Now set the teeth and stretch the nostril wide.
A separate safety office?
Hold hard the breath and bend up every spirit.
Report language in a House appropriations bill for FDA outlines the creation of an independent office within the agency to evaluate a drug's post-market safety profile.
Straining upon the start. The game's afoot.
According to Representative Rosa DeLauro (D, CT), who chairs the House Appropriations subcommittee, this new FDA office would (per the Pink Sheet) “avoid the potential for bias that arises when FDA staff who approve a drug are the same people who make decisions when a marketed drug's safety is called into question.”
This is a bad idea for many reasons, let me mention two:
(1) How can you determine a drug’s “safety” without also understanding its real world concomitant benefit?
(2) The more-than-implied accusation that FDA staff that worked on a drug’s ultimate approval cannot be trusted to view safety issues without “bias” is entirely untrue and highly insulting. Who can be trusted? FDA's own "Bard of Safety" -- David Graham? Shame. Shame. Shame.
Representative DeLauro did not provide specific language on a separate safety office during the subcommittee markup, but noted that she developed it with assistance from Senator Charles Grassley (R, IA), and Representative Maurice Hinchey (D, NY). Mr. Hinchey introduced H.R. 4816, the FDA Improvement Act of 2010, which would establish within FDA an independent Center for Post-Market Drug, Device and Biologics Safety and Effectiveness.
Once more unto the breach, dear friends, once more.
On the DDMAC front, the report calls for $3 million more for Abrams & Associates to review DTC materials and an additional $2 million for professional communications.
Depending on where you sit, that’s either too much or too little.
But when the blast of war blows in our ears,
Then imitate the action of the tiger
