Law Commons^™

The Patent Option, Daniel J. Gervais

Daniel J Gervais

There is a shift in the shape of intellectual property (IP) tools used to strengthen and lengthen the right of pharmaceutical companies to exclude others from making and marketing their products. Patents have traditionally been the tool of choice. Over the past two decades, however, pharmaceutical companies have increased their degree of reliance on a right known as “data exclusivity.” This right, which now exists in most major jurisdictions, is the right to prevent third parties from relying on the clinical trial data submitted by another pharmaceutical company to obtain marketing approval for a bioequivalent or biosimilar product. The right …

The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan

Srividhya Ragavan

This Article is set in the background of the consequences of the WTO’s prescriptions on patenting of life-saving medications which has largely contributed to the morphing of patents o n life-saving medication into a luxury. Remarkably, there has been a transformation of the role of patents in the context of pharmaceutical innovation into a strategic business tool leading to a larger interest in creation and sustenance of regulatory rights. The biggest global development in this area is an increased effort to strengthen exclusivity using regulatory protections for all chemicals, and even, biologics, involved in all stages of drug development. Consequently, …

How Does My Work Become Our Work? Dilution Of Authorship In Scientific Papers, And The Need For The Academy To Obey Copyright Law, Sean B. Seymore

Sean Seymore

Professors enjoy a world of extensive institutional autonomy and individual academic freedom. Universities and courts defer to a professor’s judgment for “genuinely academic decisions” unless they depart from academic norms. Universities, courts, and professional societies should intervene, however, when academic norms and custom do not comport with the law.

Reconciling The Lanham Act And The Fdca: A Comment On Chris Hurley’S Note, Christopher B. Seaman

Christopher B. Seaman

No abstract provided.

Direct-To-Consumer Genetic Testing: Learning From The Past And Looking Toward The Future, Stephanie Bair

Stephanie Bair

A decade after the complete sequencing of the human genome, we have seen a proliferation of genetic testing services marketed directly to the consumer and purporting to use genetic information to generate individualized health information. These tests have been subject to only minimal regulation, despite the fact that scientists and policymakers have serious concerns about both the clinical effectiveness of the tests and the safety of releasing certain types of health information to the public without the supervision of a health care professional. Proponents of minimal regulation argue that the tests allow for patient autonomy and privacy of genetic information, …

Science, Public Bioethics, And The Problem Of Integration, O. Carter Snead

O. Carter Snead

Public bioethics — the governance of science, medicine, and biotechnology in the name of ethical goods — is an emerging area of American law. The field uniquely combines scientific knowledge, moral reasoning, and prudential judgments about democratic decision making. It has captured the attention of officials in every branch of government, as well as the American public itself. Public questions (such as those relating to the law of abortion, the federal funding of embryonic stem cell research, and the regulation of end-of-life decision making) continue to roil the public square. This Article examines the question of how scientific methods and …

A Failure To Consider: Why Lawmakers Create Risk By Ignoring Trade Obligations, David R. Kocan Professor

David R. Kocan Professor

The U.S. Congress frequently passes laws facially unrelated to trade that significantly impact U.S. trade relations. These impacts are often harmful, significant, and long-lasting. Despite this fact, these bills rarely receive adequate consideration of how they will impact trade. Without this consideration, Congress cannot properly conduct a cost-benefit analysis necessary to pass effective laws. To remedy this problem, the U.S. Trade Representative should evaluate U.S. domestic law to determine whether it is consistent with international trade obligations. Moreover, the U.S. Congress committee structure should be amended so that laws that might impact trade are considered within that light. In the …

Effectuating Change In The Regulation Of Hiv Vaccines, Scott M. Engstrom

Scott M Engstrom

HIV has been at the forefront in politics, medicine, and law since its discovery in 1981. Over thirty years have passed since the virus began a wave of fear made worse by a sensationalist media. Though much of the uproar has dulled, the lasting effects on the American Psyche have remained as the AIDS death toll has risen. Although the medical community has made significant progress in managing the infection through complex drug cocktails, prevention remains the most effective tool in the fight against AIDS. However, the old aphorism “an ounce of prevention is worth a pound of cure” has …

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

Jonathan R. K. Stroud

No abstract provided.

The Death Of Jesse Gelsinger: New Evidence Of The Influence Of Money And Prestige In Human Research, Robin Fretwell Wilson

Robin Fretwell Wilson

Ten years ago, Jesse Gelsinger died while participating in a human gene therapy trial at the University of Pennsylvania (“Penn”). His death came to signify the corrosive influence of financial interests in human subjects research. After Jesse's death, the media reported that one researcher. Dr. James Wilson, held shares in a biotech company, Genovo, which stood to gain from the research's outcome — shares that The Wall Street Journal later valued at $13.5 million, although Wilson maintains he did not make nearly this much. At the time Penn authorized Wilson's deal, internal Penn documents implicitly valued Wilson's stake in Genovo …

Dead People Don’T Eat: Food Governmentenomics And Conflicts-Of-Interest In The Usda And Fda, Gabriela Steier

Gabriela Steier

Conflicts of interest permeate the governance of the federal advisory committees that issue recommendations to consumer protection agencies, such as the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA), and, therefore, American consumers need a federal solution to protect their health from biased recommendations. In order to promote a business-friendly food pyramid, agribusinesses and food industrialists lobby for dietary guidelines to adapt the dietary guidelines illustrated by the food pyramid to boos their sales. The resulting guidelines cause great damage to public health, environmental pollution, and loss of democratic freedoms. As a result, the FDA …

Honey, It’S All The Buzz: Regulating Neighborhood Beehives, Patricia E. Salkin

Patricia E. Salkin

Beekeeping’s popularity has surged in recent years, perhaps culminating in the introduction of the first ever White House bee hive. Local Apiaries provide a wide variety of benefits to communities, ranging from pollination services for gardens to producing honey that can be used in a wide array of foods and products. Apiaries are not always welcome in a community, however, perhaps because of their potential to cause a nuisance, or to harm crops or people. Although beekeeping regulation implicates both state and federal concerns a number of localities have developed unique and practical regulations that promote backyard beekeeping, while maximizing …

Commercial Freedom Of Speech Vs. Consumers' Right To Know: Milking The First Amendment For All It's Worth, Jessie Nibley

Jessie Nibley

The FDA's antagonism toward mandatory disclosure by food producers of information consumers want has left states to institute their own laws and policies to ensure consumers can make purchasing decisions based on all of the facts they deem important. However, these state laws face First Amendment challenges by food manufacturers who fear that consumers may shun their products if given too much information about certain foods and how they are produced. The First Amendment interests of consumers and food producers are thus at odds and must be balanced. This paper examines the approaches of two Circuits addressing state labeling regimes …

Room For Two In Tobacco Control: Limits On The Preemptive Scope Of The Proposed Legislation Granting Fda Oversight Of Tobacco, Christopher N. Banthin, Richard A. Daynard

Richard A. Daynard

This article examines the public health authority states have to reduce tobacco use in light of the Food and Drug Administration's oversight of tobacco. The authors point out that states have achieved dramatic reductions in tobacco use in the past with little assistance from federal authorities. Indeed, often federal statutes impeded state efforts. The authors examine the preemptive scope of FDA oversight and conclude that states retain and, in some cases, actually improve their legal options for reducing tobacco use under the FDA legislation.

Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin

Keren F. Bisnauth

The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In …

Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer

Parker Tresemer

Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …

Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin

Keren F. Bisnauth

The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In …

The Change In Knowledge Proposal: Repairing Preemption Doctrine In Medical Products Liability, Yite John Lu

Yite J Lu

This Article proposes a new rule that would allow the FDA to achieve the best balance of medical product availability and safety without interference from tort law when the agency has adequately reviewed the safety science. After an analysis of the FDA’s competency to review, and manufacturers’ ability to hide, safety concerns, this Article argues that FDA review is adequate during the initial approval process, but the agency cannot adequately respond to newly acquired safety information that arises post-market. To take advantage of this finding, the change in knowledge proposal would require tort plaintiffs to show a change in the …

Milking It: Reconsidering The Fda’S Refusal To Require Labeling Of Dairy Products Produced From Rbst Treated Cows In Light Of International Dairy Foods Association V. Boggs, Laurie J. Beyranevand

Laurie J Beyranevand

The Sixth Circuit Court of Appeals’ recent decision in International Dairy Foods Association v. Boggs, while ultimately resulting in regulation pertaining to milk labeling that is similar to regulations in other states, provides a useful framework for challenging the Food and Drug Administration (FDA)’s contention that it lacks the authority to mandate labeling of milk from cattle that have been treated with the hormone rBST. The court in Boggs found that a compositional difference exists between milk from cows treated with the hormone and those that were not, which could be considered a material fact mandating labeling under the Food, …

Food And Drug Law As Intellectual Property Law: Historical Reflections, Kara Swanson

Kara W. Swanson

No abstract provided.

“Supplementing” The Dshea: Congress Must Invest The Fda With Greater Regulatory Authority Over Nutraceutical Manufacturers By Amending The Dietary Supplement Health And Education Act. 98 Cal. L. Rev. 493., Rahi Azizi

Rahi Azizi

ABSTRACT This paper addresses serious deficiencies in the Dietary Supplement Health and Education Act, or "DSHEA." In it, I argue that the DSHEA (a federal statute passed by Congress in 1994, superseding the Food Drug and Cosmetics Act as the applicable law governing the sale of nutraceutical products) gives impermissible latitude to manufacturers of dietary supplements by allowing them to sell products without establishing whether they are safe or effective. The DSHEA also allows manufacturers to employ unsubstantiated and misleading labeling claims in marketing their products. I assert that the DSHEA promotes deceptive labeling practices. I also suggest that the …

Maintaining Incentives For Healthcare Innovation: A Response To The Ftc's Report On Follow-On Biologics, Christopher M. Holman

Christopher M Holman

Congress is considering legislation that would create an abbreviated FDA approval process for follow-on biologics (FOBs), which proponents anticipate will promote competition and lower prices in the market for biologic drugs. In June of 2009 the FTC published a report on FOBs (“the FTC Report”), which attempts to forecast the nature of competition between innovator biologics and FOBs, and offers a number of substantive recommendations regarding specific provisions of the various FOB bills. In particular, the FTC Report concludes that there is essentially no justification for the inclusion of a substantial data exclusivity period (“DEP”) for innovators in pending FOB …

These Statements Have Not Been Approved By The Fda: Improving The Post-Approval Regulation Of Prescription Drugs, Christopher R. Page

Christopher R. Page

The American public’s confidence in the FDA is waning in the midst of increased reporting of inefficiencies in the agency. The missteps by the FDA in the post-approval regulation of prescription drugs are magnified by the pervasive use of prescription drugs in the market. This article identifies these missteps. It also chronicles the response of the state attorneys general to this void in regulation, from the famous class action suit against the tobacco industry to the Oxycontin litigation to the recent Vioxx settlement.

This response to the public’s lack of confidence is accomplished through lawsuits against pharmaceutical companies under state …

Preserving Human Potential As Freedom: A Framework For Regulating Epigenetic Harms, Fazal Khan

Fazal Khan

Epigenetics is a rapidly evolving scientific field of inquiry examining how a wide range of environmental, social, and nutritional exposures can dramatically control how genes are expressed without changing the underlying DNA. Research has demonstrated that epigenetics plays a large role in human development, and disease causation. In a sense, epigenetics blurs the distinction between “nature” and “nurture” as experiences (nurture) become a part of intrinsic biology (nature). Remarkably, some epigenetic modifications are durable across generations, meaning that exposures from our grandparents’ generation might affect our health now, even if we have not experienced the same exposures. In the same …

Promoting, Prescribing, And Pushing Pills: Understanding The Lessons Of Antipsychotic Drug Litigation, Douglas Mossman, Jill Louise Steinberg

Douglas Mossman

Ineffectiveness of prescription drugs, hidden drug hazards, and advertising violations have led to several drug recalls and numerous lawsuits against pharmaceutical companies in recent years. These suits have involved several varieties of medications, but psychoactive medications have figured especially prominently. A recent $1.4 billion settlement by Eli Lilly & Company related to improper promotion of its top-selling drug olanzapine included the largest individual corporate criminal fine in U.S. history. Improper promotion is far from the sole reason why olanzapine and other “second-generation” antipsychotic (SGA) drugs have become so successful. Rather, the widespread adoption of SGAs represents a collective judgment error …

International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth

Gary E. Marchant

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether …

International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth

Gary E. Marchant

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether …

Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard

Vicki W Girard

This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and unchallenged, …

Pharmaceutical Lemons: Innovation And Regulation In The Drug Industry, Ariel Katz

Ariel Katz

Before a new drug can be marketed the Food and Drug Administration must be satisfied that it is safe and effective. According to conventional wisdom, the cost and delay involved in this process diminish the incentives to invest in the development of new drugs. Accordingly, several reforms aimed at restoring such incentives have been implemented and others have been advocated. This paper challenges the central argument in the debate on the topic, namely that drug regulation and drug innovation are necessarily at odds with each other. Although intuitively appealing, the argument that drug regulation negatively affects the incentives to innovate …

The Preemption Pentad: Federal Preemption Of Products Liability Claims After Medtronic [V. Lohr], Robert B. Leflar, Robert S. Adler

Robert B Leflar

Taking the language of the federal consumer protection statutes out of historical context and inattentive to those laws' original purposes, judges dissatisfied with the expansion of state products liability law have in recent years read preemption provisions of these federal statutes to bar a wide range of claims that would otherwise be viable under state law. In Medtronic v. Lohr, the Supreme Court (per Justice Stevens) severely constrained the scope of the federal preemption defense in the context of the federal medical device law. But the implications of the Medtronic decision for cases involving products in other regulatory categories remain …