Law Commons^™

Burning Questions: Changing Legal Narratives On Cannabis In Indian Country, Robin M. Rotman, Sam J. Carter

Faculty Publications

In the not-so-distant past, thoughts of Cannabis legalization in the United States were radical. In the present day, the narratives around Cannabis are changing. The term “present day” affixes this Article to early 2023, a snapshot in time. To understand the current legal narratives surrounding Cannabis, and what they might become in the future, it is important to examine the history of Cannabis law and policy in United States. This Article begins by discussing Cannabis regulation in the United States, from the rise of federal regulation to the gradual deregulation by states with tacit federal consent. The Article then examines …

Solutions Still Searching For A Problem: A Call For Relevant Data To Support "Evergreening" Allegations, Erika Lietzan, Kristina M. L. Acri

Faculty Publications

For years pharmaceutical policymaking discussions have been revolving around allegations of supposed “evergreening” by pharmaceutical companies, and policymakers have considered a range of significant policy reforms — including to antitrust law and drug regulatory law — to address this purported problem. This paper evaluates empirical data offered to substantiate “evergreening” and explains that these data — though mostly accurate — do not support proposed policy changes.

The “evergreening” claim is that by securing additional patents and FDA-related exclusivities after approval of their new drugs, brand drug companies enjoy a period of exclusivity in the market that is longer than the …

Ignoring Drug Trademarks, Erika Lietzan

Faculty Publications

If you walk into a pharmacy with a prescription for Merck’s ZOCOR, which contains simvastatin, the pharmacist will probably give you a product containing simvastatin made by another company. The pharmacist will dispense a “generic” simvastatin product. State generic substitution laws, passed in the 1970s to help the government save money by switching patients to cheaper generic drugs, either permit or require this substitution. But drug brand names -- such as ZOCOR -- are trademarks. Like other trademarks, they distinguish goods in the market from others, and they signal the source of the goods. These state laws essentially treat the …

Distorted Drug Patents, Erika Lietzan

Faculty Publications

Drug patents are distorted. Unlike most other inventors, drug inventors must complete years of testing to the government’s specifications and seek government approval to commercialize their inventions. All the while, the patent term runs. When a drug inventor finally launches a medicine that embodies the invention, only a fraction of the patent life remains. And yet, conventional wisdom holds — and empirical studies show — that patent life is essential to innovation in the pharmaceutical industry, perhaps more so than any other inventive industry. Congress tried to do something about this in 1984, authorizing the Patent and Trademark Office to …

Access Before Evidence And The Price Of The Fda's New Drug Authorities, Erika Lietzan

Faculty Publications

Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by the FDA or proven safe and effective to the FDA's standards. (Sometimes this happens because the FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the United States "gold standard" for new drug approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. …

The Surprising Reach Of Fda Regulation Of Cannabis, Even After Descheduling, Erika Lietzan, Sean M. O'Connor

Faculty Publications

As more states legalize cannabis, the push to "deschedule" it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis - cannabidiol (CBD) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA's focus on precise analytical characterization and on individual active and inactive ingredients may be …

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

Paper Promises For Drug Innovation, Erika Lietzan

Faculty Publications

Innovation does not stop when a new medicine is launched. Development of new uses for already approved drugs, in particular, can make profound contributions to the public health. Whether a new use is suspected during the initial premarket trials, identified through focused research after approval, or discovered serendipitously by physicians treating patients, however, it requires extensive clinical testing before it can be approved by FDA. This testing takes time and money — three to five years on average, and as much as $300 million. This Article considers the incentives that federal law offers to companies to make this investment: patent …

A Solution In Search Of A Problem At The Biologics Frontier, Erika Lietzan

Faculty Publications

This short paper comments on Professor Carrier's new article, Biologics: The New Antitrust Frontier. His article makes a profound initial contribution to a new area of scholarship, based on a large body of prior work considering antitrust issues relating to small molecule drugs. But Professor Carrier’s article, like my own forthcoming piece on innovation and competition in the biologics marketplace, is inherently speculative. We are making our best judgments about the nature of a still emerging marketplace and likely conduct in that marketplace, based on our understandings of a new regulatory framework that is itself still emerging, the broader legal …

The History And Political Economy Of The Hatch-Waxman Amendments, Erika Lietzan

Faculty Publications

Reform of the Hatch–Waxman generic drug framework is in the air. Scholars, consumer advocacy groups, regulated industry, and policymakers are engaged in heated debate about perceived shortcomings in the scheme, flaws, and unexpected loopholes. Changes in how the U.S. Food and Drug Administration (FDA) implements the law, as well as changes to the law itself, are under serious consideration. These policymaking discussions take place against a backdrop of shared assumptions about the origins and nature of the original Hatch–Waxman legislation — assumptions that this Article claims are wrong. Convention wisdom holds that the Hatch–Waxman legislation was a delicate compromise privately …

Assessing The Relative Influence And Efficacy Of Public And Private Food Safety Regulation Regimes: Comparing Codex And Global Gap Standards, Sam F. Halabi, Ching-Fu Lin

Faculty Publications

An extensive global system of private food regulation is under construction, one that exceeds conventional regulation, thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been the primary designers of this new food regulatory regime. These groups have established alliances that compete with national regulators in complex ways. This article analyzes the relationship between public and private sources of food safety regulation by examining standards adopted by the Codex Alimentarius Commission, a food safety organization …

The Uncharted Waters Of Competition And Innovation In Biological Medicines, Erika Lietzan

Faculty Publications

In 2010, Congress fundamentally changed how federal law encourages the discovery and development of certain new medicines and for the first time authorized less expensive “duplicates” of these medicines to be approved and compete in the marketplace. The medicines at issue are biological medicines, generally made from, or grown in, living systems. Many of the world’s most important and most expensive medicines for serious and life–threatening diseases are biological medicines.

We have a profound interest in understanding and evaluating the impact of this legislation on innovation and competition. Scholars and courts considering this question may be tempted to reason from, …

The Law Of 180-Day Exclusivity, Erika Lietzan, Julia Post

Faculty Publications

In 1984, Congress created a statutory pathway for approval of generic drug applications and included an incentive for generic applicants to challenge the patents claiming the reference drugs on which they based their applications. The first generic applicant to file an ANDA with a patent challenge is eligible for 180 days of generic market exclusivity. This article is the fourth in a series of articles describing the resulting body of law, as interpreted and applied by FDA (in regulations, guidances, citizen petition responses, and individual decisions awarding and denying exclusivity) and the courts. The heart of the article is section …

Gras-Fed Americans: Sick Of Lax Regulation Of Food Additives, Martha Dragich

Faculty Publications

Americans are “GRAS-fed” because of a “loophole” in the strict regime Congress provided for the regulation of food additives. Additives - and food products containing them - are exempt from this strict regime if they are accorded GRAS (Generally Recognized as Safe) status. The guidelines Congress provided for achieving that status by scientific evidence of safety are no longer observed. Most additives are determined by the producer alone to be GRAS. At the same time, Americans’ consumption of highly processed foods continues to rise, giving rise to long-term health problems that are increasingly tied to diet. The average American’s diet …

The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi

Faculty Publications

The 2009 Family Smoking Prevention and Tobacco Control Act endeavored to alter the regulatory regime for tobacco products in the United States by allocating authority to regulate tobacco products to the U.S. Food and Drug Administration (FDA). While the law aims at greater transparency in the constituent components of cigarettes and non-combustible tobacco products, it also includes a provision which will bring FDA’s consumer protection and tobacco control mandates into tension: Section 911’s process for the approval of modified risk tobacco products. That provision allows tobacco manufacturers to submit applications to label products as “reduc[ing] the harm or the risk …

The Codex Alimentarius Commission, Corporate Influence, And International Trade: A Perspective On Fda's Global Role, Sam F. Halabi

Faculty Publications

Section 305 of the FDA Food Safety Modernization Act specifically calls for FDA to develop recommendations on whether and how to harmonize requirements under the Codex Alimentarius Commission (“Codex”), an international organization charged with developing food standards, guidelines, codes of practice and “other recommendations to ensure fair practices in food trade and protect[ion of] the health of consumers.” FDA’s International Food Safety Capacity-Building Plan is largely supportive and deferential to Codex, concluding that “the use of Codex standards helps assure a safe global food supply.” To be sure, Codex’s stated mission and policies should create and facilitate adoption of universal …

Legal Preparedness And Ebola Vaccines, Sam F. Halabi, John T. Monahan

Faculty Publications

On Dec 9, 2014, US Secretary of Health and Human Services Sylvia Burwell issued a declaration under the US Public Readiness and Emergency Preparedness Act to provide immunity from legal claims in the USA related to manufacturing, testing, development, distribution, and administration of three candidate Ebola vaccines except in instances of willful misconduct. Although progress in combating Ebola in west Africa has shifted public attention away from vaccine development and deployment, we should not forget that the management of legal liabilities related to vaccines has been an important subject of discussion between national governments, international organizations, vaccine manufacturers, and other …

Sharing The Burden Of Ebola Vaccine Related Adverse Events, Sam F. Halabi, John Monahan

Faculty Publications

Based upon past experience with other vaccines, the proposed administration of Ebola vaccines (once testing has been completed) will inevitably result in at least some adverse events that will give rise to legal liabilities of only crudely estimable magnitude at this time. Manufacturers, beneficiary governments (e.g., Guinea, Liberia, Sierra Leone), supporting governments (e.g. U.S., U.K.), individuals suffering adverse events, and populations benefiting from widespread vaccination against the Ebola virus all have a shared interest in recognizing, understanding, and managing potential liability as effectively as possible within the framework of a global public health response. There are multiple options available to …

Pharmacy Compounding After The Drug Quality And Security Act, Erika Lietzan

Faculty Publications

On November 27, 2013, President Obama signed into law the Drug Quality and Security Act ("DQSA"), which amends the Federal Food, Drug, and Cosmetic Act ("FDCA") to add statutory provisions addressing drug compounding and supply chain issues. This article discusses Title I of this legislation, known as the Compounding Quality Act, and draft compounding guidances subsequently issued by the Food and Drug Administration ("FDA"). Section I provides a brief history of FDA's regulation of compounding activities before the Compounding Quality Act's enactment. Section II reviews the Compounding Quality Act and FDA's new draft guidances. Section III considers some of the …

A New Framework For Assessing Clinical Data Transparency Initiatives, Erika Lietzan

Faculty Publications

Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of their medicines, expecting the information to be kept confidential, as has been the practice of regulators around the world for decades. Over the last ten years, however, pressure has been mounting for regulators or industry to release this information. Legal scholars have generally taken the view that no relevant doctrines or bodies of law preclude the release of this material and that public policy considerations compel its release. This article argues that the scholarship to date has overlooked key considerations: the special issues presented by operation …

Do You Know What's On Your Plate?: The Importance Of Regulating The Processes Of Food Production, Martha Dragich

Faculty Publications

This article argues that the current regulatory approach-focusing on the supposed equivalence of new foods to traditional ones-is unduly narrow, particularly given the characteristics of the modem food system. To achieve the broad objectives of the FDCA in the context of the industrialized, highly processed, and global food supply of the twenty-first century requires adopting a broader understanding of consumer protection needs with respect to food. The FDCA itself is written in very broad terms and provides much of the authority needed today. The FDA's enforcement capacity, however, already is severely strained.52 Moreover, the scientific basis for some process- oriented …

Thoughts On Preemption In The Wake Of The Levine Decision, Erika Lietzan, Sarah E. Pitlyk

Faculty Publications

This article discusses the prospects for preemption doctrine in the wake of the Supreme Court’s decision in Wyeth v. Levine. Part I describes the Levine decision. Part II examines the majority’s holding as it relates to impossibility preemption and considers the future of the doctrine in failure-to-warn suits after Levine. We argue that the announced standard for impossibility preemption — the clear evidence standard — should be interpreted reasonably and not in a manner that effectively eviscerates the doctrine. We also describe other instances of impossibility in the food and drug regulatory context that were not presented to the Court. …

Unofficial Legislative History Of The Biologics Price Competition And Innovation Act 2009, An, Erika Lietzan, Krista Hessler Carver, Jeffrey Elikan

Faculty Publications

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act of 2009 (BPCIA) which created a regulatory pathway for, and scheme for litigation of patent issues relating to, “biosimilar” biological products. This article discusses the history of the BPCIA and explains its provisions. Section I provides background and a history of the regulation of drugs and biological products in the United States. Section II describes the growing interest in biosimilar approval from the early 2000s through September 2006, when the legislative debate began in earnest. Section III describes the legislative and stakeholder process from …

A New History And Discussion Of 180-Day Exclusivity, Erika Lietzan, David E. Korn, Shaw W. Scott

Faculty Publications

This is the third in a series of articles on 180-day exclusivity. The first article traced the history of 180-day exclusivity from 1984 through its amendment in 2003 and court cases in 2004. A second article, published by two of the authors in 2007, updated the earlier piece through the end of 2006 but was arranged by issue rather than in a chronology. This article, which includes a third author, provides a comprehensive resource on 180-day exclusivity for old abbreviated new drug applications (ANDAs) (but less detail in some places where the 2007 article may be referenced) and focuses more …

Issues In The Interpretation Of 180-Day Exclusivity, Erika Lietzan, David E. Korn

Faculty Publications

Congress created 180-day exclusivity for generic drug applicants in the 1984 Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) and amended it substantially in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The core concept of this exclusivity as it has been applied by FDA and the courts is that the first generic drug applicant to challenge an innovator's patent is entitled to six months of exclusivity against subsequent patent challengers for the same innovator drug. The 180-day exclusivity provision is governed by sections 505(j)(5)(B)(iv) and 505(j)(5)(D) of the FDCA, and it is intended …

A Brief History Of 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan

Faculty Publications

This article summarizes the history of the 180-day exclusivity provision in the Hatch- Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA). Part II presents the statutory language, as amended in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), and summarizes the law that applies to new abbreviated new drug applications (ANDAs) (those filed after December 8, 2003, provided there was no paragraph IV certification to the listed drug prior to December 8), as well as the law that applies to all other ("old") ANDAs. Part III describes the legislative history of the original 1984 …

2004 Update - 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan

Faculty Publications

This article updates the author's previously published article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work.

The Authority Of A Court To Order Disgorgement For Violations Of The Current Good Manufacturing Practices Requirement Of The Federal Food, Drug, And Cosmetic Act, Erika Lietzan, Elizabeth M. Walsh

Faculty Publications

This article addresses the question as to whether a federal court has the authority to compel a pharmaceutical company to disgorge profits obtained from an alleged violation of the FDCA, specifically the failure of a pharmaceutical company to comply with current good manufacturing practices (GMPs). Section II of this article summarizes the article to which we are responding. In all fairness, it did not purport to be a full-blown defense, and we expect the agency's comprehensive defense of disgorgement would be considerably more detailed. Section III turns to the Sixth Circuit case on which FDA rests its argument for disgorgement, …

An Overview Of Canadian Privacy Law For Pharmaceutical And Device Manufacturers Operating In Canada, Erika Lietzan, John K. Fuson

Faculty Publications

On April 13, 2000, the Canadian Parliament enacted by Royal Assent the Personal Information Protection and Electronic Documents Act (PIPEDA). The Act requires private organizations to comply with a code of “fair information practice,” which mandates individual consent for the collection, use, and disclosure of personal information. PIPEDA complements the Federal Privacy Act, which places similar obligations on government institutions. On January 1, 2002, the Act began to apply to personal information (including personal health information) collected, used, or disclosed by a federal work, undertaking, or business, and personal information (including personal health information) disclosed by any organization for consideration …