A compromise bill that supporters say gives the U.S. Food and Drug Administration great regulatory control over drug compounders has been announced by congressional leaders from both the House and Senate, but it is unclear whether it has the support of the FDA itself.
The compromise was disclosed late Wednesday in news releases issued by U.S. Sen. Lamar Alexander, R-Tenn., and a bipartisan group of House leaders, including U.S. Rep. Henry Waxman, a California Democrat.
The agreement comes a year after the beginning of a fungal meningitis outbreak that took the lives of 16 patients treated in Tennessee and 64 nationwide. The deadly outbreak has been blamed on a Massachusetts drug compounding company that shipped fungus-tainted spinal steroids to health care providers in 20 states.
Industry officials said the compromise had been worked out over the weekend, but they expressed concerns the FDA had last-minute objections.
Erica Jefferson, FDA spokeswoman, said she could not immediately comment on the matter. Actual copies of the legislation were not immediately available.
continue to read here
No comments:
Post a Comment