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The U.S. Food and Drug Administration (FDA) is one of the country’s most critical health agencies. With jurisdiction over everything from foods, dietary supplements and bottled water, to prescription drugs, cosmetics and tobacco (not to mention medical devices and diagnostics), FDA is responsible for products that impact every American on a daily basis.
But while these products are vastly different from one another, as Dr. Susan Alpert stresses, FDA’s mission remains the same: To protect and promote the public health.
When it comes to medical technology, FDA protects the public health by evaluating new products to make sure they are safe and effective before being allowed on the market. At the same time, the agency aims to promote public health by reviewing devices and diagnostics as efficiently as possible to get these innovations to the patients and physicians that need them.
These two distinct objections are frequently “in tension with each other,” Alpert points out. FDA has to thoroughly examine the evidence for a new product – which often involves thousands of pages of supporting, science-based documentation – to determine its safety and effectiveness. But no amount of evidence will ever be 100% complete, just as no medical intervention will be 100% risk free. If that was the threshold and FDA was only charged with protecting the public health, no new innovations would come to market.
But FDA is also charged with promoting the public health. There are patients across the U.S. desperate for advancements, battling conditions with little or no treatment options, and there are medical technologies in the pipeline waiting to serve them. So the agency must make a judgement call based on the available evidence if the benefit of a new device outweighs the risk and how it will impact the lives of patients.
As Alpert explains, FDA makes sure the evidence of safety and effectiveness is “enough” but “doesn’t hold back too much” patient access to potentially life-changing innovation.
Listen to Susan’s take on FDA’s mission in the video below and learn more about the FDA regulatory system.
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