April 21, 2016

Nick Manetto: 21st Century Cures Act Provisions to Bring 'Clarity' to Patient Experience Data Process

Drug and device companies have asked the Food and Drug Administration (FDA) to incorporate patients’ experiences into its review and approval of medical products, and two provisions in the 21st Century Cures bill indicate the agency will soon be developing a framework to do just that. As noted in CQ News, the provisions will require the FDA to create a procedure for drug and device developers to submit patient experiences for consideration in FDA review—and to consider such data when approving products for additional uses.

Nick Manetto, principal for FaegreBD Consulting, told CQ News that these provisions will help drug and device companies determine how to use patient data when developing new treatments.

“There’s a need for some more definition to the whole process without becoming overly bureaucratic […] but the reality is that the framework could benefit from some greater clarity and I think that’s what you’re seeing from [these] provisions,” Manetto said.

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