FDA and the industry share thoughts at FDLI risk management conference
Earlier this month, while Washington was bustling with Inaugural preparations, there was an excellent meeting in the capital on pharmaceutical risk management, hosted by the Food and Drug Law Institute (FDLI) at the offices of Morgan, Lewis & Bockius LLP. The impetus of the meeting was to provide a forum for some of the authors of the recently published text, Pharmaceutical Risk Management: Practical Applications (FDLI, 2008) as well as other experts within the industry and within the FDA. Industry veteran Wayne Pines, who edited the book along with me and my colleague at ParagonRx, Gary Slatko, chaired the conference.
I would like to share with you some of the more-intriguing thoughts to come out of the conference, as well as a few news tidbits – but first let me say that if you would like to obtain a complete transcript of the conference or to buy a copy of PRM: Practical Applications, please contact the FDLI website at www.fdli.org.
Now, some notes coming out of the conference that I think might be of potential interest to all of us who work with REMS, risk management in general, and the appropriate use of medicines and medical devices:
- REMS Guidances. Claudia B. Karwoski, Director, Division of Risk Management, Office of Surveillance and Epidemiology, CDER, FDA, broke any suspense about whether REMS guidances would be issued any day now. Not. While the FDA hopes to have them out by year’s end, they are still in the midst of collecting opinions and information.
- Moving Beyond REMS Design to Resourcing REMS Implementation. Janice K. Bush, Vice President – Benefit Risk Management/Translational Pharmacovigilance at Johnson & Johnson, reminded participants that the design of a REMS is “like childbirth” – it can be painful, and there is a lot of care and feeding to be done after it is created. For development stage products, the implementation of the REMS will occur at the most busy time in the lifecycle of a pharmaceutical company – during product launch. Most employees associated with the new product will already be working their “day jobs” to support product launch, and dedicating the necessary time and effort to launch the REMS program will be challenging. Gary Slatko, Chief Medical Officer at ParagonRx, suggested establishing a REMS Coordination Office within companies and applying project management techniques to assure that internal and external resources are all “in sync” while implementing a REMS.
- Medication Guide Assessment. The most frequently used REMS element to date has been a medication guide. Of the 25 REMS approved to date, 19 required a medication guide. FDA has required the sponsor to assess the effectiveness of the med guide, and this has been challenging for sponsors. In particular, sponsors have been challenged to design assessments that verify distribution of med guides by pharmacists and the adherence to/understanding of med guide directions by patients. Claudia Karwoski indicated there is no current expectation that sponsors need to directly quantify the dispensing of med guides by pharmacists (but she would welcome any suggestions). Rather surveying patient recall of receipt of med guides is a typical method being employed by sponsors.
- Creating Commercial Benefit. Clearly, the purpose of REMS is to mitigate risks associated with certain medications. Yet, risk mitigation need not occur at the expense of commercial success. In fact, Slatko presented research findings demonstrating that there are combinations of REMS tools that, if designed and implemented property with regard to the needs of all parties, can actually increase a physician’s intention to prescribe a potentially risky product. The increase in intended prescribing between a program physicians consider to be too-restrictive and a program physicians consider to be appropriate can be on the order of a 250 % increase.
- The Need for Further Group Dialogue. Obviously there were many more intriguing presentations and thoughts brought up during discussions. As a result, meeting participants proposed that we use existing technology to create a continuing community of discussion about REMS, risk management in general and appropriate use of medications and devices. This online community will foster ongoing dialog and knowledge-sharing among thought leaders, regulators, and industry professionals in risk management. Please click here if you would like to be a part of that community.
Finally, I would appreciate hearing your thoughts and additions if you attended the conference and general feedback from those of you who did not.
I’ll be back with more observations about our exciting, emerging discipline next week.
Jeff