“This pandemic has shown us, very clearly, how we can better prepare for the next threat, and that is by being a better partner to the private sector.”
Today, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled “Examining Our Covid-19 Response: An Update from Federal Officials.” This is the Committee’s first hearing on the coronavirus pandemic in this Congress with Administration officials from the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Department of Health and Human Services (HHS).
In his prepared opening remarks, Senate HELP Committee Ranking Member Richard Burr (R-NC) urged the CDC, NIH, FDA, and HHS to take stock of coronavirus preparedness and response shortfalls and to keep pace with science by utilizing private sector partners and innovators. Additionally, Ranking Member Burr highlighted the successful policies and programs that enhanced America’s response efforts, such as the laws allowing for Emergency Use Authorization and Operation Warp Speed. Ranking Member Burr pressed these officials to apply this framework in addressing the nation’s next set of public health challenges.
WATCH: Ranking Member Burr delivers opening remarks before the Committee’s first coronavirus hearing with federal officials
“Continuity will be critical as we work through the lessons learned from the COVID-19 pandemic and move into the next phase of our response and, hopefully, our recovery.
“America needs to reopen our schools, reopen our businesses, and open up to global commerce. The actions taken by each of your offices affect these goals.
“This pandemic has shown us, very clearly, how we can better prepare for the next threat, and that is by being a better partner to the private sector.
“Dr. Walensky, I am going to start with you because you have the hardest job ahead of you. The bottom line is that there is a clear and compelling need for significant reform at the CDC. Your agency is responsible for communicating to Americans, based on facts, how to return to some form of normalcy, but the guidance documents coming out of the CDC have been two steps behind the data.
“As I mentioned, your best tool to keep pace with the science is the private sector. Let me be blunt: CDC’s go-it-alone mentality on testing was arrogant and wrong. Let me propose a solution based on the success that Dr. Hahn at the FDA led last year: lean on your private sector partners – commercial labs, academic centers, and large-scale test makers…
“The same is true of your surveillance systems… We need a layered surveillance system, in partnership with the private sector, states, and local public health experts to get a true picture of the threats on the ground. The COVID relief packages have given CDC billions of dollars to modernize these systems. CDC must not hoard that money for yourselves, instead use these funds to identify technologies that better equip us.
“Dr. Fauci – welcome back. You and I have worked on these issues together for more than two decades. A lot of what we built worked. The NIH recognized the importance of technology, leveraging existing clinical trial and research networks, extending partnerships with the private sector… Now, the challenge will be for your center, along with the other institutes and centers at the NIH, to maintain this pace, and apply it to the next challenge or set of health care challenges in the future. Voices at the NIH will be important in determining how can we expand, solidify, and maintain this public-private approach to the biggest health care issues facing our country.
“Dr. Marks, this is where you, and your efforts at CBER come in. The pandemic has broken the model at the FDA, and the agency should not go back to its historical approach. Dr. Hahn used his emergency authorities exactly how we envisioned the FDA using them. In my mind he, you, and the dedicated professionals at the FDA are the unsung heroes of the federal response… Now, as the makers of these products – vaccines, tests, and treatments – apply for full approval, the agency should take this opportunity to use real world information to inform their review, and I hope that you take advantage of the unique opportunity you have here.
“Each medical product center at the FDA can apply their practices during the pandemic to the applications that come across reviewer’s desks. We can accelerate development to the benefit of patients here in the United States, and around the world for more than just COVID but for cancer, diabetes, and more.
“Dr. Kessler, you were serving as FDA Commissioner when our first conversations about pandemic preparedness began. Now, you are in a position to help use those authorities to their fullest extent. Operation Warp Speed has used NIH’s expertise in early research, BARDA’s contracting, advanced development and manufacturing capabilities, and the [Department of Defense’s] logistical muscle to achieve scientific breakthroughs that can rescue the world from this virus. Operation Warp Sped was a huge success and I’m glad that you are planning on building on that success going forward.
“Warp Speed showed us where some of our gaps in countermeasure development existed. We need ways to rapidly identify candidates for tests, treatments and antivirals, and vaccines. This is an area primed for partnership with academia and especially the private sector. We also learned that our manufacturing capabilities came up short. But we saw a remarkable thing when private sector drug makers partnered with their competitors to make more vaccine.
“Now, one year into the pandemic, even as the vaccine offers hope that the return to normal will continue and speed up, the offices and responsibilities that each of you hold will become more challenging. Not only will you be required to maintain the pace and urgency of our current response, but to begin to change the architecture of our public health agencies. The novel coronavirus has irreversibly altered our ability as the federal government to interact with innovators that bring real solutions to the greatest health care challenge in generations. Do not take this moment for granted. Strengthen the relationships and partnerships that have been established during the response. Take stock of the needs that still exist, and how partnerships like these can help to address them.”
Last week, the Senate HELP Committee held its first hearing of the year focused on the response to the coronavirus pandemic with state and local officials. During the hearing, Ranking Member Burr underscored the critical role state and local officials play in leading the response to the pandemic.
To read Ranking Member Burr’s full prepared opening statement, click here.