FDA Approves Use of Real-World Data in Medical Applications Following Trump Directive
FDA Commissioner Dr. Marty Makary joins ‘Varney & Co.’ to discuss the FDA’s plan to cut red tape, declining men’s testosterone levels, and his visit to Novartis’ manufacturing site.
In a move that echoes President Donald Trump’s call for accelerated medical innovation, FDA Commissioner Dr. Marty Makary announced a significant policy shift. The FDA will now allow companies to submit real-world data in drug and device applications, a change aimed at cutting costs, reducing delays, and paving the way for 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 stated in an exclusive interview on FOX Business’ “Varney & Co.” Monday.
For years, companies faced barriers in utilizing “real-world evidence”—data sourced from cancer registries, insurance claims, hospital records, and everyday patient outcomes—because the FDA mandated that identifiable patient information accompany it. This requirement effectively stifled innovation.
FDA RECALLS BLOOD PRESSURE MEDICATION OVER CHOLESTEROL DRUG CONTAMINATION
By eliminating this requirement, the FDA can now consider broader, de-identified data that reflects treatment effectiveness outside the confines of clinical trials. This change has the potential to expedite approvals and expand the evidence base for new therapies.
Commissioner of Food and Drug Administration Marty Makary delivers remarks alongside U.S. President Donald Trump on Oct. 16, 2025, in Washington D.C. (Kevin Dietsch/Getty Images / Getty Images)
Dr. Makary highlighted that despite the new policy, the FDA will still require clinical trials for most drugs, except those targeting rare diseases. “We recently announced a shift from requiring two clinical trials for every drug application to one well-controlled, statistically powerful trial,” he added.
In an FDA press release, the agency confirmed it is immediately removing the barrier for medical device applications and plans to update guidance for drugs and biologics accordingly.
FDA Commissioner Dr. Marty Makary weighs in on the agency removing black box warnings on menopause therapy, the long-term effects of GLP-1 medications, and Obamacare policyholders struggling with surging health insurance costs.
“If the reviewers at the FDA find the real-world data submitted unsatisfactory, they will inform the companies,” Makary explained. “However, the previous requirements for real-world data were so burdensome that only 12 drugs in the last 14 years utilized it in their approval applications.”
Food and Drug Administration Commissioner Marty Makary speaks as he joins U.S. President Donald Trump in the Oval Office at the White House on May 5, 2025, in Washington, D.C. (Getty Images)
The FDA is now encouraging applicants to leverage databases such as the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program, hospital systems databases, insurance claims databases, and electronic health record networks. These resources provide insights that traditional clinical trials often overlook.
“This will foster more innovation, reduce delays, and lower R&D costs, which could lead to lower drug prices,” Makary concluded.
FDA Commissioner Dr. Marty Makary joins ‘Varney & Co.’ to discuss the FDA’s plan to cut red tape, declining men’s testosterone levels, and his visit to Novartis’ manufacturing site.
In a move that echoes President Donald Trump’s call for accelerated medical innovation, FDA Commissioner Dr. Marty Makary announced a significant policy shift. The FDA will now allow companies to submit real-world data in drug and device applications, a change aimed at cutting costs, reducing delays, and paving the way for 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 stated in an exclusive interview on FOX Business’ “Varney & Co.” Monday.
For years, companies faced barriers in utilizing “real-world evidence”—data sourced from cancer registries, insurance claims, hospital records, and everyday patient outcomes—because the FDA mandated that identifiable patient information accompany it. This requirement effectively stifled innovation.
FDA RECALLS BLOOD PRESSURE MEDICATION OVER CHOLESTEROL DRUG CONTAMINATION
By eliminating this requirement, the FDA can now consider broader, de-identified data that reflects treatment effectiveness outside the confines of clinical trials. This change has the potential to expedite approvals and expand the evidence base for new therapies.
Commissioner of Food and Drug Administration Marty Makary delivers remarks alongside U.S. President Donald Trump on Oct. 16, 2025, in Washington D.C. (Kevin Dietsch/Getty Images / Getty Images)
Dr. Makary highlighted that despite the new policy, the FDA will still require clinical trials for most drugs, except those targeting rare diseases. “We recently announced a shift from requiring two clinical trials for every drug application to one well-controlled, statistically powerful trial,” he added.
In an FDA press release, the agency confirmed it is immediately removing the barrier for medical device applications and plans to update guidance for drugs and biologics accordingly.
FDA Commissioner Dr. Marty Makary weighs in on the agency removing black box warnings on menopause therapy, the long-term effects of GLP-1 medications, and Obamacare policyholders struggling with surging health insurance costs.
“If the reviewers at the FDA find the real-world data submitted unsatisfactory, they will inform the companies,” Makary explained. “However, the previous requirements for real-world data were so burdensome that only 12 drugs in the last 14 years utilized it in their approval applications.”
Food and Drug Administration Commissioner Marty Makary speaks as he joins U.S. President Donald Trump in the Oval Office at the White House on May 5, 2025, in Washington, D.C. (Getty Images)
The FDA is now encouraging applicants to leverage databases such as the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program, hospital systems databases, insurance claims databases, and electronic health record networks. These resources provide insights that traditional clinical trials often overlook.
“This will foster more innovation, reduce delays, and lower R&D costs, which could lead to lower drug prices,” Makary concluded.
