As if to help clear the decks at CDER, whose drug-safety flounderings more than anything else provoked passage of the Democrat-driven FDA Amendments Act 9/20, the Bush Administration late Friday (9/21) announced the abrupt elevation of CDER director Steven Galson to acting surgeon general effective 10/1, and his temporary replacement by FDA chief medical officer Janet Woodcock, who held the post for 11 years until 2005. Late Friday is the customary Washington time for announcing major changes to which the government does not want to draw much attention.
Galson’s tenure at CDER’s helm was characterized by major public turbulence on the subordination of drug safety reviews to drug-approval reviews, which he tried to reverse. It was also characterized by his
discomfort with the highly politicized Plan B emergency contraceptive OTC-switch controversy. Although his final decision ultimately was in line with the Bush Administration’s unstated position on it, this cost him much respect in the ranks below, among Capitol Hill Democrats and among women’s health activists. His elevation to acting surgeon general thus may be regarded as a kind of golden parachute, and a reward for loyal service, as the Administration prepares to work as cooperatively as it can with its Democratic adversaries in implementing the FDA Amendments Act. Galson will now be out of the line of fire, and the widely respected Woodcock, who will continue her chief medical officer/deputy commissioner roles, will not draw the same flak because she does not have the same “baggage” with the Democratic majorities who will be supervising that implementation.
FDA commissioner Andrew von Eschenbach told employees 9/21 that a national search for a permanent CDER director will begin “immediately.” Outlining an approach that will likely take months to complete, he promised that “All highly qualified internal and external candidates will be considered. We will assemble an FDA search committee to ensure input from FDA staff, and we will also seek external stakeholder consultation. We plan to conclude this search expeditiously in order to have permanent leadership in place as soon as possible.”
He said he also “look[s] forward to the continued leadership of Dr. Doug Throckmorton as deputy director of CDER to provide valuable continuity.”
Calling Galson’s new assignment an honor that is “well deserved,” von Eschenbach said he had “an exemplary record of service at the FDA since joining the agency as deputy director of CDER in May 2001. ... No one in the FDA has demonstrated a stronger commitment to promoting and protecting the public health than Dr. Galson.”
For von Eschenbach’s official announcement of the changes, click
here.
In a farewell message to CDER employees, Galson wrote:
“It is with mixed emotions that I announce that, beginning October 1, I will be leaving CDER to become acting surgeon general. This is an exciting opportunity for me to serve the country as a public health educator and leader and drive the advancement of the PHS Commissioned Corps.
“The timing is never right for an unexpected leadership change. I did not see this opportunity coming. The decision to leave CDER was difficult, particularly knowing the enormous challenges we face. At the same time, I am proud of the strong management team in place in the Center and our accomplishments together over my tenure. We have undergone multiple external reviews related to drug safety and have emerged with a robust plan to improve the way we work together and make our regulatory decisions. We have established a Drug Safety Oversight Board that provides new opportunities to manage and resolve difficult post marketing decisions. Just this week we awarded a $1.5 million management consulting contract to assist us with implementation of the IoM recommendations on cultural improvement. Also this week we published the first FDA Drug Safety Newsletter, fulfilling a commitment to improve how we communicate with health care practitioners on emerging issues. Our senior leadership team has been focused on process improvement across the Center and we are implementing a suite of important changes in many areas — although the process improvement journey in a regulatory agency is never over. Our SMT [strategic management team] just completed a retreat during which we identified our vision for future — a vision that will be shared with you at the State of CDER speech next month. We have created the new position of associate Center director for analysis and strategic initiatives and brought Dr. Theresa Mullin on board to help lead us forward on the many complex tasks ahead. With the passage of major FDA legislation in Congress we are positioned to move into the next few years with more resources and more authority. We have strong support from the commissioner and the agency’s senior leadership team. I know that after my departure the Center will continue to move forward on the critical public health priorities you address every day.
I am deeply privileged to have worked alongside such a dedicated and talented group of public servants. I am particularly grateful to Doug Throckmorton, whose calm and skilled hand at my side has helped the Center thrive through some particularly challenging times. From all of you — CDER’s pride and lifeblood, I have learned so much during my tenure at CDER that will continue to influence my public health work. Thank you.”
*** FDA Webview is the leading online FDA news center. To learn more about our services, visit us at www.fdaweb.com and request a free trial.
