BIO Joins Coalition to Strengthen FDA

Echoes Call For Increased Public Support</p>

WASHINGTON, D.C. (September 25, 2006) – Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO), today joined a distinguished and diverse group of former government officials and representatives of patient groups, consumer advocacy organizations and industry associations to announce the formation of the Coalition for a Stronger FDA.

“BIO is proud to join this broad, diverse coalition,” said Greenwood. “Our members overwhelmingly support the group’s goal: To ensure a strong and consistent public commitment to resources for the FDA in order for the agency to fulfill its mission of guaranteeing the safety, efficacy and security of the products it regulates.”

Greenwood commented that while the FDA continues to set the global “gold standard” for regulatory science and consumer protection, it has been forced to address an ever-increasing array of issues and revolutionary food and medical advancements with tightening resources. 

“While there have been increases in public funds for the FDA, the agency’s funding has not kept pace with its growing responsibilities. In recent years, the FDA’s responsibilities have expanded to include more counterterrorism activities, pandemic disease preparation, food safety activities, and more. The FDA’s total appropriations are currently less than the agency’s actual cost of doing business,” Greenwood noted.

Greenwood added that the biotechnology industry is particularly concerned about the agency’s increasing reliance on user fees to help make up for federal appropriations challenges.

“User fees now account for more than 59 percent of funding for FDA’s human drug review – or a 700 percent increase since 1993 when the Prescription Drug User Fee program was implemented,” Greenwood stated. “If this high rate of corporate funding continues, it will undermine public confidence in FDA’s independence.  While user fees play a key role in providing multi-year predictability and stability for the FDA, they were never intended to replace annual federal appropriations.”

In closing, Greenwood emphasized the importance of the Coalition’s goal.

 “Securing adequate support for the FDA in the coming years is particularly important as the agency prepares to address the coming wave of exciting new biomedical advances,” he stated. “Without appropriate resources at the FDA, new therapies for major diseases could be seriously slowed if the agency were to become a bottleneck for the approval of new products. Companies could face increased difficulty obtaining funding for innovative research and development without a clear review and approval timeline, jeopardizing U.S. leadership. Consumer confidence in food and drug safety will erode.”

 “By working together with the other members of this effort, we hope to bring about greater public confidence in the FDA’s ability to make independent, scientifically and medically appropriate regulatory decisions on the safety and effectiveness of new food and medical products,” said Greenwood. “At the same time, we can help ensure improved patient access to novel therapies.  In the end, this effort can be a win-win for consumers, for the FDA and for the industries it regulates.”

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and 31 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products.