Column: FDA user fees support medicine
Every five years, Congress must reauthorize the Food and Drug Administration’s user fee programs for generic drugs, prescription drugs, biosimilar biological products and medical devices. These programs are critical to patients, drug and device manufacturers, and the millions of Americans who work hard every single day to deliver new treatments and cures. At its core, reauthorization and updates to the FDA user fee programs will enable U.S. manufacturers to get their breakthrough products to market faster all while maintaining the highest levels of patient safety.
And in some good news that you may not have heard about: Congress came together to overwhelmingly pass legislation that would do just that and last Friday President Trump signed our bill into law.
The FDA Reauthorization Act of 2017 is a bipartisan bill that updates and reauthorizes these critical user fee programs. Specifically, it will make common-sense reforms to the FDA such as facilitating the availability of over-the-counter hearing aids, enhancing generic drug competition to help lower prices, and improving fee structures to help small businesses thrive and grow. Without swift enactment of this legislation, the FDA would be forced to start laying off up to 70 percent of their employees that approve drugs and devices. That would have a devastating impact not only on local pharmaceutical firms but to patients and consumers who may be forced to needlessly suffer without the availability of potentially life-saving new drugs or devices.
Beyond the public health benefits, this legislation is critical to thousands of jobs, particularly here in Michigan. We are home to medical device maker Stryker Corp., the generic drug maker side at Perrigo Co., Pfizer Inc.’s largest manufacturing site, and dozens of smaller biotech and manufacturing firms. In recent months, I’ve visited with workers and leaders at these innovative companies, including Pfizer, which recently announced a multimillion dollar expansion in Michigan that will bring in more than $2 billion in economic activity annually and 5,680 jobs to our state. Folks at these firms have told me it is vital for this legislation to move forward to protect these local jobs as well as patients who will benefit from the new therapies the FDA helps get to market.
I have a long record of supporting medical innovation, research, the development of new drugs and devices and, of course, good-paying local jobs right here at home. Now that our groundbreaking, bipartisan 21st Century Cures Act is law, reauthorizing these FDA user fee programs is an important next step to ensuring these jobs stay here in Michigan and patients across the country benefit from improved, life-saving therapies. I was proud to champion this legislation and was pleased to see such strong bipartisan support for it in the U.S. House of Representatives and in the U.S. Senate.
Workers, job creators, and patients here in Michigan and across the country depend on this legislation. We just delivered.
Rep. Fred Upton represents Michigan’s 6th Congressional district.