"For FDA, innovation is not just about new ideas, but it is about making sure that those new ideas truly translate into the products and opportunities that people need and count on," Commissioner of Food and Drugs, Margaret Hamburg, explained in her opening address at FDLI's 54th Annual Conference.
Her April 5 speech focused on innovation at the Food and Drug Administration (FDA) and in FDA-regulated industries. "As we as a nation look ahead into the 21st century, we are realizing how important it is for us to stimulate our industries, encourage entrepreneurship and creativity, and prepare our citizens for the future. And for all of that, we need innovation," she said, "But at the FDA, innovation has always been a central focus. Even though we aren't always fully recognized for it—we have a long history of innovation at the FDA. In fact, it is part of our mission."
Hamburg gave examples of scientific breakthroughs FDA scientists made early in the 20th century, developing the Howard Mold Count to identify "worm-eaten refuse" in ketchup, and scientific advances FDA scientists are making now, like "using whole genome sequencing technology to help trace the source of a recent Salmonella outbreak in eggs back to the contaminated product and from there to the contaminated food facility."
She pointed out that FDA-regulated products account for more than 20 percent of consumer spending the United States, that FDA-regulated industries provide many high-paying jobs, and that some have a positive international trade balance.
"Our mandate is enormous—and what we do really matters to the lives of Americans every day. Which is why it is so important that it is clear: our role is to facilitate innovation, not to impede it," Hamburg said. She acknowledged that FDA has been blamed as a culprit of the increasing cost of bringing medical products to market. "In fact, our rate of approvals has not slowed for many years, even as products become more complex."
Hamburg explained that FDA is pursuing a few related ways to support innovation at the agency- regulatory reform, strengthening science, reducing scientific uncertainty and economic policy.
Recent regulatory reform efforts Hamburg discussed include 510(k) reform, which allows most medical devices an expedited FDA review. "Under these reforms, we will streamline 510(k) submissions for eligible devices, clarify criteria for eligibility, and provide a more efficient review process," said Hamburg.
Also in the device realm, Hamburg discussed new premarket review efforts to improve predictability, consistency and transparency. She also explained new FDA partnerships in the drug area "to strengthen the scientific underpinnings of our regulatory work and better harness advances in science and technology to make the review process more effective and efficient."
Hamburg's view on reducing scientific uncertainty is that "Much of regulatory uncertainty is rooted in scientific uncertainty: a lack of clear, reliable data that supports decision making for product safety and efficacy." She explained that promoting regulatory science is a major priority at FDA. New regulatory science investments include new initiatives, partnerships with the National Institutes of Health, and, resources willing, Hamburg said, Centers for Excellence at academic institutions funded by FDA, focused on research in regulatory science.
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