This post is part of a series of quarterly roundups on scientific integrity.
During the last quarter of 2022, Congress passed an omnibus spending bill that increased research funding and included some — but definitely not all — provisions recommended by scientific integrity advocates. The Biden administration took limited, and still inadequate, steps to address COVID-19. And multiple agencies considered ways to improve equity in the benefits of public programs, opportunities to influence regulation, and research grant awards.
Concluding the 117th Congress and looking toward the next one
The 117th Congress managed to pass a spending bill in late December, just in time to avert a government shutdown. The $1.7 trillion omnibus increased the budgets of several agencies, including the National Institutes of Health, National Science Foundation (NSF), Department of Energy, and National Oceanic and Atmospheric Administration. Increases at agencies such as EPA were enough to keep up with inflation but not to boost programs. The NSF’s additional $1 billion was in partial fulfillment of the CHIPS and Science Act’s funding authorization, and it came with a requirement for the agency to remove bias in its grant-awarding process and address the power dynamics between senior investigators and students that can lead to harassment.
The omnibus also included the Electoral Count Act and Presidential Transition Improvement Act, which protect against efforts like the January 6th Capitol insurrection to subvert presidential elections. However, these bills do not address states’ restrictive election laws or judicial dismantling of the Voting Rights Act, as UCS Senior Voting Rights Fellow Michael Latner pointed out.
Also contained in the spending bill was the Food and Drug Omnibus Reform Act (FDORA), which includes several provisions to improve clinical trial diversity and modernize the agency’s pathway for accelerated approval. FDORA requires the drug companies sponsoring trials to submit to FDA “diversity action plans” for all phase III clinical trials and most device studies that include the sponsors’ goals for enrollment, their rationale, and an explanation for how they hope to achieve their enrollment targets; however, there is no enforcement mechanism. FDORA also slightly revises the accelerated approval pathway, which is used for drugs that treat serious diseases for which there are no other treatments. The existing process allows FDA to approve these drugs based on preliminary, inconclusive data, but requires that manufacturers continue to study the drug after it is on the market to confirm whether it is safe and effective. However, there is often a delay of several months or years before those confirmatory studies are even started, and many years before they are completed. FDORA provisions codify FDA authority to enforce post-approval clinical trial requirements, but fail to require that post-market studies be underway prior to approval or to set a deadline for product removal if trials are not conducted or the product is not shown to have a clinically meaningful benefit. The bill also does not include any provisions of the VALID Act, which would have provided FDA with the authority and resources necessary to ensure that the highest-risk lab-developed diagnostic tests (such as cancer tests and genetic tests) are accurate. As introduced in the Senate, the VALID Act would have covered 200,000 existing lab-developed tests (many of which are inaccurate) but would have finally required new, very high-risk tests to be regulated by the FDA to make sure they are accurate.
Also not included in the omnibus were two important bills that the House had passed but the Senate had not. The Whistleblower Protection Improvement Act would have established parity for federal government whistleblowers with 16 laws passed since 2000 for private-sector employees in different industries. The Preventing a Patronage System Act would have blocked future administrations from implementing schemes like the Trump administration’s Schedule F, which would have stripped civil service protections from a large swath of agency employees and enabled the administration to replace them with people selected based on their politics rather than expertise.
The midterm elections resulted in a divided 118th Congress, with Democrats controlling the Senate and Republicans the House of Representatives. The president’s party typically loses seats in midterm elections, so the fact that Democrats held so many House seats and gained a Senator was counter to past trends. Having the Democratic caucus in control of the Senate—as opposed to the even split of the 117th Congress—will allow that chamber to approve nominees more quickly. However, having each party controlling one chamber will make passage of future spending bills challenging.
Looking ahead: Congress will need to pass either a new funding bill or a continuing resolution by September 30, 2023, in order to avoid a government shutdown.
Limited progress and missed opportunities on COVID-19
Since late October, CDC has been reporting weekly, instead of daily, COVID-19 case and death data. The loss of daily information came at the same time that experts who had advised the Biden transition on the pandemic described themselves as “deeply dismayed by what has been left undone” in the federal COVID response, and recommended several improvements, ranging from a stronger data collection infrastructure to systematic improvements for indoor air quality. A few weeks later, the journal Nature published the results of a consensus process involving 386 experts from around the world, which generated 41 consensus statements and 57 recommendations in the areas of communication, health systems, vaccination, prevention, treatment and care, and inequities. Although the Biden administration seems happy to keep promoting vaccination, the US performs poorly in most of the recommended areas.
CDC Director Rochelle Walensky did finally start encouraging mask-wearing again in early December, when the combination of COVID-19, influenza, and RSV led to a spike in hospitalizations. The Biden administration announced that people can once again request four free COVID-19 rapid tests per household, and the National Institutes of Health launched the MakeMyTestCount.org website to collect at-home testing data that otherwise would not be included in the calculation of test positivity totals and rates. The White House held a summit on the challenges of and opportunities for improving indoor air quality. These are all steps in the right direction, but they do not negate the fact that the Biden administration seems to want to deny the reality that COVID-19 is still sickening and killing thousands of people every week. Black, Hispanic, and American Indian/Alaska Native populations remain at higher risk of COVID-19 infection, hospitalization, and death compared to the non-Hispanic white population.
One particular problem with the administration’s approach is that CDC’s “community levels” only indicate high levels of COVID-19 when the virus is already widespread; transmission levels, which it reported earlier in the pandemic, are a much better indicator of when preventive strategies such as mask mandates are warranted. If CDC once again focused on transmission levels, and/or emphasized increases of the virus in wastewater, state and local officials might find it easier to adopt mask requirements. And if Congress hadn’t failed to appropriate additional federal funding, perhaps the administration would do more to give people access to masks, tests, or even air filters as well as vaccines.
Another problematic action that CDC has failed to reverse even in the face of rising COVID-19 case counts is September guidance removing mask requirements for healthcare facilities. Some states still require masks in healthcare settings, but in much of the country both patients and healthcare workers face higher risks of infection when they encounter patients who (whether they know it or not) have COVID-19. The Occupational Safety and Health Administration in early December sent the White House Office of Information and Regulatory Affairs (OIRA) the text of a proposed rule to protect healthcare workers from COVID-19. Though the text of the draft rule has not been made public, it’s possible that it will require healthcare employers to create plans to protect their workers from COVID-19, and such plans could include mask requirements. “As of December 7, more than 5,500 health care workers have died of COVID, including nearly 500 nurses,” said Deborah Burger, president of National Nurses United. “We applaud OSHA for fulfilling its commitment to issue a permanent standard for health care workers, and we strongly urge OIRA to complete its review of the permanent standard as quickly as possible.”
Looking ahead: OIRA should complete its review of OSHA’s draft rule within 90 days of receiving it. After that, the draft rule will be open for public comment.
Advancing equity in federal programs, regulations, and grantmaking
President Biden’s Justice40 Initiative aims to ensure that 40 percent of the benefits of several forms of federal investment go to disadvantaged communities that are marginalized, underserved, and overburdened by pollution. In November, the White House Council on Environmental Quality launched version 1.0 of the Climate and Economic Justice Screening Tool, which will help identify disadvantaged communities that should receive program benefits. Groups at elevated risk from pollution were also a topic of a recent National Academies of Sciences, Engineering, and Medicine report on how EPA conducts the integrated science assessment that informs national ambient air quality standards. While the National Academies authors were largely positive about EPA’s scientific approach, they also recommended that EPA more fully assess the impacts of air pollutants on sensitive populations (such as children, the elderly, and people with asthma) and communities.
Another piece of the Biden-Harris administration’s plans to advance equity came in the form of a listening session about how the Office of Information and Regulatory Affairs (OIRA) can improve participation in the regulatory process. The meeting announcement explained that “the regulatory process works best when we hear directly from members of the public, including traditionally underserved communities, and they have a say and a stake in their government.” James Goodwin of the Center for Progressive Reform attended the session and provided input about how OIRA can make it easier for the public—and particularly members of structurally marginalized communities—to influence how regulations are developed and implemented.
Federal agencies can also advance equity by revising their processes for allocating grant funding to researchers. A new study accepted by the peer-reviewed journal eLife reports that in National Science Foundation grantmaking, white principal investigators are consistently funded at higher rates that principal investigators of other races. The authors found that expert panels consistently gave lower scores to proposals from Black and Asian scientists; one of their recommendations is to convene review panels that reflect the diversity of the communities whose grants they are evaluating. At the National Institutes of Health (NIH), a new proposal for scoring research applications would no longer ask reviewers to rate researchers’ expertise or their institutions’ access to resources, a move that aims to address the problem of NIH funding disproportionately going to already well-resourced institutions.
Looking ahead: NIH is accepting comments on its proposal for scoring research applications until March 10, 2023; it will then incorporate comments and revise the plan.
Also:
What Opioid Lawsuits Can Teach Us About Climate Courtroom Battles
FDA Delays Key Advisory Committee Meeting on OTC Birth Control
The Next Abortion Fight Could Be Over Wastewater Regulation
As Workers Battle Cancer, The Government Admits Its Limit for a Deadly Chemical Is Too High
FDA ‘Failed’ the Public and a Whistleblower By Ignoring Science
Dems’ Final COVID Report Slams Government Failures. Congress May Repeat Them.
We Finally Have a Confirmed Head of the White House Regulatory Office
New Resources:
Climate Science Legal Defense Fund resource: Political Action Toolkit
Government Accountability Project resource: On the Front Lines of Democracy: A Guide to Whistleblowing for Election Workers