Kansas governor Sebelius to lead US health and human services
This article was originally published in Scrip
US President Barack Obama's nomination of Kansas governor Kathleen Sebelius as health and human services (HHS) secretary should accelerate both the appointment of an FDA commissioner and federal policy shifts on medicines importation and embryonic stem cell research.
Kansas Governer, Kathleen Sebelius nominated for HHS Secretary
Ms Sebelius's nomination was announced one month after Tom Daschle, the initial nominee and a close advisor to Mr Obama, withdrew his name owing to tax problems. Mr Daschle was to hold a dual role, also heading a new office on health reform in the White House. His withdrawal from both positions was a blow to advocates seeking quick movement on changes to the healthcare system and delayed the nominations of new leaders for agencies within HHS, such as the FDA and Centers for Medicare and Medicaid Services (CMS).
Healthcare policy expert Nancy-Ann DeParle has been named to lead the White House health reform office. She was administrator of the Health Care Financing Administration (now the CMS) from 1997-2000 and is currently managing director of CCMP Capital, a private equity firm. She is also a director for several healthcare services companies, including the pharmacy benefits manager Medco.
Both women will play pivotal roles in spearheading the development and implementation of healthcare reform initiatives. In his fiscal 2010 budget proposal, Mr Obama proposed to create a $634 billion reserve over 10 years to help fund a major expansion of healthcare coverage. As HHS secretary, Ms Sebelius would also oversee the $1.1 billion in comparative effectiveness research funding included in the recent economic stimulus package.
Ms Sebelius has served as Kansas's Democratic governor since 2003. Before that she was the state's elected insurance commissioner and succeeded in blocking the sale of a large insurance company there. As governor she has experience running the state's Medicaid programme for the poor, although her efforts to expand healthcare coverage by raising the cigarette sales tax were blocked by Republicans.
She will head an HHS department encompassing 65,000 employees if confirmed by the Senate, where her positions on abortion could draw opposition from conservative Republicans. Although she was raised Roman Catholic, she has taken actions supporting abortion rights.
The innovator group PhRMA said Ms Sebelius "is a wise choice to guide the president on shaping healthcare reform. Gov Sebelius combines the vital combination of skills that it will take to accomplish this challenging job: toughness and an intimate understanding of the healthcare challenges that face our nation in these tough economic times".
Nevertheless, the pharmaceutical industry will not be cheering the governor's position on drug importation. She succeeded in having Kansas join a multi-state consortium that allowed residents to order cheaper medicines from Canada, the UK and Ireland, according to the Washington Post.
The administration's fiscal 2010 budget outline suggests there will be a change in long-standing FDA/HHS policy against importation, which has always been premised on safety concerns. "The budget supports the FDA's new efforts to allow Americans to buy safe and effective drugs from other countries," the outline says. Further details are expected next month.
Having an HHS nominee in place also could finally spur a reversal of federal funding restrictions for embryonic stem cell research. Upon taking office, Mr Obama was expected to quickly issue an executive order overturning the funding limits imposed by President George W Bush in 2001, but that has not yet happened.
At a recent press briefing, BIO president and CEO Jim Greenwood said he assumes the lack of White House action was due to the delay in lining up an HHS secretary. "I think it's probably just as a matter of protocol they'd like to have the secretary in place," he said. "I don't think they're necessarily waiting for a [National Institutes of Health] director to be in place in order to do that. That's my assumption, that there's no ideological policy issue here."
An executive order is expected in advance of congressional action on stem cell legislation. In late February a bipartisan group of senators introduced a measure to allow federal funding of research using stem cell lines derived from excess in vitro fertilisation embryos. It is the same measure that passed both chambers of Congress in 2007 but was vetoed by Mr Bush.
The naming of an HHS secretary should accelerate an announcement about new leadership at the FDA, which is currently being helmed by chief scientist Dr Frank Torti on an interim basis. The names most frequently cited for the FDA's top leadership posts are former New York City health commissioner and HHS assistant secretary Dr Margaret Hamburg, currently a senior scientist at the non-profit Nuclear Threat Initiative, and Dr Joshua Sharfstein, the health commissioner of Baltimore City, Maryland.