Category: Blog

Federal, State, and local laws all play a massive role in perpetuating healthcare inequities. Preemption is the idea that when two authorities conflict with each other, the higher authority of law will displace the law of  lower authority. In recent years, many states have restricted local laws regarding public health policy through preemption.  This practice became popular in many states during the COVID-19 pandemic, where many local governments were enacting orders to deal with the pandemic.  Many states, such as Iowa, Oklahoma, and Tennessee in turn enacted statutes stating the local governments could not impose certain restrictions, such as requiring citizens to wear masks or show proof of vaccination.

However, problems with state preemption do not stop at purely public health matters. The effects of this new trend will have significant effects on many different regulations, such as economic opportunities, housing, employee benefits, and technology, which all, in turn, can have a severe effect on healthcare and access to healthcare. This use of preemption is important for many reasons, as the states can now utilize preemption to cause harm to many citizens, contributing to the already wide gaps of health disparity.

For example, laws such as requiring businesses to provide for paid family leave and raising the minimum wage for local workers are some proffered by local governments.   However, state laws have shut many of these laws down. Requiring businesses to provide paid family leave can promote public health when there is a short-term disability, sickness, or something else short-term in a family.  This time off would allow the family or person to recover, therefore promoting public health at the local level. However, if states do not allow for this paid time off, many are forced to work through their disabilities, sickness, or other problems. Further, another common local law is adding a local sales tax to smoking and vaping products to prevent youths from obtaining and using them.  However, these once again are struck down at the state level. These laws would prevent the adverse effects of smoking and vaping among youths, which could be a huge problem in the community, but the local government is preempted by state laws.

State legislatures are using this doctrine to advance anti-LGBTQ+ healthcare bills, especially in southern states.  In recent years, states have blocked local LGBTQ+ nondiscrimination protections, banning gender affirming healthcare, and targeted curriculum in schools. For example, in March 2024, Alabama recently passed an Anti-LGBTQ bill which preempts protections for LGBTQ individuals at the local level. There are numerous examples of these types of bills that are being introduced and passed into law daily. This is detrimental for LGBTQ+ healthcare, and is one of the many ways state preemption of local laws is affecting people today. 

Overall, preemption removes opportunities for effective, local public health action and instead prevents leaders from tackling problems in their community.  Local leaders are better at framing the issue, building local partnerships, and getting the message out to the communities. The weight of preemption today is much heavier than it was five years ago, and this needs to change for city leaders to effectively respond to the changes and problems in their communities. To combat these issues, federal and state governments should avoid framing preemptive legislation in a way that hinders public health initiative in the community. way that hinders public health initiatives in the community. The federal and state governments need to fully anticipate and understand the effects their preemptive laws will have on local communities moving forward.

In the wake of the Dobbs v. Jackson Women’s Health decision, the future of the clinical research landscape for women’s health has largely been in question. Recent data suggests that the U.S. is moving backward when it comes to pregnancy-related complications and continues to have the highest rate of maternal mortality among high-income countries. Females make up over half of the U.S. population, but medical conditions that affect them continue to be underfunded at alarming rates. According to the National Institutes of Health, 80% of maternal deaths are preventable, but severe maternal morbidity has almost doubled in the last ten years. Despite 80% of those who are pregnant taking at least one medicine, pregnant women and women of childbearing potential have long been excluded from many medical trials. When women experience pregnancy, their pre-existing conditions do not go away, but the understanding of them largely does.

Even before the Supreme Court’s pivotal decision in Dobbs, the United States has experienced major challenges when it comes to inclusion and representation in clinical trials. Paternalistic views on protecting women and their future children allowed women to be excluded from trials based on their reproductive potential until 2000 when the Food and Drug Administration required their inclusion for trials involving life-threatening diseases. Restrictions on pregnant women were even more stringent due to “potential fetal risk.” Women of color, and black women specifically, have long been underrepresented in clinical trials, despite knowledge that many conditions such as gestational diabetes, affect women of color at a higher rate than white women. 

The decision in Dobbs will only further the gender and diversity gap in clinical research. Researchers are likely to cease trials in states where access to abortion is restricted due to increased liability to themselves and their patients. Research into birth control and hormone therapies could now be viewed as illegal. Trials, especially involving reproductive treatments, often involve regular pregnancy tests. A positive test followed by a miscarriage could cast suspicion onto both providers and patients and in states such as Texas, both could be liable for criminal prosecution. In states where abortion access is available, patients might be more hesitant to enter trials due to an overall environment of increased scrutiny of their personal health decisions.

The potential harm to women’s health in America cannot be overstated. Due to increased concerns over legal risks, the costs to include female participants in clinical trials will increase and will likely have an adverse effect on the number of women included in trials broadly. Because medication affects men and women differently, decreasing the percentage of women in clinical studies will reduce the safety and efficacy of new treatments. Healthcare providers may face increasing situations where they must decide whether to prescribe medication to a pregnant woman without knowing the effects it may have on their patient’s health or their fetus. The majority of Black Americans now live in restricted states, largely in the Deep South, and are likely to be summarily excluded from participating in trials where a drug could pose a potential risk to a fetus. The process of clinical research as we know it is likely to be rewritten. 

The Federal Trade Commission filed another ambitious lawsuit on September 20, 2024, against three major pharmaceutical benefit managers (PBMs) that serve as middlemen between pharmaceutical manufacturers and commercial insurers. The defendants are CVS Health’s CareMark, Cigna’s Express Scripts, and UnitedHealth’s OptumRx, who together control the affordability and accessibility of 80% of prescriptions in the U.S. The FTC’s administrative complaint alleges that the PBMs violated The FTC Act 15 U.S.C. § 45 which prohibits “unfair or deceptive acts or practices in or affecting commerce.” The FTC argues the three PBMs have engaged in unfair practices by creating exclusive drug formularies that favor including drugs with higher rebates and fees which drives insulin inflation and harms vulnerable patients.

Exclusive drug formularies created by PBMs have flipped the pharmaceutical industry competitive market upside down to where competition drives insulin prices upwards, instead of down. Around 2012, PBMs implemented these formularies to ensure covered drugs which they resold to commercial insurers were safe and effective. However, the exclusivity of formularies forced pharmaceutical manufacturers to raise list prices of drugs to maintain their profits while increasing the rebates for PBMs. Manufacturers that do not raise drug prices or offer larger rebates risk losing millions of dollars in drug sales. Therefore, uninsured patients must fund larger rebates by paying increased drug prices or else forgo essential pharmaceutical treatment. Patients are also harmed by PBMs favoring high-list price (usually name brand) drugs when creating their formularies. Because pharmaceutical manufacturers can offer larger rebates for name brand drugs, PMBs exclude cheaper generic drugs to increase their profits. Consequently, insured patients are forced to spend more than necessary for critical drugs which they purchase frequently such as insulin.

Exclusive drug formularies specifically harm diabetic patients who cannot reasonably choose to discontinue purchasing insulin, switch insulin products, or switch health plans to avoid these harmful practices by PBMs. They unfairly force vulnerable patients to bear the financial burden of increasing PBM profits or risk great bodily harm from stopping medication.

Insulin has been used for more than a century to manage diabetic blood sugar levels and has been reasonably priced for 85 years prior to 2012. However, when PBMs began implementing exclusive drug formularies, between 1999 to 2017, prices increased steeply. During this time there was a 1200% increase in the list price of insulin from $21 to $274. U.S. consumer spending on insulin has also tripled since 2012, from $8 billion to $22.3 billion. Insulin is relied upon by 8 million diabetic Americans for disease management and is inexpensive to manufacture, yet its list price is inexplicably and unjustly exorbitant.

Although the Inflation Reduction Act has capped costs for patients with Medicare, increased insulin list prices have harmed uninsured patients. These uninsured diabetics are forced to pay the list price for insulin out-of-pocket. PBMs are aware that approximately one-quarter of patients can no longer afford insulin and reported that 1 million Americans ration their insulin which can have severe consequences, including death.

To be held liable for “unfair acts or practices in or affecting commerce” under The FTC Act, the three PBMs practices must be found to have (1) caused or were likely to cause substantial injury to consumers, (2) not have been reasonably avoidable by consumers, and (3) not been outweighed by countervailing benefits to consumers or to competition. If the three PBMs charged with violation of The FTC Act are found to have used unfair practices when implementing exclusive drug formularies, there are implications for the whole pharmaceutical industry which could hugely reign in drug pricing.

The future of the case against the three PBMs could hinge on the results of the 2024 Presidential election. Vice President Harris has shown interest in holding PBMs accountable for their actions in drug pricing inflation while former President Trump has yet to mention drug price inflation during his 2024 campaign. Further adding to the uncertainty of the suit is the divide among Republican officials over whether the FTC is overreaching, or PBMs should be held accountable.

Regardless of the election results, action is needed to prevent further harm from befalling vulnerable patients forced to pay the full list price for critical drugs like insulin.

In July 2021, President Biden issued an Executive Order directed at promoting competition in the American economy. A portion of that order directed changes to address drug pricing, and some provisions directed the Food and Drug Administration (“FDA”) and the United States Patent and Trademark Office (“USPTO”) to communicate regarding drug pricing. The USPTO is the government entity that grants patent applications, including those on pharmaceuticals and medical devices, while the FDA reviews and approves drug, biologic, and medical device applications for use and sale in the United States. The FDA additionally grants exclusivities which prevents the agency from reviewing any applications of competitor products for a period defined by statute.

The landscape of pharmaceutical patents and drug approvals has led to some negative effects including anti-competitive promotion of patented drugs and unbalanced research and development. This problem can occur when manufacturers report statements to the FDA during the drug approval process that conflict with those made to the USPTO during the process of obtaining a patent (“patent prosecution”). Because most of the information going to the FDA is confidential, it is usually not available to the USPTO during patent prosecution, and most patent examiners are untrained on using the FDA’s information to determine patentability.

The Executive Order was issued to address these issues between patents and other laws being misused to delay or prohibit competition between generic drugs and branded pharmaceuticals. In addition to the Executive Order, Senators Leahy and Tillis have asked the USPTO to take action. As the system currently stands, the solution to these conflicting statements has been to invalidate patents using the inequitable conduct doctrine, but the confidential nature of the FDA information makes the doctrine difficult to apply. The inequitable conduct finding renders all claims on a patent unpatentable or invalid under a USPTO statute.

In response to the order and the ongoing problems, the FDA and the USPTO began communications. They have held various seminars, including cross-training on patents and drug approval pathways in March and July 2023. In addition, the USPTO held a virtual panel on the duty of disclosure and reasonable inquiry in relation to patent prosecution as well as a joint virtual and in-person collaborative listening session with the FDA in 2023 for the public to weigh in.

One of the more recent developments was in June 2024, when the USPTO published results from a drug patent and exclusivity study. The study was designed to investigate the current timeline from the initiation of a New Drug Application (“NDA”) to the entrance in the market of a generic drug. The study found that in some cases, the generic launch was not impacted by patent and exclusivity calculations but by other factors, although the time period from filing an NDA to a generic launch is influenced by the relations between patents and FDA regulations.

            In the United States, the right-to-die through physician-assisted-suicide (“PAS”) and euthanasia has been hotly debated for years.  Scholars define PAS as the “prescription of lethal medication to be voluntarily self-administered.”  Conversely, euthanasia is defined as the “deliberate, direct causation of death by a physician.”  Although “medical assistance in dying” is legal in various countries, including Canada, PAS is only legal in eleven jurisdictions in the United States.

            Research has shown that by 2020, “about 5,330 people in the U.S. have died with medical assistance.”  Of the individuals who requested PAS, 95.6% were non-Hispanic White and 75% had been diagnosed with cancer.  According to a 2020 Gallup poll, 74% of Americans favor euthanasia, while 61% favor PAS.  Thus, while more Americans favor euthanasia than PAS, overall, Americans tend to support individuals’ right-to-die.

There are compelling ethical arguments for legalizing individuals’ right-to-die.  For example, advocates of PAS argue that PAS allows individuals to retain autonomy when making end-of-life decisions.  Moreover, medical professionals who perform PAS show individuals compassion because they prevent individuals from suffering.  Conversely, critics argue that the Hippocratic Oath forbids medical professionals from performing PAS because medical professionals must “do no harm.”  Thus, critics argue that medical professionals should not perform PAS because medical professionals serve as healers and PAS is antithetical to healing.

            The Supreme Court first analyzed the right-to-die under the Due Process Clause of the U.S. Constitution in Cruzan v. Missouri Department of Health.  In Cruzan, the Court held that individuals who lack decision-making capacity do not have the right-to-die unless there is “clear and convincing evidence” of their end-of-life care wishes.  The right-to-die was further examined in Washington v. Glucksberg, where the Supreme Court held that PAS is not a “fundamental right” protected by the Constitution.  Similarly, in Vacco v. Quill, the Court held that a state could outlaw PAS without violating the Equal Protection Clause.

            Advocates have pushed for change following the Supreme Court’s decisions in Cruzan, Glucksberg, and Quill.  For example, Dr. Jack Kevorkian, also known as “Dr. Death,” was an adamant supporter of PAS, after having performed approximately 130 PAS during his career.  Dr. Kevorkian, who was sentenced to prison in 1999, had “goaded prosecutors into coming after him so that the legality of assisted suicide and euthanasia could have a full airing in court – and in the news media.”  Following Dr. Kevorkian, other advocates have included Derek Humphry, who published his bestselling book, “Final Exit,” and Brittany Maynard, who requested PAS after being diagnosed with terminal brain cancer.

            Policymakers have made recent efforts to legalize PAS.  In February, the Illinois legislature considered SB3499, which would permit “aid-in-dying medication that will allow the patient to end the patient’s life in a peaceful manner.”  Additionally, the Pennsylvania legislature is considering legalizing PAS.

Although there are many states that remain opposed to PAS, advocates should continue to push for individuals’ freedom to choose their end-of-life care.  Ultimately, individuals should have the right-to-die in a safe and compassionate manner, provided that all safeguards are undertaken to prevent undue influence.

Federal efforts to rein in prescription drug costs have attracted media coverage and legal opposition. Now, innovative state efforts to limit drug price increases are attracting significant legal scrutiny. At the end of March, Amgen filed a lawsuit in the United States District Court for the District of Colorado seeking to stop the state’s Prescription Drug Affordability Review Board (“PDAB”) from implementing a price cap on its arthritis drug Enbrel. The lawsuit highlights a growing push among states to create affordability boards to limit drug price increases, nine of which have passed similar laws as of late 2023.

In February 2024, PDAB unanimously declared that Enbrel was unaffordable, allowing the board to consider setting a price cap on transactions involving the drug. The decision came just weeks after Amgen announced that Enbrel produced fourth-quarter sales of more than $1 billion for the company. Amgen argued the statute authorizing PDAB was unconstitutional, providing four reasons to support the company’s claim. First, the company argued that the statute violated the United States Constitution’s Supremacy Clause by conflicting with federal patent laws. Second, the company argued that PDAB violated the Due Process Clause of the Fourteenth Amendment since it lacked a specific standard to determine whether a drug is unaffordable or when to implement a price cap. Third, the company alleged that PDAB violated the Supremacy Clause through the authorizing statute allowing PDAB to impose a payment limit that would apply to Medicare reimbursement. Fourth, the company argued that the statute’s regulation of transactions outside Colorado violated the Commerce Clause.

While Amgen’s actions have significant implications for the regulation of drug prices in Colorado, the lawsuit will be closely watched by states that have created similar boards or are contemplating doing so in the future. As of late 2023, nine states have passed legislation to create similar drug pricing boards, and other state legislatures have introduced more than 200 bills to create such boards. The attempts are designed to address the increasing cost of prescription drug prices but vary in their methods. Some, such as Colorado, allow for the establishment of upper payment limits to directly control the prices of what they deem to be unaffordable drugs, while others are only authorized to make recommendations to the state’s legislature. Colorado’s board is also notable in the sense that it can exert authority over commercial health plans, not just state health plans. In addition to varying levels of authority, the Commonwealth Fund noted that other important considerations in how the boards are structured have included ensuring a sustainable funding source, how members of the board are appointed, and the board’s ability to access data on the drugs it reviews.

The economic and legal outlook for Colorado’s attempt to rein in drug prices, and those of its fellow states, remains uncertain. Due to many states being in the early stages of the review process, it may be a while before policymakers and stakeholders get a good sense of whether these boards can create downward pressure on prices.

Similarly, the legal outlook for these boards remains clouded as well. Scholarly publications have noted the relatively novel legal issues that these boards present to the courts, with the only clues in a healthcare context provided dating back to a related Maryland effort. In 2017, the United States Circuit Court of Appeals for the Fourth Circuit struck down Maryland’s attempt to prohibit certain price increases on the grounds that the statute interfered with the federal government’s authority to regulate interstate commerce.

Amgen’s lawsuit in the District Court for Colorado will likely provide more clues as to whether these latest attempts to broaden access to unaffordable prescription drugs will present a viable and legal tool to lower prices. Regardless, it is clear that solutions, be they federal, state, or otherwise, are urgently needed to address what can only be called a crisis of affordability for drugs that provide life-changing results to patients across the country.