Alliance for a Stronger FDA emphasizes critical role in US biomedical research and public health

In a recent meeting of the U.S. Senate Committee on Appropriations, the critical role of the Food and Drug Administration (FDA) in advancing biomedical research and innovation was underscored by various stakeholders. The Alliance for a Stronger FDA, representing over 150 organizations, emphasized the FDA's importance in safeguarding public health and maintaining the United States' leadership in global biomedical innovation.

The discussions highlighted that the FDA not only ensures the safety of food and cosmetics but also plays a pivotal role in regulating medical interventions that benefit both companion animals and food animals. This regulatory oversight is essential for fostering an environment where biomedical research can thrive, ultimately leading to new treatments and cures for diseases affecting millions of Americans.

Key statistics presented during the hearing revealed a significant increase in clinical trials, with a 38% rise in active trials at the Center for Drug Evaluation and Research (CDER) since 2014. Notably, trials for cell and gene therapies have tripled, indicating a robust pipeline of innovative treatments. The FDA's ability to efficiently review and approve these medical innovations is crucial for attracting private investment in the biopharmaceutical sector, which supports over 4 million jobs in the U.S.

The meeting also pointed out that the U.S. accounted for 35% of all global clinical trial starts in 2024, with emerging biopharma companies leading the charge. These companies, often in their early stages of development, rely heavily on a supportive regulatory environment to secure funding for their clinical programs.

Moreover, advancements in medical technology were highlighted, with the FDA authorizing a fivefold increase in innovative medical devices since 2009. The agency's recent approvals of groundbreaking technologies, such as over-the-counter continuous glucose monitors and AI-enabled diagnostic tools, showcase its commitment to embracing innovation.

As the meeting concluded, stakeholders reiterated the necessity of a well-resourced and innovation-friendly FDA to ensure the health and well-being of millions of Americans. The discussions reflect a shared understanding that the FDA's expertise is vital for realizing the potential of new medical technologies and maintaining the United States' position as a leader in biomedical research. The Alliance for a Stronger FDA expressed its commitment to supporting these efforts, emphasizing the importance of collaboration between the FDA and various stakeholders in the biomedical field.