiming for both efficiency and the robust scientific scrutiny essential for public health.