The Senate just passed the FDA Revitalization Act, S. 1082, Final vote was: 93/1 -- with the one "Nay" vote coming from Bernie Sanders, the junior senator from Ben & Jerry's.
Some notable amendment wrap-ups:
Grassley amendment: to require the Office of Surveillance and Epidemiology and the Office of New Drugs at FDA to make joint decisions with respect to an action related to post marketing safety issues, labeling changes, post-approval studies and restrictions or use of drugs with serious risks. In the case of disagreement between the two offices, the Commissioners office would have made the determination.
Failed by a vote of 46/47
Durbin amendment: to disallow members of FDA advisory committees with a conflict of interest to vote on consideration of approval of a drug where they have a financial interest, refines evaluation and criteria for term of appointment to an advisory committee, limits waivers for conflicts of interest per committee meeting.
Failed by a vote of 47/47
Needless to say, the additional amendment victories of free speech (DTC) and safety (importation) make Kenzi an exciting and important step forwards towards 21st century public health.
Some notable amendment wrap-ups:
Grassley amendment: to require the Office of Surveillance and Epidemiology and the Office of New Drugs at FDA to make joint decisions with respect to an action related to post marketing safety issues, labeling changes, post-approval studies and restrictions or use of drugs with serious risks. In the case of disagreement between the two offices, the Commissioners office would have made the determination.
Failed by a vote of 46/47
Durbin amendment: to disallow members of FDA advisory committees with a conflict of interest to vote on consideration of approval of a drug where they have a financial interest, refines evaluation and criteria for term of appointment to an advisory committee, limits waivers for conflicts of interest per committee meeting.
Failed by a vote of 47/47
Needless to say, the additional amendment victories of free speech (DTC) and safety (importation) make Kenzi an exciting and important step forwards towards 21st century public health.
