If you can't measure it, then it doesn't count.
The FDA plans to draft guidances on how companies should create goals for a REMS and on the other metrics needed to determine if those goals are successfully met and a guidance on methodologies for assessing REMS. (FDA agreed in the PDUFA V commitment letter to issue a draft assessment guidance by the end of September 2014.)
An OIG review of 49 REMS, and the FDA’s reviews of those assessments states the obvious, “If FDA does not have comprehensive data to monitor the performance of REMS, it cannot ensure that the public is provided maximum protection from a drug’s known or potential risks.”
But sometimes the obvious is important to state.
According to the Pink Sheet, “FDA currently possesses no way to force sponsors to provide the needed assessment data, so OIG recommends the agency seek enforcement authority from Congress. FDA agreed that this recommendation should be pursued if an opportunity arises. That opportunity could be the reauthorization of the Animal Drug User Fee Act, which is eyed as a means to gain approval of a track and trace system.”
We’ll see if that dog hunts.
