Food and Drug Law Commons^™

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 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 …

Persistent Threats To Commercial Speech, Jonathan H. Adler

Faculty Publications

The current Supreme Court is very protective of speech, including commercial speech. Threats to commercial speech persist nonetheless. This article briefly examines two: the use of commercial speech restrictions as a form of rent-seeking, and compelled commercial speech. Regulation of commercial speech is sometimes used to protect established corporate interests from competitors who are less able to bear the costs of regulation, with consequences that extend beyond the economic marketplace. In the case of commercial speech, courts have also been unduly deferential to claims of a consumer “right to know” as a basis for mandated labeling and disclosure. Greater and …

Compelled Commercial Speech And The Consumer "Right To Know", Jonathan H. Adler

Faculty Publications

Compelled commercial speech, including mandatory labeling and the disclosure of factually true information, should not be seen as a separate category of speech under the First Amendment. Rather, compelled commercial speech should be understood as a type of commercial speech and be subject to the same level of protection as commercial speech generally. Accordingly, commercial speech compulsions, such as mandatory disclosures and labeling requirements, must be supported by a substantial government interest under the Central Hudson framework. The assertion of a consumer “right to know” does not constitute such an interest and cannot, by itself, justify compelled commercial speech within …

Baptists, Bootleggers & Electronic Cigarettes, Jonathan H. Adler, Roger E. Meiners, Andrew P. Morriss, Bruce Yandle

Faculty Publications

Electronic cigarettes pose a competitive threat to the makers of cigarettes and other tobacco products, as well as to nicotine replacement therapies such as nicotine gum and patches. A common response to such a threat is support for government regulation to suppress competition. Predictably, cigarette manufacturers and other threatened producers, as well as the governments that earn revenue from tobacco taxes, are supporting greater regulation of electronic cigarettes that would replicate the cartel-supporting rules of the Master Settlement Agreement. These efforts are aided by anti-smoking organizations that would like to prevent the growth of demand for electronic cigarettes. This episode …

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 …

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 …

Regulating The Underground: Secret Supper Clubs, Pop-Up Restaurants And The Role O F Law, Sarah B. Schindler

Faculty Publications

Instagram pictures of elegantly plated dinners, long farmstyle tables, and well-to-do people laughing in what looks like a loft apartment are followed by commenters asking, “Where is this?” This is the world of underground dining. Aspiring and established chefs invite strangers into their homes (or their friends’ stores after hours, or the empty warehouse at the edge of town, or the nearest farm) for a night of food and revelry in exchange for cash. Although decidedly antiestablishment, these secret suppers and pop-up restaurants are popular—there are websites to help people locate them, and many respected publications have penned stories about …

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 …

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Faculty Publications

The past several decades have seen the creation of transformative new technologies that are being used to design innovative consumer product ingredients never seen before in nature. Examples include the use of nanotechnology and genetic modification, and, right around the corner, cloning and lab grown meat. These innovative technologies are harbingers of more pioneering consumer product ingredients to come. The remarkable pace of the development of ground-breaking new technologies means that the population is being steadily exposed to novel ingredients with unknown health risks.

Optimally, the Food & Drug Administration ("FDA") should be regulating these innovative, novel ingredients in consumer …

Symposium On Commercial Speech And Public Health, Jonathan H. Adler

Faculty Publications

Does the constitutional protection of commercial speech impair the government's ability to protect and promote public health? Or does the commercial speech doctrine itself enhance consumer education and harness market competition to advance public health? Do First Amendment limitations on regulation of commercial messages unduly retard governmental efforts to safeguard consumers? Or do they properly constrain illiberal paternalism? If the Court has been over-protective of health-related commercial speech, is there a principled place to redraw the line? And how should those governmental agencies entrusted with the power to protect public health and welfare respond to these constitutional constraints?

The editors …

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 …

Dying To Know: A Demand For Genuine Public Access To Clinical Trial Results Data, Christine Galbraith Davik

Faculty Publications

Four years ago at the age of 34, I heard the awful words "I'm sorry, but you have breast cancer" coming from my doctor. After the initial shock of the diagnosis wore off, I like many others who have faced life-threatening diseases began to work with a team of physicians to develop an appropriate treatment plan, which included contemplating enrollment in a clinical trial. Quite unexpectedly, my position as an intellectual property professor whose scholarship focuses primarily on information control, my role as a member of my university's Institutional Review Board that oversees studies involving human subjects, and my newly …

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 …

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.

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 …

Regulating Genetically Modified Foods: Is Mandatory Labeling The Right Answer?, Jonathan H. Adler

Faculty Publications

What I want to talk about are some legal issues relating to labeling and, in particular, constitutional issues relating to mandatory labeling for genetically modified foods or food products that may contain genetically modified components. This is a separate issue from whether or not the FDA, or some other agency, has sufficient statutory authority at present to mandate labeling, and that is something worth discussing. Even if they do have such authority, or even if Congress tomorrow were to give the FDA such authority or were to require the FDA to impose labels on genetically modified foods, or if a …

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 …

Two Degrees Of Speech Protection: Free Speech Through The Prism Of Agricultural Disparagement Laws, Howard M. Wasserman

Faculty Publications

In the wake of a 1989 national television broadcast reporting the alleged cancer risk of a chemical applied to apples on trees, many states passed agricultural product disparagement (APD) statutes. These statutes grant civil causes of action to the growers and sellers of perishable food products, against anyone who speaks negatively or disparagingly, without basis in scientific evidence, about the product's safety. In this Article, Howard M Wasserman explores the interplay between the APD statutes and the First Amendment. First, Mr. Wasserman discusses the three categories of restrictions on the freedom of speech, focusing primarily on private civil tort actions …

Does The Fda Have Authority To Regulate Human Cloning?, Elizabeth Price Foley, Elizabeth C. Price

Faculty Publications

Examines the FDA's statutory authority to regulate human cloning.

Teaching The Elephant To Dance: Privatizing The Fda Review Process, Elizabeth Price Foley, Elizabeth C. Price

Faculty Publications

Considers the implications of privatizing the Food and Drug Administration's (FDA) review of the safety and efficacy of medical devices and drugs. Concludes that the FDA's flaws - namely, a risk avoidance culture and autocratic style of regulation - can only be accomplished by breaking the agency's monopolization of this review function.

The Renewed Concern Over Soil Erosion: The Current Federal Programs And Proposals, Linda A. Malone

Faculty Publications

Because soil erosion affects the quantity and quality of farmland, it is a matter of great concern for both the government and the farm industry. Whereas in the past concern was over the potential damage to productivity, concern is now being voiced over off-site damage and water pollution. There are numerous federal programs set up to fight soil erosion, but they are all voluntary, thereby making it difficult for the government to target funds. The author reviews the seriousness of the problem, looks at the numerous government programs, and then analyzes the Food Security Act of 1985—the first act to …

A Historical Essay On The Conservation Provisions Of The 1985 Farm Bill: Sodbustin, Swampbusting, And The Conservation Reserve, Linda A. Malone

Faculty Publications

No abstract provided.

Generic Competition And Pharmaceutical Innovation: The Drug Price Competition And Patent Term Restoration Act Of 1984, James J. Wheaton

Faculty Publications

This article critiques the Drug Price Competition and Patent Term Restoration Act of 1984. Part I traces the background of the two major sections of the Act by examining the recent trend toward generic competition in the pharmaceutical industry and the need perceived by some industry observers for additional incentives to pharmaceutical research. Part II of the article describes and discusses the sections of the Act designed to benefit the two segments of the pharmaceutical industry. Part III addresses the likely effect of the Act on generic competition, and Part IV provides a parallel analysis for the research-intensive pharmaceutical firms. …