Law Commons^™

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 …

Why Punish Pharma For Making Medicine? Preserving Patent Protections And Cutting Consumer Costs, Alex Wharton

Vanderbilt Journal of Entertainment & Technology Law

The push to lower pharmaceutical drug prices has taken a stronger foothold in legislative and executive actions in recent years. With average prices rising continuously over the past decade, many consumers struggle to pay for the medications they need-—insulin being the most often cited example. Accordingly, a variety of solutions have been suggested. Some solutions support reducing barriers for generic drugs to provide competition to the big brands, others push for greater regulation of manufacturers’ ability to price their drugs, and some proposals seek greater transparency to promote price negotiations, especially when compared to prices abroad. Most concerningly, however, one …

Executive Capture Of Agency Decisionmaking, Allison M. Whelan

Vanderbilt Law Review

The scientific credibility of the administrative state is under siege in the United States, risking distressful public health harms and even deaths. This Article addresses one component of this attack-—executive interference in agency scientific decisionmaking. It offers a new conceptual framework, “internalagency capture,” and policy prescription for addressing excessive overreach and interference by the executive branch in the scientific decisionmaking of federal agencies. The Article’s critiques and analysis toggle a timeline that reflects recent history and that urges forward-thinking approaches to respond to executive overreach in agency scientific decisionmaking. Taking the Trump Administration and other presidencies as test cases, it …

Potus And Pot: Why The President Could Not Legalize Marijuana Through Executive Action, Robert Mikos

Vanderbilt Law School Faculty Publications

Could the President legalize marijuana, without waiting for Congress to act? The 2020 Presidential Election showed that this question is far from hypothetical. Seeking to capitalize on frustration with the slow pace of federal legislative reform, several presidential candidates promised they would bypass the logjam in Congress and legalize marijuana through executive action instead.

This Essay warns that such promises are both misguided and dangerous because they ignore statutory and constitutional constraints on the President’s authority to effect legal change. It explains why supporters of marijuana reform should be wary of legalizing the drug through executive action, even if that …

We Need A Cole Memorandum For Magic Mushrooms, Robert Mikos

Vanderbilt Law School Faculty Publications

In fall 2020, as the nation elected Joe Biden to be our Forty-Sixth President, Oregon voters also passed a noteworthy new drug law reform. Known as Measure 109, Oregon’s path-breaking law legalizes the use of psilocybin, a hallucinogenic substance found in magic mushrooms. Measure 109 is designed to unlock the therapeutic potential of psilocybin, which advocates tout as an effective and safe treatment for depression and other psychological conditions.

Given the burgeoning interest in psychedelics, many people are excited to see how Oregon’s psilocybin experiment pans out. But at this point, it remains unclear whether the experiment will even get …

Interstate Commerce In Cannabis, Robert Mikos

Vanderbilt Law School Faculty Publications

By the end of 2020, more than thirty states had legalized cannabis containing tetrahydrocannabinol ("THC") for at least some purposes.' Each of these states has authorized firms to produce and sell cannabis within its borders. In 2019, those state-licensed firms did a brisk business, selling more than $13 billion worth of cannabis.

However, none of that $13 billion of cannabis is now being sold (legally) across state lines. Instead, each legalization state now has its own, hermetically sealed local cannabis market, supplied entirely by cannabis cultivated and processed inside the state. For example, the $1.75 billion worth of cannabis that …

The Regulation Of Commercial Speech: Can Alternative Meat Companies Have Their Beef And Speak It Too?, Eryn Terry

Vanderbilt Journal of Entertainment & Technology Law

Would you eat a hamburger that was made in a petri dish? Consumers may have this option soon as laboratory-grown meat begins to hit supermarket shelves. Laboratory-grown meat is made from animal stem cells that eventually transform into primitive fibers and tissue within the confines of a petri dish. Although a lot remains unknown about laboratory-grown meat, consumers can think of it as meat production without the farm. How might consumers react to meat labels indicating that their products were made in a petri dish? Laboratory-grown meat companies have yet to find out, as some states have passed laws that …

Reputation And Authority: The Fda And The Fight Over U.S. Prescription Drug Importation, Thomas J. Bollyky, Aaron S. Kesselheim

Vanderbilt Law Review

There is popular and bipartisan support for legalizing the importation of lower-cost medicines from Canada to help reduce the high prescription drug costs that Americans pay. Despite the wide interest in this policy, attempts over the last sixteen years to create a formal system for large-scale prescription drug importation in the United States have failed. The Trump Administration recently issued a final rule to enable the legal importation of prescription drugs from Canada, but the rule has important design flaws and seems destined to suffer a similar fate as previous efforts.

In this Article, we argue that prescription drug importation …

The Evolving Federal Response To State Marijuana, Robert Mikos

Vanderbilt Law School Faculty Publications

The states have launched a revolution in marijuana policy, creating a wide gap between state and federal marijuana law. While nearly every state has legalized marijuana in at least some circumstances, federal law continues to ban the substance outright. Nonetheless, the federal response to state reforms has been anything but static during this revolution. This Essay, based on my Distinguished Speaker Lecture at Delaware Law School, examines how the federal response to state marijuana reforms has evolved over time, from War, to Partial Truce, and, next (possibly) to Capitulation. It also illuminates the ways in which this shifting federal response …

Has The "M" Word Been Framed? Marijuana, Cannabis And Public Opinion, Robert A. Mikos, Cindy D. Kam

Vanderbilt Law School Faculty Publications

Over the past two decades, a growing cadre of US states has legalized the drug commonly known as “marijuana.” But even as more states legalize the drug, proponents of reform have begun to shun the term “marijuana” in favor of the term “cannabis.” Arguing that the “M” word has been tainted and may thus dampen public support for legalization, policy advocates have championed “cannabis” as an alternative and more neutral name for the drug. Importantly, however, no one has tested whether calling the drug “cannabis” as opposed to “marijuana” actually has any effect on public opinion. Using an original survey …

The Authorization Continuum: Investigating The Meaning Of "Authorization" Through The Lens Of The Controlled Substances Act, Breanna C. Philips

Vanderbilt Law Review

Federal prohibitions are ubiquitous in society. These prohibitions may be absolute, providing no exceptions, or they may be qualified, providing exemptions that allow specified parties to avoid a law's reach. The power to exempt parties from a prohibition is not limited to the federal government; it may be delegated to states or smaller polities as well. This is the structure that Congress employed when enacting the Mail Order Drug Paraphernalia Control Act: the Act bans, among other things, the sale and distribution of drug paraphernalia but provides an exemption for "any person authorized by local, State, or Federal law."

While …

Pharming Out Data: A Proposal For Promoting Innovation And Public Health Through A Hybrid Clinical Data Protection Scheme, Lea M. Gulotta

Vanderbilt Journal of Transnational Law

The pharmaceutical industry, one of the largest industries in the world, is rapidly becoming globalized. Clinical trials, which are required for drugs to be approved for human use, are increasingly performed outside of the pharmaceutical company's home country in an attempt to save money. This is mainly due to drug development's steep costs, and the high risks involved in an industry where only 12 percent of products that begin development ever make it to market. In order to help offset these risks and encourage innovation, many countries offer clinical trial data certain protections through patents, market exclusivity, or trade secret …

Constructing A "Creative Reading": Will Us State Cannabis Legislation Threaten The Fate Of The International Drug Control Treaties?, Michael Tackeff

Vanderbilt Journal of Transnational Law

While marijuana remains illegal at the federal level in the United States, state-level efforts to legalize cannabis have gained enormous momentum in recent years. The federal government, which possesses only limited power to stop this trend, has responded by grudgingly allowing such efforts to proceed, maintaining that its inaction on the issue comports with the international drug control regime. This presents a particularly complex problem for international policymakers and legal scholars, who worry that this state-federal conflict may render international drug treaties meaningless. This Note argues that the federal government's strategy is a productive lens through which to view an …

Prescriptions At A Price: America's Opioid Crisis And The Increasing Toll On Drug Record Privacy, Reem Blaik

Vanderbilt Journal of Entertainment & Technology Law

How should the US Constitution govern patient privacy in the face of a public health emergency? Declaring the United States' opioid crisis as a public health emergency may put the already-compromised integrity of drug record privacy at higher risk by virtue of emerging administrative responses, existing Supreme Court precedent, and acquiescent state laws. The White House convened a summit on opioids where the then-US attorney general discussed law enforcement responses to the crisis. Although the Fourth Amendment protects against unreasonable searches and seizures, the Supreme Court's third-party doctrine generally grants state and federal actors access to records released to third …

Risky Business? The Trump Administration And The State-Licensed Marijuana Industry, Robert A. Mikos

Vanderbilt Law School Faculty Publications

While it is clear that the new attorney general opposes state marijuana reforms, it is less clear what he will or even could do to block those reforms or to curb the industry that has flourished under them. The popularity of reforms, limits on federal resources, and legal doctrines like the anticommandeering rule all limit the DOJ’s ability to shut down the state-licensed marijuana industry. While Jeff Sessions may never embrace reforms, he may choose to pursue other tactics, like anti-marijuana media campaigns, to curb the use of marijuana and the harms caused thereby. Only time will tell, of course, …

Mystery Date: Advocating For A Harmonized System Of Expiration Date Labeling Of Food, Akshat Tiwari

Vanderbilt Journal of Transnational Law

Americans throw out roughly 25 percent of the food they bring home. Negative perceptions associated with expiration dates are a leading cause for this waste. However, a complex patchwork of state-run regulatory regimes and varying terminology makes it difficult for consumers to determine whether a food product is unsafe to eat or simply past a peak quality level arbitrarily set by manufacturers. Regulatory trends in Europe, the United Kingdom, Canada, Australia, and New Zealand suggest a move towards binding expiration date labeling through guidelines for establishing a "best before" or "use-by" date. This Note examines laws currently in place in …

Should All Drugs Be Patentable?: A Comparative Perspective, Cynthia M. Ho

Vanderbilt Journal of Entertainment & Technology Law

Although there has been substantial discussion of the proper scope of patentable subject matter in recent years, drugs have been overlooked. This Article begins to address that gap with a comparative perspective. In particular, this Article considers what is permissible under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as how India and Canada have utilized TRIPS flexibilities in different ways to properly reward developers of valuable new drugs, while also considering the social harm of higher prices beyond an initial patent term on drugs.

This Article brings valuable insight into this area at a critical …

Preemption Of State Law Claims Involving Medical Devices: Why Increasing Liability For Manufacturers Is A Perilous But Pivotal Proposition, Neil M. Issar

Vanderbilt Journal of Entertainment & Technology Law

A circuit split regarding the preemptive scope of the Medical Device Amendments of 1976 (MDA) has widened over the past several years. The split encompasses both the circumstances under which the MDA implicitly preempts state law claims and the scope of the MDA's express preemption provision. Manufacturers of medical devices regulated by the Food and Drug Administration (FDA) enjoyed many years of favorable rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction on monitoring or enforcement actions. However, the circuit split is reshaping the litigation landscape, and injured plaintiffs may rely on certain Circuit …

Marijuana Localism, Robert A. Mikos

Vanderbilt Law School Faculty Publications

The states have wrested control of marijuana policy from the federal government, but they risk losing some of their newfound power to another player: local governments. Hundreds of local communities are now seeking to establish their own marijuana policies, from legalization to prohibition and a variety of idiosyncratic regulatory schemes in between. These local efforts raise one of the most important and unresolved questions surrounding marijuana law and policy: What authority, if any, should states give local governments to regulate marijuana? This Article provides some guidance on this question. It starts by identifying two competing considerations that help determine whether …

The International War Against Doping: Limiting The Collateral Damage From Strict Liability, Thomas W. Cox

Vanderbilt Journal of Transnational Law

The World Anti-Doping Agency (WADA) and the World Anti-Doping Code are largely considered the model for an effective and well-coordinated antidoping regime. This model has allowed numerous sports and various countries to secure the same rules for domestic and international athletes. Within this regime, strict liability for prohibited substances stands as the "cornerstone." Strict liability has allowed antidoping officials to prosecute doping violations through an effective testing regime. However, this principle occasionally implicates innocent athletes with no intention of performance enhancement. This Note proposes that WADA modify its criteria for including substances on the Prohibited List and suspend strict liability …

Seeing Through The Murky Vial: Does The Fda Have The Authority To Stop Compounding Pharmacies From Pirate Manufacturing?, Michael Snow

Vanderbilt Law Review

In late 2012 and early 2013, tainted steroid shots from the New England Compounding Center ("NECC") caused fifty-five deaths and 745 cases of fungal meningitis in twenty states.' On October 1, 2012, the Food and Drug Administration ("FDA") inspected NECC and found vials of steroids filled with enough floating contamination to be visible to the human eye. These NECC steroid shots were distributed primarily to treat back pain, but the patients who received them were injected with foreign matter containing the deadly fungi Exserohilum rostratum or Aspergillus fumigatus. The earliest reported death from fungal meningitis caused by NECC was seventy-eight-year-old …

Preemption Under The Controlled Substances Act, Robert A. Mikos

Vanderbilt Law School Faculty Publications

States are conducting increasingly bold experiments with their marijuana laws, but questions linger over their authority to deviate from the federal Controlled Substances Act. The CSA bans marijuana outright, and commentators have assumed that Congress sought to preempt all state laws that might somehow conflict with the CSA. Under the preemption rule now in vogue, state marijuana reforms are preempted if they either require someone to violate the CSA or, more controversially, if they pose an obstacle to Congress’s objective of eradicating marijuana. Seeking to avoid such conflicts, government officials have scuttled a number of important state marijuana reforms. This …

Pay-To-Delay Settlements: The Circuit-Splitting Headache Plaguing Big Pharma, Shannon U. Han

Vanderbilt Journal of Entertainment & Technology Law

At its passage, the Hatch-Waxman Act was hailed as a much-needed step in making generic drugs more readily available to consumers, easing some of the heavy burdens placed on consumers by the necessary, but flawed, patent system that essentially granted brand-name pharmaceutical manufacturers a de facto economic monopoly over their drugs. One consequence of the Act, unforeseen by legislators and regulators, was the creation of a perverse incentive on behalf of pharmaceutical patent holders to pay alleged patent infringers substantial cash payments to delay entry into the particular drug market. These pay-to-delay settlements--or reverse-payment settlements--have been at the center of …

Reconsidering The U.S. Patent System: Lessons From Generics, Molly F.M. Chen

Vanderbilt Journal of Transnational Law

Scholars and pharmaceutical industry representatives consider the United States a worldwide leader in pharmaceutical innovation. However, the recent expansion of the international generics market has threatened the strength of the U.S. pharmaceutical industry. The pressure has led to the U.S. market's overreliance on a patentability standard that blocks generics competition without contributing substantially to the state of the art. This Note contrasts the U.S. nonobviousness standard and patent linkage regime with those of generics giants India and Israel and considers the effects of these policies on the relevant national and international generics industries. This Note proposes that the United States …

Wine Wars: How We Have Painted Ourselves Into A Regulatory Corner, Rachel M. Perkins

Vanderbilt Journal of Entertainment & Technology Law

A private citizen can violate the Constitution in two ways. The first is by enslaving another person, an atrocious act that should be proscribed by the highest law in the land. The second is by transporting alcohol across a state line in violation of the laws of that state. The two actions are hardly of the same magnitude.

The history of alcohol regulation has been a litany of failed attempts--on both the state and federal levels. Each new layer of legislation created additional problems. Most are familiar with the infamy of Prohibition, the federal ban on the manufacture or sale …

Allocating Liability For Deficient Warnings On Generic Drugs: A Prescription For Change, Sarah C. Duncan

Vanderbilt Journal of Entertainment & Technology Law

Brand-name pharmaceutical companies create pioneer drugs that cure diseases around the world. However, because research and development costs are very high, brand-name drugs are expensive. In response to escalating costs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act") to promote generic competition. As generics become more prominent in the pharmaceutical marketplace, individuals injured by generic drugs are suing the manufacturers with more frequency. The cases often turn on which company should bear the liability for failing to warn--the brand-name manufacturer or the generic drug maker. Although the injured person took the generic drug, …

Over The Counter But Under The Radar: Direct-To-Consumer Genetics Tests And Fda Regulation Of Medical Devices, Lauren B. Solberg

Vanderbilt Journal of Entertainment & Technology Law

Direct-to-consumer genetic tests are laboratory-developed tests that are marketed and sold directly to consumers. They typically do not require a prescription or any other involvement from a consumer's health care provider. Consumers order these tests online and return a specimen, usually a saliva sample, directly to the laboratory. The results are mailed directly to the consumer, and no health care provider or insurance company need ever learn the contents of these results. The FDA does not currently regulate direct-to-consumer genetic tests, though tests for hundreds of different diseases are readily available to the public.

The FDA's approach to regulating genetic …

On The Limits Of Supremacy: Medical Marijuana And The States' Overlooked Power To Legalize Federal Crime, Robert A. Mikos

Vanderbilt Law School Faculty Publications

Using the conflict over medical marijuana as a timely case study, this Article explores the overlooked and underappreciated power of states to legalize conduct Congress bans. Though Congress has banned marijuana outright, and though that ban has survived constitutional scrutiny, state laws legalizing medical use of marijuana constitute the de facto governing law in thirteen states. This Article argues that these state laws and (most) related regulations have not been, and, more interestingly, cannot be preempted by Congress, given constraints imposed on Congress's preemption power by the anti-commandeering rule, properly understood. Just as importantly, these state laws matter, in a …

Giving The Terminally Ill Their Due (Process): A Case For Expanded Access To Experimental Drugs Through The Political Process, Linda K. Leibfarth

Vanderbilt Law Review

The stated purpose of the Food and Drug Administration ("FDA" or "Agency") is "to promote and protect the public health." In furtherance of this end, the FDA has created a regulatory framework to ensure that drugs marketed to the general public are both safe and effective. However, critics insist that the FDA's paternalistic drug approval process does little to achieve its goal. At the onset of the AIDS epidemic in the 1980s, criticism of the FDA intensified, as the FDA's lengthy and expensive drug approval process hindered terminally ill AIDS patients' access to potentially lifesaving treatment. Advocates for these patients …

An Intellectual Property Food Fight: Why Copyright Law Should Embrace Culinary Innovation, J. Austin Broussard

Vanderbilt Journal of Entertainment & Technology Law

In the United States, dining has become an increasingly popular form of leisure and entertainment, generating an estimated $537 billion in 2007. However, dining represents only one aspect of the modern food economy; cooking and dining are regularly featured in newspapers and magazines, while celebrity chefs tout their own brands on television. Eating has been transformed from a mere perfunctory activity into big business. Increasing competition for the attention and money of restaurant patrons has prompted chefs of grande cuisine to differentiate their menus by creating unique dishes. The time and labor that chefs sink into this form of innovation …