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Writer's pictureSanjay Trivedi

Change of FDA Commissioner may impact Indian Pharma companies


FDA Commissioner Scott Gottlieb has resigned & his resignation will take effect in about a month. An acting commissioner will likely be named soon. Indian Pharma companies, with the maximum US FDA-approved manufacturing sites outside the US and supplying 40 per cent of the generic formulations marketed in the US, may feel the impact of this resignation & new appointment to be announced shortly.

CDC, NCI, and FDA released findings from the 2018 National Youth Tobacco Survey. The findings include current use of seven tobacco products, including cigarettes, cigars, e-cigarettes, smokeless tobacco, pipe tobacco, hookah tobacco, and bidi, as well as findings on use of multiple products and frequency of use. The results show that there were alarming increases in current use of any tobacco product among both middle and high school students between 2017 and 2018, primarily because of an increase in e-cigarette use.

Scott said that the rapid increasing popularity of e-cigarettes among youth is one of the most troubling public health issues today. The 2018 National Youth Tobacco Survey found a 48% increase from 2017 among middle school students who currently use e-cigarettes. FDA is committed to reducing death and disease from tobacco, and ending youth use, until my last day at the agency - and then for all the decades thereafter. We have no more impactful tool to reduce mortality than our tool of tobacco product regulation.

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