Begging questions about REMS

FDA's draft guidance on the content of REMS submissions raises almost as many questions as it answers, including how drug makers are supposed to monitor third parties - over which they have no authority - without violating privacy laws. Nor is there a mechanism to assess whether the REMS tools will actually make patients safer or merely reduce access to treatment.

The Food and Drug Administration Amendments Act (FDAAA) of 2007 authorized the agency to require applicants to submit a proposed Risk Evaluation and Mitigation Strategies (REMS) document to ensure that the benefits of a drug outweigh the risks. A REMS may be requested during the drug application process if a safety signal emerges in clinical trials, or after a drug has been approved if a safety concern arises post-market.

More than 100 REMS are now posted on FDA's website.

The latest guidance was not required by law. Rather, it was done to give sponsors an idea of format and contents. The agency posted the guidance in September 2009 and the comment period closed in December.

While the draft gives assessment timelines, protocols for changes to an approved REMS and contact information, it does

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