Public Health Product Hops

Pharmaceutical product hops extend market monopolies and increase costs, often at the expense of patients. An integral part of product life cycle management strategies by brand manufacturers, product hops often represent a last-ditch effort to preserve market share in the face of generic competition. Yet industry advocates would maintain that this is essential follow-on research and development, producing novel products that would otherwise never reach the market. Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered important public health interests? Sometimes product hops arise due to safety concerns raised by FDA or pressure from other public health agencies. For instance, a push from Congress and the EPA to remove chlorofluorocarbons from all consumer and industrial products resulted in a switch to hydrofluoroalkane propellants in respiratory inhalers. In another instance, concerns about the opioid crisis fueled the development of abuse-deterrent formulations of opioids as part of a public health response to the crisis. Despite the public health motivations driving each scenario, I find that some public benefit may have been achieved, but at substantial expense to both payers and patients. I explore the potential benefits of a “public health product hop” in more detail using the recent push to approve over-the-counter versions of intranasal naloxone. I develop a framework for rewarding product hops that provide a meaningful and quantifiable public health benefit. In these instances, I argue for time-limited regulatory incentives that more equitably reward manufacturers for advancing important public health-goals while ending incentives for purely profit-driven product hops

Unpatenting Product Hops

On July 9, 2021, President Joseph R. Biden signed Executive Order 14036 (“Promoting Competition in the American Economy”), which directed the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to collaborate on new approaches to increasing competition and lowering prices in the pharmaceutical marketplace. In response, the USPTO outlined several new initiatives, among them an intent to improve the robustness and reliability of issued patents.A major impetus for the Executive Order was the pervasive nature of pharmaceutical product hopping, which occurs when manufacturers introduce new follow-on versions of lucrative pharmaceutical products to the market, like extended-release forms of drugs or modifications to device components of combination therapeutics. Product hops are usually intended to mitigate lost market share due to generic competition or thwart generic competition entirely. Yet the small added value of these new products is usually far outweighed by excess costs to payers and patients alike. Product hops remain an essential part of product lifecycle management strategies due to patents, which discourage manufacturers from entering lucrative markets, encourage settlement and delayed generic entry, and undermine the fundamental constitutional intent of the patent system—a time-limited exclusive right.Elevating patentability standards at the USPTO could mitigate product hopping through the rejection of weaker patents, which should eventually curtail patent applications from manufacturers that attempt to create “new,” yet arguably uninventive, products intended primarily to capture market share from would-be competitors.This article evaluates the core elements of patentability and relevant case law, highlighting opportunities for the USPTO to strengthen its review of pharmaceutical patents. When coupled with regulatory reforms that further mitigate the impact of product hops, pharmaceutical research and development may pivot away from product life cycle management strategies and toward transformative innovation that accelerates the development of the next generation of therapeutics and cures

I’m Not Lovin’ It: Re-Thinking Fast Food Advertising

In 1971, the Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”) agreed to prevent injury and deception to the consumer in advertising, detailing their respective roles in a Memorandum of Understanding (“MOU”). The MOU has been amended and an addendum added since 1971, but the material provisions have remained consistent for over a half-century. The FTC has regulatory authority over fast food advertising while the FDA regulates fast food, which creates a proverbial fork in the road. The fork in the road widens when considering the FDA has an active role in curbing the obesity epidemic through consumer education while the FTC is not concerned with public health, but rather focuses on consumer deception and misinformation. Therefore, to curb the obesity epidemic and educate the American public, the MOU between the FTC and FDA should be amended so the FDA gains primary responsibility over fast food advertising. This paper also proposes solutions to fast food advertisements, aimed at better educating and reminding the consumer of the negative consequences associated with fast food. Part I of this paper will discuss the scope and regulation of the FTC, previous enforcement proceedings against fast food advertisements, and current litigation relating to fast food advertising. Part II will then discuss potential regulations the FDA could enforce if the agency assumed regulatory authority over fast food advertising. Part III will be broken down into three sections detailing solutions: disclosing negative health reminders during advertisements, prohibiting advertisements of unrealistic products, and disincentivizing fast food advertisements in general

I’m Not Lovin’ It: Re-Thinking Fast Food Advertising

In 1971, the Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”) agreed to prevent injury and deception to the consumer in advertising, detailing their respective roles in a Memorandum of Understanding (“MOU”).1 The MOU proscribes that the FTC regulates truth in advertising relating to foods, drugs, devices and cosmetics while the FDA controls labeling and the misbranding of foods, drugs, devices, and cosmetics shipped in interstate commerce.2 The MOU has been amended and an addendum added since 1971, but the material provisions have remained consistent for over a half-century.3 Importantly, the FDA and the FTC have varying goals and differing structures. The FDA is part of the Executive Branch and is primarily responsible for the protection of public health via the regulation of certain health-related products, so that those products can achieve a certain efficacy or social “value.”4 On the other hand, the FTC is an independent agency that interacts with all three branches of the federal government, ensuring the integrity of the market process rather than focusing on a product’s specific social “value”.5 Typically, the FDA ensures compliance on the front end by approving consumer disclosures in advance while the FTC provides back end relief by regulating specific claims that have already been advertised.

I’m Not Lovin’ It: Re-Thinking Fast Food Advertising

In 1971, the Federal Trade Commission (“FTC”) and the Food and Drug Administration (“FDA”) agreed to prevent injury and deception to the consumer in advertising, detailing their respective roles in a Memorandum of Understanding (“MOU”). The MOU has been amended and an addendum added since 1971, but the material provisions have remained consistent for over a half-century. The FTC has regulatory authority over fast food advertising while the FDA regulates fast food, which creates a proverbial fork in the road. The fork in the road widens when considering the FDA has an active role in curbing the obesity epidemic through consumer education while the FTC is not concerned with public health, but rather focuses on consumer deception and misinformation. Therefore, to curb the obesity epidemic and educate the American public, the MOU between the FTC and FDA should be amended so the FDA gains primary responsibility over fast food advertising. This paper also proposes solutions to fast food advertisements, aimed at better educating and reminding the consumer of the negative consequences associated with fast food. Part I of this paper will discuss the scope and regulation of the FTC, previous enforcement proceedings against fast food advertisements, and current litigation relating to fast food advertising. Part II will then discuss potential regulations the FDA could enforce if the agency assumed regulatory authority over fast food advertising. Part III will be broken down into three sections detailing solutions: disclosing negative health reminders during advertisements, prohibiting advertisements of unrealistic products, and disincentivizing fast food advertisements in general

Labeling Energy Drinks: Tackling a Monster of a Problem

Energy drinks first rose to popularity in the 1980s. Red Bull energy drinks were the first of its kind, opening the door to a new consumer and regulatory landscape. Since Red Bull first launched, multiple companies have released countless new energy drink products. Some energy drinks, like Red Bull, contain less than 100 mg of caffeine per 8 oz can. However, other energy drinks contain much higher amounts of caffeine. A 12 oz can of Celsius contains 200 mg of caffeine, and up until recently, Celsius offered a product called Celsius Heat, a 12 oz can containing 300 mg of caffeine. In addition to high caffeine amounts, energy drinks often contain herbal stimulant additives, vitamin and mineral mixtures, and sugar. There is very little information available on the long-term effects of these stimulant mixtures on the body. Although many consumers purchase energy drinks because of their caffeine content, many are left in the dark when it comes to labeling transparency and are unaware of their true contents. Energy drinks are classified as dietary supplements, meaning they are not directly regulated by the FDA before hitting store shelves. Instead, energy drink labels follow standards promulgated under the Dietary Supplement Health and Education Act (DSHEA). DSHEA imposes lax labeling regulations on energy drinks, which leaves consumers unaware of the dangers of high caffeine content, stimulant additives, proprietary blends, and excessive sugar. In this article, we discuss the dangers of energy drinks, the current regulatory framework and the problems it causes, the need for correcting these problems, and potential policy changes

AI Renaissance: Pharmaceuticals and Diagnostic Medicine

The explosive growth of Artificial Intelligence (AI) in the modern era has led to significant advancements in the world of medicine. In drug discovery, AI technology is used to classify proteins as drug targets or non-targets for specific diseases, more accurately interpret and describe pharmacology in a quantitative fashion, and predict protein structures based on only a protein sequence for input. AI methods are used in drug development to generate predictive models for drug screening purposes, refine and modify candidate structures of drugs to optimize compounds, and predict a drug’s physiochemical properties, bioactivity, and toxicity. For medical devices, the advancement of AI technology in the areas of colonoscopy, percutaneous coronary intervention (PCI), acute stroke and intracranial hemorrhage (ICH), vascular surgery, and ophthalmology may offer increased efficacy as compared to traditional patient-care techniques in diagnostic medicine.While use of AI in pharmaceutical development processes and diagnostic medicine increases, the rapidly growing technology has substantial barriers to overcome. The combination of AI with other novel technologies (e.g., nanotechnology) is anticipated to provide solutions to problems in drug development, model selection, drug screening, and even in clinical trials. Advancements in AI-enabled imaging analysis will be increasingly used in the fields of radiology and pathology, bringing with it increased efficiency in traditional patient-care techniques. Challenges in data representation, data labeling, small sample sizes, data privacy, ethical concerns, and interpretation of models present barriers for AI developers and interested clinicians to overcome when further developing AI technology in the pharmaceutical and medical diagnostics industries. These industries must also consider the importance of patent rights in the considering whether to invest in further development of AI technology, as the United States and other countries debate whether AI-assisted invention should be patentable.As governments consider the implications of an AI-enabled world, it will be crucial for the United States government to develop comprehensive legislation and regulations for the increasingly widespread technology. As sentiment from American citizens, corporate leaders, and government officials grows increasingly available, President Biden’s Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence stands out as a substantial starting point for anticipated legislation. Debate as to how AI should be regulated points to a logical conclusion: Congress should create a new federal agency with the sole purpose of regulating AI technology, developers, and sellers. This newly created agency must consider appropriate regulatory schemes, the need for interaction between all interested agencies and industries, and proper enforcement techniques such as licensure, monitoring, and legal penalties

Immunity Through Bankruptcy for the Sackler Family

In August 2023, the U.S. Supreme Court temporarily blocked one of the largest public health settlements in history: that of Purdue Pharma, L.P., reached in bankruptcy court. The negotiated bankruptcy settlement approved by the court would give a golden parachute to the very people thought to have ignited the opioid crisis: the Sackler family. As the Supreme Court considers the propriety of immunity through bankruptcy, the case has raised fundamental questions about whether bankruptcy is a proper refuge from tort liability and whether law checks power or law serves power. Of course, bankruptcy courts often limit liability against a distressed company, but here, the Sacklers did not themselves declare bankruptcy. Instead, they added about $6 billion to the pot—compared with$600 billion in annual costs from the opioid crisis, by some estimates—and are allowed to keep any remaining profits. The bankruptcy court justified immunity on the grounds that the Sacklers’ money was protected in offshore accounts and trusts and therefore could not be reached through tort liability—all the better to have them participate voluntarily. In other words, the Sacklers laid the groundwork for their own immunity by sheltering the money they withdrew from Purdue. We have doubts that a single court should have the enormous power of shielding the Sackler Family from all future civil liability for the opioid crisis, simply to enlarge a settlement. Public health litigation has the power to address root causes of public health crises by disincentivizing unscrupulous actors. Granting these actors immunity may insulate them from public criticism while undermining the important role of courts as an avenue of recourse. Upholding immunity for the Sackler family would lay the groundwork for future executives to ride a company into the ground, at the expense of public health, golden parachute ready and waiting

Labeling Energy Drinks: Tackling a Monster of a Problem

Energy drinks first rose to popularity in the 1980s after the creation of Red Bull. In addition to high caffeine amounts, energy drinks often contain herbal stimulan