In accomplishing the goal of developing a nuanced understanding of the patient experience by disease, it is critical that any future Office of Patient Affairs at the FDA (OPA-FDA) be conscious of the broad range of diseases and patient experiences, and deliberate in drawing out and responding to the full spectrum of the patient experience and voice in terms of what is clinically meaningful.
Our comments are focused on the issues of inclusion and barriers to participation, but also on the broader issue of making sure that patients’ perspectives are truly representative of all patients, and that issues of safety and effectiveness of medical devices are at the forefront.
The USA Patient Network respectfully urges senators to not advance the Senate’s Innovation for Healthier Americans bills or the House’s 21st Century Cures Act during the lame-duck session of Congress, but instead wait for when they have more time to carefully weigh each aspect of the bills in 2017.
“It often takes months or even years for the F.D.A. to detect patterns of failure,” said Jack Mitchell, director of health policy for the National Center for Health Research in Washington. “Post-market surveillance of medical devices continues to be dangerously slow an...