Jill Wechsler
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After months of turmoil over drug safety, vaccine shortages, and pressure to import low-cost drugs from abroad, FDA faces
further upheaval from within. Commissioner Lester Crawford resigned abruptly in September after only two months in the top
spot. The White House named Andrew von Eschenbach, director of the National Cancer Institute (NCI) at the National Institutes
of Health (NIH), as acting FDA commissioner. But his initial decision to remain NCI director while taking the helm of FDA
raised an outcry. Von Eschenbach agreed to drop day-to-day management of NCI in the face of clear conflicts of interest between
advocating for speedy access to new cancer treatments while overseeing the assessment of the safety and effectiveness of those
therapies.
Von Eschenbach reassured FDA staffers that he would work hard to ensure a "smooth transition" and to keep agency efforts "on
track." FDA leaders insist they will carry on as usual during the transition to new leadership. Following Crawford's terse
resignation announcement, Deputy Commissioners Scott Gottlieb, Janet Woodcock, Murray Lumpkin, and Patrick Ronan sent a message
to all FDA employees emphasizing their commitment to the agency and intention of continuing its important work. Von Eschenbach
is familiar with the FDA drug testing and review process from collaborative NCI-FDA efforts. He has been enthusiastic about
joint initiatives to validate biomarkers and advance personalized medicine.
Von Eschenbach also is highly regarded in the cancer research field, knows his way around Capitol Hill, and has personal connections
to the Bush family from his leadership position at Houston's M.D. Anderson Cancer Center. Cancer patient groups have praised
his support for accelerating access to new treatments, and biotech companies publicly applauded the choice. James Greenwood,
president of the Biotechnology Industry Organization, described the acting commissioner as someone with "unique insights into
the critical need to advance new treatments for patients with life-threatening illnesses."
NOTHING PERMANENT
However, von Eschenbach officially remains director of NCI, a position he wants to retain because HHS secretary Mike Leavitt
has indicated that the acting commissioner will not be named to take the reins at FDA permanently. Von Eschenbach's enthusiasm
for approving new drugs quickly has drawn fire from parties that are equally concerned about protecting relatively healthy
patients from high-risk medicines. In addition, the acting commissioner knows little about the many complex and critical regulatory
programs that FDA oversees, such as concerns about the safety and testing of implantable medical devices. FDA staffers already
are finding it difficult to move forward with controversial initiatives. A much-anticipated white paper on follow-on biologics,
for example, won't be released any time soon, apparently to give the lawyers time to further examine policy and legal issues.
At FDA, von Eschenbach has to deal with many of the issues that plagued Crawford and delayed his confirmation by the Senate
last spring. FDA still faces proposals from Congress to overhaul its oversight of drug safety arising from the Vioxx debacle,
to ensure adequate supplies of vaccines for influenza and childhood diseases, and to permit broader access to the morning-after
pill, Plan B. Although Congressional leaders, manufacturers, and the bioresearch community have urged the White House to name
a qualified individual for that spot as soon as possible to head FDA permanently, the cloud hanging over Crawford's departure
won't make it easy to attract a talented scientist and administrator to the job. Senate Democrats refuse to consider candidates
with ties to the pharmaceutical industry, and conservative Republicans want someone who shares their political views. Current
FDA officials face difficulties because of close ties to recent agency missteps. Further complicating the picture is an investigation
into the reasons for Crawford's surprise resignation; Senate leaders who backed Crawford's appointment want to know whether
they were denied access to important information during the confirmation process. FDA desperately needs a strong leader who
can restore public trust in the troubled agency – but this may be hard to find.
ASSESSING SAFETY
An immediate challenge for FDA's leadership is to reassure its constituents that drug safety problems are not creating a go-slow
approach in FDA review offices. Some observers believe that safety concerns are delaying the approval of important new therapies,
and that advisory committee meetings spend more time than is warranted discussing minor adverse events. FDA recently postponed
approval of Celgene's blood disorder treatment, Revlimid (lenalidomide), pending further review of the company's risk-management
plan for preventing pregnant women from using this newer version of thalidomide.
