Tag: pharmaceutical

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.

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. 

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.

The ADHD Medication Shortage: DEA Regulations and Limitations to Addressing the Public Health Crisis

The United States is facing an attention-deficit/hyperactivity disorder (ADHD) crisis with issues arising out of the great demand for first-line pharmacotherapy amid widespread shortages. Concerns about overmedication, particularly in children and young adults, qualify the necessity of strategic industry regulations and practices. Enforcing a balance of proper access and production of ADHD pharmacotherapy while mitigating risks of substance abuse in this line of drug treatment is vital to the health and well-being of the public.

More than 3.4 million children are currently prescribed ADHD medications, leading to federal concern about overmedication for chronic conditions in pediatric populations. Further, the American Psychiatric Association reported that adult ADHD diagnoses rose annually from 2020 to 2023, adding additional pressure to a strained healthcare infrastructure.

Pharmacy supply shortages have resulted in patients often driving long distances to pick up their prescription, particularly impacting rural and underserved communities. Lacking medication as prescribed leads to patients experiencing detriments in managing their daily life, and severe physical and mental withdrawal symptoms.

Despite these robust demands, patients are facing widespread prescription treatment shortages. As of late 2025, the Drug Enforcement Agency (DEA) has acknowledged that the existing national inventory of Schedule II substances, including d-amphetamine and methylphenidate, is inadequate to meet “legitimate patient needs.” In response, the DEA increased the Aggregate Production Quotas (APQs) for these active ingredients of first-line ADHD treatments for 2025. This action allows manufacturers to increase production and pharmacies to increase inventory, better meeting medication demand.

The DEA is responsible for enforcing regulations governing ADHD medication dispensing under the Controlled Substances Act (CSA). Stimulant medications containing the active ingredients falling under the APQ increase are typically recognized by their brand names of Adderall, Vyvanse, Concerta, and Ritalin. These medications are allocated to the Schedule II class for their associated risks with “misuse, addiction, overdose, and diversion.”

Limitations to the authority of the DEA in addressing the stimulant pharmacotherapy access crisis intersect with the market. Despite the DEA increasing the quota, the inventory of this class of products is not expanding to the capacity allocated for production. An analysis by the DEA in 2022 found that manufacturers sold only 70 percent of the volume allocated by the quota, excluding one billion additional doses from production that could have gone to the market.

In another study between 2001 and 2023 analyzing derivatives for prescription amphetamine shortages, 58 percent of manufacturers did not disclose a reason for the shortage. Other manufacturers reporting on the shortage have cited a mismatch in supply and demand, and manufacturing problems and delays.

Anticompetitive actions by manufacturers have also created structural barriers to market access. The class action Barbara et al. v. Shire brought forth allegations that brand-name manufacturers were paying rival drug makers to delay releasing generic versions of Adderall XR. This lawsuit exposed violations of the Sherman Act which bans monopolies and unreasonable trade restraints, risking supply shortages and price inflation.  

The DEA works in conjunction with the FDA to regulate prescription stimulants. Recognizing the supply issues with the drugs, the two agencies issued a letter asserting their intention to understand, prevent, and reduce the impact of the shortages in pharmaceutical supply chains. However, neither agency manufactures drugs nor can they require pharmaceutical companies to increase production. While recognizing the importance of responsible prescribing practices, the agencies have called on pharmaceutical manufacturers to increase production to meet the quotas and help mitigate the stimulant drug shortage crisis the United States is facing.

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.

DTC Advertising Under Fire: A Turning Point for Drug Promotion?

The Trump Administration has taken assertive steps to rectify the overmedicalization of American citizens by increasing oversight of Direct-to-Consumer (“DTC”) prescription drug advertising. Specifically, President Trump delegated authority to the Food and Drug Administration (“FDA”) to implement stringent regulations to ensure patients receive balanced information. The Administration has emphasized that DTC advertisements have become increasingly misleading by omitting critical risk information, glamorizing the use of prescription medication, and deterring patients from cheaper or healthier alternatives.

On September 9, 2025, President Trump released an Executive Memorandum that underscored the prominence of deceptive DTC advertisements and the necessity for stricter regulation. The memorandum authorized the FDA and the Department of Health and Human Services to “regulate prescription drug advertising” by ensuring compliance with the principles of transparency and accuracy. President Trump additionally commanded the Commissioner of Food and Drugs to enforce the Federal Food, Drugs, and Cosmetics Act (“FDCA”) in connection with DTC advertising in the pharmaceutical space.

The Administration has pursued three key strategies to regulate DTC advertisements. Their approach includes (1) issuing warning letters to pharmaceutical companies, (2) reforming the adequate provision rule, and (3) restricting social media advertisements. Experts anticipate an increase in agency activity in the coming months.

Following President Trump’s memorandum, the FDA has released over 100 warning or untitled letters to various pharmaceutical companies, telehealth providers, and online pharmacies to target deceptive advertising practices. On September 16, 2025, the agency issued over 60 warning letters citing alleged violations of the FDCA. The violations primarily involved minimizing risks or side effects and publishing misleading content about medications. In light of this action, Alnylam Pharmaceuticals Inc. removed a DTC advertisement for its new heart medication, Amvuttra. The FDA alleged that the advertisement, which broadcast patients being active, was misleading because it indicated that patients with heart disease “can be carefree.” While President Trump’s initiative may reduce faulty advertisements, it may also limit patients’ access to information on transformative medications. However, these are merely pre-enforcement measures, and actual enforcement will possibly require the Department of Justice to intervene on behalf of the FDA.

The FDA is additionally establishing a regulatory framework to “close the ‘adequate provision’ loophole created in 1997,” which allows pharmaceutical companies to “conceal critical safety risks” in their DTC advertisements. Before the adoption of the adequate provision rule, DTC advertisements were obligated to include full boxed warnings and clearly state all risks. Further, in the 1990s, over 130 enforcement letters were issued annually to ensure compliance. After 1997, pharmaceutical companies circumvented these rigorous requirements due to the ease of restrictions, which permitted them to only include the most prevalent risks. This led to a profound increase in DTC advertisements, and in 2024, pharmaceutical companies spent $10.8 billion on advertising. From 1997 to 2016, there was a 460% increase in DTC advertisement spending.

Pharmaceutical companies have used the rise of social media to expand DTC advertising. However, according to the FDA, 88% of top-selling drug advertisements on social media allegedly failed to comply with the agency’s requirements of balanced information. Phase three of the Administration’s reform targets influencer partnerships, sponsored advertisements, and AI-generated content.

While the Trump Administration has illuminated the negative effects of DTC advertising, it is vital also to consider positive factors. The increase in patient exposure to drug advertisements provides crucial information about possible treatments or relief, and allows patients to make inquiries with their doctors. Additionally, DTC advertisements permit individuals to stay informed about pioneering developments in the pharmaceutical industry. With heightened awareness, the word-of-mouth spread of positive experiences can help inform others about possible treatment avenues.

President Trump’s DTC advertisement restriction is likely to be met with legal ramifications. Legal action to challenge the paradigm shift would plausibly be focused on First Amendment and commercial free speech rights. A 1980 Supreme Court case, Central Hudson Gas & Electric Corporation v. Public Service Commission of New York, established a four-part test to evaluate the constitutionality of regulation. Essentially, Trump’s administration would have to affirm that their regulations would strictly benefit public health—yet pharmaceutical companies could adequately counter-argue using the aforementioned positive factors. To efficiently navigate this evolving climate, pharmaceutical companies and the government should collaborate on policies going forward.