Politics & Perspective
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 cures to some of the world’s cruelest diseases – including public health and economic crises we have faced in more cancer, Alzheimer’s, diabetes, Sickle Cell Disease, and so than a century, the eyes of the world turned to Southwest many others. We’ve also seen a record number of new drugs Michigan to watch as the first shipments of Pfizer’s life- approved, including new generics, which have helped lower saving COVID-19 vaccine were packaged into trucks healthcare costs and improve health outcomes for millions and sent across the country. of Americans. Now, more than seven months From day one, we aimed later, several safe and effective to advance medical research, vaccines have been developed and foster a new era of medical deployed in record time thanks innovation, and make real to the successful collaboration reforms to FDA processes between Operation Warp Speed and procedures that would and America’s innovative private help expedite the approval of sector. groundbreaking cures. Our However, the timely approval focus was – and continues to of the first COVID vaccine be – entirely on renewing hope can also be traced back to my for patients and their families landmark 21st Century Cures because we know that far too Act, which I spearheaded with many folks have lost loved ones my colleague Rep. Diana DeGette to vicious ailments. With that in (D-CO), and was signed into law mind, we wanted to be sure that by President Obama in 2016. the revolutionary discoveries This bipartisan legislation has made by some of our nation’s helped accelerate the approval and brightest scientific minds could delivery of life-saving treatments, be approved as quickly as cures, medical devices, and yes, possible while still adhering Because of our bipartisan vaccines – bringing them to to the highest scientific and work, more than 150 market faster and more efficiently medical standards. For this million Americans are than ever before. Most notably, reason, we made it a top priority 21st Century Cures increased to increase access to enhanced fully vaccinated against the National Institutes of Health clinical trial designs and, most COVID-19 (NIH) budget by some $45 billion, importantly, the use of realincluding $1.8 billion for the Beau world evidence at the FDA Biden “Cancer Moonshot” to better prevent and screen for when developing new treatments. As we now know, the use cancer, $1.5 billion for the BRAIN initiative to improve of real-world evidence – data regarding the potential benefits our understanding of diseases like Alzheimer’s, and $500 or risks of a drug derived from sources other than traditional million for the Food and Drug Administration (FDA) to clinical trials – has played an increasingly important role in spur stem cell research. expanding access to cures and cutting-edge innovation. While we were hopeful that 21st Century Cures Now, we need to roll up our sleeves, replicate our would make a significant impact, we never expected it successful 10-month mission to manufacture, approve, to play such an outsized role so quickly. Because of our distribute, and inject millions of vaccines nationwide, and bipartisan work, more than 150 million Americans are apply this process to other tragic illnesses and diseases. fully vaccinated against COVID-19 – a milestone that once There are still too many patients who face real uncertainty seemed insurmountable – and we’re on the cusp of finding and fear with no treatments in sight, and that’s why we must 16
RIPON FORUM July 2021
