The Changing REMS Landscape

The Changing REMS Landscape

As the sixth year of the REMS era begins, FDA’s use of Risk Evaluation and Mitigation Strategies (REMS) continues to decline.  Since 2007 when the FDA Amendments Act (FDAAA) went into effect, there have been more than 200 REMS imposed, but only 74 currently remain in the marketplace. 

Although the FDA is requiring REMS less frequently, when imposed, REMS are more complex and have a larger impact on the healthcare system. These more complex REMS programs include elements to assure safe use (ETASU).

 

 

 

 

 

 

 

 

 

 

 

In 2008, REMS with ETASU accounted for only 16% of the total number of REMS approvals. In 2012, REMS with ETASU represented 55% of the total number of REMS approvals. The number of REMS approvals is anticipated to remain low in 2013, but REMS are not being eliminated.  The REMS landscape is just changing. By leveraging the experience and expertise of UBC, you can ensure that the REMS for your product is designed and implemented successfully and is based on current marketplace trends.

To learn more, please contact me.