If recent events are any indicator, REMS programs are here to stay. Risk strategists are becoming as key to drug approval as manufacturing quality assurance.
The FDA appears to be approaching its use of REMS in classic scientific fashion, scrutinizing program implementations for insights to shape future risk mitigation efforts. As the regulator studies what's effective and applies that knowledge, both patient safety and patient compliance with drug regimens are likely to improve.
But manufacturers face a moving target in REMS creation. Risk strategists need to keep pace with regulatory thinking. And they need to begin doing so in the early stages of drug development.
Three REMS experts--Annette Horner of CIS, Jeffrey Fetterman, Paragon Rx, and Frank Gallo, PPD--offer their tips for early-stage thinking on program development in our special report. Their opinions have been shaped by the multiple-sponsor experiences of consultants and service providers. In short, start early and think broadly, both in terms of drug life cycle and the needs of the various parties involved in the making, prescribing and taking of a drug. Read the report ⇒