CLEVELAND - A health care future of genomic-based and personalized medicine "cannot happen without a stronger FDA," Andrew von Eschenbach, the agency's acting commissioner, said here during a luncheon session Tuesday, the first day of BIO's fourth annual MidAmerica Venture Forum.
With attendees filling up half of the Founder's Ballroom in the Intercontinental Hotel and Conference Center, part of the 140-acre campus of The Cleveland Clinic Foundation, von Eschenbach reiterated the need for changes at the agency. His remarks came just days after the Institute of Medicine released a report highlighting problems at the FDA, including a lack of adequate funding and clear regulatory processes.
Since leaving the National Cancer Institute a year ago to accept the position at the FDA, von Eschenbach said the agency faces challenges, not only from technological advances that have led to the need for new regulatory processes and guidelines, but also from the growing number of areas under its purview.
The job of the FDA should be to act as the bridge between drug discovery and development and drug approval, von Eschenbach said, adding that 24 percent of all consumer products in the U.S. are regulated by the FDA, and over the last several years the list of products has grown to include biologics, nutraceuticals and biodefense agents.
But "the bridge of the past cannot handle that traffic," he said. "We need a new bridge."
Or more accurately, "We must morph the bridge into the new reality."
Von Eschenbach offered up some broad recommendations for the agency, such as clearly defining the regulatory processes and implementing pre-application consultations to ensure that companies know what's expected for approval, because in drug development, "we'd rather the first application be successful," he said
But that increased efficiency and assistance would require a larger work force, and that requires more funding.
The IOM report "points to the fact that the FDA is chronically underfunded," BIO President and CEO Jim Greenwood told BioWorld Today.
Greenwood announced Monday that BIO had joined forces with other leaders in the food and drug industries, as well as consumer and patient groups, to appeal lawmakers to increase the agency's funding.
BIO also is a staunch supporter of von Eschenbach's confirmation as the official FDA commissioner, and Greenwood said the lack of a confirmed leader for the agency has led to "a wobbly FDA that's uncertain of itself."
Von Eschenbach has been acting FDA chief since September 2005 when President Bush chose him to replace former FDA commissioner Lester Crawford, who abruptly resigned only two months after receiving Senate confirmation. As the previous head of the National Cancer Institute, von Eschenbach gained Bush's official nomination for the top FDA position in March. His nomination was cleared last week by the Senate's Health, Education, Labor and Pensions Committee though it still faces hurdles in the full Senate. (See BioWorld Today, Sept. 21, 2006.)
Von Eschenbach's keynote address was a highlight of the two-day MidAmerica Venture Forum, which aims to bring together more than 300 executives from private bioscience firms and VCs across the Midwest and from other areas of the country.
Unlike its counterparts on the East and West Coasts, the Midwest biotech sector "didn't have a head start" when it came to building its biotech industry, Greenwood said, "but it has the ingredients," including a host of academic and research institutions, not the least of which is The Cleveland Clinic, along with technology transfer and incubator organizations that have become adept at turning out small biotech firms.
As the host state, Ohio has established its own efforts to encourage an increase life sciences presence. Gov. Bob Taft took the stage briefly Tuesday morning to review the state's Third Frontier program and the plan to provide $1.6 billion in funding for business development. Since its inception, more than half the funds invested have gone to the growing bioscience sector.
The conference ends today.