Health Law and Policy Commons^™

Statins And Adverse Cardiovascular Events In Moderate-Risk Females: A Statistical And Legal Analysis With Implications For Fda Preemption Claims, Theodore Eisenberg, Martin T. Wells

Cornell Law Faculty Publications

This article presents: (1) meta-analyses of studies of cardioprotection of women and men by statins, including Lipitor (atorvastatin), and (2) a legal analysis of advertising promoting Lipitor as preventing heart attacks. The meta-analyses of primary prevention clinical trials show statistically significant benefits for men but not for women, and a statistically significant difference between men and women. The analyses do not support (1) statin use to reduce heart attacks in women based on extrapolation from men, or (2) approving or advertising statins as reducing heart attacks without qualification in a population that includes many women. The legal analysis raises the …

Beetles For Breakfast: What The Fda Should Be Telling You, Kaycee L. Wolf

Journal of Food Law & Policy

Imagine sitting down to breakfast and eating strawberry yogurt with a glass of grapefruit juice. You think you are eating a healthy meal, but along with vitamins, calcium, and nutrients, you are getting a side of crushed beetles. Cochineal extract and carmine, two color additives derived from the cochineal beetle, color many foods such as strawberry yogurt. When people consume products with color additives, most do not realize that they could be ingesting insects, which can also be potentially dangerous, not to mention possibly unappetizing or upsetting. Imagine that one minute you are sitting down to eat a healthy cup …

Uncapping The Bottle: A Look Inside The History, Industry, And Regulation Of Bottled Water In The United States, Joyce S. Ahn

Journal of Food Law & Policy

"Agu chupa! Agu chupa!" As we drove through the lush rolling hills of northwestern Rwanda, a crowd of young children appeared from the tea fields and repeatedly shouted these words to us. The taxi driver explained that the children wanted our "water bottes." Aware that visitors often drink bottled water, the children run alongside taxis with the hopes of obtaining the plastic bottles. Although Rwandan children typically carry their drinking water in tightly-woven baskets, the modern plastic bottles have become popular and prized possessions.

Restricting Access To Unapproved Drugs: A Compelling Government Interest , Peter M. Currie

Journal of Law and Health

The prospective review and approval of drugs is central to the public health mission of the United States Food and Drug Administration (FDA). Requiring pharmaceutical manufacturers to generate information about their products' safety and efficacy enables the agency to evaluate the risks and benefits associated with their use, thereby preventing overly harmful products from reaching the market. The majority of consumers benefit from this intervention by gaining access to an array of drugs that are proven to be safe and effective. Thus, governmental regulation in this area is arguably justified because the aggregate social welfare is substantially improved. However, this …

United States Food Law Update, Michael Tingey Roberts, Margie Alsbrook

Journal of Food Law & Policy

This update summarizes some of the significant changes and developments in food law over the first half of 2006. Not every change in food law is included; instead, this update provides a starting point for scholars, practitioners, food industry members, and policymakers determined to understand the shaping of food law in modern society. Tracing the development of food law through these updates, which appear in each issue of the Journal of Food Law & Policy, also provides historical context for the development of significant food law issues over time. New developments in state law, while certainly important and deserving in …

Creating Balance: Problems Within Dshea And Suggestions For Reform, Jennifer Akre Hill

Journal of Food Law & Policy

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed into law on October 25, 1994. At the signing, President Clinton endorsed the "intense efforts" of manufacturers and legislators to change the "treatment of dietary supplements under regulation and law." Further, the bill was signed with the hope that it would benefit consumers by permitting more access to dietary supplements and more choices for consumer directed healthcare. In support, politicians on both sides of the aisle claimed the DSHEA as a victory for consumer freedom, populist protection, and preventative medicine.

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …

Drug Regulations And The Constitution After Western States, Margaret Gilhooley

University of Richmond Law Review

No abstract provided.

The Use Of Placebos In Clinical Trials: Responsible Research Or Unethical Practice?, Sharona Hoffman

Faculty Publications

Developments in medical research have been occurring at a rapidly increasing rate during the past two decades. Expanding budgets, augmented computer capabilities, and new research tools have all dramatically enhanced research technology. Accompanying the proliferation of medical research are increasing concerns about research risks. This article focuses on placebo-controlled clinical trials. The use of placebos enables clinical investigators to compare results from subjects taking an experimental intervention to results from a group that is receiving an inactive substance, such as a sugar pill, in order to determine the efficacy of the new medication. In recent years, some surgeons have also …

Making Clinical Trials Safer For Human Subjects, Michael S. Baram

Faculty Scholarship

Clinical trials, in which new biotech and other medical products are tested on human subjects, provide much of the data used by the FDA to determine whether the products are suitable for routine use in health care. Thus, the trials are of obvious importance to medical progress and improvement of public health, and to those who have career and financial interests at stake. But clinical trials are also important to the human subjects involved because the products being tested on them may remedy their illnesses, but may also pose risks since the products have usually not been previously tested on …

Will A Lawsuit A Day Keep The Cyberdocs Away? Modern Theories Of Medical Malpractice As Applied To Cybermedicine, Ruth Ellen Smalley

Richmond Journal of Law & Technology

Rivaled only by lawyers, those who earn their livelihood by practicing medicine are viewed by many as America's Public Enemy No. 1. This perception is due to the rising cost of medicine, the over-scheduling of patients, and the poor bedside manner that many people associate with a trip to the doctor's office. However, the advent of the Internet and its proliferation into schools, offices, and homes has placed medical opinions only a mouse click away. Websites, such as cyberdocs.com, allow patients to type in a description of their ailments and receive diagnoses and treatment advice from an on-line medical professional …

Hormone Replacement Therapy, Or Just Eat More Meat: The Technological Hare Vs. The Regulatory Tortoise, Leticia M. Diaz

Faculty Scholarship

Is meat with its high fat content the real culprit, or is it the FDA-approved growth hormones, the same hormones that have been rejected in Europe, that should bear the blame? Why is eating less meat associated with a lower incidence of many types of cancer? Could it be chemical overload? American women are about five times more likely to develop breast cancer than are women in less developed countries.

Direct-To-Consumer Advertising Of Prescription Drugs: After A Decade Of Speculation, Courts Consider Another Exception To The Learned Intermediary Rule, Mae Joanne Rosok

Seattle University Law Review

This Comment will explore whether Washington courts should recognize direct-to-consumer advertising as an exception to the learned intermediary rule. With the ultimate goal of advocating the best protection for the consumer, the discussion will suggest that Washington courts should not create an exception. A review of other exceptions to the learned intermediary rule does not support abandoning the doctrine when a drug company advertises its product directly to consumers. Nevertheless, advertising does affect consumer purchases and does influence consumer choices, and drug companies should accept the responsibility to present balanced information. This responsibility should encompass more than meeting the minimum …

Is It Worth The Trouble? The New Policy On Dissemination Of Information On Off-Label Use Under The Food And Drug Administration Modernization Act Of 1997, Elizabeth Weeks Leonard

Scholarly Works

On January 14, 1998 the Food and Drug Administration (FDA) approved the use of a product previously marketed as Excedrin Extra Strength^® for use in treating migraine headaches. As part of the approval for the new use of the product, FDA required the pharmaceutical manufacturer of Excedrin^®, Bristol-Myers Squibb, to relabel and repackage the product. The new product is called “Excedrin Migraine^®” and is sold side-by-side with Excedrin Extra Strength^®. Both over-the-counter (OTC) products contain the same active ingredients: 250 milligrams of acetaminophen, 250 milligrams of aspirin, and sixty-five milligrams of caffeine. Many …

Blood As A Biological "Drug": Scientific, Legal, And Policy Issues In The Regulation Of Placental And Umbilical Cord Stem Cell Transplantation, Jennifer Kulynych

University of Richmond Law Review

Not all blood cells are created equal. Some are born, carry out their appointed tasks-red blood cells oxygenating the blood, white blood cells fighting infection-and die. But an elusive subset have special properties: they are the progenitors of all the many types of peripheral (circulatory) blood cells, and as such, they have the potential to reconstitute an entire blood supply. Known as hematopoietic stem cells, these blood cells reproduce indefinitely. For patients with leukemia or other blood diseases, the transplantation of hematopoietic stem cells from another person's bone marrow can provide the gift of life.

Protecting Soldiers From Friendly Fire: The Consent Requirement For Using Investigational Drugs And Vaccines In Combat, George J. Annas

Faculty Scholarship

In 1990, following Iraq's invasion of Kuwait, the Department of Defense (DOD) sought a waiver of the informed consent requirements of existing human experimentation regulations from the Food and Drug Administration (FDA). With this waiver, DOD could authorize military use of investigational drugs and vaccines on soldiers involved in the Gulf War without their informed consent. The basis of the waiver request was military expediency. In DOD's words: "In all peace time applications, we believe strongly in informed consent and ethical foundations... but military combat is different." DOD's rationale was that informed consent under combat conditions was "not feasible" because …

The Food And Drug Administration's Final Rule On Tobacco Advertising Is All Butt Final: Commercial Speech Doctrine Will Be Tested Once More Under A Stricter Central Hudson Analysis In The Aftermath Of 44 Liquormart, Inc. V. Rhode Island Comment., Joe R. Hinojosa

St. Mary's Law Journal

In 1996 the Food and Drug Administration (FDA) promulgated regulations affecting the advertising, sale, and promotion of tobacco. President Clinton supported the FDA’s claim it has the power to regulate tobacco products not as drugs, but as medical delivery devices of nicotine. Meaning tobacco sellers, retailer, distributors, and manufacturers would be subject to strict rules concerning how and where tobacco products may be advertised, distributed, and promoted. Despite the FDA’s claims, these measures were oriented toward discouraging children from smoking. Opponents of the regulations claim the restrictions constitute blatant infringement of commercial speech. The FDA argues that while advertising is …

Is Law The Prescription That Can Cure Medicine?, Samuel Gorovitz

Journal of Law and Health

Now medical care has been transformed. We recognize that the human organism is a complex interaction of many different systems-respiratory, circulatory, neurological, digestive, and so on. Some of them can fail and create both problems and opportunities we did not formerly have. One of the opportunities we now have is that we can keep people alive who in an earlier era would not have survived. And one of the problems we now have is also that we can keep people alive who in an earlier era would not have survived. Some of them are kept alive with such diminished capacity …

Nicotine Withdrawal: Assessing The Fda's Effort To Regulate Tobacco Products, Lars Noah, Barbara A. Noah

Faculty Scholarship

At a press conference held on August 23, 1996, just one year after initially revealing his plans, President Clinton announced sweeping federal regulations to combat the underage use of tobacco products. The Food and Drug Administration (FDA) subsequently published a lengthy preamble to accompany the final regulations, detailing the Agency's assessment of the problem and responding to numerous public comments to its notice of proposed rulemaking (NPRM). Characterizing the growing use of tobacco products as a "pediatric disease," FDA Commissioner David Kessler previously had vowed to alter the smoking habits of the newest generation of tobacco users in order to …

Prescription Drug Design Liability Under The Proposed Restatement (Third) Of Torts: A Reporter's Perspective, James A. Henderson Jr.

Cornell Law Faculty Publications

No abstract provided.

Rx: Just What The Doctor Ordered: International Standards For Medical Devices, Mindy H. Chapman

Northwestern Journal of International Law & Business

This Comment demonstrates why the FDA should amend its medical device regulations to emulate those of the European Community. There are two major benefits of a single set of international standards. First, a single set of international standards assures safe medical devices both in the United States and on the international market. Second, the United States will have a greater opportunity to export medical devices to the newly prosperous European Community resulting in greater financial returns and job opportunities for Americans.

New Fda Drug Approval Policies And Hiv Vaccine Development, Wendy K. Mariner

Faculty Scholarship

Conducted a study of Food and Drug Administration (FDA) law and policy including interviews with FDA officials in the Center of Biologics Evaluation and Research and the Office of the General Counsel. Suggests that the new FDA drug review policies do not fit vaccines. Instead, the nature of vaccines, and HIV vaccines in particular, argues for adherence to a more rigorous form of review. (JLN)

Informed Consent And The Investigational Use Of Medical Devices: A Comparison Of Common Law Duties With Those Imposed On Researchers Under Section 520(G) Of The Medical Device Amendments Of 1976, Thomas G. Field Jr., Dominic Piacenza

Law Faculty Scholarship

This paper will deal with with exemption granted [under the Medical Device Amendments Act of 1976] for the investigational use of devices subject to premarket testing, and more particularly, with the obligation of an investigator seeking such exemption to secure an informed consent agreement from human subjects (or their representatives) under § 520(g)(3)(D) of the Act. It will also consider the relationship between the statutory obligation and that which might be imposed by the common law of negligence.