Let’s build on the successes of Cures Act, Operation Warp Speed

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 life-saving COVID-19 vaccine were packaged into trucks and sent across the country. Now, 10 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 the landmark 21st Century Cures Act, which I spearheaded in the House with my colleague Rep. Diana DeGette (D-Colo.) and was signed into law by President Barack 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, it increased the National Institutes of Health 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 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 186 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. 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 possible while still adhering to the highest scientific and medical standards.

For this reason, we made it a top priority to increase access to enhanced clinical trial designs and, most importantly, the use of real-world evidence at the FDA when developing new treatments. As we now know, the use of 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 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 illnesses and diseases.

Rep. DeGette and I have joined forces again to continue that important work with the introduction of our Cures 2.0 bill, which builds upon the tremendous success we had with 21st Century Cures and will help pave the way for more innovation and more cures. Our legislation—among a number of provisions—would continue to help modernize the FDA, streamline its regulatory framework, and encourage innovative clinical trial design and patient-focused drug development. We know that personalized care, instead of a one-size-fits-all approach to healthcare, prioritizes the well-being of patients and their families, thus improving health outcomes and, in many cases, saving lives. Those are exactly the results we can achieve when we safely and rightfully cut burdensome red tape that prevents the development of new drugs and treatments, and instead fosters a new era of medical miracles.