The House Committee on Energy and Commerce may propose "emergency legislation" requiring FDA to inspect and approve drug manufacturers before they ship products to the U.S., according to letters sent Feb. 21 to FDA and the Health and Human Services Department by Chairman John Dingell and Rep. Bart Stupak, Subcommittee on Oversight and Investigations chairman. The Michigan Democrats are investigating whether such legislation is necessary "to protect Americans" following FDA's failure to inspect a Chinese manufacturer that may be connected to the roughly 350 adverse events and four deaths related to Baxter Healthcare's injectable blood thinner Heparin (1"The Tan Sheet" Feb. 18, 2008, p. 15). The chairmen lambaste FDA, alleging the agency "abandoned ... its vital pre-approval inspection policy for the U.S. drug supply." In addition, they ask FDA, HHS and Baxter to turn over records related to the Heparin scare for further review...

FDA is modifying the charter for its Risk Communication Advisory Committee to reflect new powers the agency gained as part of the passed FDA reauthorization bill

Compliance consultants warn that certain dietary supplement good manufacturing practices violations are inspection "showstoppers" and will draw agency enforcement