“It’s critical that companies be able to step up and do what they can to make a difference without being bogged down by red tape.”

Upton Lays Out Key Elements of 21st Century Cures 2.0 and Applauds Private Sector Response to COVID-19 

WASHINGTON, DC – In remarks Wednesday afternoon before a virtual meeting of The Ripon Society, U.S. Rep. Fred Upton (MI-6) gave an update on the federal government’s response to COVID-19 with regard to public health and economic recovery and what he sees as the next step forward.

In 2016, the  21st Century Cures Act was passed by Congress and signed into law, and as Chairman of the Energy and Commerce Committee at the time, Upton, pictured above working from his home in Michigan, played an instrumental role in its creation and passage. Supported overwhelmingly by both Democrats and Republicans alike, it was heralded as a bipartisan triumph in an otherwise divided time.

“Diana DeGette and I have been working since the end of last summer on a ‘2.0’ version of this legislation,” he said, referring to the Democratic Congresswoman from Colorado who was his co-author on the original bill.  “There’s been a lot of listening. We’ve talked to some of the disease-focused groups.  We’ve talked to researchers.  We spent some time with Francis Collins at the NIH, who does such a wonderful job.

“Today, Diana and I had a conference call with Steve Hahn, the relatively new commissioner of the FDA. And earlier this week, we put out a 12-page concept paper that lays out some of the key elements of this new plan.”

The concept paper can be found on Upton’s website by clicking here. The key elements of the plan include:

–  Public Health and Pandemic Preparedness:  Among other things, the lawmakers are exploring ways to improve our nation’s pandemic surveillance and testing capabilities, support antimicrobial resistance product commercialization and expand vaccine education and surveillance. They are also considering ways to create a COVID-19 Rare Disease Support Program and establish a federal grant program to help patients and their families afford the cost of medical care involving pandemics.

–  Caregiver Integration: With many Americans receiving care at home, lawmakers are considering how Cures 2.0 could create educational programs and training for caregivers to learn skills. This could help them to augment a care team and complement, not compete with, a clinical visit.

–  Patient Engagement in Health Care Decision-making: Another goal of Cures 2.0 will likely be improved health literacy and access to health information. The goal of these provisions would be to help patients better understand their diseases or conditions, and thus empower them to become part of the decision-making process and take steps to get well.

–  Diversity in Clinical Trials: Diversity in clinical trials is essential to ensuring medical products are safer and more effective for patients. The lawmakers are exploring provisions that could help ensure that regulators, industry, patients, and researchers continue to improve diversity. This could also help improve access to already covered medical services at clinical trial sites.

–  Food and Drug Administration Modernization:  While the first Cures Act took steps to foster the development of digital health technologies, including at FDA, through inclusion of the Software Act, the lawmakers believe Cures 2.0 can help ensure that FDA’s regulatory framework is collaborative and inclusive of the various centers within the agency. DeGette and Upton also hope the legislation could help enable FDA to provide grants in the area of innovative clinical trial design and patient-focused drug development to further build the science in these areas. Another goal of Cures 2.0 is to speed up the development and utilization of real-world data (RWD) and real-world evidence (RWE).

–  Centers for Medicare & Medicaid Services ( CMS)  Modernization: Modernizing coverage and care delivery in the United States is another top priority for DeGette and Upton. In order to do this, DeGette and Upton are seeking additional stakeholder feedback on how the U.S. can keep pace with technological and scientific advances, and what specific provisions must be included in the final Cures 2.0 package.

Upton expressed hope that progress will continue to be made on Cures 2.0 so Congress can build on the success of the original legislation.  “As Steve Hahn said today,” the Michigan lawmaker remarked, “we wouldn’t be where we are in terms of potential for having a successful vaccine without having  21st Century Cures done. We are going to end up with a vaccine maybe even a year earlier than we would have before.”

Following his opening remarks, Upton took a number of questions, including one  about federal regulations and whether anything could be rolled back to facilitate COVID-19 treatment and vaccine development.

“We asked Steve Hahn about that,” he stated, “and we have an Energy and Commerce call tomorrow with Francis Collins.  As we go through this, we’re asking if there is anything we can do in a safe and responsible manner to eliminate burdensome regulations.  

“It’s critical that companies be able to step up and do what they can to make a difference without being bogged down by federal red tape.  In Michigan, they have. In fact, we’re working with the FDA to make sure there’s a certification to clean N-95 masks instead of a one-time-and-done use. Michigan State University has come up with what they think is a pretty solid proposal, and it’s undergoing a certification now by the FDA.”

Upton was also asked his thoughts on the supply chain and whether more is needed to be done to bring manufacturing home rather than relying on companies and factories overseas.

“I heard from one of my hospitals a couple weeks ago,” he recounted.  “They had ordered a good share of PPE and thought they had a contract, but two days before it was supposed to come, it was taken by somebody else. So it really is an issue. The bottom line is we should bring some of these jobs and production back here.”

Finally, Upton was asked about the Paycheck Protection Program (PPP) and how he has seen it help companies in Michigan as they try to weather the storm.

“To the businesses I’ve talked to, it is a lifeline,” Upton stated frankly. “They would not have survived this and their employees wouldn’t have either.”

The Ripon Society is a public policy organization that was founded in 1962 and takes its name from the town where the Republican Party was born in 1854 – Ripon, Wisconsin. One of the main goals of The Ripon Society is to promote the ideas and principles that have made America great and contributed to the GOP’s success. These ideas include keeping our nation secure, keeping taxes low and having a federal government that is smaller, smarter and more accountable to the people.