Digital Commons Network^™

Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka

Vanderbilt Law Review

When health is at stake, bureaucratic delays can be disastrous. This is especially true in the field of pharmaceutical regulation. Fortunately, concerned parties—ranging from research institutions and universities to doctors and pharmaceutical companies—can file citizen petitions to urge the Food and Drug Administration (“FDA”) to regulate potentially risky drugs through Risk Evaluation and Mitigation Strategies (“REMS”) programs. But despite submitting comprehensive citizen petitions calling for changes to REMS determinations, petitioners regularly await the FDA’s response for years. When these petitioners, still awaiting an FDA determination, have sought recourse in the courts, the agency has argued that these petitioners have not …

Re-Regulating Dietary Supplements, Jessie L. Bekker, Alex Flores, Michael S. Sinha

Journal of Food Law & Policy

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under DSHEA, the FDA has limited authority to review dietary supplements before entering the market. Unlike pharmaceuticals, which must be proven safe and effective prior to approval and marketing, dietary supplements can be sold to consumers without such reassurances. We call on Congress to amend DSHEA to …

Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales

University of Miami Law Review

Cosmetics only first became regulated after a series of tragic events where users were seriously harmed from the use of cosmetic products. These tragic events prompted legislators to enact the Food, Drug, and Cosmetics Act of 1938. Before then, law makers feared that regulating the cosmetic industry would lower the tone of legislation because they considered the cosmetic industry to be inconsequential. At present, the regulatory system in place to protect vulnerable cosmetic consumers is nearly identical to when it was enacted over eighty-six years ago—even though the cosmetic market looks nothing like it did back then. The consumer base …

Following The Framework: Intentional Genomic Alterations In Animals, Sarah Copper

Journal of Food Law & Policy

Intentional genomic alterations in animals or genetically engineered animals have existed in their modern form since the 1980s. However, the introduction of these animals into our food supply has been a more recent development. The federal government has taken steps in an attempt to regulate these products in a streamlined and efficient manner but has faced criticism in their approach. While the Food and Drug Administration (“FDA”) is currently responsible for the regulation of intentional genomic alterations (“IGAs”) in animals, there is significant effort behind transferring that oversight to the United States Department of Agriculture (“USDA”). However, in the meantime, …

The Cow Has Left The Barn: Updating Standards Of Identity To Reflect Consumer Understanding Of Plant-Based Foods, Nicholas G. Miller

Journal of Food Law & Policy

Have you ever seen “tofurkey” at the supermarket and thought it was a rare, delicious cousin of the turkey? The animal based food industries, led by milk and meat producers, are claiming that the reasonable consumer might. On the other hand, the plant based food substitutes are appearing on supermarket shelves with increasingly bold names for their products that tap into our familiarity with animal-based foods, using names like “Beyond Meat.” Where do we draw the line on what plant based food can be called? And who should draw that line? This paper examines the debate surrounding the labeling of …

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …

Trust The Science But Do Your Research: A Comment On The Unfortunate Revival Of The Progressive Case For The Administrative State, Mark Tushnet

Indiana Law Journal

This Article offers a critique of one Progressive argument for the administrative state, that it would base policies on what disinterested scientific inquiries showed would best advance the public good and flexibly respond to rapidly changing technological, economic, and social conditions. The critique draws on recent scholarship in the field of Science and Technology Studies, which argues that what counts as a scientific fact is the product of complex social, political, and other processes. The critique is deployed in an analysis of the responses of the U.S. Centers for Disease Control and Food and Drug Administration to some important aspects …

Reforming Reimbursement For The Us Food And Drug Administration’S Accelerated Approval Program To Support State Medicaid Programs, Rachel Sachs, Julie M. Donohue, Stacie B. Dusetzina

Scholarship@WashULaw

Importance The US Food and Drug Administration (FDA) has an accelerated approval program that has become the subject of scholarly attention and criticism, not only for the FDA’s oversight of the program but also for its implications for payers.

Observations State Medicaid programs’ legal obligations to provide reimbursement for accelerated approval products have created fiscal challenges for Medicaid that have been exacerbated by industry’s changing use of the accelerated approval program over time. Although strategies for accelerated approval reforms have been proposed, most focus on reforming the FDA’s accelerated approval pathway and product regulation without taking into account the implications …

Insulin Federalism, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

Faculty Publications & Other Works

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

Going Hemp Wild: Understanding The Challenges And Opportunities For Fda Regulation Of Cbd In Food Products, Hannah Catt

Journal of Food Law & Policy

After the passage of the 2018 Farm Bill, champions of hemp began to tout opportunities for farmers and businesses involved with the crop. The industry has rallied around one of hemp’s major byproducts, cannabidiol, or CBD. However, the demand for CBD has left the Food and Drug Administration (“FDA”) playing catch-up. This article explains what CBD is, how it is derived, current FDA-approved uses, and a current path forward for the FDA in creating guidance for industry and consumers.

Welcome To The World Of Tomorrow: An Exploration Of Cell-Based Meats And How The Fda And Usda May Protect Intellectual Property Rights, Sean A. Grafton

Catholic University Journal of Law and Technology

Lab-grown meats are ready to be sold in United States markets. However, the meat product needs approval from regulators such as the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”). The regulation approval process takes a significant amount of time. This approval period will cut into the lab-grown meat producers’ patent time, rendering a period of the patent ineffective.

This Comment analyzes the effect of, and possible changes to, our current laws on the emerging lab-grown meat market. To look at this problem, this Comment compares FDA and USDA regulations, analyzes the Hatch-Waxman Act, and …

Three Framing Of "Faster" At The Fda And The Federal Right To Try, Jordan Paradise

Faculty Publications & Other Works

In May 2018, Congress passed the controversial Right to Try (“RTT”) Act, creating a process for terminally ill patients to request access to investigational drugs. The federal RTT Act is not the first legal mechanism that fosters quicker access to investigational drugs. This new right to try is distinct from existing pathways created by law, regulation or federal administrative agency policy. Various mechanisms facilitated by the U.S. Food and Drug Administration (“FDA”) are significantly more substantial and important in the context of “faster” access to therapeutic products. These mechanisms lie along a spectrum of product development spanning investigational new drug …

Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens

Articles, Book Chapters, & Popular Press

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …

Puff Puff Pass The Legislation: A Comparison Of E-Cigarette Regulations Across Borders, Rachel E. Zarrabi

Journal of the National Association of Administrative Law Judiciary

This comment explores the types of legislation, approaches to regulating e-cigarettes, and analyzes whether the FDA’s campaign and current regulations are effective. So far, it appears that the United States is ahead of the game with its new, aggressive proposal for regulating e-cigarettes. The FDA is standing against the companies and products that target youthful consumers. Most countries acknowledge the gaps in current scientific research regarding the long-term health risks of vaping, and some are waiting to take a legislative stance until it is clearer which side of the health line e-cigarettes fall. Section II of this comment discusses the …

Beauty Shouldn’T Cause Pain: A Makeover Proposal For The Fda’S Cosmetics Regulation, Lauren Jacobs

Journal of the National Association of Administrative Law Judiciary

The American cosmetics industry is not required by the Food and Drug Administration (FDA) to conduct pre-market safety assessments of cosmetics. The FDA only reviews personal care products when people voluntarily report problems. Further, companies continue to test animals for cosmetics, despite the FDA’s recommendation that manufacturers seek more humane and accurate testing. Although the FDA does not require animal testing for product safety or premarket approval, the United States is one of the largest users of laboratory animals for product testing. There are two pending pieces of legislation, which if passed would be the first acts of cosmetic regulation …

A Corporate Duty To Rescue: Biopharmaceutical Companies And Access To Medications, Rebecca E. Wolitz

Indiana Law Journal

Controversies regarding the pricing of biopharmaceutical products are pervasive. Patients must choose between treatment and rent, prescriptions go unfilled, and health systems are forced to restrict access to life-saving medications— all because of cost. Though there is often consensus that these issues are problematic, there is disagreement as to what are appropriate solutions and who has responsibility to bring about those solutions. Most efforts to address biopharmaceutical pricing concerns focus on governmental regulation. This Article has a different focus. It provides a legal and normative analysis of a form of corporate self-regulation that could help address access and pricing concerns—a …

A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho

Indiana Law Journal

Is more information always better? First Amendment commercial speech jurisprudence takes this as a given. However, when information is only available from a self-interested and marketing-savvy pharmaceutical company, more information may simply lead to more misinformation. Notably, doctors are also misled. This can result in public health harms when companies are promoting unapproved uses of prescription drugs that the Food and Drug Administration (FDA) has approved for other purposes—commonly referred to as “off-label” uses. Contrary to judicial presumptions, as well as the presumptions of some doctors and scholars, doctors are not sophisticated enough to always discern what is true versus …

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs

Articles

Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.

Drug Approval In A Learning Health System, W. Nicholson Price

Articles

The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

Improving Generic Drug Approval At The Fda, Kathleen Craddock

Michigan Journal of Environmental & Administrative Law

Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …

Fighting For Your Life In America: A Study Of "Right To Try" Laws Throughout The Country, Danielle Delgrosso

St. John's Law Review

(Excerpt)

This Note argues that there should be a federal statute granting terminally ill patients access to experimental drugs, but that the Trickett Wendler Act, as written is not the proper vehicle for change. An ideal congressional “Right to Try” statute should be crafted to make experimental drugs realistically obtainable for terminally ill patients while protecting those patients and their quality of life. The Trickett Wendler Act’s weaknesses prevent it from reaching this objective because it is too deferential to already unclear state Right to Try laws. Part I explores the right to try movement generally, explaining what a “right …

Serving Up Allergy Labeling: Mitigating Food Allergen Risks In Restaurants, Marie C. Boyd

Faculty Publications

Allergens in restaurant food cause many allergic reactions and deaths. Yet no federal, state, or local law adequately protects people from these harms. Although federal law requires the labeling of “major food allergens” in packaged food, there are no allergen labeling requirements for restaurant-type food. In addition, existing food safety requirements for restaurants are inadequate to prevent allergen cross contact.

The existing legal scholarship on food allergens in restaurants is limited. Much of the legal scholarship on labeling in restaurants focuses on menu labeling — the provision of calorie and other nutrition information to combat obesity. The requirements of Section …

Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen

Articles

In 2015, one of us published a peer-reviewed study, together with colleagues at the University of California, San Francisco, replicating prior research from the US Food and Drug Administration (FDA) detecting a designer stimulant, β-methylphenylethylamine, in sports, weight loss, and “cognitive function” supplements sold in the United States. The confirmatory study prompted the FDA to take enforcement action against companies selling the stimulant as a dietary ingredient. One of the companies that received an FDA warning letter sued the study’s authors for $200 million in damages for libel, claiming, without supporting scientific evidence, that multiple statements in the article were …

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

The Epipen Problem: Analyzing Unethical Drug Price Increases And The Need For Greater Government Regulation, Talal Rashid

University of Miami Business Law Review

In recent years, some pharmaceutical companies have started increasing the price of their existing drugs to exorbitant levels. Often, these drugs are medically necessary for patients, who are left to take on the high costs of the medicine. One recent example is Mylan, who raised the price of the EpiPen by four hundred percent, solely for the profit of its own company and to the detriment of consumers who rely on the EpiPen. Similar patterns of drug price increases have occurred in the past and will likely happen again in the future. This Comment will seek to identify the common …

The Recent Enactment Of National Mandatory Gmo Labeling Law: Superior To A Voluntary Labeling Scheme But Unlikely To End The Labeling Controversy, Nan Feng

Seattle University Law Review

Part I of this Note provides background information about the major controversies related to GM foods, including the debate about whether such foods should be labeled, and the history of GMO labeling laws in the United States. Part II compares S. 764 with H.R. 1599 and explains why a national mandatory labeling approach is superior to the voluntary labeling approach advocated by the House. Part III discusses the potential drawbacks and effect of S. 764 and finally concludes that the rulemaking process that will follow may create controversies and litigation.

Citizen Petitions: Long, Late-Filed, And At-Last Denied, Michael A. Carrier, Carl Minniti

American University Law Review

No abstract provided.

Price Controls Through The Back Door: The Parallel Importation Of Pharmaceuticals, A. Bryan Baer

Journal of Intellectual Property Law

No abstract provided.