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Wednesday, Sep 16 2015

Full Issue

Obama Picks Cardiologist Robert Califf As Nominee For FDA Commissioner

Califf joined the Food & Drug Administration as a deputy commissioner last February following years as a researcher and administrator at Duke University and was considered a likely candidate for the top job.

President Obama on Tuesday nominated cardiologist Robert Califf to lead the Food and Drug Administration (FDA), which has been without an official head since the beginning of April. Califf, a renowned researcher who spent most of his career at Duke University, joined the FDA in February to become the deputy commissioner for medical products and tobacco. (Ferris, 9/15)

The nomination comes after the resignation this spring of Margaret A. Hamburg, who left the agency in March after a six-year tenure marked by a wave of new drug approvals, as well as legislation to overhaul the nation's food safety system and begin regulating tobacco products for the first time. Stephen Ostroff, previously the FDA's chief scientist, has served as acting commissioner in recent months. (Dennis, 9/15)

President Barack Obama has nominated the Food and Drug Administration鈥檚 second-highest ranking official, Dr. Robert Califf, to lead the agency, which regulates consumer products ranging from medications to seafood to cigarettes. The White House made the announcement late Tuesday in a statement naming officials nominated for various federal posts. (Perrone, 9/15)

Meanwhile, the FDA also orders a sales聽halt聽for four types of R.J. Reynolds cigarettes -

The Food and Drug Administration halted the sale of four types of R. J. Reynolds cigarettes on Tuesday, saying the company failed to prove that they were not more harmful than products already on the market. The agency ordered retailers who sell any of the cigarettes to stop immediately and to dispose of them within 30 days or face financial penalties or criminal prosecution. (Tavernise, 9/15)

The affected cigarettes 鈥 Camel Crush Bold, Pall Mall Deep Set Recessed Filter, Pall Mall Deep Set Recessed Filter Menthol and Vantage Tech 13 鈥 have a combined U.S. market share of less than 1% and aren鈥檛 expected to have a significant impact on sales. But the move could signal a tougher regulatory stance as the FDA reviews thousands of applications for new tobacco products. It comes after the FDA sent warning letters last month to three companies, including Reynolds American, for violating federal law by marketing some of their brands as 鈥渁dditive-free鈥 or 鈥渘atural.鈥 (Esterl, 9/15)

For the first time, the Food and Drug Administration has ordered a major tobacco company to stop selling several types of cigarettes. The FDA on Tuesday ordered the R.J. Reynolds Tobacco Company to stop selling four products: Camel Bold Crush, Vantage Tech 13 and the regular and menthol versions of Pall Mall Deep Set Recessed Filter cigarettes. The FDA has ordered other cigarettes off the market before, but those actions involved much smaller companies selling much less popular cigarettes. (Stein, 9/15)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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