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How the 21st Century Cures Act Paved the Way for the COVID-19 Vaccine

by FRED UPTON

Since last December, at the peak of one of the worst public health and economic crises we have faced in more than a century, the eyes of the world turned to Southwest Michigan to watch as the first shipments of Pfizer’s lifesaving COVID-19 vaccine were packaged into trucks and sent across the country. Now, more than seven months later, several safe and effective vaccines have been developed and deployed in record time thanks to the successful collaboration between Operation Warp Speed and America’s innovative private sector.

However, the timely approval of the first COVID vaccine can also be traced back to my landmark 21st Century Cures Act, which I spearheaded with my colleague Rep. Diana DeGette (D-CO), and was signed into law by President Obama in 2016. This bipartisan legislation has helped accelerate the approval and delivery of life-saving treatments, cures, medical devices, and yes, vaccines – bringing them to market faster and more efficiently than ever before. Most notably, 21st Century Cures increased the National Institutes of Health (NIH) budget by some $45 billion, including $1.8 billion for the Beau Biden “Cancer Moonshot” to better prevent and screen for cancer, $1.5 billion for the BRAIN initiative to improve our understanding of diseases like Alzheimer’s, and $500 million for the Food and Drug Administration (FDA) to spur stem cell research.

While we were hopeful that 21st Century Cures would make a significant impact, we never expected it to play such an outsized role so quickly. Because of our bipartisan work, more than 150 million Americans are fully vaccinated against COVID-19 – a milestone that once seemed insurmountable – and we’re on the cusp of finding

cures to some of the world’s cruelest diseases – including cancer, Alzheimer’s, diabetes, Sickle Cell Disease, and so many others. We’ve also seen a record number of new drugs approved, including new generics, which have helped lower healthcare costs and improve health outcomes for millions of Americans. From day one, we aimed to advance medical research, foster a new era of medical innovation, and make real reforms to FDA processes and procedures that would help expedite the approval of groundbreaking cures. Our focus was – and continues to be – entirely on renewing hope for patients and their families because we know that far too many folks have lost loved ones to vicious ailments. With that in mind, we wanted to be sure that the revolutionary discoveries made by some of our nation’s brightest scientific minds could be approved as quickly as Because of our bipartisan possible while still adhering work, more than 150 to the highest scientific and medical standards. For this million Americans are reason, we made it a top priority fully vaccinated against to increase access to enhanced

COVID-19 clinical trial designs and, most importantly, the use of realworld evidence at the FDA when developing new treatments. As we now know, the use of real-world evidence – data regarding the potential benefits or risks of a drug derived from sources other than traditional clinical trials – has played an increasingly important role in expanding access to cures and cutting-edge innovation. Now, we need to roll up our sleeves, replicate our successful 10-month mission to manufacture, approve, distribute, and inject millions of vaccines nationwide, and apply this process to other tragic illnesses and diseases. There are still too many patients who face real uncertainty and fear with no treatments in sight, and that’s why we must

continue to do everything in our power to help them. fosters a new era of medical miracles.

Fortunately, Rep. DeGette and I have joined forces As we finally turn the corner on this awful pandemic, again to continue that important work with the introduction we cannot sufficiently express our gratitude for all the of our Cures 2.0 bill, which builds upon the tremendous scientists, healthcare workers, and innovators who success we had with 21st Century Cures and will help worked in record time to find a vaccine for the devastating pave the way for more COVID-19 virus. Our job innovation and more cures. now is to take what we Our legislation – among a Our job now is to take what we learned the past year and number of provisions – would continue to help learned the past year and half a half and apply it to the hundreds of thousands of modernize the FDA, and apply it to the hundreds of diseases that still afflict so streamline its regulatory thousands of diseases that still many Americans and their framework, and encourage families. From defeating innovative clinical trial afflict so many Americans cancer to curing diabetes, design and patient-focused and their families. developing and delivering drug development. We new lifesaving cures is a know that personalized mission that must unite us care – instead of a one-size-fits-all approach to healthcare all. And it is one that we can achieve – together. RF – prioritizes the wellbeing of patients and their families, thus improving health outcomes and, in many cases, saving Fred Upton represents the 6th District of Michigan in the lives. Those are exactly the results we can achieve when we U.S. House of Representatives and served as Chairman safely and rightfully cut burdensome red tape that prevents of the Committee on Energy and Commerce from 2011 to the development of new drugs and treatments, and instead 2017.