D2 Pharma Consulting develops "REMS Challenges and Real World Solutions" White Paper

Oct 21 2009

D2 Pharma Consulting LLC (D2) is a best-in-class national consulting company that works with pharmaceutical and biotech manufacturers on the implementation of REMS compliant distribution programs, in addition to other commercialization activities. D2 structures REMS distribution programs on behalf of their clients that leverage supply chain efficiencies while complying with FDA mandates.

D2 Pharma Consulting has developed a White Paper: REMS Challenges and Real World Solutions. The D2 REMS White Paper has been acknowledged as the standard for developing solutions for pharma and biopharma and is available at No Cost upon request.

On September 30, 2009, FDA announced the availability of the long awaited first draft FDA REMS GUIDANCE DOCUMENT, which are required for certain drugs or biologics. The document is entitled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS) Assessments, and Proposed REMS Modifications.” http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf

Passed in 2007, The Food and Drug Administration Amendments Act (FDAAA) expanded FDA’s authority to require a REMS, if the agency deems it necessary to ensure that the benefit outweighs the risk of certain products. While much of the information in the guidance is not new, it is one of the first times that FDA has shared its thinking to this extent with the public. The guidance addresses three main areas, including:

1. Content of a REMS

2. REMS assessment and modification of a REMS

3. Communication with FDA regarding REMS

This is the most comprehensive communication, to date, from FDA on the subject of REMS. While it is crucial to mitigate the risks inherent in certain products, the best REMS program is built around the optimal distribution strategy, thereby avoiding unintended consequences of limiting patient access, by creating overly burdensome operational requirements.