Biotech Values

[iwfal]

21st Century Cures:

This bill, like many, offers both promises and perils.

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The good things in CuresNow



One critical element is that is will incorporate more of the patient experience than ever before. As Dr. Janet Woodcock, MD, PhD, the director of the U.S. FDA Center for Drug Evaluation and Research, and a surprisingly strong advocate for the bill, noted, “Patient-focused drug development has the potential to become the most transformational piece of this bill.” She hopes that 21st Century Cures will help collect data from a broad range of patients in a “structured way,” including details about the burden of their disease and what matters to them. This reflects the “societal shift from the doctors telling you what you have…to the patient as a navigator.”

FWIW "patient experience" is a buzzword that essentially means anti-science. As Woodcock so aptly demonstrated in the Etep approval. And that is supposed to be one of the "good things" in the act? So you can see why some (including myself) are more than a little worried about the act.

BTW - there have been things that have sped approval while maintaining science quality. E.g. Breakthrough Designation (e.g. allowing ph2's to become ph3's if the earlier results are dramatic enough.). But 21st Century Cures isn't remotely aligned with that.