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U.S. Department of Health and Human Services

About FDA

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A Note from the Commissioner

When I became Commissioner a little over two years ago, I was struck by the magnitude of the challenge before me. FDA is responsible for ensuring the safety, efficacy, and security of drugs, vaccines and other biological products, medical devices, and certain products that emit radiation, as well as oversight of the safety of our nation’s food supply, cosmetics, dietary supplements, animal drugs and feed, and the regulation of tobacco products. In other words, our agency is entrusted with promoting and protecting the health and well-being of anyone who eats, takes an over-the-counter painkiller or prescription drugs, uses a medical device, or has an x-ray. In fact, FDA-regulated products account for approximately 25 cents of every consumer dollar spent in the U.S.

But we also have another important role: promoting the science and innovation it takes to ensure that the nation is fully equipped to address the health challenges we face today and will see in the future. Of course, innovation is not just about new ideas, but about making sure those new ideas truly translate into the products and opportunities people need and count on.

Today we are at a critical moment for innovation. Despite the struggling U.S. economy, American pharmaceutical, biotech, and medical device companies have maintained a competitive advantage in the global marketplace and continue to represent three of the few U.S. manufacturing sectors that maintain a positive trade balance. But there are some signs that the health of these industries may be at increasing risk, jeopardizing a critical piece of our economy and, more importantly, obstructing patients’ access to new therapies. Today’s medical product pipeline, despite a number of groundbreaking new drugs approved this year, does not have enough new products to sustain the health of the industry in the long-term or address many of the chronic diseases afflicting Americans every day.

While FDA has a strong record of performance, I believe we must redouble our efforts and take proactive steps to be even better. So I’ve spent countless hours meeting with—and listening to—the various stakeholders in the medical product development ecosystem. We’ve discussed the challenges ahead for everyone involved, as well as what does and doesn’t work in the current FDA regulatory framework. During the course of our internal reviews and discussions with stakeholders, several common themes emerged. In response, we have put together this initiative to outline some important steps we can take to address these issues and drive innovation forward.

Building on existing efforts, such as the groundbreaking Critical Path program introduced in 2004 and the Advancing Regulatory Science Strategic Plan published in August, this agenda focuses on implementing and institutionalizing new programs and reforms within FDA to address the most immediate concerns we’ve been hearing from stakeholders. It covers everything from streamlining and reforming FDA regulations to creating a new expedited drug development pathway.

This document lays out a brief assessment of the medical product landscape and its current state. The document also outlines how FDA is working to position itself not only as a positive driving force in the ecosystem as a regulator, but also to facilitate medical product innovation. It is important to note that while these are important first steps to address the immediate concerns before us, this is an ongoing initiative at the agency and will be expanded beyond the reforms outlined in this document.

It is clear that our nation is at an important crossroads, where the science before us presents unprecedented opportunities to create new and better medical products and promote better health for the public. But we must act now and work together to capitalize on this groundbreaking science in order to bring safer and more effective treatments to American families and keep our position as the global leader in scientific innovation. I truly believe FDA’s innovation initiative will help move us toward this important goal.

Table of Contents: Driving Biomedical Innovation

Next Section: Overview