FDA makes REMS a drug approval staple

St. Louis-based law firm Bryan Cave expects the FDA to step up its risk evaluation and mitigation strategy activities in the coming year. "Stakeholders have expressed that they would like PDUFA V [the next update of the act that allows the regulator to collect fees from the drug industry] to work out the kinks in how the safety program is implemented," according to a bulletin to its clients.

Stakeholders at the mid-April public meeting also said they want the regulator to issue guidance that will streamline the review process, and involve doctors and pharmacists earlier in the process.

Separately, and as if on cue, the RPM Report says that the regulator is developing a grid of the five basic factors that need to be addressed in any decision on the commercial availability of a drug. The fifth of these concerns a drug's level of risk management. "FDA is going to take that into consideration in every decision; sponsors who ignore or underplay the identification of who should use the product and who might use it will have a gap in their filings," according to the report.

The FDA, through its REMS negotiations with drugmakers over the last two years, has already tipped its hand that risk management is now a formal component of drug approval.

- here's the Bryan Cave bulletin
- see the RPM article