Tag: pharmaceutical

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.

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.

Pharma Transparency Bill Wains in California as Price-Gouging Discussion Gains Momentum Nationally

On August 17, California lawmakers killed a drug price transparency bill, putting to rest a policy that would have major implications on the pharmaceutical industry in the United States’ most populous state. The bill, which was first introduced by State Senator Ed Hernandez (D-West Covina) in February 2016, sought to require drug makers to report and explain any price pharmaceutical increase of ten percent within any given twelve-month period, as well as justify any drug price of at least $10,000 within thirty days of moving to that amount and require insurers to disclose how much money they spent on drugs. While the bill received far-reaching support from healthcare providers, insurers, patient advocacy groups, labor groups, and business groups alike, it was met with fervent opposition by pharmaceutical companies.

According to the Los Angeles Times and lobbying activity filings, Hernandez’s legislation was one of the most lobbied bills of current the session, with at least seventy groups spending  money to advocate for or against it. “It’s probably amongst one of the more heavily lobbied bills — similar to tobacco and the most controversial bills,” the measure’s author, Senator Hernandez, told The Times.  However, by August 17, after four amendments, Hernandez pulled the plug on it entirely, stating that the amendments made it difficult to accomplish the bill’s intention, which would have “shed[] light on the reasons precipitating skyrocketing drug prices.”

The demise of this legislation is another huge win for Big Pharma lobbyist PhRMA, which in October 2015 won a summary judgment ruling in the United States District Court for the District of Columbia, blocking certain hospitals from receiving discounts for pricey orphan drugs. It also comes at a time when pharmaceutical companies, biotech firms, and orphan-drug makers have come under high scrutiny for price gouging, including the 5,455% price increase of HIV and Malaria-treatment medication, Daraprim, from $13.50 to $750 per pill in September 2015. Earlier this month, the uptick of the price of the allergic reaction-treating EpiPen Auto-injector medical device – from $57 to $600 between 2007 and 2016 – as its maker anticipates the arrival of a generic competitor, though, its non-generic, brand name competitor Auvi-Q was recalled in 2015 over dosage concerns.

A proponent for changes to Big Pharma since the 1990s, United States Senate Bernie Sanders (I – VT) made “out of control” prescription drug pricing a key issue during his 2016 presidential campaign. After winning the Democratic nomination, Presidential hopeful Hillary Clinton has carried the torch, speaking out on drastic price increases, sending stocks for EpiPen-maker, Mylan, tumbling.

With little being done by the United States Congress on the issue of drug price transparency, fourteen state legislatures have introduced measures to reign in prices. As of 2016, only Vermont has been successful in passing a bill, while others stall or fail outright, as is the case in California.

The pricing war in California now marches to the ballot in November. Citizens will vote on an initiative that would prohibit state agencies, like Medical (the state’s version of Medicaid) and Medicare from being charged any more for drugs than the United States Department of Veterans’ Affairs.

Pharmaceutical Company Preemptively Files Free Speech Suit Against The FDA

By: Nawa Arsala

Free speech is fundamental to the fabric of the United States. Americans fight for it zealously, regardless of the context, from political contributions to cartoon drawing contests. This battle has extended to the pharmaceutical industry. In an unconventional move, a small, Dublin-based pharmaceutical company, Amarin, filed suit against the Food & Drug Administration arguing that it has a constitutional right to share certain information about its product with doctors for unapproved uses.

The FDA approved Amarin’s drug Vascepa in 2012. It is a prescription form of fish oil that is used along with a low-fat and low-cholesterol diet, to lower high levels of triglycerides (fats) in adults, which is linked to heart disease. After the drug’s approval, Amarin requested permission to give doctors information regarding a study that showed Vascepa can reduce the triglyceride levels in less-severely affected patients, not just high-risk patients. The FDA ultimately rejected their request. Amarin’s issue is that many doctors already prescribe Vascepa to patients who do not have abnormally high triglyceride levels. The discretion of the physician to prescribe for an off-label use is perfectly legal and has been deemed the practice of medicine, which the FDA does not have jurisdiction to regulate. Manufacturers on the other hand, cannot promote for off-label uses.

Amarin wants to send doctors clinical trial data they described as “supportive but not conclusive research” that their drug could reduce the risk of heart disease in patients with less severe conditions than were initially approved for. The FDA denied Amarin’s request to share this information with doctors, and Amarin filed their suit. The FDA found that the “hypothesis that a triglyceride-lowering drug significantly reduces the risk for cardiovascular events among” individuals with less severe symptoms, failed to be proven in clinical trials. Nonetheless, Amarin feels its First Amendment right is being infringed upon by not being able to share this use with doctors. Amarin has not been accused of wrong-doing by the FDA yet, but they are possibly the first pharmaceutical company to sue the FDA preemptively. This could be because dietary supplement forms of fish oil are legally permitted to make the same statement without such rigorous regulation by the FDA. However, there seems to be increased regulation of dietary supplements as well after several injuries have been reported using weight loss supplements.

In a private letter to physicians who are paid to speak on behalf of its company, Amarin writes, “if we receive a judgement in our favor, we will move rapidly to deliver to you additional Company-approved training and updated promotional speaker materials related to the court’s interpretation of free speech related to the ANCHOR results.” In reality, free speech is not as romantic as the founding fathers would have hoped, especially in closely regulated markets such as the pharmaceutical industry. Courts consider several factors in determine if the government is infringing on First Amendment rights including, whether a substantial governmental interest being asserted, whether the regulation directly advances that interest and whether it is not more extensive than necessary.

Amarin may look to a fairly recent case in which a pharmaceutical sales representative’s conviction was overturned because the information he shared was not false or misleading. As a matter of fact, Amarin’s attorney ascertains precisely that, that the clinical trial data is truthful and not misleading. The U.S. Department of Justice and State attorney generals have increasingly used the Federal False Claims Act as an enforcement mechanism against health care fraud. The government believes that by promoting off-label uses, the manufacturers caused pharmacies to falsely claim Medicaid payment for drugs in ways unapproved by the FDA. Amarin is at risk for violating the FCA if they proceed in sharing the data directly to the doctors.

Drugs have and continue to save countless lives. The FDA has the duty, through a rigorous preapproval process, to ensure drugs are safe and effective before they are on the market. However, it is the stance of Amarin, that since off-label usage is already so commonplace by physicians and legal, providing more information, rather than less, is safest for the patient to promote overall health and more informed decision-making by physicians.