Source: United States Senator for North Carolina Richard Burr
07.27.21
Senate HELP Committee Ranking Member Burr underscores importance of CDC reform, securing our supply chain, enhancing medical countermeasures
Today, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, “The Path Forward: Building on Lessons Learned from the COVID-19 Pandemic.”
Ranking Member Burr’s Full Prepared Opening Statement:
“Thank you, Senator Murray for holding this hearing today.
“Even before the first case was identified in America, this Committee has been extremely dedicated, in a bipartisan manner, to understanding the impact of the COVID-19 pandemic.
“Just last week, we heard from our federal response team about the ongoing outbreak and what our next round of challenges may be.
“I am particularly looking forward to today’s hearing because we are focused on this question – where do we go from here?
“I have worked on preparedness issues for a long time, and can see pretty clearly where some of our country’s vulnerabilities lie.
“My first priority is no secret – the CDC is in desperate need of reform.
“The primary reform CDC needs is to its culture. It is critical that CDC engage with the private sector and academia, and integrate new technology to keep the American people safe from 21st century public health threats.
“The cultural changes are always the most difficult, but it’s possible. I know it because I’ve accomplished it.
“I went through this in 1997 with the FDA. That cultural reform over 20 years ago, and other laws along the way, gave the agency the tools it needed to quickly respond and fight COVID-19.
“And the FDA was a shining success. Vaccines, treatments, and tests approved in record time while maintaining the gold standard of safety and efficacy.
“Over the last year, this Committee has learned that the CDC did not have the surveillance tools in place to track the spread of the virus in near real-time; had not hired the experts to meet its biosurveillance mission, despite Congressional authority to do so; experienced massive and systemic failures in deploying tests to public health labs, which delayed our testing in the critical early days of the response and cost lives; poorly communicated with Americans and was too often two steps behind the science; and, its leadership is reluctant to meet with innovators raising their hands to help.
“While I am critical of the CDC, it is because I believe that we have a responsibility to protect the public health and I want to help the CDC do it better. I want to help it get better.
“As a result of COVID-19, the agency has new resources and new tools to be the world’s premier public health agency once again.
“We need to make sure they know what their mission is and focus the CDC on the right priorities. Business as usual needs to be over.
“I am looking forward to hearing from our witnesses today on this extremely important task.
“We all witnessed the breaks in our medical supply chain during COVID-19.
“Our just-in-time inventory systems that supported our health care providers were overwhelmed in the early days of the response.
“I have no doubt that every member of this Committee received the same heartbreaking calls that I did from their hospitals.
“Brave, tired frontline workers asking for any help that we could provide to get masks, gowns, and other medical supplies.
“I’ve mentioned in previous hearings the need to closely examine the effects of the pandemic that we did not anticipate – and our supply chain is the best example.
“Who would have expected companies like Hanes in my state to make masks, or for Merck to offer their Durham facility to make another drug company’s vaccine?
“The efforts of the private sector to meet the demand are truly unprecedented.
“As the federal government, our ability to affect the supply chains for medical supplies is limited.
“The federal government is just four percent of the purchases of PPE – the other 96 percent belongs to the private sector, who have far greater capabilities to increase our preparedness if leveraged appropriately.
“Our reforms need to focus on sustainable policies that endure after the attention to this response fades.
“When we designed the Stockpile, it was with a bioterror event in mind.
“The Stockpile should serve as a bridge for acute, time limited events, not as the primary source for surge-level medical needs.
“It houses our countermeasures for Ebola, anthrax, and smallpox, but we could never maintain the level of PPE and ancillary medical supplies that we have purchased for COVID-19 in the long term. And, that was never the goal.
“As the author of BARDA and a big fan of Project BioShield, I remember how we’ve had to fight for every bit of funding for these programs during peacetime.
“We cannot put our supply chain needs in the same position. We need to keep the private sector nimble and creative at meeting demand and retain the market incentives not governmental commands.
“With COVID-19, we had no choice but to innovate.
“There were no shelf-ready tests, treatments, or vaccines.
“There was no humming manufacturing line capable of making vaccines to combat this novel virus
“Even with our investments over the years in BARDA, the ASPR, and the Stockpile – we needed lead time.
“A clear gap in our readiness capabilities is the work on the front end for countermeasures.
“Early-stage discovery, like what occurred through NIH and BARDA’s RAD-x initiative, and NIH’s newly announced AvIDD (“avid”) program, will help build our library of medical platforms and technologies that we can pull off the shelf when the next novel pathogen arrives on our doorstep.
“But these programs need partners – and the engagement of academia, alongside the private sector can produce the innovative products we need to be ahead of the curve.
“Once we develop the countermeasures, we also need to manufacture them at scale which will depend on private sector partners to rise to the challenge.
“The FDA is a key partner in this enterprise, and was prepared with the tools needed to truly rise to the challenge in facing COVID-19.
“FDA has reviewed and authorized almost 400 tests, 11 therapeutics, and three vaccines for emergency use that have changed the trajectory of the COVID-19 pandemic.
“Two of the vaccines depend on a brand new platform. In fact, many of the countermeasures used to tackle COVID-19 use platform-based technologies.
“Most of these countermeasures were developed for COVID-19 in less than a year. A process that usually takes more than 3 times that amount of time.
“The agency’s actions to help speed development of needed medicines sends a signal to innovators that the FDA can be more nimble, more approachable, and more efficient in its ability to bring new hope to all American patients, not just in response to COVID-19.
“But it doesn’t stop once these products are authorized.
“We need to get them into the hands of doctors and nurses to help patients, just as urgently today to address the Delta variant as we did previously in the response.
“Senator Murray and I know that our priorities are a big undertaking.
“The lessons learned from this pandemic, and the solutions at hand, will likely be different for each state, locality, and community.
“The HELP Committee has a long, bipartisan history of putting in the work to bring together the right answers to the problems facing Americans.
“Our goal is to provide a targeted legislative response this fall to the biggest gaps in our preparedness architecture.
“To our witnesses today, you are a part of this process.
“Your testimony can help us understand where you all witnessed the biggest gaps in our preparedness and response framework, and how best to address those gaps so we can leave our framework better prepared than we found it.
“I thank the Chair.”