Report Urges FDA to Beef Up REMS and Supply Chain Tracking to Improve Drug Safety

A new report says the FDA has the greatest potential to improve drug safety if the agency's Risk Evaluation and Mitigation Strategies (REMS) are improved in two fundamental ways.

First, the policies need to take advantage of new technologies, such as electronic medical records, genetic testing and electronic tracking. And secondly, they need to incorporate the real life experiences and insights of all stakeholders, such as patient advocates, prescribers, pharmacists, academics, payers and sponsors.

The report, titled Optimal Futures for Risk Evaluation and Mitigation Strategies, is the result of a September 2009 workshop sponsored by the Society for Women's Health Research and facilitated by the Institute for Alternative Futures. It makes recommendations for the "optimal future" of REMS and also addresses the potential for unintended consequences that could make future REMS problematic, citing the need for policies to assess differences between patient groups when determining strategies to mitigate risk and for uniform standards to assure both innovator and generic manufacturers are held to the same requirements when implementing restricted distribution programs.

Back in 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) gave FDA new powers to require Risk Evaluation and Mitigation Strategies (REMS) for higher risk drugs and biologics. It is important to note, however, that FDAAA does not address problems such as manufacturing failures or tainted chemicals coming from overseas.

Now that more than 80 percent of the bulk substances used in drugs comes from foreign sources, the significant supplier risks involved are impossible to ignore.

Fortunately, this new report also recommends that FDA integrate REMS with its new Sentinel System to assure the safety of the drug supply chain as globalization brings new threats to the U.S. market. The FDA launched the Sentinel Initiative in May 2008 as a way to begin electronically tracking drugs, biologics and medical devices.

"Although REMS provides an avenue to reduce patient risks associated with medicine use, a number of important challenges still need to be addressed," says Phyllis Greenberger, President and CEO of the Society for Women's Health Research. "This report is intended as a nationwide call to action and is provided as a common framework for developing new policies and protocols to assure the safe use of all medicines posing safety risks."

The complete report, Optimal Futures for Risk Evaluation and Mitigation Strategies, is available from IAF.