Final Word: New Organization Forms to Help FDA Fulfill its Mission

The Biotechnology Industry Organization is joining with industry organizations, patient advocacy groups, and consumer advocates to form the Coalition for a Stronger FDA (www.fdacoalition.org).

The FDA's ability to operate a modern, scientifically based program has never been more important, and the need to strengthen the world's foremost consumer protection agency has never been more urgent.

James Greenwood

The coalition is a broad-based bipartisan group whose honorary cochairs are the last three Health and Human Services secretaries—Tommy G. Thompson, Donna E. Shalala, and Louis Sullivan.

Coalition members overwhelmingly support the organization's goal: ensuring a strong and consistent public commitment to resources for the FDA, to help the agency fulfill its mission of guaranteeing the safety, efficacy, and security of the products it regulates.

Why is the coalition needed? Today's FDA faces a complex and challenging array of increased responsibilities and issues, from drug safety, to bioterrorism surveillance activities, to expanded activities surrounding food safety. But there has not been a comparable increase in resources to support these increased responsibilities.

Take the biotechnology field, for example. The FDA is preparing for the coming biotech revolution, which—thanks in part to a recent doubling of the National Institutes of Health's (NIH) budget—will bring an exciting array of new therapies and technologies that will benefit consumers around the world. We must ensure that FDA has the resources it needs to obtain life-saving and enhancing products to market as quickly, safely, and effectively as possible. The agency and the administration have worked hard to prepare for these challenges. But to fully realize this potential revolution, FDA must be able to continue its global leadership in food and drug regulation. The agency must have adequate resources to ensure consumer safety, while providing an efficient process to move new products and technologies into the marketplace efficiently and transparently.

Without sufficient resources at the FDA, new therapies for major diseases could be seriously slowed as the agency becomes a bottleneck for the approval of new products. Companies will face increased difficulty obtaining funding for innovative research and development without a clear review and approval timeline—thereby jeopardizing US leadership in vital fields.

A key to bolstering FDA and its mission is securing balanced and consistent funding. This can lead to greater public confidence in the organization's ability to make independent, scientifically, and medically appropriate regulatory decisions on the safety and effectiveness of new food and medical products that are beneficial to everyone.

This is the heart of what we in the Coalition for a Stronger FDA are trying to accomplish. We are going to do it by working together with all interested parties. The coalition plans to work directly with policymakers to advocate for increased appropriations and stronger public support. We also are planning a national campaign to educate the public and policymakers on the need for a stronger FDA. We plan to build awareness of the current deficiencies and new challenges, as we build a case for increased support—and a stronger FDA.

Taxpayers and consumers deserve nothing less.

James Greenwood is President and CEO, Biotechnology Industry Organization, 1225 Eye Street, NW Ste. 400. Washington, DC 20005-5958,202.962.9200 jgreenwood@bio.org