Law Commons^™

Protecting Research Data Of Publicly Revealing Participants, Ellen Clayton, B. A. Malin, Kyle J. Mckibbin

Vanderbilt Law School Faculty Publications

Biomedical researchers collect large amounts of personal data about individuals, which are frequently shared with repositories and an array of users. Typically, research data holders implement measures to protect participants’ identities and unique attributes from unauthorized disclosure. These measures, however, can be less effective if people disclose their participation in a research study, which they may do for many reasons. Even so, the people who provide these data for research often understandably expect that their privacy will be protected. We discuss the particular challenges posed by self-disclosure and identify various steps that researchers should take to protect data in these …

Minding The Gaps In Regulation Of Do-It-Yourself Biotechnology, Barbara J. Evans

UF Law Faculty Publications

This Symposium confronts the reality that genetic technologies – not just genetic tests, but tools for altering plant, animal, and human genomes – are rapidly becoming and indeed already are consumer technologies. People can experiment with and apply these technologies in disintermediated formats, potentially without the involvement of national research funding agencies, professional scientists, physicians, genetic counselors, regulators, and traditional medical product manufacturers. The framework of 20th -century medical product and practice regulations assigned each of these parties a role in promoting ethical, safe, and effective biomedical research and health care. Do-it-yourself biotechnology (DIYbio), which includes direct-to-consumer (DTC) and do-it-yourself …

Fda’S Efforts To Tame The 'Wild West' Of Regenerative Medicine, Christopher M. Holman

Faculty Works

Stem cell-based regenerative therapies hold the potential to address a host of health concerns, particularly congenital, age-related, and trauma-induced injuries, and diseases involving organ and tissue degeneration, conditions that have proven refractory to conventional drug-based approaches. For the time being, however, there is little in the way of solid evidence supporting the safety and efficacy of most cell-based therapeutic approaches (with the notable exception of hematopoietic stem cells used to treat diseases of the blood and immune system). This Holman Report begins with an overview of the current uncertain regulatory status of regenerative medicine in the U.S., including several draft …

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. …

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Can Speech By Fda-Regulated Firms Ever Be Noncommercial?, Nathan Cortez

Faculty Journal Articles and Book Chapters

This Article considers whether speech by pharmaceutical, medical device, and other FDA-regulated companies can ever be noncommercial and thus subject to heightened protection under the First Amendment. Since the U.S. Supreme Court first recognized a right to commercial speech in 1976, there have been 24 published federal judicial opinions in which an FDA-regulated firm has argued that its speech was protected. Courts have categorized the speech as commercial in all but two cases, neither of which involved FDA rules or enforcement.

I examine the tests and factors courts claim they use when making this threshold distinction, then identify the various …

Can Law Improve Prevention And Treatment Of Cancer?, Roger Magnusson, Lawrence O. Gostin, David Studdert

O'Neill Institute Papers

The December 2011 issue of Public Health (the Journal of the Royal Society for Public Health) contains a symposium entitled: Legislate, Regulate, Litigate? Legal approaches to the prevention and treatment of cancer. This symposium explores the possibilities for using law and regulation – both internationally and at the national level – as the policy instrument for preventing and improving the treatment of cancer and other leading non-communicable diseases (NCDs). In this editorial, we argue that there is an urgent need for more legal scholarship on cancer and other leading NCDs, as well as greater dialogue between lawyers, public health practitioners …

The Money Blind: How To Stop Industry Bias In Biomedical Science, Without Violating The First Amendment, Christopher Robertson

Faculty Scholarship

The pharmaceutical and medical device industries use billions of dollars to support the biomedical science that physicians, regulators, and patients use to make healthcare decisions—the decisions that drive an increasingly large portion of the American economy. Compelling evidence suggests that this industry money buys favorable results, biasing the outcomes of scientific research. Current efforts to manage the problem, including disclosure mandates and peer reviews, are ineffective. A blinding mechanism, operating through an intermediary such as the National Institutes of Health, could instead be developed to allow industry support of science without allowing undue influence. If the editors of biomedical journals …

Drugged, Carl E. Schneider

Articles

The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …

Dimensions Of Equality In Regulating Assisted Reproductive Technologies, Mary Crossley

Articles

Although concerns about individual liberty and the nature and extent of reproductive freedom have tended to dominate discussions regarding the proliferation of and access to reproductive technologies, questions about the implications of assisted reproductive technologies (ARTs) for equality have also arisen. Despite the high number of invocations of equality in the literature regarding ARTs, to date little effort has been made to comprehensively examine the implications of ARTs for equality. This short Article seeks to highlight the variety of equality issues that ARTs present and to develop a framework for classifying different types of equality issues. Specifically, I suggest that …

Internet Pharmacies: Why State Regulatory Solutions Are Not Enough, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

Internet pharmacies are an economic and communications miracle--and a regulatory nightmare. It is estimated that Americans spent some $3.2 billion in 2003 on medications from the Internet, but Internet pharmacies permit consumers to evade long-standing regulatory protections, particularly those that rely on the oversight of drug prescribing and dispensing by licensed physicians and pharmacists.

Bioethics With A Human Face, Carl E. Schneider

Articles

This Article and the successor article I will shortly publish grow out of one reaction I have had to years of reading bioethical and legal literature. Let me begin by putting the point in its simplest, even crudest, form: That literature too often discusses the problems of health care in so disembodied and denatured a way that the patients and physicians, the family and friends, the dread and the disease are quite abstracted from the scene. The result is a literature that critically limits itself and that crucially oversimplifies the issues it confronts. There are, of course, reasons bioethical and …

Characteristics And Constitutionality Of Medical Legislation, Harry B. Hutchins

Articles

Right to practice medicine regulated by statute.--In the absence of a statute upon the subject, any person is at liberty to practice medicine or surgery or both. This is the common law. And yet in the absence of a statute the physician necessarily assumes certain responsibilities that grow out of his relation to those whom he treats. He is bound to bring to the discharge of his duties the learning, skill and diligence usually possessed and exercised by physicians similarly situated. In other words, while in the absence of statutory regulation, the door of the profession is open to all, …