FDA Rolling Out IT Modernization Plan Shortly
FDA is just weeks away from announcing a new plan to modernize its technology infrastructure to help it keep pace with the evolving tech landscape in product development and surveillance. Addressing a Reasearch!America conference in Washington, DC 9/6, acting commissioner Ned Sharpless said an improved information technology platform will have numerous advantages, “including allowing us to support increasing use of [real world evidence] and other new types of data in our regulatory decisions.”
To review and evaluate novel products, an up-to-date information technology (IT) platform will be key, Sharpless said, especially for products utilizing artificial intelligence or advanced manufacturing techniques. Investment in IT will also help the agency further its hopes for using cloud computing and storage at the agency. “We’ve jumped into cloud computing in a big way, already using this technology in innovative ways, allowing sponsors and reviewers to exchange messages and datasets in real-time,” he said.
Sharpless also took the opportunity to address the need for high-quality data throughout a product’s life cycle, from pre-market development to clinical trials, to post-market safety surveillance. “But to fulfill these responsibilities, we must be able to integrate the increasing wealth of available data into effective regulatory decision-making,” he said. “Data itself, while useful, is not necessarily transformative. We must turn it into smart data that is usable to connect cutting-edge scientific discoveries to the real-world products and solutions that make a meaningful difference in people’s lives.”
Sharpless said FDA is working with researchers to establish new linkages between complex and diverse data sets, harnessing real world data, and using novel analytical approaches. “By gathering better quality data and mining that data in new ways, we can more effectively make scientific progress, find additional answers, develop new products, and, ultimately, help more people,” he said.
Without identifying any company by name, Sharpless ended his talk by addressing the need for “good” data versus “bad” data being submitted to FDA. Presumably, he was discussing data manipulation concerns recently raised by the controversial approval of AveXis’ Zlogensma (see earlier story).
“And here,” Sharpless continued, “let me dwell for a moment on what I mean by ‘good’ as opposed to ‘bad’ data. Every day there’s new research that offers great promise. But some of this rapid desire for progress comes a risk: the potential for taking a shortcut with the FDA, by collecting not good but bad data, and then submitting this bad data to us in support of a medical product.”
Sharpless said bad data can result from several causes — “but two important causes are sloppy, slipshod data collection or even data falsification. It can be difficult for the FDA to tell these apart, because they differ in terms of intent; that is, if data are bad because of carelessness or because of fraud. But from one point of view, it does not matter that much whether we are dealing with incompetence or malfeasance, because either case can lead to a regulatory decision that harms patients.
“We simply cannot tolerate deception of any kind," he continued. "Now, I do not wish to imply this problem is rampant, or even that it is increasing in frequency (in fact we have no evidence of that). But we do see data fraud at FDA, and more than I would have expected prior to coming to the agency. And I would argue that these instances are rare, they are significant because even a few examples can damage public confidence in the approval process.”
And Sharpless acknowledged that FDA lacks the resources to check every piece of research submitted, and sponsors must be trusted at some level. “But we will be vigilant concerning the accuracy of the research we review,” he said. “And when we do identify data fraud, we will use the full range of our authorities to address this; including civil and criminal penalties.”