MDDI_Medical Device & Diagnostic Industry

MDDI, June 2014

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Washington Wrap-Up 18 | JUNE 2014 Image courtesy of HHS.GOV Good Riddance to HHS Secretary Kathleen Sebelius Sebelius, who resigned in April, has the dubious distinction of being the only secretary to reverse an FDA scientific finding in the service of politics. JIM DICKINSON H HS secretary Kathleen Sebelius, repository of all of FDA's statu- tory powers and the least compe- tent and most politically meddlesome sec- retary in my 40 years of reporting on FDA activities, stepped down from her position in April 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 plati- tudes spouted by President Obama and a few others to save a little face for having ap- pointed her in the first place. She was the first HHS secretary to coun- termand—bypassing the commissioner— a public commitment by a high-ranking 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, not- withstanding 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, FDA 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 rollout, 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 untranspar- ent 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 thank- less task, and a real issue, exemplified by the Sebelius experience, remains: How do we attract the best people to do it? Public ser- vice pays less than comparable private sec- tor work, and public service employees are often vilified for their efforts. 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. Sebelius FDA Seeks Comments on IDE Live Case Presentation Guidance FDA has released for comment a draft guidance, Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials, to describe important infor- mation that should be provided in an origi- nal IDE application or a supplement to an IDE application when a sponsor anticipates including a live case presentation during a clinical investigation. The document is also intended to pro- vide guidance to institutional review boards on factors to consider when evaluating an investigation that contains a live case pre- sentation. According to the guidance, a live case presentation generally involves a video broadcast of an ongoing surgical or per- cutaneous procedure, often accompanied by live narration by, or audience or expert panel interaction with, the operating sur- geon, or a video recording of the procedure for later broadcast. FDA says it expects very few inves- tigations conducted under an IDE will need live case presentations. But in a few studies, such presentations may increase awareness of the study for potential in- vestigators and facilitate recruitment of subjects. The draft guidance is intended, in part, to improve the quality of information sub- mitted by sponsors in an IDE application or supplement and to ensure consistency in reviewing those submissions. It is expected to reduce the need to submit an IDE supple- ment solely for purposes of conducting a live case presentation after an IDE applica- tion has been approved. ES450947_MD1406_018.pgs 06.03.2014 02:38 UBM black yellow magenta cyan

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