INTERIM FDA COMMISSIONER 'A TROUBLING CHOICE' TO SOME STAKEHOLDERS
The Bush administration's choice of Andrew von Eschenbach to be the interim FDA commissioner is raising concerns among various stakeholders, who say his role as director of the National Cancer Institute (NCI) and his alleged decision to continue to run that group shows a lack of the necessary objectivity and dedication needed to run the FDA. These groups also question whether Eschenbach's goal of accelerating approvals of cancer drugs could result in a lowering of drug approval standards.
The Bush administration named Eschenbach acting commissioner after Lester Crawford abruptly quit as head of the agency. While the agency has argued that Eschenbach has the experience and expertise to do the job, various sources in Congress, the industry and the public interest sector are questioning the move.
Sources from such varied entities as the Senate Health, Education, Labor and Pensions (HELP) Committee, Public Citizen, the Biotechnology Industry Organization (BIO) and the Center for Science in the Public Interest (CSPI) said that Eschenbach's role as head of NCI, an NIH agency that interacts closely with the drug industry, raises objectivity questions. The sources also noted that von Eschenbach's pledge -- as reported by the Associated Press -- to keep his NCI post while running the FDA is unrealistic.
The Bush administration's selection of Eschenbach is a "troubling choice," said CSPI official Merrill Goozner, because the NCI lobbies the agency for changes in policy and has numerous ties to industry. The NCI leader also being in charge of the FDA represents a "structural conflict of interest" that needs to be addressed, Goozner added.
Eschenbach's interest in accelerating approvals of cancer-treating drugs has also raised concerns among stakeholders, some of whom noted that a shorter approval window could compromise drug safety.
HELP Committee spokesman Craig Orfield noted that Eschenbach has a "sterling reputation," but cautions that his alleged decision to take the FDA position while continuing to run the NCI is a problem. The HELP committee, which has jurisdiction over the FDA, is currently reviewing this issue, Orfield said.