Volume 62 Issue 4
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Table of Contents
> In Search of a Coherent Framework: Options for FDA Oversight of Genetic Tests
by Gail H. Javitt, Adjunct Professor, Georgetown University Law Center, Washington, DC
> Unlabeled Drug Samples and the Learned Intermediary:
The Case for Drug Company Liability without Preemption
by Susan Poser, Associate Professor, University of Nebraska College of Law, Lincoln, NE
> Medicare’s Revised Clinical Trial Policy and Clinical Trial-Related Provisions of FDAAA:
What Is a Sponsor to Do?
by Kirk Dobbins, Counsel, King & Spalding, LLP, Washington, DC
and
Kay Scanlan, Consultant, King & Spalding, LLP, Washington, DC
> Regulation of Dietary Supplement Advertising: Current Claims of Interest to the Federal Trade Commission, Food and Drug Administration and National Advertising Division
by John E. Villafranco, Partner, Kelley Drye Collier Shannon, Washington, DC
and
Andrew B. Lustigman, The Lustigman Firm, P.C., New York, NY
> Investigator Financial Disclosures and Its Effect on Research Subjects
by Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, P.C., Washington, DC
and
Gregory A. Guagnano, Associate Professor of Sociology and Anthropology,
George Mason University, Fairfax, VA
> Sword or Shield? An Overview and Competitive Analysis of the Marketing of “Authorized Generics”
by Saami Zain, Assistant Attorney General, Antitrust Bureau, New York State Office of the Attorney General, New York, NY
> Henna Tattooing: Cultural Tradition Meets Regulation
by Carrie Griffin Basas, Visiting Assistant Professor, The Dickenson school of Law, Pennsylvania State University, Carlisle, PA
> Examining Mandatory HPV Vaccination for All School-Aged Children
by Rebecca E. Skov, Partner, Skov, Burkhalter, & Skov, L.L.P., Houston, TX
> Closing the Gaps—Enhancing the Regulation of Genetic Tests Using Responsive Regulation
by Stuart Hogarth, visiting research fellow, Institute for Science and Society, University of Nottingham, UK
and
Kathy Liddell, lecturer, Faculty of Law, University of Cambridge, UK
and
Tom Ling, Professor of Public Policy, Anglia Ruskin University, Cambridge, UK
and
Simon Sanderson, lecturer in primary care genetics, Public Health Genetics Foundation, Cambridge, UK
and
Ron Zimmern, Director, Public Health Genetics Foundation, Cambridge, UK
and
David Melzer, Professor of Epidemiology and Public Health, Peninsula Medical School, Exeter, UK
> Access to Clinical Devices through Nontraditional Routes
by Robert J. Klepinski, officer, Fredrikson & Byron, P.A., Minneapolis, MN
Author: Gail H. Javitt
62 Food and Drug Law Journal 617-652 (2007).
Genetic testing has become an integral part of health care. With tests available to diagnose, treat, or predict more than 1400 diseases, obtaining an accurate and reliable genetic test result is increasingly critical for appropriate patient management.
However, the regulatory environment for genetic testing has not evolved as quickly as the technology itself, and the safety and effectiveness of most genetic tests today are not assured by the government.
To date, FDA has played a limited role in regulating genetic tests. Recently, the agency has signaled interest in increasing its oversight, but has yet to articulate a cogent framework for oversight. Some argue that greater FDA involvement is needed, while others assert that the FDA lacks jurisdiction and that its involvement will deter availability of new tests.
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Unlabeled Drug Samples and the Learned Intermediary:
The Case for Drug Company Liability without Preemption
Author: Susan Poser
62 Food and Drug Law Journal 653-694 (2007).
This is the first article to undertake a systematic legal analysis of the issue of liability for harm from sample prescription drugs.
This article maintains that people who suffer injuries resulting from the absence of warnings on samples of prescription drugs be permitted to sue drug manufacturers directly in tort, the learned intermediary rule notwithstanding. Various rationales for the learned intermediary doctrine do not apply to sample prescription drugs.
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Medicare’s Revised Clinical Trial Policy and Clinical Trial-Related Provisions of FDAAA:
What Is a Sponsor to Do?
Authors: Kirk Dobbins and Kay Scanlan
62 Food and Drug Law Journal 695-708 (2007).
Manufacturers often are actively engaged with FDA and other federal agencies when designing and managing clinical trials on new drugs and medical devices prior to commercialization. Too often, however, manufacturers focus exclusively on FDA regulatory review without incorporating Medicare and private health insurance coverage requirements into clinical trial design.
CMS makes Medicare coverage and payment decisions based on its authority under Section 1862(a) of the Social Security Act. The agency’s interpretation of Sections 1862(a)(1)(A) and (E) as the statutory basis for promulgating coverage policy has been inconsistent and called into question. Despite concerns raised by CMS’s interpretation of its legal authority, the agency recently revised Medicare clinical trial coverage requirements.
Shortly before CMS issued its revised coverage policy on October 17, 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA) September 27, which contains important clinical trial-related changes. As a result of the clinical trial-related changes in FDAAA, CMS delayed implementation of significant changes to its clinical trial coverage policy proposed during the policy reconsideration process. With this changing landscape, what is a manufacturer to do?
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Regulation of Dietary Supplement Advertising: Current Claims of Interest to the Federal Trade Commission, Food and Drug Administration and National Advertising Division
Authors: John E. Villafranco and Andrew B. Lustigman
62 Food and Drug Law Journal 709-726 (2007).
Federal and state authorities are focusing increased attention on the advertising and marketing of dietary supplements. Under a liaison agreement, the Federal Trade Commission (FTC) acts as the primary regulator of dietary supplement advertising, and the Food and Drug Administration (FDA) has primary enforcement responsibility for dietary supplement claims made in “labeling.”
In addition to the FTC and FDA, the National Advertising Division of the Council of Better Business Bureaus (NAD) plays an active role in shaping dietary supplement advertising. The NAD is an industry-funded, self-regulatory body that reviews nationally disseminated advertising for truth and accuracy. Although not binding on the FTC, NAD decisions may influence the course of FTC enforcement action. In particular, if an advertiser either refuses to cooperate with NAD proceedings or fails to comply with an NAD decision, the NAD has the power to refer cases to the FTC, and the FTC tends to give the referred cases high priority.
Like the FTC, the NAD has taken a particular interest in dietary supplement advertising in recent years, establishing a body of precedent that serves as an effective guide to responsible marketers. The NAD recently partnered with the Council for Responsible Nutrition (CRN), a prominent dietary supplement trade organization, to expand its review of dietary supplement advertising.
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Investigator financial Disclosure and Its Effect on Research Subjects
Authors: Jeffrey N. Gibbs and Gregory A. Guagnano
62 Food and Drug Law Journal 727-738 (2007).
Recently, there has been considerable discussion regarding conflicts of interest by clinical investigators. One recurring question has involved the extent to which an investigator’s financial stake must be disclosed to potential subjects.
The authors conducted a pilot study to determine how disclosure would affect the willingness of potential subjects to participate in a study. A total of 297 undergraduate students were asked how likely they would be to enroll in a hypothetical study involving a dietary supplement. Each student was told that the investigator had one of three levels of financial interest. To assess the possible interaction between financial stake and riskiness of participation, students also were presented with three different risk levels.
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Sword or Shield? An Overview and Competitive Analysis of the Marketing of “Authorized Generics”
Author: Saami Zain
62 Food and Drug Law Journal 739-778 (2007).
In 1984, Congress enacted legislation to encourage generic competition in the pharmaceutical industry. The legislation resulted in a boon to the generic drug industry and substantial lost sales and profits to the branded drug industry. Branded manufacturers responded with various strategies that have had the effect of impeding generic competition; several of which have been criticized and resulted in litigation and government enforcement actions. This article discusses a relatively novel, increasingly employed strategy: the marketing of “authorized” generics by branded drug companies.
An “authorized” generic is essentially the branded drug, but labeled and marketed as a generic. In the short term, authorized generics appear to increase competition and lower prices for generics. Consequently, proponents have heralded the practice as pro-consumer. However, others (including generic drug companies) call foul, claiming that by reducing generic profits, authorized generic may limit or deter generic competition, especially if expected profits are less then expected costs.
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Henna Tattooing: Cultural Tradition Meets Regulation
Author: Carrie Griffin Basas
62 Food and Drug Law Journal 779-804 (2007).
As options for personal body art increase, individuals may choose to permanently decorate their bodies with permanent or temporary tattoos. Tattooing of both kinds has become a more mainstream practice, prompting FDA to increase its involvement in the industry. Through the case study of henna tattoos, or mehndi, this article explores the history of that form of temporary tattoo, its use in minority communities and the complications of regulating the practice.
Currently, FDA does not approve the use of henna or mehndi for direct application to the skin. Under the cosmetics and color additives regulations, henna has only been approved for use on the hair. Building on sociocultural and scientific data, the article draws a distinction between henna tattoo products that contain pure henna powder, and those products that have been adulterated with PPD, lead, or other dangerous diluents. These products are often referred to as “black” or “blue henna” because of the characteristically dark images they produce. The author recommends that FDA permit pure henna to be sold in tattoo kits and other forms specifically for application to the skin. Then FDA could direct its energies on the adulterated products and more dangerous practices, such as permanent tattooing, to avoid excessive interference with relatively safe cultural practices.| Back to top |
Examining Mandatory HPV Vaccination for All School-Aged Children
Author: Rebecca E. Skov
62 Food and Drug Law Journal 805-830 (2007).
Recently, there has been a major breakthrough in cancer prevention in the form of the Human Papillomavirus (HPV) vaccine, Gardasil. This vaccine prevents 70% of cervical cancers and 90% of genital warts caused by HPV; however implementation of the vaccine has been an uphill battle.
This article examines the history of cervical cancer, the HPV virus itself, the decline of the American vaccine manufacturing industry and the new HPV vaccine.
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Closing the Gaps: Enhancing the Regulation of Genetic Tests Using Responsive Regulation
Authors: Stuart Hogarth, Kathy Liddell, Tom Ling, Simon Sanderson, Ron Zimmern and David Melzer
62 Food and Drug Law Journal 831-848 (2007).
Successive policy reports in Europe, the United States and elsewhere have concluded there is a need to enhance the regulatory regime for the evaluation of novel genetic tests.
Addressing the gaps in the existing regulatory framework presents a particular challenge. This article outlines the regulatory gaps in a number of countries and discusses how they might be addressed. It proposes a model based on a minimal set of requirements for statutory premarket review supported by a strengthened system of postmarket evaluation which draws on a range of non-statutory oversight mechanisms.| Back to top |
Access to Clinical Devices through Nontraditional Routes
Author: Robert J. Klepinski
62 Food and Drug Law Journal 849-864 (2007).
There are many situations where there is a pressing need to use an investigational device to protect the health and safety of a patient before the device is commercially available. Both Congress and the U.S. Food and Drug Administration (FDA) have established regulatory pathways to address this need.
This article is a synopsis of the various possible methods for distribution of such devices and their relative practicality. The following regulatory pathways are addressed:
• Emergency Use
• Compassionate Use
• Continued Access
• Treatment IDE
The article discusses the phenomenon that there appears to be an inverse relationship between the formality of the regulatory structure for a method and its usability. The most informal regulatory pathways appear to be most used and most successful
The article also discusses the difficult questions for industry as to what rules apply to the informal uses and what compliance positions may be taken by FDA.| Back to top | |