FDA commissioner: Updated regulations will help further healthcare innovation

Friday, January 20, 2017

Source: FierceHealthcare

The U.S. Food and Drug Administration doesn't have a reputation for speed and adaptability, but according to its top administrator, the agency has developed a new regulatory process to rapidly approve technology that will support federal initiatives geared towards healthcare innovations, including precision medicine. 

The FDA has reengineered its process to accommodate advancements in next-generation sequencing (NGS), advanced DNA testing that can improve disease diagnosis, treatment and prevention by mapping out a patient’s genetic makeup, Robert M. Califf, M.D., commissioner of the FDA, wrote in Wired.

The FDA has been rethinking its approach to NGS regulatory approval since President Obama announced the Precision Medicine Initiative, which got a $1.4 billion boost from the recently enacted 21st Century Cures Act.

According to a recent survey, 21st Century Cures has won support from the majority of patients, although some researchers have called for a more cautious approach to genetic testing.

Industry experts have said hospitals can take proactive steps to prepare for the new law by updating clinician support systems and putting more emphasis on mental health services.

To ensure the accuracy of NGS tests, while also facilitating innovation, the FDA has created an open source cloud-based portal called precisionFDA that allows the agency to keep pace with technological breakthroughs. A new streamlined approach for regulatory approval will ensure the FDA is fulfilling its duty to protect patients without stymieing innovation, Califf said, highlighting draft guidance released by the FDA in June.

“Our goal is to help developers move efficiently from concept to commercially viable products by reducing uncertainty, encouraging best practices, and providing the regulatory flexibility that test developers need to innovate,” Califf wrote.

In another nod to the FDA’s desire to foster stronger partnerships with the private sector, Califf also announced a new database available to both public and private entities to conduct large-scale safety evaluations of medical devices. The agency will also draw from the database when making regulatory decisions.

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