The spending sequestration, scheduled for Jan. 2, has left a question mark hanging over activities at the FDA, National Institutes of Health and other federal agencies. The administration missed its Sept. 6 deadline to provide Congress with a report identifying all the federal accounts to be sequestered and estimating the percentage of the cuts that would be applied to achieve the mandated savings in fiscal 2013.

The FDA's Cardiovascular and Renal Drugs Advisory Committee voted against approval of Cornerstone Therapeutics Inc.'s lixivaptan for hyponatremia in association with syndrome of inappropriate antidiuretic hormone secretion (SIADH), even though lixivaptan met the surrogate endpoint and raised no safety concerns in the SIADH population.