FDA Reforms Needed to Transform Healthcare: Report
Reforms to FDA are part of six steps to transform healthcare now identified by the National Opinion Research Center (NORC) at the University of Chicago for the Healthcare Leadership Council. The group’s 2/17 report says there is a broad consensus in the U.S. among healthcare providers, payers, clinicians, patients, and consumers that the nation’s healthcare system does not operate at a level that generates optimal value. “There is significant room for improvement in elevating quality, cost-efficiency, and sustainability,” it says. “There is a gap between the innovations being developed in all sectors of healthcare and the ability to deliver those improved products and practices to patients.”
Those stakeholders participating in the Healthcare Leadership Council’s National Dialog for Healthcare Innovation agreed that focused action in these areas can significantly elevate health system value:
FDA reforms; comprehensive care planning; medication therapy management; health information interoperability; changes to federal anti-kickback and physician self-referral laws; and health information flow improvements focused on patient privacy laws and regulations.
The dialog participants found that there are “unnecessary delays in bringing new, improved treatments and technologies to patients due to redundant and counter-productive regulations from FDA.” They said that encouraging policy changes that streamline the agency’s responsibilities, while ensuring that manufacturers remain accountable, could enable the agency to focus on high-priority activities and speed approval of new medicines and healthcare products.
Participants also identified unnecessary and redundant regulations that if addressed could accelerate patient access to new innovations. They include:
eliminating the prohibition on using a single institutional review board of record for medical device trials; allowing companies to make certain changes to devices without a premarket submission, as long as the companies’ quality systems have been certified as capable of evaluating such changes;· timelier recognition of standards established by international or nationally-recognized standards organizations to improve regulatory efficiency and reduce the time to bring medical technology to patients; expanding the definition of valid scientific evidence to include evidence described in well-documented case histories; providing greater training and achieving improved understanding of the use of least burdensome provisions to increase efficiency and consistency for FDA and manufacturers; and increasing flexibility for biopharmaceutical manufacturers, payers, and providers to share scientific and healthcare economic information to optimize the clinical benefits of prescribed treatments.