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U.S. Department of Health and Human Services

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Driving Biomedical Innovation: Fact Sheet

The U.S. Food and Drug Administration (FDA) plays an important role in industry’s efforts to develop and bring to market new drugs and medical devices for American patients. U.S. companies investing in research and development are now poised to translate these recent scientific breakthroughs into medical products of unprecedented importance for public health.

FDA in Action

Recognizing FDA’s critical role in fostering medical progress, FDA’s Commissioner Dr. Margaret Hamburg initiated a major effort to identify areas where agency reforms could help reinvigorate industry’s quest for new, state-of-the-art medical products.

To obtain the best information, FDA officials hosted a series of public hearings and participated in other external meetings to solicit outside views of its stakeholders, including frank conversations with industry representatives, health care professionals, academicians and consumer advocates. As a result of these discussions, FDA has identified several areas for reform that aim to address stakeholder concerns, while simultaneously stimulating medical product development.

A new FDA report titled Driving Biomedical Innovation: Initiatives for Improving Products for Patients identifies seven areas where FDA actions can help facilitate medical product innovation. They include:

Rebuilding FDA’s small business outreach services

Innovation begins with the small business community. Small businesses have built much of the foundation of innovative FDA-approved medical products, including drugs, devices, biologics, and diagnostics. After an internal review of the small business resources at FDA, as well as discussions with small business owners, it became clear that FDA needs to strengthen its outreach to small businesses and and ensure that individuals with small business expertise can serve as a resource to others on FDA issues. To that end, FDA will establish a FDA Small Business Liaison program and a Young Entrepreneurs program, as well as establish a new partnership with the U.S. Small Business Administration. Through these efforts and others, FDA will continue to work to address the needs of small medical product companies through efforts to make the review process easier and more transparent, as well as by providing information that can help businesses prepare for the final phases leading to product approval and marketing.

Building the infrastructure to drive and support personalized medicine

One of the most profound changes to medicine is the move toward tailored therapies, or personalized medicine. The ability to treat a certain type of patient who has a specific form of a disease eliminates the current trial-and-error process, reducing the need to expose patients to drugs that won’t work for them. FDA will continue its leadership role in this area by building a system to support the development of these more personalized medicines, including investments in regulatory science and by clarifying agency policies.

Creating a rapid drug development pathway for targeted therapies

While there is general agreement that targeted therapies should be developed quickly, there is not a common understanding of how to speed up development while simultaneously gathering adequate evidence about the safety and effectiveness of the product. In response to this challenge, FDA will host a series of scientific meetings with a diverse group of stakeholders intended to achieve a common understanding of steps needed when an investigational drug being studied for a serious disease shows exceptional promise during the early stages of development.

Harnessing the potential of data mining and information sharing, while maintaining strong privacy protections

Information technology is transforming the U.S. healthcare system and—through innovative capabilities—improving how we think about the development of new tools for medicines and how we can utilize patient information in a responsible way while protecting patient privacy. FDA currently houses the largest known repository of clinical data and our ability to analyze these data sets could revolutionize the development of new patient treatments that allow us to determine how different types of patients respond to therapy. To harness the potential of information sharing and data mining, FDA is rebuilding its IT and data analytic capabilities and establishing science enclaves that will allow for the analysis of large, complex datasets while preserving patient privacy.

Increasing consistency and transparency in the medical device review process

In January 2011, FDA announced plans to make improvements to medical device review process designed to encourage innovation within the medical device community. This effort included 25 actions that FDA’s medical device center, will take this year to improve the predictability, consistency, and transparency of its premarket review programs—important steps necessary to encourage innovation, address perceived barriers that can impede a product’s timely progress to market while assuring that devices are both safe and effective. These FDA actions are designed to attract investors to innovative companies, predict estimated regulatory costs, and bring safe and effective products to patients more quickly.

Training the next generation of innovators

One of our current economic challenges is the availability of jobs, including those in the biomedical enterprise that require highly technical and practical knowledge and expertise. Many of these jobs remained unfilled because there are not enough qualified candidates with the necessary skill sets to fill these positions. Building on the success of FDA’s Fellowship program, FDA is designing a new Future Innovators Program that will bring practical regulatory science and policy training together to meet the scientific and technological demands of the 21st century. Under this competitive program, FDA will bring promising candidates into the agency for training and experience that will provide FDA with important outside expertise and perspective while equipping these innovators with highly marketable skills and experience.

Streamlining and reforming FDA regulations

In addition to developing new regulatory approaches designed to speed up access to innovative new therapies that are safe and effective for patients, FDA is also taking proactive steps to reform its existing regulations. At the direction of the President and the Commissioner and based on public feedback, the agency is reviewing its current regulations to identify burdensome, unclear, obsolete, ineffective, or inefficient regulations.

Moving Forward

The agency remains committed to continuing our dialogue with companies, innovators, and other stakeholders to identify barriers to progress and better define what steps need to be taken to overcome any obstacles to innovation. These areas are important first steps to address the immediate concerns confronting FDA and its stakeholders. This is an ongoing initiative that the FDA expects to expand beyond the reforms outlined in the report.

The ultimate goal of FDA is to bring safe and effective treatments to American families and keep our position as the global leader in scientific innovation.

Table of Contents: Driving Biomedical Innovation