REMS Vendor Disruptions Prompt Greater US FDA Scrutiny - Pink Sheet

Linda Pissott Reig, shareholder in the firm's FDA practice, was quoted in Pink Sheet article "REMS Vendor Disruptions Prompt Greater US FDA Scrutiny."

Linda spoke with reporter Brenda Sandburg about the important role that vendors play in Risk Evaluation and Mitigation Strategy (REMS) programs. 

“The collection of information, and the analysis of data about vendor substitution, could be impactful if the GAO report results in an ability to learn from past experience,” Reig said. “For example, what has worked well previously and what has contributed to changes? Where might a different approach be beneficial for vendor substitution in the future? A retrospective review can benefit drug sponsors as well as healthcare providers, pharmacies, patients, and others.”

“All of these stakeholders have a genuine interest in prompt access to medical treatments as well as ensuring that significant drug risks are mitigated,” she added.

The bill also includes a “no delay” provision that specifies that “nothing in this section shall delay agency action on any modification to a risk evaluation and mitigation strategy.” Reig said this is important because it helps avoid any interruption in treatment when a vendor change is needed.

Reig noted that there have been vendor changes that occurred without incident, while other times vendor changes have posed challenges. 

“This is understandable as REMS programs can have many facets with various stakeholders and different systems that must communicate with each other,” she said. She noted that the FDA has at times waived particular REMS requirements or relaxed certain requirements when a vendor change has posed challenges.