- Guest blog by Roger Morris, The LondonBritian Company -
You’ve heard all the analogies: Is the glass half empty or half full? Does the dark storm cloud have a silver lining?
I was constantly reminded of this during the Food & Drug Law Institute’s latest conference on REMS held February 16 in Washington, D.C., as the residents and transportation system was trying to dig out of one-two snowstorms. It was an interesting conference, one that built substantially on the groundwork done at last year’s REMS conference which the FDLI co-hosted with ParagonRx.
The morning sessions delved into a litany of problems:
- Who decides what the goals of a REMS are and what constitutes success?
- Why should pharma and bio companies initiate voluntary REMS or significant risk management work in the absence of a mandate to do so from the FDA?
- How can the FDA possibly ask pharma to audit the pharmacy and distribution portions of a REMS when the manufacturers have absolutely no legal authority to do so – in fact, may be legally prohibited from doing so?
- And how can the work being done on a class-wide opioids REMS be a template for anything other than disaster?
But after lunch, the sun starting peaking out from behind the clouds, and the glasses on the speakers’ podium were definitely half-full. Two speakers in particular addressed the upsides of REMS.
Gretchen Dieck of United BioSource made three cogent points about pre-approval risk planning:
- REMS are an opportunity, not a burden
- Waiting until approval to start planning a REMS is too late
- The earlier a company starts with REMS during product development, the greater flexibility the REMS has
Then Gary Slatko of ParagonRx put meat on the bones:
- An early start to REMS planning allows companies to effectively find gaps and measures to plug them
- A REMS “ownership” plan gets rid of the “unwanted baby” phenomenon
- Planning beyond minimal REMS compliance will allow program modifications as needed in practice
In some ways, the conference showed that there are two parts of the REMS evolution. The “morning people” continue to emphasize the problems involved and fully flesh them out, while the “afternoon people” use this information to find ways to overcome these same problems.
For more information on REMS, go to www.paragonrx.com. For a conference transcript, go to www.fdli.org.
– Roger