PPC CAPITOL CONNECTION

July 17, 2024

What Matters Now in Washington:

  • House Labor-HHS bill advances out of committee which calls for large funding cut to the National Institutes of Health (NIH). More…
  • The All of Us Research Program has announced a delay in launching pediatric enrollment due to lack of adequate program funding for the current fiscal year. More…
  • The Supreme Court overturned the decades-old “Chevron Deference” precedent, giving the judiciary greater say in what federal agencies can do. More…
  • The Supreme Court invalidates the Bureau of Alcohol, Tobacco and Firearms’ (ATF) ban on bump stocks. More…    
  • President Biden announces new immigration executive actions aimed at enhancing security along the southern border and actions to keep immigrant families together. More…
  • The Food and Drug Administration (FDA) authorized the first menthol favored e-cigarette products, a move that will create an opening for more children to begin using menthol products. Other e-cigarette updates include the reversal of an FDA marketing ban on JUUL e-cigarettes, and a Senate hearing that underscored the failure of federal agencies to enforce laws designed to protect children from harmful tobacco products. More…
  • PPC members authored policy commentaries in Pediatric Research exploring the intersections of child health policy, advocacy, and pediatric research.More…
  • Find new funding opportunities, research findings, and more below.More…
  • See what other developments we’re tracking with implications for child health advocacy.More…

HOUSE LABOR-HHS COMMITTEE ADVANCES FY25 SPENDING BILL. The House Appropriations Committee advance the Fiscal Year (FY) 2025 Labor-HHS-Education spending bill. The bill calls for a 7% cut to the budget for the Department of Health and Human Services (HHS), as well as a large-scale reorganization for the National Institutes of Health (NIH).

The $107 billion allocated to HHS in the bill is $14 billion below President Biden’s FY25 budget request. While the bill maintains a flat budget for NIH at $48 billion, the bill’s proposed NIH restructuring plan would shrink the number of research centers and streamline research while increasing congressional oversight. Specifically, the bill would consolidate 27 of the agency’s existing research centers to 15. Among the centers risking elimination, the bill proposes collapsing the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) into a new institute focused on disability related research only. There are concerns that dissolving NICHD will result in a lack of representation for child health priorities within NIH. Also included in the bill are contentious policy riders such as eliminating funding for the Title X family planning program and for gender-affirming care. The bill would also eliminate HHS programs related to gun violence prevention research.

Despite the child health challenges present in the bill, it does contain some advocacy successes. Crucially, the bill includes $10 million for the Pediatric Subspecialty Loan Repayment Program (PSLRP), maintaining FY24 levels. Thanks to advocacy from the PPC and allied health organizations, the committee approved language directing HRSA to work with stakeholders to ensure the program’s application process reflects the true nature of pediatric subspecialty practice, having acknowledged the underrepresentation of pediatric medical subspecialists, pediatric surgical specialists, and child and adolescent psychiatrists in the initial awards for 2023. Specifically, the bill instructs HRSA to incorporate into the application process clinical hour requirements and site eligibility criteria that are in line with pediatric specialty practice and reflective of the regionalization of pediatric specialty care.

As legislators work on final budget proposals that can clear the Senate and be signed by the president, this bill may experience major changes. House Democrats have fought against the riders in the legislation. Democrats raised objections with overhauling NIH programs in the absence of holding public committee hearings. The Senate version of this bill is certain to look drastically different, as Senate Democrats and the Biden Administration are committed towards maintaining spending levels set out by the 2023 Fiscal Responsibility Act. While the House-proposed bill is highly unlikely to become law in this appropriations cycle given the current political landscape, its introduction reveals that overhauling parts of NIH are Republican priorities during the appropriations process, and that these proposals could be on the table again in the future.

ALL OF US DELAYS THE LAUNCH OF PEDIATRIC ENROLLMENT. The National Institutes of Health (NIH) has announced further delays to launching pediatric enrollment into the All of Us Research Program.  Established after passage of the 21st Century Cures Act of 2016, the program has enrolled hundreds of thousands of participants nationwide since its inception, but children are being left behind.

Since its inception, the NIH has received more than $3 billion for All of Us in direct funding through both the Cures Act and the annual appropriations process. However, while base funding for the program remained flat in the final FY24 budget, funding for the Cures Act significantly decreased. As a result, All of Us received $357 million for this fiscal year, representing a decrease of $184 million (34%) compared to FY23 appropriations. After this reduction became known, All of Us leadership announced further delays to initiating pediatric enrollment.

In FY25, Cures Act funding will decrease again from $235 million to $36 million, and if base funding for All of Us remains flat again, the program will see a 71% funding cut from its FY23 level. President Biden’s FY25 budget request funds All of Us at $541 million, making up for further reductions in Cures Act funding in FY25, and restoring the program to its FY23 funding level. Increased program funding will be necessary to ensure pediatric enrollment moves forward in FY25. Additionally, NIH must ensure that pediatric enrollment into All of Us remains a top priority in the months ahead.

SUPREME COURT STRIKES DOWN THE CHEVRON DEFERENCE. In the case of Loper Bright Enterprises v. Raimondo, the Supreme Court ruled 6-3 to strike down the decades-old “Chevron deference” precedent. Chevron deference, as established in Chevron USA v. Natural Resources Defense Council in 1984, had long maintained that federal courts should defer to relevant executive agencies in interpreting ambiguities in laws passed by Congress provided that their interpretation is reasonable. For almost four decades, the Chevron Deference had empowered federal regulatory agencies to fill in the gaps in congressional statutes, giving them much-needed flexibility to establish regulations in important policy areas such as environmental protections and healthcare.

By striking down this precedent, the Court has essentially disempowered executive branch agencies to make timely and evidence-based decisions regarding programs and policies related to the health and well-being of children. For example, agencies such as the Center for Medicare & Medicaid Services (CMS) will now be constrained in their ability to interpret intricate policy and regulatory details surrounding Medicare, Medicaid, and CHIP. Instead, these decisions will now largely be litigated within the judicial system.

SUPREME COURT ISSUES RULING ON BUMP STOCKS. On June 14, the Supreme Court released an opinion in the case Garland v. Cargill, which dealt with the legality of a ban on “bump stocks.” These rifle attachments allow a shooter to fire continuously, giving a semi-automatic weapon nearly the same firing rate as a machine gun. In a 6-3 ruling along ideological lines, the Court ruled that the Federal Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) exceeded its authority when it issued a rule that classified bump stocks as machine guns in 2017.

The Trump Administration originally ordered the ban following a deadly 2017 Las Vegas mass shooting where a single gunman used multiple guns modified by bump stocks to kill 60 people and injuring 400 others. The subsequent ATF regulation banned bump stocks on the grounds they transform legal semi-automatic weapons into illegal machine guns. In ruling this latest decision, the Supreme Court rejected the ATF’s reasoning behind its regulation and has effectively affirmed the legality of bump stocks.

PRESIDENT BIDEN ANNOUNCES NEW IMMIGRATION ACTIONS. On June 4, the Biden Administration announced new restrictions on immigration asylum policy. Under this order, access to asylum between ports of entry will be unavailable once the average number of individuals seeking asylum at the southern border exceeds 2,500, with a few exceptions for unaccompanied children. Migrants who violate the policy will be turned away at the border and be forced to either stay in Mexico or return to their country of origin. Failure to comply may result in a five-year ban on reentry to the U.S. The border will reopen when the average number of daily border crossings drops to 1,500. The asylum restrictions of this policy are now in effect, as the Biden Administration has determined the 2,500 thresholds have been met. The president’s order makes use of section 212(f) of the Immigration and Nationality Act, which allows the president to suspend the entry of foreigners who are deemed “detrimental to the interests” of the U.S. This is the same authority used by the Trump Administration when it attempted to bar travel from visitors or migrants from predominantly Muslim countries, an action that was halted during litigation proceedings before eventually being struck down. As such, it is highly expected that this latest policy will be challenged in court. Additionally, since the policy would not apply to unaccompanied children, there are concerns with this policy about its impact on families who may feel pressured to self-separate at the border to get their children across.

In a more generous immigration action, on the 12th anniversary of the Deferred Action for Childhood Arrivals (DACA) program, the Biden Administration announced two additional immigration actions. The first action will allow noncitizen spouses and children of US citizens to apply for lawful permanent resident status without leaving the country. This policy will allow more families of mixed immigration status to remain together in the US throughout the immigration process and offer protection for about 50,000 noncitizen children under the age of 21. The second action will ease the process for people who earned college degrees in the US, including DACA recipients, to receive work visas.

FDA AUTHORIZES FIRST-EVER MENTHOL-FLAVORED E-CIGARETTE PRODUCTS. On June 21, the Food and Drug Administration (FDA) authorized the sale of four menthol-flavored e-cigarette products under the NJOY brand, which is owned by tobacco giant Altria.

This authorization represents the first-ever FDA authorization of non-tobacco flavored e-cigarettes and comes despite mounting evidence pointing to menthol tobacco products’ appeal to youth. The decision also gives credibility to vaping companies’ longstanding argument that their products are effective smoking cessation tools. Prior to this announcement, FDA had authorized only 23 e-cigarette products, and none of them came in a flavor other than tobacco. Yet, thousands of illegal non-tobacco flavored-e-cigarettes have flooded the market for years and have landed in the hands of children.

This latest authorization by FDA stands in contrast to the agency’s own conclusions that flavored e-cigarettes, including menthol products, have fueled a youth vaping epidemic. In its announcement, FDA said it may still suspend or withdraw this authorization if there is found to be a significant increase in youth use of menthol-flavored e-cigarettes.

— FDA RESCINDS BAN ON JUUL E-CIGARETTE PRODUCTS. The FDA announced it will be rescinding its marketing denial orders (MDOs) against JUUL Labs, Inc. tobacco products, including e-cigarettes. These MDOs, originally issued in June 2022, called for JUUL tobacco products to be removed from the market after the agency concluded that the company failed to show that the sale of these products would be appropriate for public health. However, FDA issued an administrative stay in July 2022 after determining there are scientific issues unique to JUUL that warrant additional review. In its June 6 update, FDA cited this review and ongoing litigation as the basis for the recession. The agency emphasized that the decision to rescind is neither an authorization nor denial of JUUL’s marketing applications, but that the applications return to pending status under review by the FDA.

— SENATE JUDICIARY COMMITTEE HIGHLIGHTS YOUTH E-CIGARETTE EPIDEMIC. On Wednesday, June 12, the US Senate Judiciary Committee held a hearing entitled “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes“. In the hearing, senators of both parties grilled regulators and industry representatives on the epidemic of teen e-cigarette use, pushing for more action to be taken to crack down on illegal flavored e-cigarettes that attract children.

In recent years, FDA’s Center for Tobacco Products (CTP) has faced criticism over its failure to effectively regulate e-cigarettes, allowing the market to be flooded with youth-appealing products that lack the requisite FDA authorization to be sold legally and fueling a youth nicotine epidemic that continues to this day. Under a federal court order, the FDA faced a deadline of September 9, 2021, to rule on e-cigarette premarket applications. Almost three years later, FDA has still not completed this review, and thousands of unauthorized e-cigarettes have flooded the market in the meantime, remaining widely available and easily accessible to kids. More than 2.1 million youth currently use e-cigarettes, 90% of whom have reported using flavored e-cigarettes, despite none of them being authorized by the FDA.

The backlog of applications that vape companies have submitted for FDA approval – which regulators are legally required to review – has caused the FDA to operate more slowly, according to CTP Director Brian King. During the hearing, King stated that FDA received 27 million applications for e-cigarette products. But unlike producers for drugs and medical devices, who pay user fees to fund the agency’s work, the FDA is not allowed to collect such fees from e-cigarette makers. King requested the committee for the authority to fund this increased workload.

Susan Walley, MD, MHCM, NCNTT, FAAP, the Immediate Past Chair for the AAP’s Section on Nicotine and Tobacco Prevention and Treatment, also served as a witness for the hearing. Dr. Walley spoke about her first-hand experience witnessing nicotine addiction take hold among her teenage patients within days of experimenting with e-cigarettes. She stated the brain is more susceptible to nicotine addiction during adolescence and that with repeated exposure, youth eventually become dependent on nicotine. Dr. Walley called on the federal government to take immediate action to remove unauthorized e-cigarettes from the market by issuing steeper fines, seizing more illegal products, and criminally prosecuting bad actors, and emphasized the need for Congress to better fund these enforcement efforts.

PPC POLICY COMMENTARIES. Members of the PPC have authored commentaries detailing the policy implications of research published in Pediatric Research. You can read these PPC-authored commentaries online:

KEY RESEARCH UPDATES FROM NIH 

WHAT WE’RE READING: