They want to setup what is called REMS which means each patient, prescriber, distributor, and pharmacy completes the enrollment process to become enrolled in the FOCUS Program.
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163655.htm
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163655.htm