The Health 202: The 21st Century Cures Act helped accelerate covid vaccines, and lawmakers say their new version could do more.

The U.S. has gotten a crash course over the past 18 months in just how important the biomedical research pipeline can be, as scientists turned years of basic science research into highly effective vaccines against the coronavirus in record-time.

Now, lawmakers say the U.S. is due for big investments to its biomedical infrastructure.

Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) are pushing a bill that would build on the 21st Century Cures Act, a major overhaul in biomedical research passed in 2016 designed to speed up the pipeline for medical innovation.

DeGette and Upton have dubbed their new bill, currently in draft legislation form, "Cures 2.0." Among other things, it would create an Advanced Research Projects Agency for Health, or ARPA-H, dedicated to medical innovations against some of the most difficult diseases. Supporters say the new agency will be modeled off the Defense Advanced Research Projects Agency, or DARPA, the research branch of U.S. defense, which is credited with helping develop the Internet.

Cures 2.0 would introduce funding to increase pandemic preparedness, provide support to improve the diversity of clinical trials, ramp up access to telehealth, and incentivize research into new antibiotics.

I spoke with DeGette and Upton about why they thought the 21st Century Cures Act needed an update and the prospect for the bill's passage.

The following was lightly edited for clarity and brevity.

H202: Why update the Cures Act? Walk me through the thinking behind Cures 2.0.

DeGette: When we did 21st Century Cures it was a three-year process and really was a sweeping revision of the way we do biomedical research at the [National Institutes of Health], and then drug and device approval at FDA. It's been wildly successful. Many people think we got the covid vaccine much more quickly than we otherwise would have because some of the provisions in 21st Century Cures, but as with any big piece of legislation, we realized there were still some improvements. One of the improvements is streamlining and improving the way drugs and devices are funded at [Centers for Medicare & Medicaid Services] because of course you can approve it, but if you can't pay for it, then it's no use to the patients. Another big issue is how do we use big data to help us push research in rare diseases and in cancer. A third thing we wanted to look at is what we can do for vaccine approval and speeding vaccines up, not just covid, but of course other vaccines. And of course, last but not least, we're very excited about the White House initiative for ARPA-H, which will use unique ways to try to find the cures to the thorniest issues we have.

Upton: We started [21st Century] Cures, which Obama signed in 2016, in 2014, so it's really been seven years. Diana and I embarked on this at the beginning of last year. Covid delayed things. Our goal is to get it to the president before the year is out … [The 21st Century Cures Act] has been remarkably successful and we want to build on that success, particularly as we look at telehealth, better trials.

Rep. Fred Upton (R-Mich.) listens during a news conference with members of the House Problem Solvers Caucus. (Stefani Reynolds/Bloomberg)

H202: You said that some have credited the original 21st Century Cures Act with helping develop the coronavirus vaccines. Tell me about that.

Upton: When we got the Cures Act done, we included expediting approvals of drugs and devices, coupled with $45 billion in more health research spending over a 10-year span. Pfizer is the largest employer in my district. They dropped everything and went all-hands-on-deck. When they thought they had the answer with the vaccine, they were able to produce it before they got the emergency use authorization to do so … They started [production] in September. By the time, they got the EUA in December, they already had millions of doses manufactured, frozen. The day after they got the EUA, the trucks could roll out of portage. Moderna, same thing.

DeGette: The increased powers to the FDA for early approval allowed them to put together Operation Warp Speed… The money they put behind [the federal vaccine initiative] wasn't because of 21st Century Cures Act, but the increased ability to be nimble, a lot of that came from [it].

H202: What lessons have we learned from the pandemic about what is possible in terms of innovation?

DeGette: Surely the mRNA platform for the vaccines has been a huge advance. I think that it's going to be open for scientists in so many other areas with other vaccines and other research. If you think about the effectiveness of the mRNA vaccines, Moderna, Pfizer, it's extraordinary. … The mRNA platform has been around for a while, but this is the first time it's been used for vaccines, and that's a big game changer.

H202: Tell me a little more about ARPA-H, the proposed agency focused on medical innovation.

Upton: We were terribly excited about Biden's proposal on ARPA-H. This will be a legacy item for him… It is going to be an independent group housed within NIH that will really be able to make some exciting advances as we try to find cures. They're going to be very nimble ... DARPA got out [from under] the defense bureaucracy and began to look at things like the Internet. This is going to try to be run in the same way.

H202: Some scientists have criticized the decision to house ARPA-H inside NIH, expressing concerns that the new institution will get caught in existing health bureaucracy. Was there ever any consideration about making ARPA-H a separate entity?

DeGette: There have been a lot of opinions about where ARPA-H should be housed. Some people think it should be stand-alone; some people think in NIH. That's not the big issue. The big issue to me is how do you structure the agency so it has its strict lanes and doesn't get subsumed with the bureaucracy. We'll draft so it has independence and the nimbleness it needs to find innovative cures.

Rep. Diana DeGette, D-Colo., asks a question during a hearing in 2018 on the opioid epidemic in Washington. (Alex Brandon/AP)

H202: The 21st Century Cures Act made it easier to expedite drug approvals, but that approval process has come under increased scrutiny with the approval of aduhelm, a controversial Alzheimer's drug. What do you make of that case?

DeGette: When we enacted the legislation, we wanted to put the paradigm in place. Now there are several investigations going around that Alzheimer's drug. The issue is not safety. It's whether it is effective for people with early onset Alzheimer's. You don't want people like us making those decisions. You want scientists to make those decisions. Those discussions are ongoing, but the bottom line is that it's not a safety issue, it's a question of if it's effective.

H202: People sometimes despair of bipartisanship in Congress, especially when it comes to health care. What has made it successful in this case?

DeGette: Fred and I always say, disease doesn't discriminate based on party registration. There is a deep desire to expedite cures for disease … [And] there's a lot more bipartisan issues in health care than people realize.

Upton: Diana and I recently spoke in a committee addressing the question of how do we make Congress work. She and I testified for an hour … I couldn't ask for a better partner than Diana. We've been to each other's districts. Our offices are on the same floor.

H202: What's the plan for passing Cures 2.0?

Upton: The good news is this is going to happen. We're open to listening to good ideas that make sense in building a stronger coalition … When we did [the 21st Century] Cures, it passed 392-26 in the House. It was three years of work. How do you get that through the Senate without any hearings and the threat of the filibuster? Because of the margin and outreach that we did. And we needed every day. We're looking to build that same coalition.

DeGette: We're going to try to take it through regular order. We're going to try to take it through hearings in the health subcommittee and a markup in the full committees, to the House floor and then on to the Senate. Members of Congress and the leadership are familiar with the Cures framework already from doing 21st Century Cures, and there's a lot of bipartisan and bicameral interest in it. We're not going to wait for something else to put it on to.

Ahh, oof and ouch

AHH: The U.S. reached Biden's 70 percent vaccine-target one month late.

Seventy percent of U.S. adults have received at least one dose of a coronavirus vaccine — the milestone coming one month after the July 4 deadline that President Biden set for it, The Post reports.

"Unlike a year ago, we have the ability to save lives and keep our economy growing," Biden wrote on Twitter. "We know we can dramatically lower the cases in the country. We can do this. Get vaccinated."

The United States reached a milestone of getting at least one coronavirus vaccine dose to 70 percent of adults on Aug. 2. (Reuters)

Rising case numbers, driven by the more contagious delta variant, seem to be driving increased uptake of vaccines. New daily reported deaths have gone up by 33 percent and hospitalizations by 46 percent on average in the last seven days compared to the week before, according to Centers for Disease Control and Prevention data.

The senator, who was vaccinated in December, started experiencing flu-like symptoms on Saturday after meeting with other lawmakers in Senate and GOP functions without a mask. His case represents the first "breakthrough" infection in the Senate.

"Graham's announcement follows a week of rising tensions on Capitol Hill over a renewed call for mask-wearing by the Capitol physician after the Centers for Disease Control and Prevention updated its guidance in response to the growing number of infections across the country stemming from the delta variant of the virus," The Washington Post's Max Hauptman, Paul Kane and Seung Min Kim report.

Graham credited the coronavirus vaccine with protecting him from more severe illness.

"I am very glad I was vaccinated because without vaccination I am certain I would not feel as well as I do now. My symptoms would be far worse," he said.

"It seems like ancient history right now, but there was a time in which a vast majority of Americans agreed on certain things when it came to the coronavirus pandemic. And high on that list was masks," The Post's Aaron Blake reports.

"Even as then-President Donald Trump was eschewing them last year, Americans were on a very different page. An Associated Press-NORC poll in July 2020 showed that fully 75 percent of Americans supported not just wearing masks, but requiring them in public when you were around someone else. Just 13 percent disagreed. Even Republicans agreed with mandates, 58-27," he writes.

But after public health agencies and local governments loosened mask restrictions, many Americans are not eager to return to masking. A new Monmouth University poll released Monday morning shows only a little more than half of Americans support "instituting, or reinstituting, face mask and social distancing guidelines in your state." This response was not even in relation to a mask mandate, but instead to the much lower bar of reinstating guidance.

It's one of several surveys showing declining acceptance of mask mandates.

"Interestingly, there might actually be as much or more appetite for a more intrusive mandate: vaccination. One survey released last month found that 64 percent of Americans support requiring everyone to get a coronavirus vaccine. Another also showed the number around 6 in 10," Aaron writes.

Tensions escalated sharply Monday between liberal Democrats and President Biden over the end of an eviction moratorium aimed at preventing people from losing their housing during the pandemic, The Post's Sean Sullivan, Marianna Sotomayor and Tyler Pager report.

White House officials say that the Centers for Disease Control and Prevention found no legal authority to extend the moratorium.

Rep. Cori Bush (D-Mo.) protests the expiration of the eviction moratorium on the Capitol steps. (Stefani Reynolds/Bloomberg)

"That, however, did not satisfy liberal lawmakers, who were fuming that the White House had not prevented the moratorium from expiring Saturday in the first place," our colleagues write. "They called on Biden to unilaterally extend the federal protections, which they said would buy Congress time to find a longer-term solution, even if that meant inviting a legal challenge."

"The White House did not handle this well. I think they did not think about this eviction moratorium in a serious way," said Rep. Pramila Jayapal (D-Wash.), chair of the Congressional Progressive Caucus.