December 2020

Focusing on the Patient: Implementation of Key 21st Century Cures Act Provisions and Recommendations for the Future

Food and Drug Law Institute

Faegre Drinker Consulting principals Nick Manetto and Tim Franson and Faegre Drinker Consulting director Lauren Bloch authored an article with Annie Kennedy, Chief of Policy & Advocacy at the EveryLife Foundation for Rare Diseases for Food and Drug Law Institute, titled “Focusing on the Patient: Implementation of Key 21st Century Cures Provisions and Recommendations for the Future.”

Over the past decade, Congress has enacted several laws to infuse the perspective of the patient into the therapy development and regulatory review processes, known as patient engagement or patient-focused drug development.

In their article, the authors examine the legislative history behind Sections 3001 and 3002 of the 21st Century Cures Act and how these important provisions have been implemented by the Food and Drug Administration. The authors also analyze the strengths as well as the deficiencies associated with both provisions and, based off their analysis, offer recommendations for policies and practices to further strengthen the implementation of these provisions and for the enactment of additional changes through legislation.

The authors add that interest in patient engagement policy continues to expand as legislators, regulators, industry, and patient stakeholders turn their attention to the Prescription Drug User Fee Act (PDUFA) VII, which must be enacted by September 2022.

Full Article

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