FDA tobacco regulation burns out
This article was originally published in The Tan Sheet
Executive Summary
A provision mandating FDA regulation of tobacco products was struck from the $140 bil. American Jobs Creation Act in the Senate Oct. 6. Co-sponsor Mike DeWine (R-Ohio) called the apparent defeat of the "Youth Smoking Prevention and Public Health Protection Act" a "missed opportunity to pass one of the most important public health provisions that the Congress could ever consider." The FDA regulation bill originally passed the Senate in July (1"The Tan Sheet" July 19, 2004, In Brief)...
You may also be interested in...
FDA tobacco regulation re-lit?
"Family Smoking Prevention and Tobacco Control Act" (S 2974) survives the Senate, passing by unanimous consent and moving to the House Oct. 10. The bill, introduced by Sen. Mike DeWine (R-Ohio) and co-sponsored by Sens. Ted Kennedy (D-Mass.) and Jim Jeffords (I-Ver.), was originally included as part of the $140 bil. American Jobs Creation Act. However, the provision in the JOBS Act, which would give FDA regulatory authority over tobacco products, was excised before the bill moved into conference (1"The Tan Sheet" Oct. 11, 2004, In Brief)...
Tobacco bill passes Senate
Branded and generic nicotine replacement therapy products may get quicker routes to market under an amendment to the American Jobs Creation Act of 2004 (HR 4250), which passed the Senate July 15. The amendment, introduced by Sen. Mike DeWine (R-Ohio), would allow FDA regulation of tobacco products and provide a buyout for tobacco farmers. For NRT marketers, the provision advocates the use of time-and-extent applications and other FDA fast-tracking of smoking cessation products, reflecting DeWine's earlier bill (1"The Tan Sheet" May 24, 2004, p. 9)...
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.