Good Riddance to Kathleen Sebelius at HHS

Posted in Regulatory and Compliance by Jamie Hartford on April 21, 2014

Commentator Jim Dickinson says Sebelius, who resigned April 10, has the dubious distinctions of being the first HHS secretary to reverse a public commitment by a high-ranking FDA official and the only secretary to reverse an FDA scientific finding in the service of politics.

Jim Dickinson

HHS secretary Kathleen Sebelius, repository of all of FDA’s statutory powers and the least competent and most politically meddlesome secretary in my 40 years of reporting FDA activities, has stepped down under fire for lapses having little or nothing to do with FDA.

But FDA will profit from her departure, and no one will long remember the platitudes spouted by Obama and a few others to save a little face for having appointed her in the first place.

She was the first HHS secretary to countermand, bypassing the commissioner, a public commitment by a high FDA career official. This was the promise in 2012 made by CDRH director Jeffrey Shuren to render a decision in a petition to reconsider a controversial 2009 “safe and effective” finding on dental amalgam notwithstanding its scientifically documented toxic 50% mercury content.

Even as the New York Times published an in-depth investigative report that detailed numerous ways HHS operatives under Sebelius were invading FDA scientific decision-making on drugs, sunscreens and food labeling, Sebelius plunged in deeper.

She became the only HHS secretary ever to have reversed an FDA scientific “safe and effective” finding on a drug in the service of politics, namely the Plan B emergency contraceptive’s safety and effectiveness for underage girls.

This set a shameful precedent that future secretaries will be tempted to emulate, and it sent a demoralizing message to FDA managers and scientists: your most diligent efforts are subject to political reversal. Regrettably, commissioner Margaret Hamburg did not, so far as is publicly known, object.

In the matter that is more germane to her overdue fall, the debacle of the Obamacare roll-out, Sebelius’s terminal failing was cited by an anonymous White House source in the Wall Street Journal as being “regularly overruled on policy matters by the White House.” In an administration as untransparent as Obama’s it is remarkable that such a seemingly candid comment could ever have leaked from such a high source.

Public service can be and often is a thankless task, and a real issue, exemplified by the Sebelius experience, remains: How do we attract the best people to do it? They are paid less than comparable private sector work would pay, and they are often vilified for it.

Fortunately, most do not do it for the money or the power, but for the honor of attempting to do their part for the American public at the call of the President.

I would not profess to know whether this was Sebelius’s reason for accepting a novice president’s invitation to the cabinet.

Jim Dickinson is MD+DI's contributing editor.


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It's All Politics

People need to understand that Secretaries serve at the behest of the President of the United States. Nothing more, nothing less. Whatever problems people may have had with Ms. Sebelius, people must put those issues in context with the Administration and the political and socioeconomic times in which she served. To truly assess a person's competence in the Health and Human Services role, one must view this person through that particular mud-covered lens. I submit that this is impossible, and I don't think Ms. Sebelius was any better or worse than any other person in her position.

Paul Stein

Political partisanship

I don't expect this level of political partisanship from a professional organization. I do expect professionalism and guidance for the industry. Your mission statement, lest I need to remind you, is:

"... to help medtech industry professionals develop, design, and manufacture products that comply with complex and demanding regulations and evolving market requirements."

I don't see anything about partisan & divisive political ad hominem (or ad feminam in this case) attacks listed there. This editorial falls far short of the tone & quality I expect from MD+DI.

Who's being a political partisan here?

With all due respect I profoundly disagree.

The opinion piece didn't exhibit political partisanship, Rather, it expressed an opposition to Ms. Sibelius' injection of politics into what should be science-based policy-making.

If you are truly opposed to the injection of politics into medicine, you should join Mr. Dickinson in cheering her departure.

Now, perhaps we can get the FDA back to making decisions based on the science, *not* based on political considerations, as it should.