REMS Experience Counts

REMS Experience Counts

We’ve heard from pharmaceutical manufacturer sponsors that the thought of having the FDA mandate a Single Shared System REMS on their product gives them nightmares.   Well, we’re here to tell you, there’s no need to lose sleep. 

In 2010, the FDA initiated a Single Shared System REMS for certain drug classes that involve multiple products by multiple manufacturers.  And, since that time, UBC has been a part of every Single Shared System REMS program. 

So, what does that mean?  Well, we think it means a lot, but we can sum it up in one word.  Confidence. 

Being a part of each of these Shared Systems REMS means manufacturers have confidence that UBC Pharma Services will: 

  • Develop evidence that may influence the need or lessen the burden of key FDA mandated requirements within the REMS
  • Ensure accurate and timely safety reporting related to each specific product
  • Work with a centralized team to collect and report patient data, with intelligent dashboards
  • Demonstrate that the REMS is effective through tools such as Knowledge Attitude Behavior (KAB) Surveys
  • Develop and monitor physician and patient registries
  • Deliver turnkey services, which enable us to leverage category leading technology platforms, seasoned REMS strategists, and implementation teams
  • Address  critical FDA feedback  based on learned experience (understanding the landscape and capitalizing on our knowledge and experience)
  • Utilize experience to design REMS programs that allow for cost and operational efficiencies

The table below provides an overview of the currently approved Single Shared System REMS.

Name of Shared System REMS

Date REMS Approved

Extended-Release and Long-Acting Opioid Analgesics REMS

  • 12 brand products and 23 generic products by 19 manufacturers

7/9/2012; modified 8/28/2012

Teratogen REMS

  •  7 products by 5 manufacturers

10/22/2010

Mycophenolate REMS

  • 23 products by 11 manufacturers

9/25/2012

Transmucosal Immediate-Release Fentanyl (TIRF) Products REMS

  • 8 products by 7 manufacturers

12/28/2011; modified 6/5/2012

If your product becomes part of a Shared System REMS, let us share our experience and expertise with you.