A bipartisan think tank is calling on Congress to enable the Food and Drug Administration to use hospital electronic health records and crowd-sourced patient experience data to transform the drug and medical device approval process.
On Monday, the Bipartisan Policy Center kicked off its five-point “FDA: Advancing Medical Innovation” initiative, focusing on the agency’s role in biomedical research and how big data – currently soloed in healthcare IT systems and patient social networks – can improve personalized medicine, genomics, molecular pathways and other cutting-edge treatments.
“Our inefficient, less-than-modern, drug discovery and device approval process drives up cost and delays treatment,” said the initiative’s co-chair, former Senator Bill Frist. “We must accelerate the process of getting safe and effective drug and medical devices to patients.”
In particular, Frist noted that the FDA’s current review processes fail to reflect advances in the aggregation and analysis of real-time patient data at hospitals and healthcare, as well as from patient-focused social networks.