Category: Blog

Compounded GLP-1s: Filling a Medical Need But Posing What Dangers?

There are many drugs on the market created in a myriad of ways with some manufacturing processes less regulated, and therefore more dangerous, than others. One such method is called human drug compounding. Compounding occurs when a licensed physician or person under the supervision of a licensed pharmacist combines ingredients to form a medication designed for a specific patient. Compounded drugs can be incredibly important: they fill the gap for patients requiring specific strengths or dosages not available on the commercial market, they can remove allergens from drugs for patients with allergies, and they can change the form of the medication for patients that may have unique needs. It is also possible to create compound versions of the drugs on the FDA’s drug shortages list if the drug meets certain requirements. 

However, compounded drugs also come with a great risk: they are not FDA-approved. The Food and Drug Administration (FDA) is tasked with protecting the public health by approving drugs based on safety, efficacy, and security standards. The FDA has a robust drug approval process through which most drugs in the U.S. must pass, but compounded drugs are not subject to this process. This means that a compounded drug may not meet quality or safety standards as a traditional commercially marketed drug would.

One recent area where compounded drugs have become increasingly popular: GLP-1 drugs. A GLP-1, or glucagon-like peptide-1, is a hormone that is naturally produced in the body. Companies have figured out how to develop GLP-1s into drugs, initially to treat type 2 diabetes and more recently for weight management.

In a statement by the FDA released on February 6, 2026, the FDA announced it intended to take “decisive steps to restrict” the active ingredients of GLP-1s that are intended to be used in non-FDA approved compounded drugs in order to “safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy,” as the selling of non-FDA approved drugs is a violation of the Federal Food, Drug, and Cosmetic Act. The statement also addressed misleading advertising and marketing of companies claiming that their non-FDA approved compounded drugs were simply generic versions of FDA-approved drugs.

Hims & Hers, referenced in the letter, has been in the headlines recently. Novo Nordisk, maker of the Wegovy pill and injections, has filed a lawsuit against Hims & Hers, a telehealth provider, for marketing compounded versions of its drugs, claiming patent infringement. Recent statements by Novo Nordisk’s general counsel for global legal, IP, and security called into question the safety and risks associated with Hims & Hers products, referring to the lack of FDA regulation for compounded drugs. This is not the first legal and regulatory issue faced by a GLP-1 manufacturer. In 2024, Eli Lilly’s weight loss drugs Zepbound and Mounjaro had their active ingredient tirzepatide regularly compounded before the FDA took it off the drug shortages list. The problems are likely just beginning. Between 2019 and 2024, Medicare Part D claims increased from 4.8 million to 21.8 million for GLP-1s. In addition to Novo Nordisk’s patent suit, there is also ongoing multidistrict litigation against Novo Nordisk and Eli Lilly by patients alleging loss of eyesight from their weight loss drugs. With the explosion of GLP-1s, it is likely that more issues will arise.

The Unfinished Cleanup: PFAS in the Anacostia 

Rivers running around Washington, D.C. are no stranger to contamination. Aging combined sewer systems routinely dump wastewater into local waterways through discharges known as combined sewage overflows, while legacy pollution from past military activities pollute the water as well, particularly in the Anacostia. D.C.’s agencies have evolved to address the environmental stressors of sewage and industrial pollutants like polychlorinated biphenyls (PCBs), but certain industrial pollutants remain unaddressed. 

The Anacostia River Park, which borders the Anacostia River, is a Superfund site (a contaminated site listed under CERCLA’s National Priority List for cleanup) due to chemical dumping associated with former U.S. military activities. The river itself contains remnants of this cheap dumping practice that has harmed generations of primarily communities of color living by and off the river, from playing in its river banks to consuming its fish. After over 150 years of dumping toxic waste into the river, the Office of the Attorney General of the District of Columbia sued the U.S. government in early 2025 under CERCLA and the Brownfield Act. OAG alleged that the dumping was an intentional act of noncompliance with environmental laws, seeking “costs, damages, and a declaration of future liability” against the government. 

D.C.’s Department of Energy and the Environment (DOEE) initiated the Anacostia River Sediment Project to clean up the river’s contamination in 2013, culminating in the release of the 100% Design Report in the summer of 2025. The report outlines the remedial design with considerations such as the feasibility, cost, and benefits of certain remediation design options, factoring in stakeholder input. While the report is a milestone in clean up efforts and is partially funded by entities like Pepco who contributed to its pollution, it is largely aimed at PCB contamination, leaving out other contaminants like PFAS which have been documented to reside in the Anacostia watershed. In line with the report, D.C.’s OAG alleged that the river contained PCBs and other industrial contaminants such as heavy metals, notably leaving out any mention of PFAS – which in some regards, may be the most insidious pollutant in the river due to their persistent, bioaccumulative nature. However, the District’s 2023 suit against major chemical corporations like 3M acknowledges that corporations and the DOD used and released products containing PFAS into the river; establishing an understanding of PFAS contamination.

Per- and polyfluoroalkyl substances, or PFAS, are a class of highly persistent, stable, and health-harming chemicals that have evaded substantive national and global regulation for decades. This regulatory ‘hole’ has been permitted via a lack of governmental oversight, systemic failures to hold corporations accountable for dumping, and improper corporate disclosures as to the toxicity of the chemicals. PFAS have been shown to cause a myriad of health conditions, from increased cholesterol to developmental effects to cancer. The exposure pathways of PFAS are well documented, where the chemicals can impact humans via dermal exposure, ingestion, and inhalation and often travel through industrial discharges into bodies of water as exceptionally mobile, stable compounds. The chemicals then bioaccumulate in various ecosystems, meaning that seafood in water bodies contaminated by PFAS are unsafe to consume. DOEE’s fishing advisory issued in 2024 highlights this fact and advises the public not to eat eel, carp, striped bass, or largemouth bass caught in the Anacostia due to high PFAS levels and to instead opt for smaller fish containing less PFAS in their tissues. Maryland’s Department of the Environment similarly issued a fishing advisory for the watershed for PFAS contamination.

The chemicals as both a class and individually are not yet adequately addressed in our drinking water, let alone our water bodies. With the U.S. EPA setting back its PFAS drinking water regulations at the dawn of the second Trump Administration, it is no surprise that water bodies and water quality are not a focus in the PFAS space. There is no government attempt to remediate PFAS in the Anacostia River as there is for PCB and other harsh contaminants, but the chemicals are present. OAG’s 2023 natural resource damages complaint against chemical manufacturers, seeking monetary damages, states that “PFOA and/or PFOS were detected at all locations tested” in D.C.’s waterways. 

The Anacostia Riverkeeper found 8-10 different PFAS chemicals in the six samples collected from the river. The measurable PFOA (a common, “long chain” PFAS compound) concentrations in the samples ranged from 3.5-8 ppt, despite the EPA’s advisory limit of 0.004 ppt, and PFOS (another long chain PFAS compound) concentrations similarly ranged from 4.7-7.7 ppt, exceeding the EPA’s PFOS advisory limit of 0.002 ppt. Furthermore, the Environmental Working Group took water samples at certain locations across the U.S. and found significant levels of PFAS in samples from the Joint Base Anacostia–Bolling military installation situation along the Anacostia. For instance, one sample taken from the base was discovered to have a combined value of 10.6 ppt of the two “short-chain” PFAS (PFHxA and PFPeA) measured in the study. 

Demonstrating the urgency of the public health issue and the recognized presence of PFAS in the river, the Anacostia Riverkeeper submitted public comments to DOEE to its “Early Action Area Remedial Design Report” at the 90% design phase, urging the agency to incorporate remediation plans for PFAS in its 100% Design Report. The Riverkeeper noted that it was “irresponsible for [DOEE] to know there is PFAS contamination in the Anacostia River but to not consider it in [the] [remediation], potentially yielding a final product that is already outdated before it’s even constructed.” The agency responded that it was infeasible at that point in the project because PFAS samples were not incorporated into the plan and “revisions would delay the project by years.”

Given budgetary limitations, the decision to exclude PFAS from river remediation efforts is a multi-pronged determination based on cost, time, resources, and practicality. PFAS are notoriously difficult and costly to filter from water (although there are emerging more cost-effective techniques) and now local governments and utility companies are made to grapple with federal and corporate failures. The argument that the addition of PFAS into the plan would significantly alter a nearly decades-long remediation planning process has merits, but at the same time, PFAS remediation should become a priority for federal and local governments to protect human and ecological health. This is especially pertinent following the allegations in the District’s natural resource damages complaint. 

Although drinking water regulations are likely the first step, addressing the Anacostia’s PFAS contamination in some capacity should be made part of D.C.’s plan to remediate the river. This effort is necessary to safeguard the health of the communities that rely on and live by the river. It would also be a showing to other governments that water quality remediation includes PFAS – contaminants that have been ignored for far too long to the detriment of our health.

Deregulating the EPA: How the Elimination of the Endangerment Finding Ignores Health Consequences for Infants and Children

This month, the Environmental Protection Agency (EPA) under the Trump administration rescinded the Obama-era Greenhouse Gas (GHG) Endangerment Finding and the subsequent emission regulation standards that have accompanied it. Published by the EPA on December 15, 2009, the Endangerment and Cause or Contribute Findings for Greenhouse Gases Under Section 202(a) of the Clean Air Act found that six greenhouse gases—carbon dioxide, methane, nitrous oxide, hydrofluorocarbons, perfluorocarbons, and sulfur hexafluoride—contribute to air pollution and endanger public health and welfare of current and future generations. In the sixteen years since the endangerment finding was published, scientific evidence supporting each impact noted in the finding has become virtually indisputable; every ton of emissions increases the severity of expected climate impact, and every exposure to compound climate events “can increase morbidity and mortality.” Notably absent from the Agency’s news release is any discussion of or consideration for the health impacts that the finding sought to protect against.

Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks has directed government agencies to identify and assess environmental health risks that may “disproportionately affect children” since 1997. In its full report, the EPA uses careful language to skirt this obligation, stating that children “are not expected to experience greater ambient concentrations of air pollutants than the general population.” The statement points out the obvious–children are breathing air with the same chemical composition as everyone else–while ignoring the reality that the health consequences of air pollution have a far greater impact on growing and developing bodies than it does on fully developed adults. 

Increased concentrations of greenhouse gases have caused overall warming and more extreme weather patterns and heat events. In looking at the health impacts on children, the American Academy of Pediatrics 2024 Policy Statement outlined the specific effects of increased emissions against real health consequences. One study analyzed infant mortality data on an individual level against outdoor air temperature data for over 60,000 sudden infant death syndrome (SIDS) cases between 1972 and 2006, finding that a ten degree Fahrenheit temperature increase during the summer was associated with an 8.6% increase in the risk of SIDS. For black infants, the increased risk was 18.5%. In addition to the risk of rising temperatures, an analysis of six years of pediatric respiratory health data in San Diego County found particulate pollution from wildfires to be approximately ten times more harmful to children’s health than particulate matter from other sources. While climate change alone is not the sole cause of wildfires, the scientific consensus is that human-caused global warming contributes significantly to the trend of larger, more severe wildfires across California and the Southwest. 

Air pollution and heat exposure from climate change are also associated with adverse pregnancy outcomes. Exposure to ultrafine particulate matter is associated with increased risk of preterm birth and low birth weight, with higher risk found among black mothers, and mothers with asthma. Continued exposure to air pollution after birth can also affect lung development, leading to a greater risk of lung disease.

While the announcement from the EPA this month focused its priorities on the American consumer’s freedom to buy whatever car they want, it ignores its own origins as an agency founded on principles of achieving national air quality standards and reducing automobile pollution. The science of the last sixteen years makes it abundantly clear that not only does climate change increase the risk of negative health outcomes, but those risks are substantially higher for children and other high risk groups. The battle over this deregulation, however, has only just begun. The American Public Health Association, jointly with numerous other health and environmental groups, has already filed suit challenging the EPA and California is expected to follow soon.

Recent Bipartisan Report Raises Concerns About Incarceration of Juveniles with Mental Health Needs

The offices of Democratic Senator Jon Ossoff of Georgia and Republican Representative Jen Kiggans of Virginia have released a seminal report after conducting a more than year-long investigation into the prolonged incarceration of children with mental health conditions. They found that more than half of the surveyed juvenile detention centers reported incarcerating children who could be eligible for release to mental health care, due to a lack of available resources. Twenty facilities even reported incarcerating children without charges or with charges that would not ordinarily lead to placement in a juvenile detention center. The report indicates that these scenarios of incarceration are especially prevalent among youth with neurodevelopmental disorders, such as autism spectrum disorder. Similarly, some facilities noted that there were children being incarcerated whose charges had been dropped or who had already served their full sentence. Many of the centers reported being forced to wait weeks to months until children can access more appropriate care through in-home services or long-term psychiatric residential treatment. 

Incarceration can be incredibly damaging to a child’s physical, mental, and developmental health. Incarcerated children face limited access to evidence-based medical care, inadequate educational opportunities, and face lifelong medical and mental health outcomes, including increased risk of depression and suicide. Mental Health America (MHA) reports that placing children with behavioral health conditions in the juvenile system can be especially challenging due to their vulnerability to difficult conditions. Additionally, the Sentencing Project notes that incarcerating youth impedes both success in education and employment later in life. MHA’s call to action specifically notes that the juvenile justice system should never be used as an alternative to treatment, services, and support for children with mental health concerns.

From a legal perspective, this report raises many concerns. First, under the Violent Crime Control and Law Enforcement Act of 1994 (34 U.S.C. § 12601(a)) it is unlawful for any government agent or law enforcement officer who is responsible for juvenile justice to deprive a juvenile of their rights, privileges, or immunities secured by the Constitution. Next, the Americans with Disabilities Act (42 U.S.C. § 12132) specifically prohibits denial of services, programs, or activities of a public entity by reason of qualified disability. In addition to these, the Department of Justice utilizes the Civil Rights of Institutionalized Persons Act (42 U.S.C. § 1997(a)), the Individuals with Disabilities Education Act (20 U.S.C. § 1400), and28 U.S.C. § 517 to review and investigate systemic violations of federal law as relates to juvenile justice. 

Placing youth in juvenile detention centers as opposed to providing mental health treatment is a clear violation of juvenile due process rights (see In re Gault). There is also a clear Eighth Amendment, cruel and unusual punishment argument against the act of incarcerating youth with mental health disorders (see Graham v. Florida), as well as a Fourteenth Amendment Equal Protection argument. The Report is deeply concerning for the youth being affected by this practice, and in the words of Senator Ossoff: “no child in America should be locked up instead of getting the mental health care they need and deserve.”

Can TrumpRx Beat Big Pharma at Its Own Game?

On February 5, 2026, the Trump administration launched trumprx.gov, a government-linked prescription drug website intended to help Americans access discounted prescription medicines. The platform was unveiled by the Administration as part of a broader effort to make drug prices more affordable for U.S. patients. Rather than functioning as a traditional online pharmacy that dispenses medications directly, TrumpRx acts as a discount and price comparison portal that connects users to manufacturer or pharmacy discounts on prescription drugs. The site lists a curated set of around forty-plus brand-name drugs with reduced case prices and coupon codes that patients can use at participating pharmacies or manufacturer channels. According to the Administration, popular GLP-1 weight-loss medications and other pricier therapies are included on the list to illustrate potential savings for patients. 

Despite the White House’s promotional messaging, many health policy analysts and experts have expressed skepticism about TrumpRx’s broader effectiveness. Critics note that the site’s limited drug list — roughly 43 medications — is far smaller than what existing third-party discount tools like GoodRx or Cost Plus Drugs already offer, which cover thousands of drugs in the U.S. market. A recurring concern among experts is that many of the drugs featured on TrumpRx already have cheaper generic equivalents or lower prices available through other discount programs or traditional insurance plans, blunting the platform’s relative savings for many patients. Health policy researchers also emphasize that TrumpRx’s cash-price discounts do not generally count toward patients’ insurance deductibles or out-of-pocket maximums, a key factor in total insurance value that remains unaddressed by the site’s pricing model. 

Beyond technical critiques of the pricing model, many observers argue that TrumpRx does not tackle the systemic drivers of high prescriptions costs — such as opaque pricing negotiations, middlemen markups, and limited governmental negotiation authority — and instead delivers a limited workaround for a narrow patient segment. At the same time, early supporters of the platform contend that for some uninsured or underinsured individuals, TrumpRx may offer some relief on expensive medications — particularly those not commonly covered by insurance plans. The portal includes popular GLP-1 weight-loss drugs such as Wegovy, Ozempic, and Zepbound at significantly discounted cash prices compared with typical retail costs, which may make these treatments more accessible to patients who would otherwise pay full price out of pocket. Furthermore, the site also lists fertility medications like Gonal-F at steeply reduced prices — for example, some medications may be up to 84% off the list price — which could lower the immediate drug cost for some individuals undergoing fertility treatments, even if it does not substantially reduce the overall cost of procedures like in-vitro fertilization.  

Beyond these two categories of drugs, TrumpRx does little to tackle the deeper, structural issues in the prescription drug market, as it does not resolve prescription drug price transparency, negotiation powers, or insurance reform. In effect, TrumpRx is “a distraction from what we need to be doing” as the real world impacts for Americans’ drug costs will be modest or limited at best. 

AI & Medicare Coverage: The New WISeR Model 

On January 1, 2026, the Centers for Medicare and Medicaid Services (CMS) introduced the Wasteful and Inappropriate Service Reduction Model (WISeR). The goal of this model, according to CMS,  is to use artificial intelligence (AI) to encourage safe and effective navigation for Medicare participants on certain services, which will assist timely and appropriate payment. Additionally, the model hopes to reduce waste, fraud and abuse. 

There are two ways in which providers can seek coverage determinations through WISeR: by obtaining prior authorization by an authorized WISeR participant or by pre-payment medical review by an authorized WISeR participant. The model establishes new prior authorization requirements for services that have “little to no clinical benefit for certain patients.”  These services include skin and tissue substitutes, some nerve stimulator implants, and some services for knee osteoarthritis. This is important, because traditional Medicare historically has not required prior authorization.  However, CMS urges that WISeR does not change Medicare coverage or payment policy. Six states have been selected to test the WISeR model: New Jersey, Ohio, Oklahoma, Texas, Arizona, and Washington. The prior authorization will be determined by artificial intelligence, which is a huge concern for many people. Further, appeals are only available if a service is performed and the provider then submits a claim after not receiving prior authorization. It is unclear at this stage how long these appeals may take, however standard appeals can take months to reach a favorable decision.  

Many people within the health care industry have concerns and comments regarding the new WISeR model. For example, the American Hospital Association urged CMS to delay implementation of WISeR because of concerns with payment structure and the use of AI in Medicare. The Community Oncology Alliance expressed concerns about WISeR, stating that there are inadequate safeguards in place for the untested model, which experiments directly on Medicare beneficiaries. Further, the Center for Medicare Advocacy stated that instead of accomplishing the goals WISeR hopes to, WISeR will likely delay and even deny necessary care for some Medicare beneficiaries. The  Medicare Policy Initiative fears that WISeR will cause burdens for providers, and even cause some providers to exit traditional Medicare. At this point, it is hard to tell how the WISeR model is actually performing, but these concerns seem to be standard across the health care community. 

Further, multiple members of Congress have spoken up about the WISeR model. For example, a bill was introduced into the House of Representatives in November 2025 to prohibit the implementation of the WISeR model. Further, an amendment to the Health and Human Services, Education, and Related Agencies Appropriations Act was approved in the House in September 2025, but was not included in the final Act that was signed into law February 2026. Further, members of the Senate Committee on Finance wrote a letter to CMS in September 2025 urging them to provide further safeguards and transparencies surrounding WISeR. These safeguards include ensuring that the AI program is fully compliant with HIPAA, and that the AI will be unbiased. However, despite all of these concerns, WISeR was launched January 1, 2026.     

It will be important for CMS and the health care industry to closely monitor the new WISeR model, given all of the concerns. If it is shown that WISeR is inefficient, presents a new burden, and denies necessary medical care to Medicare beneficiaries, it will need to be reevaluated to ensure it is actually meeting the goals CMS hopes it will. Additionally, it is important that CMS constantly evaluates the safeguards and privacy considerations surrounding WISeR, to ensure beneficiaries are always protected.