FDA, Small Businesses, and the Common Goal of Advancing Public Health

By: Margaret A. Hamburg, M.D.

When federal agencies celebrated “Small Business Week” last month, FDA had special reason to pay tribute. It is well known that the U.S. biomedical industry plays an essential role not only in advancing the health of individuals, but also the health of the overall economy. Less well appreciated is that small businesses account for much of this activity.  A new FDA report issued to Congress this week describes the multitude of ways we work with small businesses to support their innovative ability to craft new treatments, medicines, and devices that improve the health of all Americans. 

Margaret Hamburg, M.D.The outreach efforts described in this report are vital, because small businesses not only have a unique role but also unique needs in their involvement with a regulatory body like the FDA. That’s why we’re working on a number of fronts to strengthen the ability of small businesses to engage and to help ensure that they are not disadvantaged by their size.

One way we do this is by reducing or even waiving user fees for small businesses that meet certain criteria. Sometimes a startup company might have a groundbreaking product, but lacks the financial resources to cover the full cost of user fees, which are paid to the FDA to help cover the cost of product reviews. Encouraging this kind of small business innovation is the reason FDA participates in the Small Business Innovation Research (SBIR) Program, which funds research and development projects that have potential for commercialization and public benefit. Since 2008, FDA has awarded 36 SBIR grants with the average grant being just over $170,000. Small businesses are also eligible to apply for more broadly available FDA grants, such as Orphan Product Grants, which address rare diseases and disorders, and are tailored to meet the focus and needs of small firms.

Perhaps even more important to small businesses than funding is information. FDA works hard to maintain a variety of communications with small businesses. Seminars, webinars, and workshops open to, and often specifically designed for, small businesses are offered throughout the year free of charge. Links to these event listings can be found in Appendix D of the report. FDA’s product centers also have dedicated small business offices that give companies direct points of contact, which are identified in our new report. These offices provide technical support and education to small companies, hold meetings to hear the views and perspectives of small businesses, develop informational materials, and provide an accessible channel through which small businesses can acquire information from FDA. I hope small businesses will take advantage of these resources and reach out to FDA’s small business contacts.

Small businesses also benefit from early communication with FDA during the product review process. This early communication is especially valuable in FDA’s Rare Disease Program in which most product sponsors are small firms and the product evaluations can be particularly complex for companies with limited resources. Our centers have found that early communication between FDA and product sponsors gets safe and effective products to consumers faster. 

I encourage you to read the report for more information on how FDA promotes innovative research by small businesses, protects small businesses from unreasonable regulatory barriers, and thereby allows American ingenuity to thrive.

Margaret A. Hamburg, M.D., is Commissioner of the Food and Drug Administration