In a widely expected move, US Department of Health and Human Services Secretary (DHHS) Kathleen Sebelius, an Obama Administration official who was appointed to the position in early 2009, will stay on in her position into at least the early parts of President Barack Obama's second term, The Hill reports.
Sebelius would be among just a small handful of Cabinet officials who would be staying on through the second term. Both she and her department are in the midst of implementing the administration's signature healthcare law, the Patient Protection and Affordable Care Act (PPACA), which contains dozens of provisions that stand to heavily impact the pharmaceutical, medical device and biotechnology industries by the time it comes into full implementation in 2014.
By staying on through at least part of a second term, Sebelius avoids a leadership void at DHHS, which would be required to have her successor confirmed by the Senate. Unlike in 2009, when the Democratic party controlled the Senate with a filibuster-proof majority of 60 members, the threat of a filibuster could be enough to derail any successor for months, if not indefinitely.
The filibuster threat against a successor would be likely, given the recent history of the Senate and its actions against similar healthcare agencies.
Obama's nominee to permanently head the office of the Centers for Medicare and Medicaid Services (CMS), Donald Berwick, was obstructed by Republicans in the Senate for more than a year, eventually causing Berwick to resign his post. The episode points to the difficulties of appointing heads of healthcare agencies at a time of political division over the implementation of the PPACA.
Sebelius has stoked controversy in the regulatory community during her first three years in office. In December 2011, she took the unprecedented step of overturning an FDA decision regarding the wider approval of Plan B One-Step, manufactured by Teva Women's Health, which regulators had approved for over-the-counter sale to all girls of "reproductive age."
Though Teva provided FDA with data to support the changes, Sebelius said that "after careful consideration," she would overrule their directive, keeping the product available as it was in the status quo.
The decision earned a swift protest from FDA Commissioner Margaret Hamburg, whose statement made clear that Sebelius' decision was made contrary to the responsibilities of FDA, precedent and the conclusions of its review staff. The decision was also panned by critics, who called it political in nature and a violation of the scientific mission of FDA. Sebelius, who was formerly the governor of Kansas, does not have a scientific background.
Since that decision, Sebelius has not exercised her authority to reverse any additional FDA decisions.