Recommendations Favor Pharmaceuticals

Source from:  Tobacco Reporter 12/16/2011

Reynolds American Inc's strategy of being an innovator in the area of potentially reduced-harm products has been struck a blow by recommendations from the US' Institute of Medicine (IoM), according to a story by Richard Craver for the Winston-Salem Journal relayed by the TMA. The IoM has recommended to the Food and Drug Administration that manufacturers have modified risk tobacco products (MRTPs) tested by FDA-approved third-party researchers before submitting them for approval. As part of its strategy, RAI bought Swedish cessation products manufacturer Niconovum in 2009 and its RJ Reynolds unit has been test marketing dissolvable smokeless tobacco products. RAI spokesman, David Howard, was quoted as saying the company would evaluate the IOM's recommendations and their applicability to FDA oversight over MRTPs. Meanwhile, David Sutton, a spokesman for Philip Morris USA, was quoted as saying that MRTP evaluation standards needed to be rigorous, yet feasible. A national policy that recognized the role of reduced harm tobacco products in improving public health was the right direction for the country, he added. Dr. John Spangler, at Wake Forest University School of Medicine, said he supported a higher scientific bar for MRTPs. But Bill Godshall, of SmokeFree Pennsylvania, criticized the recommendation, saying it would require a tobacco company to conduct far more research than the FDA required that drug companies conducted on nicotine-replacement therapy products before they could be marketed as smoking cessation aids. Enditem