FDA Shifts to Pre-Empting Drug Risks as REMS Program Reaches 'Terrible 2s'
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WILMINGTON, Del., Nov. 11 /PRNewswire/ -- A drug safety expert says the Food & Drug Administration (FDA) has shifted from its traditional role of managing pharmaceutical drug safety to trying to preempt drug risks through its REMS - Risk Evaluation Mitigation Strategy - programs, which he characterizes as having reached their "terrible twos" stage of development.
Speaking at a Cambridge Healthtech Institute conference last week, Dr. Gary Slatko, chief medical officer of ParagonRx, said that, "The FDA has been extending its REMS authority during its initial two-year period beyond safety risks, also addressing a drug's relative efficacy as well as trying to mitigate off-label uses, the normal purview of prescribing physicians."
During his talk - which tracked the evolution of the FDA's safety actions - Dr. Slatko said that, "The FDA has, during the past eight years of risk management and REMS programs, moved beyond reacting to drug safety crises with new regulations to trying to prevent crises before they happen. For better or worse, that means the FDA is now working in areas that once were handled strictly by pharmaceutical companies and addressing prescription issues that were once the special preserve of doctors."
Dr. Slatko's talk will be the focus of a webinar at 11 a.m. on Wednesday, Dec. 9, sponsored by ParagonRx, and information will be posted soon to the ParagonRx website.
ParagonRx is a Delaware-based company specializing in pharmaceutical risk management and optimal medication use and has worked with many pharmaceutical and biotech companies in formulating and enacting risk management and REMS programs.
For more information on REMS and related issues, go to www.paragonrx.com.
SOURCE ParagonRx
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