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FDA Commissioner Sees Industry Role In Regulatory Science Initiative

This article was originally published in The Tan Sheet

Executive Summary

Drug and device firms should have a seat at the table as FDA strengthens its regulatory science program and thus speeds pre-market product reviews, Commissioner Margaret Hamburg says

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Calif. nixes smoking-cessation bill

Gov. Arnold Schwarzenegger vetoes a bill that would have mandated unprecedented insurance coverage for smoking-cessation products and services in California. Senate Bill 220 cleared the state Senate in August by a 22-13 margin and was vetoed Sept. 30. "This bill represents a costly health mandate that goes beyond current federal law," Schwarzenegger wrote of SB 220, which would have required coverage of Rx and OTC cessation drugs with no copayments, coinsurance or deductibles (1"The Tan Sheet" July 12, 2010). Although the bill's proponents touted it as a means of cutting into California's $8.6 billion annual costs related to tobacco addiction, the governor signed other legislation to codify broader preventive health service coverage requirements. A spokeswoman for the American Lung Association said the group is "very disappointed" in California's failure to pass SB 220, and it will await the results of the state's upcoming gubernatorial election before setting out a plan for reintroducing the bill in 2011

FDA Strategic Documents Outline Regulatory Science Priorities

Improving regulatory tools and scientific know-how are among FDA's top priorities over the next five years, according to a draft strategic report

Calif. nixes smoking-cessation bill

Gov. Arnold Schwarzenegger vetoes a bill that would have mandated unprecedented insurance coverage for smoking-cessation products and services in California. Senate Bill 220 cleared the state Senate in August by a 22-13 margin and was vetoed Sept. 30. "This bill represents a costly health mandate that goes beyond current federal law," Schwarzenegger wrote of SB 220, which would have required coverage of Rx and OTC cessation drugs with no copayments, coinsurance or deductibles (1"The Tan Sheet" July 12, 2010). Although the bill's proponents touted it as a means of cutting into California's $8.6 billion annual costs related to tobacco addiction, the governor signed other legislation to codify broader preventive health service coverage requirements. A spokeswoman for the American Lung Association said the group is "very disappointed" in California's failure to pass SB 220, and it will await the results of the state's upcoming gubernatorial election before setting out a plan for reintroducing the bill in 2011

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