Tag: FDA

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.

Overcompensation?: The FDA Nixes Boxed Warnings for MHT Drugs

The U.S. Food and Drug Administration (FDA) recently removed boxed warnings for six menopausal hormone therapy treatments (MHTs), drugs that reduce the uncomfortable side effects of reduced estrogen levels. These are the FDA’s highest level of warnings that appear on drug packaging in bold print and warn users of serious adverse reactions or important dosing restrictions. For MHT, the boxed warning informs consumers that MHT increases the risk of cardiovascular disease, breast cancer, and dementia.

Although this may look at first glance like another one of the current administration’s attempts to flip food and drug law on its head, a closer look at the scientific findings that prompted the boxed warning indicates it’s not so simple. Originally, the FDA mandated boxed warnings for MHT drugs after the Women’s Health Initiative (WHI) conducted a study in 2002, finding coronary heart disease and invasive breast cancer as primary adverse outcomes based on largely observational data. After the warning was implemented, usage dropped 22% for menopausal women from 1999 to 2020.

However, the safety and long-term risks of MHT have been debated by scientists, particularly because of the WHI study’s controversial design. The study had two main design flaws: it included women with an average age of 63, and the study tested synthetic hormones that are not the same as MHT drugs on the market today. The average age of participants was problematic because women generally experience menopause around age 51.5, but women around 63 years old are more likely to have preexisting cardiovascular issues. Furthermore, the use of synthetic hormones in this study means the adverse health outcomes are not necessarily attributable to the MHT treatments currently on the market. Additionally, modern MHT treatments use lower doses of estrogen and can be delivered through the skin may further reduce the likelihood of adverse events.

FDA panelists were urging the removal of boxed warnings specifically for vaginal estrogen because it poses the lowest risk of adverse effects. When this route of MHT treatment is taken, less estrogen is absorbed in the patient’s bloodstream, which lowers the risk of blood clots, stroke, and cancer. However, the FDA ultimately chose to remove boxed warnings for all estrogen-containing MHT treatments.

Under the Federal Food, Drug and Cosmetic Act, drug labeling must reflect current and accurate science-based evidence without misleading consumers. There is a risk that removing these warnings about increased risks of cardiovascular disease, breast cancer, and dementia for all estrogen-containing MHT treatments was premature, despite the shortcomings of the WHI study. If labels understate risks of MHT treatment, companies may risk facing claims of misbranding drugs under the Act, even though the FDA no longer requires the boxed warning for six current MHT drugs.

Women deserve a better solution than an outdated, poorly designed study for MHT drugs. Instead of risking liability or debating whether the WHI study is accurate enough to make the FDA require boxed warnings about serious adverse effects, the government should provide a grant for a new study on MHT drugs in menopausal women with a younger average age than the previous study.

Dietary Supplement Labels: Divided Opinions on the Relaxation of Regulations 

Vitamins, probiotics, minerals, and botanicals are among the many dietary supplements used by approximately 75% of Americans to support their diets and maintain their health. Although often found in the same aisle in stores, the FDA does not regulate supplements in the same way as drugs. The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines dietary supplements as a category of foods regulated by the FDA. The Act furthermore enacted labeling requirements, including rules on the placement and contents of disclaimers and nutrition labels. The disclosures are required to remind consumers that supplements are not FDA-reviewed for safety or effectiveness before they are sold. Recently, the issue has been how much a manufacturer must disclose on a label and specifically how many disclosures are required to appear on each “panel” of a supplement label. 

In a class action suit filed against Amazon in 2023, the plaintiffs, a group of consumers, claimed that Amazon promotes and sells products that lack mandatory disclaimers on their labels, making them dangerous, defective, and illegal. The plaintiffs alleged that Amazon advertised purported benefits of certain dietary supplements not approved by the FDA without providing the required disclaimers. While the case remains ongoing, Amazon recently filed a motion to pause the suit, claiming it hinges on a regulation that the FDA announced is under revision. 

On December 11, 2025, the FDA released a letter responding to requests to amend label regulation 21 C.F.R. 101.93(d), which governs the placement of disclaimers. The current regulation, added by DSHEA, provides that statements for supplements can be made if they contain a disclaimer in bold type that reads: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” The current rules require that the disclaimer appear on each panel of a product label where a claim is made. The FDA’s December letter asserted that, based on its initial review, revising the regulation to remove the requirement that the disclaimer appear on each panel of a supplement would “be consistent with section 403(r)(6)(C) of the FD&C Act while reducing label clutter and unnecessary costs.” The letter also acknowledges that the FDA has rarely enforced this requirement and is therefore likely to propose an amendment. There is no timeline for when the rule change might take effect; however, the letter states the FDA will not enforce the existing rule while it is under review. 

The regulations would still require the disclaimer to appear at least once on the bottle, however, many consumers and critics in the medical field believe the amendment would weaken the already deficient warning system. A study done between 2004 and 2013 found that consumers made more than 15,000 reports of health problems linked to supplements to the FDA’s central reporting system. Supplements that claim to help with weight loss, sexual function, energy and muscle building have been among those found to have potentially harmful undisclosed ingredients like prescription pharmaceuticals and steroids. Public health advocacy organizations and consumers have called for reforms to the supplement regulation process including proposals of mandatory product listing, FDA standards, and premarket review. 

Some supplement retailers advertise that their supplements are voluntarily self-regulated following industry-wide initiatives which created their own standards that complement or enhance government regulations. Voluntary programs like the Council for Responsible Nutrition and the Consumer Healthcare Products Association can promote enhanced product safety and fill the gaps of government regulation. Although they present certain benefits, these programs remain limited by their lack of enforcement power and voluntary nature. 

The letter proposing the relaxation of disclaimer requirements is a step in the wrong direction for advocates who have been fighting for heightened regulation. The plaintiffs in the Amazon case say the letter should not stop their suit, because their claims include many other disclaimer violations beyond the “each panel” rule. If passed, however, many believe the amendment will be the first step toward dangerously weak warnings on supplement labels.

OpenAI to Launch ChatGPT “Health” Amidst Shifting AI Regulatory Schemes Surrounding Privacy

On January 7, 2026, OpenAI announced plans to launch of ChatGPT Health (“Health”), a new model that will allow users to connect their health records and wellness applications to the chatbot. Every week, hundreds of millions of people use ChatGPT to enquire about health and wellness. OpenAI has set out the privacy protections and controls it intends to implement in handling highly personal and sensitive information, including data encryption, data isolation, user options to delete chats from its system, and restricting inputs to Health not to train the foundational model. Similar to its existing system, Health will use a large language model (LLM) to service its users in chatting about health, reviewing medical records, summarizing visits, and providing nutrition advice, among other functions. 

Executive actions have shifted towards limiting AI regulations, attempting to maintain the United States as a global leader in AI innovation, and encouraging industries to adopt automation. In December 2025, President Trump issued the Executive Order 14365 “Ensuring a National Policy Framework for Artificial Intelligence,” attempting to deter state regulations from creating a patchwork of regulatory regimes and instead create national consistency. This action alone does not prevent state-level AI or privacy laws, however, it does establish a task force to challenge them. The EO followed a previous action which removed Biden-Era regulations placed on AI, classifying them as a hindrance to innovation and free markets.

The Food and Drug Administration (“FDA”) regulates AI Health technology, classifying certain developments as software as a medical device (SaMD) under the Federal Food, Drug, and Cosmetic (“FD&C Act”). On January 6, 2026 the FDA provided guidance on their oversight of AI devices, distinguishing low-risk products used for general wellness not to be regulated as medical devices. Software that is “unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition” is not a medical device under the FD&C Act. The FDA explicitly classified software programs as general wellness products, likely putting Health into an regulation-exempt status under the FD&C Act. 

Systems which function solely to transfer, store, convert, format, and display medical device data are characterized as Medical Device Data Systems (MDDS) are subject to the FD&C Act. However, the FDA has also clarified that Non-Device-MDDS with software functions that store patient data, convert digital generated data, or display previously stored patient data are exempt from regulation as long as they do not analyze or interpret data. This contention produces uncertainty for Health’s classification because of the functional interaction between data input and user interactions.

The Health Insurance Portability and Accountability Act (“HIPAA”) Privacy Rule ensures covered entities and business associates properly handle protected health information (“PHI”). Users submitting medical records to Health would not render OpenAI a covered entity or business associate, leaving its status as a consumer health product outside of HIPAA’s regulatory scope. Data sharing, such as what Health sets out to do across Apple Health, MyFitness Pal, and other applications, falls outside of the HIPAA framework if it is disclosed for purposes other than for treatment, payment, healthcare operations or otherwise requiring authorization by the Privacy Rule 45 C.F.R. § 164.508.

The Federal Trade Commission (“FTC”) may serve as a backup for these regulatory rollbacks. The FTC regulates healthcare privacy by providing data breach notifications. Compliance is enforced through the Health Breach Notification Rule (“HBNR”), requiring vendors of personal health records to notify the FTC and consumers if a data breach occurs. A vendor under the HBNR is any Non-HIPAA entity or business associate that “offers or maintains a personal health record.” It is uncertain whether Health will be subject to regulation under this category, or any other, despite their handling of users’ personal health record uploads. As an alternative method of accountability, the FTC may bring litigation actions, such as the recent class action settled with Flo Health Inc. for sharing proprietary health data to Facebook, Google, and others without user consent.

As the regulation landscape surrounding Health is actively evolving, it is uncertain how privacy concerns will be handled. Federal agencies and the executive are giving broad autonomy to the developers for privacy practices as AI integrates healthcare practices, leaving much of the accountability to be exercised through litigation or FTC after-actions.

The Patent Thicket Just Got Thicker: Limiting Inter Partes Review for Biologic Drug Patents

While a best-selling small molecule drug could be covered by up to five patents, biologic drugs (large chemical compounds produced by living cells) are covered by hundreds of patents. A primary purpose of patents is to give a limited monopoly to inventors to incentivize innovation, but this monopoly comes at a cost to consumers. For example, Humira (a rheumatoid arthritis medication) has 134 active patents and AbbVie Inc. charges consumers $6,500 per month for treatment. Most of these patents are “secondary patents” of questionable validity, covering things like dosage, drug formulations, and methods of using the drug to treat a new condition.

To combat these exorbitant prices, companies have been using biologic drugs as templates to produce biosimilars—therapeutically equivalent molecules. Without the extensive research and development costs associated with producing a novel biologic drug, biosimilars are brought to market and sold for less—around 90% less. Returning to the previous example, the biosimilar for Humira cost as little as $650 per month—just a tenth of the $6,500 monthly payment for the brand-name biologic.

The price of biosimilars could become even more affordable due to a recent announcement from the U.S. Food and Drug Administration (FDA) that it would be simplifying the process by which companies could bring biosimilar drugs to market. Now, the FDA will allow biosimilar manufacturers to circumvent expensive clinical testing in exchange for analytical testing. The manufacturer must show that their biosimilar does not have any clinically meaningful differences from the brand-name biologic drug (which has undergone clinical testing). The FDA used to require biosimilars to conduct “switching” clinical tests where patients would be treated first with the biosimilar drug then with the biologic drug (or vice versa) to determine any difference in responses to the drugs. If no meaningful differences were found, then the biosimilar was given “interchangeable” status, allowing pharmacists to prescribe the cheaper biosimilar instead of the brand-name biologic.

However, generic drug companies face another issue: challenging the validity of patents on a brand-name biologic drug. The web of patents protecting a single biologic drug makes it difficult for generic drug companies to enter the market because they must first demonstrate all the existing patents are invalid or not infringed by their product. Litigating these patents in a district court is expensive, complicated, and time-consuming.

Inter partes review (IPR) exists as an easier way for generic drug companies to clear out the patent thicket created by brand-name biologic drug manufacturers. However, the U.S. Patent and Trademark Office (USPTO) proposed a rule shortly before the FDA’s announcement, limiting the ability of biosimilar manufacturers to challenge the numerous patents filed on brand-name biologics. Previously, biosimilar manufacturers often used IPR through the Patent Trial and Appeal Board to challenge the validity of patents on brand-name biologic drugs. Now, IPR will not be available when “a petitioner intends to pursue invalidity challenges under §§ 102 [novelty requirements] or 103 [non-obviousness requirements] in other venues, such as district court or the U.S. International Trade Commission.” The USPTO frames this amendment as a way to “promote fairness and efficiency by channeling similar patent challenges to a single forum” and ensuring that IPRs are, not used in addition to, but as a complete substitute for, at least a phase of litigation. This has the effect of eliminating IPR as an avenue for biosimilar drugs to challenge the validity of broadly-drafted patents restricting their entry to the market, and thus increasing the cost of determining whether the numerous brand-name biologic drug patents are valid.

Allowing biosimilar manufacturers to use IPR as an avenue for challenging brand-name patent validity is important for two main reasons: lower costs and accelerated market entry. First, only 5% of prescription drugs are biologic drugs, but they account for $300 billion dollars in national total spending on medications. Thus, by creating therapeutic equivalents to patented biologics—biosimilars—which can compete with brand-name biologic drugs, prices will drop closer to the marginal cost of production and become more affordable to regular Americans. Second, legal battles between biologic manufacturers and brand-name biologics manufacturers can last years, delaying the arrival of affordable alternatives to consumers. Returning again to Humira as an example, it took seven years in court before the patent issues were resolved and the biosimilar could reach the market.

Although patents are meant to incentivize innovation by providing a limited monopoly, they are also meant to increase public access to cutting edge, socially beneficial technology, such as biologic and biosimilar drugs. By making it more difficult for biosimilar manufacturers to challenge validity of biologic drug patents, inventors and their monopoly are protected, but the USPTO has forgotten the public which patent law also seeks to protect.

Lawsuits Continue to Spike for Ozempic: Express Warranty Claims for the Drug Manufacturer

Ozempic and other GLP-1 medications have taken center stage in popular culture, reshaping how Americans think about weight loss, but they are not encountering growing legal challenges. Ozempic and related GLP-1 medications have been dominating popular culture and reframing how the entire country approaches weight loss but are now facing increasing legal challenges. Ozempic and GLP-1s are a tool for weight loss, but if it sounds too good to be true, that might just be because it is. With the rapid consumption of these medications, consumers are mounting lawsuits against the drug manufacturers for extended warranty claims, failure to warn of potential side effects, and risk association.

Originally intended for Type 2 Diabetes, Ozempic’s notoriety lies with the off-label weight loss side effect. According to the CDC, 42% of Americans suffer from obesity. GLP-1 agonists are glucose-like peptide-1,  a class of medications that lowers your blood sugar (glucose) levels to help manage and treat diabetes, but also treats obesity. Approved by the Federal Drug Administration (FDA) as a medication for diabetes, its popularity on social media and advertising has been aligned with the off-label use for weight loss. These medications reduce hunger levels and trigger insulin responses in your body by inducing naturally occurring hormones. These “Ozempic Drugs” have different names and ingredients, but all the big-name brands of this class of medications are “Ozempic” and “Wegovy,” which share the same ingredient, alongside others such as “Zepbound” and “Mounjaro”. While originally intended for the demographic of diabetes impacted individuals and those with a high BMI, the drug has become readily accessible to celebrities and individuals looking for a weight-loss supplement due to its rapid weight loss effects without the traditional output effects like intense dieting or extensive exercise.

Despite the success of the drug in treatments beyond diabetes, the lawsuits demonstrate concern about the potential, and sometimes permanent, side effects of taking these weight-loss drugs. Ozempic is manufactured by Novo Nordisk and has already amassed over 1800 lawsuits consolidated into federal multidistrict litigation, with experts estimating over $2 billion in total liability, and growing. Affected patients are claiming to have developed symptoms like gastroparesis (stomach paralysis), intestinal blockages, gallbladder and kidney injuries, alongside vision loss. The suit’s main claim is the drug manufacturer’s failure to warn patients of the potential side effects.  Litigation is in its early stages for manufacturers, but it sheds important light on the safety concerns, informed consent, and what risks should be disclosed when participating in such a popular class of medications. These recent legal disputes imply that drug manufacturers have not been explicit with warnings and potential harm associated with a semiglutide compound, and consumers should take time to consider if this is the right choice for them before starting.

With Ozempic and other GLP-1s impacting the way society views weight loss, experts see a future where many more of us are taking them. The public should recognize that pharmaceutical medications should be a tool in approaching obesity regulation, not the only approach. Having a balanced approach to weight management strategies will reduce the reliance on these medications and offset the amount of adverse consequences patients are facing from taking these medications. The fast-growing market for these medications will have lasting effects on society, and the legal implications should caution people taking or planning on taking these medications to know the risks associated with them. Drug companies should implement more comprehensive policies that will adequately warn people of the adverse side effects of these medications. The legal landscape in the future will be influenced by the increasing complexity of mainstream medications and how these large drug companies structure their warning labels.