Volume 55 Issue 4
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Table of Contents
> The
WLF Case Thus Far: Not With a Bang, But a Whimper
> Evolving
Constitutional Privacy Doctrines Affecting Healthcare Enterprises
> The
WTO Agreement on Sanitary and Phytosanitary Measures: Weakening
Food Safety Regulations to Facilitate Trade?
> A
Tale of Six Implants: The Perez v. Wyeth Laboratories Norplant Case
and the Applicability of the Learned Intermediary Doctrine to Direct-to-Consumer
Drug Promotion
> Biotechnology
on the RAC—FDA/NIH Regulation of Human Gene Therapy
> Smoke
Screen: America's Drug Policy and Medical Marijuana
> Policing
the "Wild West" World of Internet Pharmacies
> One
Decade of Food and Drug Law Scholarship: A Selected Bibliography
The
WLF Case Thus Far: Not With a Bang, But a Whimper
Author:
Richard M. Cooper
Issue: 55 Food and Drug Law Journal 477-490 (2000)
The Washington
Legal Foundation case challenged the Food and Drug Administration's
policies and practices regarding manufacturer dissemination or support
of communications about off-label uses of drugs and devices. The D.C.
Circuit Court's decision has created much confusion about the state
of the applicable law. This article explains the current situation,
while also giving background on the events that led to it and how manufacturers
may act in light of the decision.
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Evolving Constitutional Privacy Doctrines Affecting Healthcare Enterprises
Author:
Andrew S. Krulwich & Bruce L. McDonald
Issue: 55 Food
and Drug Law Journal 491-516 (2000)
The present time is a key period in the formulation of privacy rules, when numerous advocates are calling for expanded regulatory privacy protections and numerous legislators and administrators are responding sympathetically. At the same time, the constitutional framework guiding this process is both unclear and subject to imminent clarification by the Supreme Court.
This article analyzes
the judicial record indicating that the Fourteenth Amendment right of
privacy developed by the Supreme Court in the 1970s has not yet grown
to encompass patient-related information, despite its potential to impact
this area. It then analyzes two cases where potentially important Supreme
Court decisions are expected. One case involves the potential to remove
Fourth Amendment privacy protections from the public hospital environment.
The other addresses the tension between privacy statutes, or regulations,
and the First Amendment. Depending on their resolution, these cases
could strengthen the constitutional support for the proposition drawn
from earlier cases that a privacy rule is vulnerable to attack if the
privacy right involved is not carefully defined and fully substantiated
in the record, either legislative or regulatory, both as to the importance
of the privacy interest protected and the efficacy of the rule in achieving
that objective.
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The WTO Agreement on Sanitary and Phytosanitary Measures:
Weakening Food Safety Regulations to Facilitate Trade?
Author: Bruce A. Silverglade
Issue: 55 Food and Drug Law Journal 517-524 (2000)
The World Trade Organization (WTO) Agreement on Sanitary and Phytosanitary Measures (SPS) is interfering with efforts to maintain existing, and develop new, regulatory requirements that ensure the safety of the food supply. The SPS leads to downward harmonization of domestic regulatory standards to the level of weak international norms because it allows governments to challenge food safety and related consumer protection requirements in order to facilitate trade; fails to provide incentives for governments to comply with standards that provide high levels of protection to consumers; relies inappropriately on the recommendations and guidelines of the Codex Alimentarius Commission; fails to adequately address the needs of developing countries that cannot comply with world-class requirements; and sets vague rules for equivalency agreements whereby nations exempt imports from compliance with domestic standards. The U.S. government should support reform of the SPS Agreement during the ongoing WTO negotiations on agriculture. In addition, supporters of free trade should back efforts by the World Health Organization to take a greater role in regulating the international food trade in order to build consumer confidence in the safety of imported foods.
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A Tale of Six Implants: The Perez v. Wyeth Laboratories Norplant Case and the Applicability
of the Learned Intermediary Doctrine to Direct-to-Consumer Drug Promotion
Author: Mitchell S. Berger
Issue: 55 Food and Drug Law Journal 525-574 (2000)
According to the learned intermediary rule, pharmaceutical companies can protect themselves from legal liability by warning the patient's physician about a prescription drug's side effects or contraindications. With the advent of direct-to-consumer advertising, however, the traditional rationales for the learned intermediary rule have been called into question. During 1999, the New Jersey Supreme Court found, in Perez v. Wyeth Laboratories, that the company was obligated to directly warn the patient of the side effects of Norplant, a subcutaneous hormonal contraceptive that was directly advertised to patients as well as to doctors. This decision, which may alter the legal landscape with respect to direct-to-consumer advertising, is reviewed in detail in this article. The article also reviews Norplant's medical and historical background and discusses the development of the learned intermediary doctrine and direct-to-consumer advertising.
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Biotechnology on the RAC—FDA/NIH Regulation of Human Gene Therapy
Author: Joseph M. Rainsbury
Issue: 55 Food and Drug Law Journal 575-600 (2000)
Gene therapy, a procedure in which healthy genes are spliced into the cells of sick patients, constitutes the cutting edge of medical research. It already has pushed the limits of regulatory science, and if successful, it will represent a revolution in medicine. Gene therapy research on human beings is overseen both by the Food and Drug Administration and by a special consultative group known as the Recombinant DNA Advisory Committee. As a recent tragedy involving a patient-volunteer at the University of Pennsylvania illustrates, striking the right balance between the protection of humans and the promotion of promising research has proven to be a challenging task. This article provides a historical narrative of the genesis of administrative structures to regulate gene therapy. It also examines whether the history of the introduction of gene therapy can provide a regulatory success story, albeit one whose example may not be sufficiently robust to shepherd more socially divisive medical innovations from the laboratory to the clinic.
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Smoke Screen: America's Drug Policy and Medical Marijuana
Author: J. Ryan Conboy
Issue: 55 Food and Drug Law Journal 601-618 (2000)
As a result of its passage of Proposition 215, which very publicly allows for the medical use of marijuana, California placed itself in direct confrontation with the federal government's 1970 Controlled Substances Act. Used for over a century to treat the symptoms of numerous maladies, including wasting associated with AIDS and nausea induced by chemotherapy, the federal government, apparently for political reasons, refuses to publicly acknowledge the scientifically supported benefits of marijuana, although it and a number of states quietly provide for small therapeutic programs using the drug. Recognizing the medicinal value of narcotics, such as opium and cocaine, and expounding the benefits of saving uncharted rainforests to protect plants that may prove medically valuable, the US government appears to still be at war with a drug popularized by the 1960s counterculture, leaving many legitimately suffering citizens to choose between pain and jail.
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Policing the "Wild West" World of Internet Pharmacies
Author: Kerry Toth Rost
Issue: 55 Food and Drug Law Journal 619-640 (2000)
Internet pharmacies sell medication through their websites. Some of these pharmacies are simply the cyberspace version of traditional brick-and-mortar pharmacies. Other pharmacies exist only in the cyber-world, and prescriptions are filled and shipped from a warehouse. Legitimate, law-abiding Internet pharmacies benefit modern healthcare in numerous ways. Some Internet pharmacies, however, conduct illegal and unsafe prescribing and dispensing that can endanger the health of patients. Controversy exists over which regulatory body should govern the sale of prescription drugs over the Internet and how Internet pharmacies should be regulated. This article contends that cooperation between state and federal regulatory avenues can promote the safety of Internet pharmacies adequately. Furthermore, this article argues that dangers posed by foreign Internet pharmacies will grow until international regulatory cooperation is established.
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One Decade of Food and Drug Law Scholarship: A Selected Bibliography
Author: Lars Noah
Issue: 55 Food and Drug Law Journal 641-658 (2000)
This article presents a selected bibliography of significant food and drug law articles that have appeared in law journals over the last decade. Excluded are articles that have appeared in non-law journals and articles that are older than ten years. Headings are used to organize the articles into a useful list that includes topics such as Labeling and Advertising, Food Safety, Medical Products, Tobacco Products, Medical and Pharmacy Practice, Products Liability, FDA Practice and Procedure, and International Trade and Regulation. The author delves deeper within each heading and further categorizes articles under more specific subheadings, making this an excellent resource for anyone interested in the field of food and drug law.
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