OR WAIT null SECS
In the past year, FDA has imposed REMS programs for one out of four new drug approvals
The Risk Evaluation and Mitigation Strategy (REMS) requirement—a type of postmarketing compliance program—is gathering momentum at FDA, and service providers are bulking up staff to meet their clients’ needs. The latest action is the acquisition of ParagonRx (Wilmington, DE) by inVentiv Health (Somerset, NJ), the pharma services conglomerate. Purchase price was not disclosed.
ParagonRx has been in business since 2001, handling risk-management programs in pharma commercializations, medical/marketing collaborations and strategic consulting. It touts its capabilities in tailoring an engineering-type analysis, failure mode and effects analysis (FMEA) to risk management programs. REMS, which came into being with the FDA Amendments Act of 2007 as a replacement for the earlier RiskMAPS program, can represent a significant hurdle to both new and existing pharmaceuticals (see recent feature in Pharmaceutical Commerce).
inVentiv will position its latest acquisition in its Clinical services segment. The company announced a comprehensive REMS service last August, including safety and pharmacovigilance programs, patient registries and education and awareness initiatives.