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    New Commissioner Takes Post at FDA

    Robert Califf faces unfinished tobacco regulations.

    SILVER SPRING, Md. — Nearly one year after its former commissioner stepped down, the Food and Drug Administration (FDA) has a new leader.

    The U.S. Senate confirmed Robert Califf as the new FDA commissioner by an 89-to-4 vote on Feb. 24. Califf has been a prominent cardiologist and medical researcher at Duke University for more than 30 years and the FDA's No. 2 official, according to The Associated Press.

    With only a year left in President Obama's administration, Califf will be responsible for wrapping up many of its initiatives at the agency, including unfinished tobacco regulations, and food safety and labeling reforms, the news outlet reported.

    Under the Obama administration, the agency was given the authority to regulate tobacco products in the Family Smoking Prevention and Tobacco Control Act of 2009. Included in that directive are cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.

    However, the measure also gave the agency the ability to issue deeming regulations to extend its authority to cover additional tobacco products not specifically spelled out in the act. 

    For the tobacco industry, these deeming regulations, which the FDA proposed in April 2014, is probably the most-watched pending action. When finalized, the agency would have the authority to regulate electronic cigarettes, cigars, pipe tobacco, nicotine gels, water pipe (or hookah) tobacco and certain dissolvables not already under the FDA's authority. 

    Twenty months later, the proposed deeming rule is still in the hands of the White House Office of Management and Budget (OMB) for final clearance.

    Califf served as the FDA's deputy commissioner for medical products and tobacco from February 2015 until his appointment as commissioner on Wednesday. In that role, he provided executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He also oversaw the Office of Special Medical Programs.

    Prior to joining the FDA, Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and is founding director of the Duke Clinical Research Institute. 

    Former FDA Commissioner Margaret Hamburg left the agency in March. Stephen Ostroff, the FDA's chief scientist, filled the position until the new commissioner was named, as CSNews Online previously reported

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