Food and Drug Law Commons^™

The Ethics Of Industry-Funded Speakers’ Bureaus—How They Disseminate Innovation And Could Corrupt Medicine, Jennifer E. Miller, Christopher Robertson

Faculty Scholarship

It is often said that a business without marketing is dead. But when a medical product is marketed irresponsibly, it is patients who may pay with their lives. In this context, Wieberdink et al¹ examine participation in industry-sponsored speakers’ bureaus by academic clinical faculty, conceptualizing the practice as a form of conflicted and irresponsible pharmaceutical marketing. Reviewing 129 US allopathic medical school conflict-of-interest (COI) policies, they found that less than 40% prohibit industry speakers’ bureau participation outright, while 19% impose conditional restrictions, such as requiring that faculty retain control over presentation content. Wieberdink et al¹ advocate for a …

Examining Pricing And Availability For Neglected Tropical Disease Therapies In The Us, Maple Goh, Kevin Outterson, Aaron S. Kesselheim

Faculty Scholarship

Background

Neglected tropical diseases primarily affect vulnerable populations in low-resource settings worldwide. In the US, neglected tropical diseases such as Chagas, soil-transmitted helminthiases, and other infections historically impacted immigrants but are increasingly relevant for US residents with climate change. We examined the pricing, prescribing rates, and supply of therapies used to treat neglected tropical diseases in the US and their implications for accessibility and patient care. Methods

A retrospective analysis of prescription rates, wholesale acquisition costs, and shortages was conducted for 11 treatment products from 2019 to 2024, aggregating data from Symphony Metys, First Databank, NAVLIN, Red Book, and the …

Birthdate Phaseout, Katharine B. Silbaugh

Faculty Scholarship

This article explores the Nicotine Free Generation (NFG) policy, an emerging endgame strategy for tobacco products that employs a completely novel legal design. Tobacco remains the leading cause of preventable death, killing almost half of its users and imposing $600 billion in social costs each year. We see two basic choices for regulating sales: Prohibition, or a legal age-gate, such as 21 for retail sales. NFG charts a third way. Recognizing the dire harm of tobacco, and the serious consequences of abrupt prohibition, NFG lays the groundwork for a gradual transition to a sales sunset. In place of the 21 …

Patient Access In Fourteen High-Income Countries To New Antibacterials Approved By The Fda, Ema, Pmda, Or Health Canada, 2010-2020, Kevin Outterson, Ebiowei S. F. Orubu, John Rex, Christine Årdal, Muhammad H. Zaman

Faculty Scholarship

In 2010, the Infectious Diseases Society of America called for 10 new antibiotics by 2020. This goal was achieved in terms of the number of drug approvals, but actual patient access requires commercial launches in many countries, which itself requires sustainable commercial markets. Prior work has described limited access to new antibacterials in low- and middle-income countries (LMICs), in part due to the inability of many to afford these drugs. This study examines patient access for new antibacterials in the G7 and 7 other high-income countries in Europe, to better understand other barriers to patient access to effective antibacterial therapy.

American Edibles: How Cannabis Regulatory Policy Rehashes Prohibitionist Fears And What To Do About It, Connor Burns, Jay D. Wexler

Faculty Scholarship

Why can’t we buy a cannabis muffin with our morning coffee? For much of the past century, the answer was simple: cannabis was illegal. Now, however, with more and more states legalizing cannabis for adult use, the answer is far less clear. Even in those states that have legalized cannabis, the simple action of buying and eating edibles at the same location has somehow remained a pipe dream despite consumer demand. Digging a little deeper, we can see how contemporary alarmism, by rehashing the same prohibitionist rhetoric demonizing cannabis for over eighty years, has once again arisen with a new …

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 4, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

This is the fourth of a five-part series dealing with the rescission by U.S. Attorney General Jeff Sessions of the Obama-era policy that discouraged federal prosecutors from bringing charges in all but the most serious marijuana cases.

This article focuses on retail-level frauds. It proposes a limited purpose crypto currency. At the retail level the MJ Freeway or METRC software essentially functions as a marijuana-industry-specific point of sale (POS) system. It is common in retail for different industry sectors (restaurants, hotels, convenience stores, or gasoline stations) to have market-specific POS systems that are molded to fit the unique characteristics of …

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 5, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

This is the fifth part of a five-part series dealing with the rescission by U.S. Attorney General Jeff Sessions of the Obama-era policy that discouraged federal prosecutors from bringing charges in all but the most serious marijuana cases.

This article focuses on the back-end leakage in the state’s obligation to control both the physical flows of legalized marijuana, as well as the related fiscal flows (the proceeds of legalized marijuana sales). These flows intersect dramatically in retail-level frauds.

There are very few new proposals on how to solve the physical flow problems with consumer re-sales into the black market. Traditional …

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 2, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

Legalization of marijuana burdens the States with the responsibility of (a) monitoring the physical flows of marijuana through the supply chain (making sure the marijuana does not enter inter-state commerce; making sure it stays out of the hands of minors, etc.), and (b) monitoring the fiscal flows (making sure the proceeds of marijuana production do not end up in criminal hands).

The type of controls favored by the states are track and trace (TAT), or seed-to-sale (STS) systems. These systems are reasonably complex, as well as technology-intensive. Nevertheless, there are questions about whether they are adequate to the enforcement needs. …

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 1, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

On January 4, 2018, the Trump Administration through Attorney General Sessions rescinded an Obama-era policy1 that discouraged federal prosecutors from bringing charges in all but the most serious marijuana cases under the federal Controlled Substances Act,2 as well as under the Bank Secrecy Act.3 Federal law is at odds with state law in the majority of states on the legalization and subsequent state taxation of marijuana.4 Twenty-eight states and the District of Columbia have at least partially legalized marijuana. Eight of these states have legalized both medicinal and recreational use.5 With limited exceptions, legalized sales of marijuana are taxed.

We …

The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson

Faculty Scholarship

Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. …

Fda's Troubling Failures To Use Its Authority To Regulate Genetically Modified Foods, Leslie Francis, Robin Kundis Craig, Erika George

Faculty Scholarship

This Article concerns the particular regulatory responsibilities only of FDA. It sets to one side the possible regulatory authority of agencies such as the Environmental Protection Agency ("EPA") or the U.S. Department of Agriculture ("USDA"). This approach risks replicating the regulatory fracture introduced during the Reagan Administration and criticized by some scholars,¹⁵ but there is a great deal to say about current FDA practices. Out of similar considerations of space and focus, this Article also sets to one side many other important issues that surround GM foods: intellectual property rights; rights to free speech or commercial speech; fair trade …

New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson

Faculty Scholarship

As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn't mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product's risks as well. Since it's not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a …

The Presumption Against Expensive Health Care Consumption, Christopher Robertson

Faculty Scholarship

This essay, as part of a symposium in honor of Professor Einer Elhauge, starts with his recognition that, for both epistemic and normative reasons, it remains profoundly difficult to regulate particular uses of medical technologies on the basis of their cost-benefit ratios. Nonetheless, this essay argues in favor of a general regulatory presumption against consumption for the most expensive medical technology usages, which drive most of aggregate healthcare spending. This essay synthesizes twelve facts about the ways in which medical technologies are produced, regulated, studied, and consumed to suggest that it is quite unlikely that the most expensive usages of …

When Truth Cannot Be Presumed: The Regulation Of Drug Promotion Under An Expanding First Amendment, Christopher Robertson

Faculty Scholarship

The Food, Drug, and Cosmetic Act (FDCA) requires that, prior to marketing a drug, the manufacturer must prove that it is safe and effective for the manufacturer’s intended uses, as shown on the proposed label. Nonetheless, physicians may prescribe drugs for other “off-label” uses, and often do so. Still, manufacturers have not been allowed to promote the unproven uses in advertisements or sales pitches.

This regime is now precarious due to an onslaught of scholarly critiques, a series of Supreme Court decisions that enlarge the First Amendment, and a landmark court of appeals decision holding that the First Amendment precludes …

The Paradox Of Legal Equivalents And Scientific Equivalence: Reconciling Patent Law's Doctrine Of Equivalents With The Fda's Bioequivalence Requirement, Janet Freilich

Faculty Scholarship

Contrary to popular perception, generic drugs often enter the market before the patents covering their brand name counterparts have expired by making slight changes to the drug to avoid the brand name patent. These generics face a paradox: the U.S. Food and Drug Administration (FDA) requires that the generic "not show a significant difference" from the reference product, while patent law requires that the generic have "substantial differences" as compared to the reference product. The generic must be bioequivalent, but not legally equivalent, to the brand name drug. This paradox occurs frequently in the courts but has never been discussed …

Patent Infringement In The Context Of Follow-On Biologics, Janet Freilich

Faculty Scholarship

This Article fills a gap in the literature by conducting a comprehensive analysis of patent infringement in the context of follow-on biologics. Patent infringement is an important topic because, like small molecule generic drugs, follow-on biologics are likely to begin their life facing infringement suits. Because it is tremendously expensive to develop a follow-on biologic, it is vital that there be consistency in how they are treated in the courts once the inevitable patent infringement suits arrive. If follow-on biologics companies cannot predict how their product will be received in court, they may decide it is not worth the risk …

Pharmaceutical Innovation: Law & The Public's Health, Kevin Outterson

Faculty Scholarship

At last count, global pharmaceutical spending exceeded $750 billion. Unlike most medical products and services, many pharmaceuticals are sold at a price that greatly exceeds marginal cost. AIDS medicines that retail for over $10,000 per person per year in the United States can be produced generically at a marginal cost of less than $150. Patents and other related IP rights create these significant gaps between marginal cost and retail price, generating many billions of dollars in profits (patent rents) for companies.

Dirty Dancing: The Fda Stumbles On The Chevron Two-Step, Gary S. Lawson

Faculty Scholarship

Professor Lars Noah deserves much credit for exposing some of the myriad ways in which the Food and Drug Administration (FDA) has consistently sought to expand its authority through questionable, and perhaps in some cases abusive, legal practices.' As Professor Noah observes, there are signs that the federal courts' century-long honeymoon with the FDA may be ending 2 -and perhaps the FDA never deserved the solicitude that it has traditionally received from both the judiciary and Congress. 3 If Professor Noah can hasten the onset of a more realistic legal and public attitude toward the FDA, he will have performed …

Pharmacogenomics, Genetic Tests, And Patent-Based Incentives, Michael J. Meurer

Faculty Scholarship

Pharmacogenomics promises to revolutionize medicine by using genetic information to guide drug therapy. Genetic tests will help doctors improve drug safety and efficacy by better matching patients and drugs. This Article evaluates the effectiveness of patent-based incentives to create genetic tests, and the optimal mix of public and private sector pharmacogenomic R&D. Drug patent owners have a strong incentive to develop genetic tests that predict adverse drug reactions and allow them to market drugs that otherwise would be shelved. Incentives are also strong for genetic tests that are created as part of the drug development process. Incentives tend to be …

Making Clinical Trials Safer For Human Subjects, Michael S. Baram

Faculty Scholarship

Clinical trials, in which new biotech and other medical products are tested on human subjects, provide much of the data used by the FDA to determine whether the products are suitable for routine use in health care. Thus, the trials are of obvious importance to medical progress and improvement of public health, and to those who have career and financial interests at stake. But clinical trials are also important to the human subjects involved because the products being tested on them may remedy their illnesses, but may also pose risks since the products have usually not been previously tested on …

Thalidomide And The Titanic: Reconstructing The Technology Tragedies Of The Twentieth Century, George J. Annas

Faculty Scholarship

The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the …

A False Start?: The Impact Of Federal Policy On The Genotechnology Industry, Michael J. Malinowski, Maureen A. O'Rourke

Faculty Scholarship

Important scientific discoveries in the field of human genetics have been reported in the nation's major newspapers since the beginning of the decade, and these discoveries have given rise to a multi-billion dollar industry. Mr. Malinowski and Professor O'Rourke explore the impact of federal policy on the field and the resulting industry. They argue that federal policy in support of genetics research and development has not been followed by the introduction of regulatory and health policy necessary for the efficient and responsible commercialization of the industiy's products. As a consequence, Mr. Malinowski and Professor O'Rourke suggest, federal policy may have …

The Changing Landscape Of Human Experimentation: Nuremberg, Helsinki, And Beyond, George J. Annas

Faculty Scholarship

Since World War II there have been persistent efforts at both the national and international level to develop rules to protect the rights and welfare of subjects of human experimentation.' These efforts have focused primarily on codifying the rights of subjects, and protecting their welfare by prior peer review of research protocols. In recent years research regulations have been under attack by politicians, drug companies, researchers, and advocacy groups. In less than half a century, human experimentation has been transformed from a suspect activity into a presumptively beneficial activity. With this transformation, traditional distinctions between experimentation and therapy, subject and …

Charting The Future Course For Corporate Management Of Health Risks, Michael S. Baram

Faculty Scholarship

Corporations engage in technological activities of benefit to society, but thereby also create new health risks for workers, consumers, and communities. Government regulatory agencies deal with this chronic problem by conducting risk analyses and imposing various duties on private firms. Despite agency efforts and corporate compliance, health risks continue to arise and take their toll. To what extent will private firms voluntarily assume greater responsibility for preventing these health risks? This question is of increasing social importance, because the limitations of regulatory efforts are now obvious, whereas health risks are now being identified at what appears to be an increasing …