Category: Blog

The Trump Administration Issues Inconsistent Guidance Regarding Acetaminophen and Autism

The current presidential administration has placed significant focus on addressing a cited increase in the rate of autism diagnoses. Late last month, President Trump, alongside the Health Secretary, Robert F. Kennedy Jr., issued new health guidance and announced in a press conference that there is evidence of a link between the use of acetaminophen during pregnancy and neurological effects, specifically autism and attention-deficit/hyperactivity disorder (ADHD), in children post-birth. The announcement was coupled with a notice from the U.S. Food and Drug Administration (FDA) that it plans to initiate a process for a label change on acetaminophen products to inform consumers of the link, as well as a letter issued by the FDA to physicians about the potential link. The FDA’s letter specifies that “a causal relationship has not been established” between use of the medication and autism, while also asserting that clinicians may want to suggest pregnant people reduce their use of the medication. The issuance of sweeping advice from the Trump Administration in light of these inconsistencies is unsettling from a public health perspective because acetaminophen remains the recommended drug for fever reduction in pregnant people. The guidance to minimize acetaminophen use could be harmful for pregnant people because it may lead them to endure unnecessary pain and fever, which are dangerous for the pregnant person and the fetus.

In addition, mixed messages have created confusion in the legal context because of the announcement’s reliance on a study that was previously found inadmissible by a judge. In 2022, a group of families sued the maker of Tylenol, an acetaminophen product, for failure to warn consumers of the risk that prenatal exposure to the medication may create a heightened risk of autism. One of the experts used to support the families’ proposition was Andrea Baccarelli, MD, PhD, who was also cited in the Trump Administration’s recent announcement. The judge rejected this expert, as well as all of the families’ other experts, in an order in 2023, stating that the experts had “cherry-picked” data in their analyses. The case was subsequently dismissed in 2024, and the dismissal is currently on appeal.

In light of the executive branch’s reliance on one of the same experts as the families, the plaintiffs’ attorney has filed a letter with the court in support of their appeal, noting that the expert had been relied upon in the conclusions of a recent White House briefing. The lawyer notes the separation of power concerns that would arise if the ruling that this expert’s opinions are inadmissible in court is affirmed, while the opinions are simultaneously cited as valid by the executive branch. On the other hand, the attorney for Tylenol in the same lawsuit has also filed his own letter referencing the advice put out by the Trump administration as support of the defendant’s position that they have not failed to include any warning of a link to autism on their products. The defendant’s lawyer cites the language in the FDA’s letter to doctors stating that there is no causal relationship between the drug and autism. In light of each of letters, the judge has pushed back oral argument on this appeal that was set to occur on October 6, 2025 to November 17, 2025.

The use of the Trump administration’s guidance in this litigation to both support and disprove a link between Tylenol and autism emphasizes the confusion the new health guidance has created. What does this mean going forward? In the immediate future, the guidance may create fear among pregnant people about treating their pain and fever during pregnancy. If moving forward, the guidance does successfully ignite litigation aimed at a requirement to label acetaminophen products as not recommended during pregnancy, it could lead to an increase in pregnant people leaving pain and fever untreated during pregnancy, potentially putting them in danger of other complications.

Tribal Youth vs TikTok: The Fight to Protect Native American Mental Health

As technology becomes more salient in everyday life, American youth now collectively spend more time on screens than any other leisure activity. In fact, around half of American teenagers ages 12-17 self-reported four or more hours of screen time per day. Of those teenagers with four plus hours of screen time, about 25% of them showed symptoms of anxiety or depression in the past two weeks. 

The negative effects of adolescents’ high exposure to screen time are well researched, particularly its negative effects on mental health. Studies have shown that excessive screen time exposure increases the risk of depression, sleep disorders, social isolation, and other mental health issues among children and adolescents. Between 2017 and 2019, social media, one of the main sources of screen time, was associated with 30% of adolescent suicides, the leading cause of adolescent death.

A particularly vulnerable group to struggles with mental health is Native American communities. Out of all ethnoracial groups, Native Americans have the highest rates of mortality from deaths of despair (e.g., suicide, overdose, alcohol-associated liver failure). A long and dark history of oppression, forced assimilation, and violence has left thousands of Native Americans suffering from multi-generational trauma, manifesting itself in mental illness, substance use disorders, and suicide. Despite the increased need for mental health services in Native American communities, many barriers continue to limit access. Lack of funding, poverty, rural and isolated locations, mistrust in government services, and mental healthcare providers’ lack of cultural competency are only a few of the many ways access to mental health care is restricted. The historic and continuous discrimination of Native American peoples, coupled with the barriers to mental health care services, leaves these communities in a unique position of vulnerability.   

The epidemic of social media has been felt acutely amongst many Native American tribes. On September 15, 2025, the Chickasaw Nation became the latest of about half a dozen Native American Tribes to lodge claims against social media platforms. These claims allege the companies’ products (Facebook, TikTok, Instagram, etc.) are harming their youth, who are already at disproportionate risk of mental health problems and suicidal ideation. The suit claims that social media platforms design their product to addict young users and profit from their addiction. Approximately 65% of tribal youth spend three to seven hours a day on social media, reporting difficulties with time management and impulse control related to social media use. On January 8, 2025, an Apache tribe filed an extremely similar suit, alleging that these platforms have put profit above all else at the expense of the cognitive development of the tribe’s children and their vulnerability to mental health problems. 

The uptick of cases filed by Native American tribes is a small part of a larger trend in the legal community aiming to hold social media companies accountable for designing their platforms to be addictive to children and adolescents without warning of the mental and physical harm that follows. While companies like Meta, the owner of Instagram and Facebook, have made efforts to improve the safety of young users, such as Parental controls, many claims have introduced evidence suggesting their safety initiatives are little more than PR stunts. It will be crucial for regulators and lawmakers to consider the evidence produced from these lawsuits when making important decisions about the future of social media regulations.

Years of published research have time and again shown that increased social media use can lead to concerning mental health issues among children and adolescents, especially among populations who are already at an increased risk. Yet social media companies are failing to protect their most vulnerable users, children. The trend in Native American tribe suits against social media tycoons is not only crucial in repairing, restoring, and preventing the mental health crisis among young Native Americans but also a crucial step in protecting vulnerable children and adolescents across the country.

The Telehealth Cliff: Implications of Expiring COVID-19 Waivers

During the COVID-19 public health emergency, the U.S. government enacted a series of telehealth waivers that significantly expanded access to remote healthcare services. These changes were designed to address barriers to care during a time when in-person medical visits carried heightened risks of infection. By relaxing long-standing restrictions and broadening the scope of telehealth, policymakers ensured that millions of patients could continue receiving essential medical care. However, because many of these waivers were temporary, the nation does face a policy crossroad as expiration deadlines approach.

Prior to the pandemic, telehealth under Medicare was restricted by geographic and originating site limitations. Patients typically had to be in a rural area and physically present at a medical facility to access telehealth services. The COVID-19 era waivers removed these restrictions, allowing patients to receive telehealth services from the comfort of their own homes and in any location. This shift significantly expanded access, particularly for vulnerable populations, including the elderly, individuals with mobility challenges, and those living in underserved areas.

The waivers also expanded the scope of providers eligible to deliver telehealth services. Physical therapists, occupational therapists, speech-language pathologists, and audiologists were temporarily authorized to bill for telehealth services. Federally Qualified Health Centers (FWHCs) and Rural Health Clinics (RHC) were permitted to serve as distant site providers, further expanding the pool of available telehealth practitioners. Behavioral health care received significant support as well, with relaxed requirements for in-person visits and broader acceptance of telehealth for mental health treatment.

One of the most transformative flexibilities was the inclusion of audio-only telehealth visits. Recognizing that not all patients had access to reliable broadband or video technology, regulators allowed providers to conduct visits via telephone. This proved particularly valuable for low-income and rural patients, helping to close the care delivery gaps.

Prescribing of controlled substances via telehealth also saw temporary adjustments. The Drug Enforcement Administration (DEA) relaxed requirements for in-person visits before issuing prescriptions, which allowed patients to continue receiving critical medications for conditions such as ADHD, anxiety, and opioid use disorder.

As the public emergency wound down, Congress took steps to extend many of these waivers. The American Relief Act of 2025 extended telehealth flexibilities through March 31, 2025, while the Full-Year Continuing Appropriations and Extensions Act pushed the deadline to September 30, 2025. Yet, unless further action is taken, and right now none has, these waivers are set to expire, which creates what some policy experts call a “telehealth cliff.”

If these waivers expire without replacement, access to telehealth will narrow significantly. Medicare patients may once again be limited to receiving telehealth only in rural areas and from specific originating sites, reducing the ability to access care from home. Audio-only visits would no longer be reimbursed, excluding patients without video technology. Non-physician providers may lose the ability to conduct telehealth visits, shrinking the range of available services. Additionally, the more flexible rules for prescribing controlled substances remotely would tighten, requiring more in-person visits.

Now that the expiration date has passed, critical questions about the future of telehealth remain. Supporters argue that the waivers demonstrated telehealth’s effectiveness and necessity, especially in addressing disparities in access to care. They emphasize that removing these flexibilities would disproportionately harm patients in rural, underserved, and low-income communities. Policymakers have responded by introducing proposals such as the Telehealth Modernization Act, which would extend many of these flexibilities through 2027.

The telehealth waivers enacted during the COVID-19 pandemic represented a historic transformation of the US health care system. They expanded access, reduced barriers, and highlighted the potential of telehealth as a permanent feature of modern care delivery. Yet, now with the expiration day has passed, the nation must decide whether to preserve these gains or return to a more restrictive system. The outcome will shape the accessibility, equity, and effectiveness of healthcare for millions of Americans.

The Role of Local Government in Dealing with Food Deserts and Food Insecurity

Zohran Mamdani’s recent victory in the New York City mayoral democratic primary has brought national attention to his proposal for city-run grocery stores and how to address the issues posed by food deserts and food insecurity. According to the US Department of Agriculture (USDA), approximately 2.3 million, or 2.2%, of households in the continental US live more than a mile from a supermarket and do not have access to a vehicle. The USDA’s Food Access Research Atlas notes that 18.8 million Americans, or 6.1%, live more than 1 mile (in urban areas) or more than 10 miles (in rural areas) from a supermarket. This lack of access to supermarkets and healthy food poses health risks to these Americans. 

Mamdani’s pilot plan to address food deserts and food insecurity in New York City is to build five city-owned grocery stores, one per borough, focused on keeping prices low rather than making a profit. This grocery store plan is not only about addressing the lack of access to healthy food, but also about affordability. The pilot program has a $60 million estimated cost and the stores would be exempt from rent and property taxes. According to polling done by Data for Progress, 66% of likely voters support Mamdani’s plan. A 2023 report by the New York State Department of Health found rates of food insecurity in New York City vary from 39% of adults living in food insecurity in the Bronx to 22.1% in Staten Island. Food deserts can presently be found in more than 2 dozen neighborhoods in New York City.  

City-run grocery stores are not a novel idea. Many cities across the country have implemented plans similar to Mamdani’s with varying levels of success and city involvement. In the town of St. Paul, Kansas, where there had not been a grocery store for almost two decades, a city-run grocery store was opened in 2008 and continues to provide the town with healthy, affordable food. Madison, Wisconsin, and Atlanta, Georgia, have both implemented successful public-private grocery store partnerships where the cities have helped finance construction and provided tax incentives. Those plans both featured less city-government involvement than Mamdani’s, but still show that city government can play a role in combating food deserts and food insecurity.

There are differing opinions on whether Mamdani’s plan will be successful. Mamdani has famously drawn criticism from New York grocery chain CEO John Casimatidis, who sees the prospect of city-run grocery stores as a threat to private grocers that already operate on very small margins. Mamdani’s detractors also point to examples of city-run efforts gone awry. Not far from St. Paul, Kansas, a city-run grocery store, Erie Market, in Erie, Kansas, struggled to compete with the prices of other grocers that were at least a 15-20 minute drive away. Erie Market had been the only market in town, and after significant investment in the store by the town, its management and operation were transferred to a private company, and it subsequently ceased operations entirely.  

While the fact that there is a need to increase the access and affordability of healthy food in the US is clearly evident, there is still debate on what role city-run grocery stores and local governments at large have to play in solving the ongoing food insecurity and food desert crises.

Intentional Genomic Alterations: A New Development in Animal Biotechnology

The livestock industry relies on traditional breeding methods for desired traits, but this is costly and limits which animals can be bred. Intentional Genomic Alterations (IGAs) are being developed in animals to give desired traits faster. IGAs make targeted and random DNA sequence changes to an animal’s genomic DNA. This is especially helpful for the livestock industry because traditional breeding methods only give traits to offspring, but IGAs can give traits to an entire generation at once. Scientists found a gene called PRLR that, when altered, creates short, slick hair in cattle, more commonly referred to as SLICK. SLICK enhances heat stress tolerance and reduces disease susceptibility. This is especially useful for cattle farms in tropical climates because heat stress can affect milk yield and fertility. There are three cattle breeds with SLICK in the United States and Brazil. The Food and Drug Administration (FDA) approved SLICK cattle as safe for human consumption in 2022. 

The FDA regulates IGAs in animals by reviewing the product claim, how the IGA was produced and introduced to the animal, the characteristics given to the animal, the animal’s health, the durability of the desired effect, the environmental impact, whether it is safe for human consumption, and the effectiveness of the IGA. In May 2024, the FDA announced it would be collaborating with the EPA and USDA to ensure sustainability and safety in the biotechnology of IGAs. IGAs are being developed for uses other than for the livestock industry, including: biopharmaceuticals, research, xenotransplantation, therapies in companion animals, disease resistance, and food supply. There have already been drugs from IGAs approved by the FDA. A recombinant anti-thrombin drug was developed from the milk of transgenic goats. To create the drug, human DNA is inserted into the cells of goats and excreted from the offspring’s milk. The drug is in clinical trials and, if successful, will be more cost-effective than current drugs on the market for coagulation disorders.

Some IGAs are still in the developmental stage. Revivicor is a xenotransplantation company aiming to make pig kidneys and hearts viable for human transplant. Organs from another animal will be rejected by the body immediately upon implantation, but Revivicor is using IGAs to combat organ rejection. There are 10 genes in the pig genome that are edited through mutation and by adding human genes. 

Despite the benefits that IGAs may bring, there are ethical concerns for animal welfare. Making IGAs is inherently invasive and subjects the animals to surgeries, tissue sampling, and possible complications resulting in disability or death. IGAs are still in the conception stage and will have effects on the food supply, pets, pharmaceutical products, and other developments. There are areas of research of animals with IGAs that need more information, and there could be unanticipated results and concerns. For example, animal clones, copies of animals traditionally bred, have been limited recently because the offspring of the cloned animals developed varying abnormalities. Unforeseeable results are possible; however, the most recent development in IGA information is a new approval process for heritable IGAs released by the FDA. There are two parts, the first part categorizes IGAs based on their risk. Higher-risk IGAs will need the FDA’s full approval. The second part provides a guide for developers of higher-risk IGAs by giving guidelines of what is needed for the FDA to evaluate the products. This new approval process is an important step towards regulating IGAs, but it also emphasizes the need for continued research and ethical consideration.

The Impact of Tariffs on Drug Pricing and Accessibility

At the beginning of the new administration, there have been threats of tariffs on a wide variety of imported goods and against multiple nations. One such suggested tariff is that on imported pharmaceuticals. In February, the new administration suggested a 25% tariff could be imposed on imported pharmaceuticals. The impact on the healthcare industry will be far-reaching if the tariffs go into effect, as 61% of adults and 20% of children in the United States fill at least one prescription each year. Tariffs are expected to affect both drug pricing and availability, creating higher prices, increasing drug shortages, and affecting health outcomes.

Tariffs on pharmaceuticals are expected to increase drug pricing for consumers. Insurance companies are not designed to handle a twenty-five percent increase in the cost of medications, due to restrictions on pricing from programs like Medicaid, and that will result in a downstream effect on their patients. This could result in reductions in coverage or the removal of certain drugs from insurance coverage. The resulting changes in coverage and costs will fall to patients.

In part, drug pricing would also go up because it could take years and be more costly to create domestic productions for medicines that are currently being produced abroad. Drug pricing is a complex system because drug production involves multiple layers of manufacturing and steps. Some pharmaceutical companies may be better equipped to handle a pharmaceutical tariff because of existing manufacturing facilities responsible for producing active ingredients while others will struggle more because of a high proportion of active ingredients produced internationally. Those that do not have domestic facilities encounter the additional barrier of FDA regulatory requirements in creating new domestic manufacturing plants.

Drug availability is also in question under the proposed tariffs. In response to the tariff threats, some companies have already expedited shipment to the United States for certain drugs. Coupled with chronic shortages of some generic drugs in recent years, tariffs would put pressure on an already fragile industry. Tariffs could result in supply chain disruption. It is also predicted that fragile generic injectables will go into shortage.

The efficacy of tariffs is as yet unclear, but research is being compiled on possible implications. The Brookings Institution compiled research on pharmaceuticals and found tariffs will provide an incentive to increase domestic manufacturing for brand-name drugs only. This would not affect off-patent generic drugs which make up 90% of the volume of drugs and only a fraction of the costs. The study anticipates that a cut into the already small profit margins will lead to products being discontinued and a loss of some quality standards.

It is unclear precisely what tariffs will do to the pharmaceutical and patient care industries, but it is widely expected that changes will come. At a White House event on April 2, reciprocal tariffs were announced, which would have an impact on the pharmaceutical industry. The White House stated there would be “no exemptions.”  On April 9, a 90-day pause on the tariffs was instituted against most foreign countries except China. This pause is a lower reciprocal tariff, at 10%, except in industries with 25% tariffs, like aluminum and steel. Tariffs are expected to impact the pharmaceutical supply on a global level, which may result in “an extreme burden on the patient.”