FDA NEEDS CONSISTENT LEADERSHIP AND FUNDING, FORMER COMMISSIONERS SAY

A lack of consistent leadership and inadequate funding has diminished the FDA's power and credibility, four former agency commissioners said.

Congress has let the agency down in denying it reliable, good leadership and appropriate funding, the commissioners said at a Feb. 21 panel discussion at the George Washington University School of Public Health. The turnover of FDA employees during the Bush administration has been "shameful," Frank Young, commissioner from 1984 to '89, said.

The Senate confirmed Andrew von Eschenbach as the agency's current commissioner last December after overcoming several holds on his nomination. Von Eschenbach replaced Lester Crawford, who left the agency in September 2005, two months after being confirmed. Crawford pleaded guilty to failing to disclose his ownership of stocks in several firms the FDA regulates.

The lack of consistency in commissioners has allowed too much to happen too quickly, which leads to errors within the agency, lessening its credibility, Donald Kennedy, commissioner from 1977 to '79, said. The administration also interferes with the agency by trying to rework science to support policy, Kennedy added. The other commissioners agreed that using scientific evidence as the basis for all FDA decisions was the main way the agency could regain credibility.

Congress must also provide the FDA with adequate funding so the agency can rely less on user fees, the former commissioners agreed. The ratio between appropriations and user fees must be rebalanced, Kennedy said. The commissioners did not support abandoning the Prescription Drug User Fee Act, but said Congress has let the agency down by not maintaining its budget and forcing the agency to rely too much on user fees.

( http://www.fdanews.com/did/6_39/ )