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Articles 1 - 15 of 15
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America Is Tripping: Psychedelic Pharmaceutical Patent Reforms Fostering Access, Innovation, And Equity, Quentin Barbosa
America Is Tripping: Psychedelic Pharmaceutical Patent Reforms Fostering Access, Innovation, And Equity, Quentin Barbosa
Brooklyn Law Review
A resurgence in federally approved psychedelic research has spawned the Psychedelic Renaissance, and with each study it becomes increasingly clear that psychedelics have the potential to revolutionize mental health treatment. However, if Congress fails to reform the industry’s patent procedures, threats to innovation in the budding field of psychedelic medicine will manifest in their ugliest form. Psychedelics are a class of hallucinogenic drugs that primarily trigger substantially altered states of consciousness, including psychological, visual, and auditory changes. Medical research on psychedelics has produced staggering results that indicate psychedelics have the potential to be significantly more effective in treating mental illnesses …
Serving Up The Truth On America’S Failing Organic Food System, Leah M. Elefante
Serving Up The Truth On America’S Failing Organic Food System, Leah M. Elefante
Brooklyn Law Review
The organic food market in the United States has grown from a niche subset into an integral component of American food consumption. The current laws regulating the organic industry, including the recently adopted Strengthening Organic Enforcement (SOE) final rule, do not align with the average consumer’s understanding as they navigate the many options in grocery stores. This note analyzes the history and evolution of the organic food market in the United States, the process by which food producers become organic certified, and the pitfalls of the current system, which relies on definitions crafted by politicians, not scientists, and allows many …
How Public Health Informed Lawmaking Would Address The Rising Synthetic Opioid Death Toll, Jennifer S. Bard
How Public Health Informed Lawmaking Would Address The Rising Synthetic Opioid Death Toll, Jennifer S. Bard
Brooklyn Law Review
The sharply rising deaths associated with use of synthetic opioids in the United States highlight the failure of a legislative strategy focused on reducing the availability of prescription opioids. However, since synthetic opioids prescribed for pain relief have never been a major contributor to either developing opioid dependence or dying from opioid use, it is not surprising that these measures have not only failed to reduce deaths, but have also caused considerable harm to people in need of pain relief. Yet reversing them and taking a public health approach focused on preventing the most serious harms associated with synthetic opioids …
Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck
Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck
Brooklyn Law Review
Epidemics have devastated humankind for centuries. Given the simultaneous rise of advanced disease prevention and treatment and the great potential for mass public uptake, it is unsurprising that the U.S. pharmaceutical industry has grown to $775 billion in annual sales revenue. It is clear that the commercialization of important public health measures is not without controversy. Of particular debate is that vaccine and other drug manufacturers monopolize their products and control them through patent laws. Yet there is a strong dichotomy between the importance of patents and the need for public access to innovations. This is not to say that …
The Fight Over Frankenmeat: The Fda As The Proper Agency To Regulate Cell-Based “Clean Meat”, Zoe A. Bernstein
The Fight Over Frankenmeat: The Fda As The Proper Agency To Regulate Cell-Based “Clean Meat”, Zoe A. Bernstein
Brooklyn Law Review
In recent years, concern over the environmental, animal welfare, and human costs of animal agriculture has spurred an increased demand for nonanimal sourced protein. This has led to significant innovation in food technology. As part of this trend, food scientists have developed a process for in-vitro cultivation of meat cells to produce protein that is biologically and nutritionally identical to meat from traditionally raised and slaughtered animal sources, but that involves neither animal agriculture nor animal slaughter. This lab-grown “clean meat” represents a new era in food technology and is already having an effect on the existing meat industry. In …
Freedom Without Opportunity: Using Medicare Policy And Cms Mechanisms To Anticipate The Platform Economy’S Pitfalls And Ensure Healthcare Platform Workers Are Fairly Paid, Kim A. Aquino
Brooklyn Law Review
The rapidly aging population, along with the demand for innovative Medicare delivery models such as bundled payment programs have incentivized the use of technology in healthcare because of its potential to cut costs and improve quality of care. Like many industries embracing technological strides to automate and digitize services, the healthcare industry has welcomed new labor markets like the platform economy to facilitate connections between patients and workers with ease. Along with streamlining connections, the platform economy also promises workers flexibility and autonomy over their own schedule. The platform economy’s promise of freedom, however, is not enough to prevent the …
Lactose’S Intolerance: The Role Of Manufacturers’ Rights And Commercial Free Speech In Big Dairy’S Fight To Restrict Use Of The Term “Milk”, Kathleen Justis
Lactose’S Intolerance: The Role Of Manufacturers’ Rights And Commercial Free Speech In Big Dairy’S Fight To Restrict Use Of The Term “Milk”, Kathleen Justis
Brooklyn Law Review
This note examines the relationship between restrictions on commercial speech and manufacturers’ First Amendment right to describe their products to consumers, with a focus on the DAIRY PRIDE Act. It argues that broad, content-based restrictions of commercial speech, like that proposed in the DAIRY PRIDE Act, likely impose unconstitutional limitations on manufacturers’ First Amendment right to freedom of speech. This note recommends that both Congress and the FDA should refrain from passing a statute or promulgating a regulation like the DAIRY PRIDE Act. Rather, it proposes that adding rules to control the proportions and location of disclaimers on product labels …
Got Mylk?: The Disruptive Possibilities Of Plant Milk, Iselin Gambert
Got Mylk?: The Disruptive Possibilities Of Plant Milk, Iselin Gambert
Brooklyn Law Review
Milk is one of the most ubiquitous and heavily regulated substances on the planet—and perhaps one of the most contested. It is tied closely to notions of purity, health, and femininity, and is seen as so central to human civilization that our own galaxy—the Milky Way—is named after it. But despite its wholesome reputation, milk has long had a sinister side, being bound up with the exploitation of the (human and nonhuman) bodies it comes from and being a symbol of and tool for white dominance and superiority. The word itself, in verb form, means “to exploit.” It is also …
Direct-To-Consumer Calls To Action: Lowering The Volume Of Claims And Disclosures In Prescription Drug Broadcast Advertisements, Andrew Andrzejewski
Direct-To-Consumer Calls To Action: Lowering The Volume Of Claims And Disclosures In Prescription Drug Broadcast Advertisements, Andrew Andrzejewski
Brooklyn Law Review
Pharmaceutical companies advertise drugs directly to consumers via television and radio broadcast commercials, print advertisements, and the internet. Although broadcast advertisements are demonstrably unable to adequately convey risk information, a total ban on them would be too restrictive, and any regulation targeting these advertisements must withstand First Amendment scrutiny. The FDA’s recent attempts to modify its requirements for broadcast advertisements do not overcome these challenges. It is in the best interest of patients, doctors, the drug industry, and the government for Congress to authorize the FDA to regulate broadcast drug advertisements as limited calls to action, consisting of restricted product …
The “Deeming Rule”: The Fda’S Destruction Of The Vaping Industry, Lauren H. Greenberg
The “Deeming Rule”: The Fda’S Destruction Of The Vaping Industry, Lauren H. Greenberg
Brooklyn Law Review
The FDA has recently passed sweeping regulations, which classifies and then regulates electronic cigarettes as “tobacco products” in the same manner as traditional cigarettes. Though the agency reasons that unknowing adults and children may easily turn to e-cigarettes without fully understanding the potential health effects, there is a lack of conclusive evidence in this field to justify such a comprehensive regulatory scheme. Through the far-reaching “Deeming Rule,” e-cigarette manufacturers are forced to comply with financially burdensome and time-consuming requirements before taking most of their products to market. The channels by which the FDA proposes manufacturers and retailers gain permission from …
Potholes: Dui Law In The Budding Marijuana Industry, Zack G. Goldberg
Potholes: Dui Law In The Budding Marijuana Industry, Zack G. Goldberg
Brooklyn Law Review
The rapid legalization of marijuana across the United States has produced a number of novel legal issues. One of the most confounding issues is that presented by the marijuana-impaired driver. In jurisdictions that have legalized the use of marijuana, how high is too high to get behind the wheel? This note assesses the various marijuana DUI laws that states have implemented to combat marijuana-impaired driving. Many of these statutes have followed in the footsteps of the BAC-based standard used to combat drunk driving—using THC measurements to quantify a driver’s level of marijuana-based impairment. Unfortunately, unlike alcohol, the scientific properties of …
The New York Pharmaceutical Cost Transparency Act: How A Narrow View Of The Prescription Drug Pricing Puzzle Renders A Well-Intentioned Bill Irrational, John G. Curran
Brooklyn Law Review
Pricing prescription pharmaceuticals is a complex process that entails the consideration of a multitude of factors, not the least of which is the research and development expenditure exhausted by drug makers to gain FDA approval. While public sentiment has increasingly turned against the pharmaceutical industry due to its perceived greed as manifested in the high cost of its drugs, the intricacies of pricing such unique products is rarely discussed. A recently proposed New York state bill, the Pharmaceutical Cost Transparency Act (the NYPCTA), continues this unfortunate trend, by requiring companies to disclose the R&D costs of newly approved drugs in …
Perpetual Twilight: How The Usda's Change To The Sunset Process Violates The Organic Foods Production Act Of 1990, Valentina Lumaj
Perpetual Twilight: How The Usda's Change To The Sunset Process Violates The Organic Foods Production Act Of 1990, Valentina Lumaj
Brooklyn Law Review
In 1990, Congress enacted the Organic Foods Production Act of 1990 (OFPA) in response to consumer and industry demands for uniform standards in organic production. The drafters recognized that the basic tenet of the legislation was that organic foods would be produced without the use of synthetic materials, but they left room for minimal exceptions in the National List of Allowed and Prohibited Substances (the National List). The National List enumerates the exemptions for synthetic substances, as well as prohibitions of natural substances, such as arsenic, in organic production. In September 2013, the USDA amended the Sunset Process, which is …
Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi
Tainted: Food, Identity, And The Search For Dignitary Redress, Melissa Mortazavi
Brooklyn Law Review
The law recognizes a right to legal redress for exposure to food that is tainted in the sense of being toxic or poisonous, but what about exposure to food products individuals find socially, morally, or religiously repugnant? Jews eating “kosher” hot dogs containing standard non-kosher meats. Vegetarians fed beef. Muslims ingesting vitamins containing pork. Aren’t these food products also “tainted”? Despite the fact that the American legal system has long recognized the need to protect individual dignitary rights, the law provides little meaningful redress in these situations or other instances of offensive food taint. So why has food autonomy, an …
The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan Jr.
The Uneasy Case For Food Safety Liability Insurance, John Aloysius Cogan Jr.
Brooklyn Law Review
Foodborne illnesses sicken millions and kill thousands of Americans every year, leading many to conclude that our dysfunctional government food safety system, which still relies heavily on physical inspections of food and facilities, is incapable of protecting us. As a result, many now look to the private market for solutions to our food safety crisis. One private market approach, food safety liability insurance, is gaining popularity. This article examines the benefits and drawbacks to food safety liability insurance and raises doubts about its ability to improve food safety. The market for safe food is plagued by overwhelming information problems that …