October 12, 2005
Dems Attack Von Eschenbach Appointment at FDA
Reps. Henry Waxman (D-CA) and John Dingell (D-MI) today called on the Bush administration to remove Dr. Andrew von Eschenbach as interim leader at the Food and Drug Administration and move rapidly to appoint a permanent director. In a letter to HHS Secretary Michael Leavitt, the two senior Democrats on the House Government Reform and Commerce Committees, respectively, said von Eschenbach had irreconciliable conflicts of interest from his previous job as head of the National Cancer Institute.
Ted Kennedy had sounded the same theme on the Senate side immediately after the von Eschenbach appointment. And this website and Paul Goldberg's Cancer Letter have been pounding on this issue since the late Friday afternoon announcement on September 23rd.
Here's most of the House Democrats' letter:
"This dual responsibility - which exists despite Dr. von Eschenbach's pledge to give up his 'day to day' duties at NCI - opens the door to unacceptable conflicts of interest. FDA and NCI each have critical and independent roles in the drug safety system. In order to conduct a study on an experimental drug in human subjects, NCI must demonstrate to FDA that the drug is reasonably safe for initial testing in humans. Later in the drug development process, FDA is responsible for approving the same drugs that were tested at NCI.
"Having the same person at the helm of the NCI and the FDA violates the independent safeguards built into this system. There is no justification for merging these distinct roles.
"Unfortunately, Dr. von Eschenbach's responses to this conflict have been inadequate. For instance, he stated that, at FDA, he will refrain from participating in 'approval applications affecting drugs, devices, and biologics submitted by NCI or where an NCI employee was a Principal Investigator.' There may be occasions in which NCI employees invented or were involved in the early development of a particular drug compound that was then transferred to a commercial enterprise for additional development. Although that commercial enterprise would ultimately be responsible for seeking FDA drug approval, in this instance, NCI clearly would have played a significant role in the drug's development.
"Dr. von Eschenbach's prior involvement with this drug at NCI would still represent a conflict of interest.
"We are also concerned that the administration has explicitly reserved the ability to involve Dr. von Eschenbach in FDA matters in which NCI is a party on a 'case-by-case basis.' This provision negates Dr. von Eschenbach's promise to abstain from such matters. There is also no process by which the public can access information on the administration's handling of Dr. von Eschenbach's conflicts of interest as they arise.
"At a time when public confidence in the FDA has been severely undermined by a series of controversies, appointing a commissioner who faces a variety of potential conflicts of interest is a misguided choice that will seriously weaken both agencies. We urge you to insist on the appointment of an acting commissioner who is free from conflicts of interest and unencumbered by the demands of a second, equally vital role in protecting our nation's public health. Further, we urge you to nominate a permanent full-time FDA commissioner at the earliest possible moment."