FDALegislativeWatch

FDA's Labeling Rule Should Be Tweaked Firms Say. Dems Want It Squashed.

FDA appears to have a relatively smooth task ahead of itself as it works to finalize its proposed rule delineating when firms can change product labels without prior agency approval since the comments supporting the proposal contain few suggested changes.

Whether the rule would be implemented, however, remains in question, given the amount of congressional pressure on FDA to withdraw it. The administration appears committed to finalizing the proposal, but must race against the clock to finish because if it is issued late in the year, the next president may have the power to suspend it due to the 60-day latency period for most new rules.

Comparative Effectiveness Requires Openness To Variety Of Data - CBO Chief

The development of comparative effectiveness will require increased flexibility in the types of data researchers may consider, with observational data taking on a more significant role, Congressional Budget Office Director Peter Orszag suggests. Orszag spoke at a Nov. 13 press gathering to unveil the CBO's long-term outlook for health care spending.

Randomized clinical trials are generally viewed as the gold standard for evaluating medical products and services, he acknowledged. However, "it is implausible to me that to build out the evidence base that will be necessary for [comparative effectiveness research] that you are going to be able to rely exclusively on randomized control trials. I believe the medical profession will inevitably have to rely on the imperfections of econometric analysis of panel set data."

Vitamins, Supplements Added To Food Stamp Program In Senate Farm Bill

The Senate Agriculture Committee on Oct. 25 added multivitamins and other dietary supplements to food stamp coverage in legislation to reauthorize federal farm subsidy programs.