ENZI CALLS FOR VON ESCHENBACH CONFIRMATION DURING LAME DUCK SESSION
The outgoing chairman of the Senate committee with jurisdiction over the FDA is calling on his colleagues to confirm Andrew von Eschenbach as the commissioner of the FDA before the end of the 109th Congress to provide the leadership necessary to change what he calls an agency in turmoil.
"This Congress must take up Dr. von Eschenbach's nomination before we adjourn," Sen. Mike Enzi (R-Wyo.), the current chairman of the Senate Health, Education, Labor and Pensions Committee said during a Nov. 16 hearing on drug safety. The confirmation, as well as passage of Enzi's and Sen. Edward Kennedy's (D-Mass.) drug safety bill, is necessary to fix an agency beset by political influence and lacking the authority to adequately protect public health, the lawmakers said.
No FDA officials were invited to appear to answer these criticisms, however. "We didn't want the FDA to have to feel defensive," Enzi said. The fact that the agency still lacks a confirmed commissioner also played a role in his decision, Enzi added.
But that did not faze the agency. "It is up to the committee to decide who to invite as witnesses," an FDA spokeswoman said, adding that the FDA "shares the committee's commitment to drug safety and appreciates this important public dialogue."
The agency also defended its drug safety efforts. "FDA has done considerable work over the past two years to improve its approach to drug safety and is committed to taking additional steps to continue to fulfill its mission to protect and promote public health," the spokeswoman said.
The lawmakers' call for change was echoed by Sheila Burke, one of the authors of the recent Institute of Medicine report on drug safety. The FDA needs permanent leadership to fix an agency that is "dysfunctional," she said. Another witness, Jim Guest, the president and CEO of Consumers Union, said agency staff is "demoralized," with employees rapidly leaving.
Burke endorsed the Enzi-Kennedy bill, S.3807, as "enormously important" to clarify the FDA's authority in regulating industry, including giving the agency clearer powers to conduct both pre- and postmarket oversight. For instance, the agency must have unilateral authority to require labeling changes, she said.
For more information on S. 3807, go to thomas.loc.gov/cgi-bin/bdquery/z?d109:s.03807: (http://thomas.loc.gov/cgi-bin/bdquery/z?d109:s.03807:).