Echoing President Donald Trump’s call to accelerate medical innovation, Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency will no longer block companies from submitting real-world data in drug and device applications. He says the shift will cut costs, reduce delays and open the door to faster cures.
“One thing we’ve got to do is deliver on President Trump’s goal to give more cures and meaningful treatments to Americans, cutting the red tape, streamlining the FDA, modernizing the organization,” Dr. Makary said in an exclusive interview on FOX Business’ “Varney & Co.” Monday.
Makary said that for years, companies were effectively barred from using “real-world evidence” — data drawn from sources like cancer registries, insurance claims, hospital records and everyday patient outcomes — because the agency required individually identifiable patient information to accompany it.
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By lifting that requirement, the FDA says it can now consider broader, de-identified data that show how treatments work outside the narrow setting of clinical trials, potentially speeding approvals and expanding the evidence base for new therapies.
“Right now, they say that they’ve been admitting real-world data into applications, but the requirements have been so onerous that only 12 drugs in the last 14 years have had real-world data in their approval application because the requirements just got so bureaucratic,” Makary explained.
“So you can submit whatever real-world data you want now in your FDA application. We’re changing that guidance.”
In an FDA press release, the agency says it’s immediately eliminating the barrier for medical device applications, and “similarly intends to consider updating its guidance for drugs and biologics.”
“If the reviewers at the FDA don’t like the real-world data that’s submitted, they will let the companies know,” Makary said. “But requiring the real-world data fits so many onerous requirements, like having informed consent from every patient that is in the real-world data set, that’s not realistic.”
“We’re still requiring a clinical trial for most drugs, unless it’s for a rare disease. Remember, we recently announced we’re going to go from requiring a default two clinical trials for every drug application to one really well-controlled, statistically powerful trial,” he continued.
The FDA is encouraging applicants to use databases like the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Program, hospital systems databases, insurance claims databases and electronic health record networks — where millions of records offer “insights that traditional clinical trials cannot capture.”
“That’s going to allow for more innovation and less delays and lower R&D costs, which could translate to lower drug prices,” Makary said.
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