Digital Commons Network^™

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, Muhammad H. Zaman, John Rex, Christine Ardal

Faculty Scholarship

In 2010, the Infectious Diseases Society of America called for 10 new antibiotics by 2020 [1]. 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 [2]. 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 …

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

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 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 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 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. …

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 …

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 …

Counterfeit Drugs: The Good, The Bad, And The Ugly, Kevin Outterson

Faculty Scholarship

When I chose the title, Counterfeit Drugs: The Good, the Bad and the Ugly, some of my colleagues at this symposium blanched. They understood counterfeit drugs as Bad and Ugly, but resisted categorizing any counterfeit drug as Good. This article is intended to be provocative, challenging some of the conventional wisdom concerning counterfeit drugs.

We start with the fact that reports about the scope of pharmaceutical counterfeiting are remarkably anecdotal rather than empirical. As a professor once chided me, the plural of anecdote is not data. The FDA and the WHO must undertake comprehensive market surveillance to establish the true …

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, 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 …