• Appropriations Update from Capitol Hill
• Bipartisan 21st Century Cures 2.0 Act is Introduced in the House of Representatives
• The AACR Applauds the Nomination of Robert Califf, MD, as the next FDA Commissioner
• Information about an FDA Funding Opportunity in Oncology
• Applications Open for the AACR Annual Meeting 2022 Advocacy Partners Pavilion
• President Biden Signs Infrastructure Bill into Law, Providing Historic Expansion of Broadband Access
• HHS Reinstates FDA Authority Over Laboratory Developed Tests
• New Detailed Map of Cancer-Causing Air Pollution Highlights Impact on Disadvantaged Communities

Appropriations Update from Capitol Hill

-Marc B. Johnson, MPP

On December 2, Congress passed a second continuing resolution (CR) to extend funding for government agencies and programs at current levels through February 18, 2022.  House and Senate Appropriations Committee leaders continue to negotiate top-line spending levels for fiscal year 2022, which began on October 1.  In addition to agreeing to a top-line spending level, negotiators will also have to agree to individual appropriations subcommittee allocations before negotiations on a final legislative package can begin. 

Earlier this year, the House passed the majority of its fiscal year 2022 appropriations bills, including a Labor-HHS-Education (LHHS) bill that would increase National Institutes of Health (NIH) base funding by $3.5 billion. The Senate LHHS bill, introduced in October, would increase NIH base funding by $2.7 billion.

In addition to developments in government spending, there was also news on the future of Senate Appropriations Committee leadership.  Current Chairman Patrick Leahy (D-VT) announced he will not seek reelection in 2022, joining Vice Chairman Richard Shelby (R-AL) who also announced his retirement. Based on seniority, Senator Patty Murray (D-WA) and Senator Susan Collins (R-ME) are likely to become Chair and Vice Chair of the Senate Appropriations Committee in 2023, pending the results of the midterm elections.  

Bipartisan 21^st Century Cures 2.0 Act is Introduced in the House of Representatives

On November 16, Representatives Diana DeGette (D-CO) and Fred Upton (R-MI) introduced the much-anticipated H.R. 6000, the 21st Century Cures 2.0 Act. This legislation builds on their 21st Century Cures Act, enacted in 2016, which accelerated medical product development and established the Cancer Moonshot, among other critical investments. 

Cures 2.0 is designed to increase diversity in clinical trials, expand access to telehealth services under Medicare, Medicaid, and CHIP, and provide expanded collaboration between FDA and CMS to speed delivery of new discoveries. 

In addition, Cures 2.0 would strengthen the ability of the United States to respond to a future pandemic by requiring a national strategy that addresses testing, vaccines and therapeutics, personal protective equipment, and data sharing infrastructure. It would also require a large national survey to analyze long-term access to health coverage, long-term care, and disability coverage, study long-COVID in pediatric populations, and evaluate disparities in long-COVID.

This legislation also includes President Biden’s proposal to establish an Advanced Research Projects Agency for Health (ARPA-H), housed within the NIH, to fund high-risk, high-reward projects intended to develop new cures and treatments for diseases such as cancer, Alzheimer’s, and diabetes. Cures 2.0 would authorize $6.5 billion in fiscal year 2022 to remain available until expended. House Energy and Commerce Health Subcommittee Chairwoman Anna Eshoo has also introduced legislation that would authorize ARPA-H. Her bill, H.R. 5585, the ARPA-H Act, would place ARPA-H as an independent entity within HHS, rather than at NIH, and would authorize $3 billion in fiscal year 2022. Lastly, the 21st Century Cures 2.0 Act would include funding in the RISE Act, which would provide $25 billion in total, including $10 billion at the NIH, to provide supplemental funding for research institutions, universities, and public laboratories to cover costs from federally-backed projects disrupted due to the COVID-19 pandemic. 

Read the 21st Century Cures 2.0 Act, and a section-by-section summary from the sponsors. To date, no legislative hearings or markups of this legislation have been announced.

The AACR Applauds the Nomination of Robert Califf, MD, as the next FDA Commissioner

On November 12, President Biden nominated Robert Califf, MD, to serve as the commissioner of the U.S. Food and Drug Administration (FDA). Dr. Califf previously served as FDA Commissioner in 2016-2017 under the Obama Administration. Upon confirmation, Dr. Califf will take over from Janet Woodcock, MD, who has served as acting commissioner since January 2021.

A cardiologist by training and a leading expert on clinical trials, Dr. Califf founded the Duke Clinical Research Institute, the world’s largest academic clinical research organization. Dr. Califf currently serves as a professor at the Duke University School of Medicine and as head of Clinical Policy at Verily Life Sciences.

AACR President, David A. Tuveson, MD, PhD, FAACR, welcomed the news of Dr. Califf’s nomination, stating “this extraordinary time of promise requires an experienced and visionary leader at the FDA to ensure that the necessary regulatory framework is in place to approve innovating therapies that are both safe and effective, and Dr. Califf is the right person for this extremely important position.” 

The AACR was proud to work with Dr. Califf in his previous role at FDA including holding a day-long meeting in January 2016 to discuss the FDA’s views on companion diagnostics for cancer therapies, evaluation of laboratory developed tests, and regulation of next-generation sequencing-based tests. 

Information about an FDA Funding Opportunity in Oncology

The Oncology Center of Excellence (OCE) is interested in funding research external to the FDA to help advance regulatory science and innovation, particularly with a focus on applied research to help improve drug development. The attached slide has links for more information. Whitepapers for this application cycle are due by January 21, 2022.

**Broad Agency Announcement (BAA) to Advance Regulatory Science and Innovation**

BAA background information

The BAA is open to all responsible sources, including private sector and academic institutions. There are no specific educational or experience requirements for principal investigators (PI), but experience and qualification of the PI are considered as an evaluation factor during review.

The BAA results in a research contract for up to five years. It funds basic and applied research rather than non-research projects. OCE prefers to support applied research to improve drug development. Applied research focuses on solving a specific, practical problem rather than expanding general knowledge. There is no funding limitation specified by the BAA mechanism; however, individual FDA offices have limited funding to support research. Investigators should propose a cost that is reasonable to complete the research.

OCE is interested in all applied research to support oncology drug development, but specific oncology-related interest areas are included in sections 2.6, 2.7, 2.8, 2.9, 2.10, 2.11, 5.7, 5.8, 5.9, and 5.11 of the BAA announcement.

The BAA announcement (1) Describes agency’s research areas of interest for individual program requirements; (2) Describes criteria for selecting the proposals, their relative importance and evaluation method, (3) Specifies time periods for receipt of white papers/quad charts, process for accepting full proposals and, (4) Contains instructions for preparation and submission of proposals.

BAA review occurs in two stages:

• In stage 1, The white paper and quad chart will be reviewed for scientific and technical viability
• In stage 2, FDA will invite offerers to submit a full proposal provided their white paper and quad chart are scientifically and technically sound.

Additional detail about the review procedure is included in the BAA announcement.

Send to [email protected]

Information to submit BAA in oncology, visit OCE Scientific Collaborative

FY21-funded projects

Applications Open for the AACR Annual Meeting 2022 Advocacy Partners Pavilion

We invite nonprofit patient advocacy organizations focused on cancer research and supporting patients with cancer to exhibit in the AACR Annual Meeting 2022 Advocacy Partners Pavilion in New Orleans, Louisiana, (April 8-13, 2022). Accepted exhibitors will receive two complimentary registration passes. There is no fee to exhibit in the pavilion.

Apply today

President Biden Signs Infrastructure Bill into Law, Providing Historic Expansion of Broadband Access

-Calais Prince, PhD

The COVID-19 pandemic brought the importance of telehealth and updating broadband infrastructure to the forefront of public discourse. Temporary telehealth policies have been enacted at the Federal and state levels to reduce exposure risk to COVID-19 for patients seeking medical care. For many patients with cancer and survivors, the benefits of telehealth were not fully experienced because of limited internet access, varying use of electronic health records by health care providers, and cost of internet service. On November 15, President Biden signed the Infrastructure Investment and Jobs Act into law, which will put in place historic investments in broadband expansion. This will benefit more than 30 million Americans who reside in areas without broadband infrastructure that provides at least minimally acceptable speeds, as well as millions more who struggle to find affordable internet service.

The Infrastructure Investment and Jobs Act provides $65 billion to expand broadband and lower prices for internet services to help close the digital divide. This includes more than $42 billion in grants to states, Washington, D.C., and the territories focused on deploying high-speed broadband and require internet providers to provide at least one affordable plan. In addition, the package includes $2.75 billion to promote digital inclusion and equity for underserved communities. This unprecedented expansion of broadband access will close the cancer care divide by improving symptom management, communication between patients with cancer and their health care providers, and the ease of health data sharing between members of the cancer care team.  

HHS Reinstates FDA Authority Over Laboratory Developed Tests

-Nicholas Warren, PhD

Laboratory Developed Tests (LDTs) are medical tests, such as cancer gene sequencing or COVID-19 diagnostics, created by laboratories certified by the Centers for Medicare and Medicaid Services’ (CMS) Clinical Laboratory Improvement Amendments (CLIA) program. The CLIA program certifies laboratories for Medicare and Medicaid payments based on the qualifications of the laboratory personnel, site inspections, and ability to accurately quantify test samples of different analytes. However, new LDTs created by CLIA-certified laboratories are not evaluated by CMS or third party accrediting organizations for their safety or efficacy in relation to medical outcomes.

While the U.S. Food and Drug Administration (FDA) has long considered LDTs medical devices under their authority granted by the Federal Food, Drug, and Cosmetic Act, it has provided enforcement discretion toward CLIA-certified laboratories and has not required pre-market review of most LDTs. However, with the onset of the COVID-19 public health emergency, FDA started reviewing COVID-19 diagnostic tests from CLIA-certified laboratories under the Emergency Use Authorization (EUA) pathway. In the first 125 COVID-19 diagnostic EUA requests reviewed by the FDA, 82 tests (66 percent) were found to have design or validation issues. In most cases, FDA officials helped address these issues in order to bring the tests to market.

In August 2020, the U.S. Department of Health and Human Services (HHS) Secretary Alex Azar revoked the FDA’s authority over all LDTs, citing a lack of legal standing. This ruling was then reversed by HHS Sec. Xavier Becerra in November 2021, allowing FDA to regulate LDTs once again. Additionally, the regulatory environment for non-COVID-19 LDTs remains unclear with FDA claiming authority over those tests, but not requiring review.  

FDA review of LDTs has been criticized by the American Clinical Laboratory Association, which represents many diagnostic companies and CLIA-certified laboratories and prefers a nimble regulatory framework that allows rapid development of lifesaving tests. In contrast, proponents argue even greater FDA scrutiny of tests is important to ensure patients receive high-quality and accurate information regarding their health status. It will continue to be a challenge for federal policy makers to balance these competing desires.

New Detailed Map of Cancer-Causing Air Pollution Highlights Impact on Disadvantaged Communities

-Nicholas Warren, PhD

Industrial air pollution can significantly increase the risk of developing cancer for those living or working nearby. Due to the common placement of heavy industrial facilities in lower income communities and communities predominantly of racial and ethnic minorities, this pollution is also a key driver of cancer-related disparities. In fact, residents of “Cancer Alley,” an industrial region west of New Orleans, Louisiana, are up to 50-fold more likely to develop cancer than the national average. Unfortunately, due to limited regulatory enforcement and failure of polluters to use less toxic manufacturing processes or pollution-mitigating technology, these often unnecessary emissions will continue harming vulnerable communities.

The U.S. Environmental Protection Agency (EPA) regularly monitors the release of 187 hazardous air pollutants from industrial facilities all over the United States. However, the EPA only uses these data to calculate increased health risks from individual facilities, instead of estimating the cumulative risk a community faces from all nearby sources. In an effort to calculate cumulative risks and make the data more accessible to the public, data scientists and reporters from ProPublica crunched the numbers to develop the most detailed map ever of chemical air pollutants, including: formaldehyde, which is widely used in manufacturing construction materials; 1,3-Butadiene, which is an ingredient in making plastics; chloroprene, the primary ingredient for neoprene rubber; ethylene oxide, which is a precursor for a wide variety of chemicals and also used to sterilize medical equipment; and heavy metals. It is important to note that these data only include 187 hazardous air pollutants from industrial chemical releases and not other sources of air pollution like burning fossil fuels or forest fires, and therefore likely underestimates the cancer risk from air pollution.

The Clean Air Act of 1970 provides the EPA with the authority to set air quality standards to protect public health. While “the EPA strives to protect the greatest number of people” who have an elevated cancer risk of one in one million above the national average, the EPA’s National Air Toxics Assessment (NATA) regulation defines an increased cancer risk of up to one in 10,000 to be acceptable. ProPublica estimates that 74 million Americans live in areas with an excess risk of cancer of at least one in one million from air pollution, and 256,000 Americans live in areas with risks at least a one in 10,000 above average. However, even this level of risk is only considered a warning sign and does not require any legal or regulatory actions under the current statute. Under NATA, the EPA has issued enforceable air limits on certain pollutants, which can result in fines. However, the EPA has not issued an enforceable limit for several important pollutants, like chloroprene and ethylene oxide; chloroprene is the largest contributor to elevated cancer risk to residents of Reserve, Louisiana, in “Cancer Alley.” In May 2021, the EPA Office of Inspector General issued a report calling on the EPA to revisit chloroprene and ethylene oxide emission regulations. Additional regulatory protections and the resources and staff to enforce those regulations are critical to help spare these vulnerable communities from unacceptably high rates of cancer.