Volume 56 Issue 3
FDLI has initiated a policy regarding the Food and Drug Law Journal online: Only the Table of Contents and article abstracts for each issue will be posted to our website. Visitors can obtain a full text version of an entire issue. Your purchase will be processed quickly, and at reasonable rates.
Any questions or concerns regarding this policy should be directed to
Michael Levin-Epstein, FDLI's Editor-in-Chief.
Table of Contents
> FDA's Foods Programs
> The Role of the State as a Drug Purchaser
> The Vulnerability of HIPAA Regulations to First
and Fourth Amendment Attack:
An Addendum to "Evolving Constitutional
Privacy Doctrines Affecting Healthcare Enterprises"
> Federal Regulation of Single-Use Medical Devices:
A Revised FDA Policy
> The Evolution of Substantial Equivalence in FDA's
Premarket Review of Medical Devices
> PMA Primacy: Synthesizing the 35 U.S.C. §156
Patent Term Extension,
35 U.S.C. § 271(e)(1) Patent Infringement
Exemption as Currently Applied to Medical Devices, and Medical
Device Preemption Jurisprudence to Yield a Cohesive Solution Regarding
Scope of Coverage
> The National Childhood Vaccine Injury Act Turns
Fifteen
> Compensation Versus Colonization: A Common Heritage
Approach to the Use of Indigenous Medicine in Developing Western
Pharmaceuticals
FDA's Foods Program
Author: Joseph A. Levitt
Issue: 56 Food and Drug Law Journal 255-266 (2001).
Great strides have been made in food safety over the past several years.
Working together with our many federal, state, and local counterparts,
the Food and Drug Administration (FDA) now has in place a food safety
program for pathogen reduction that is stronger fundamentally than that
which existed just three or four years ago. Across government, the program
includes new surveillance systems, better prevention programs, faster
outbreak response, enhanced education, and better coordinated and focused
research and risk assessment activities. This article will recap the
food safety strategy; highlight FDA's prevention programs and other
recent actions; identify several new initiatives on FDA's short-term
horizon; highlight increases for FDA's foods program in the President's
2002 Budget Request; and foreshadow some of FDA's longer-term food safety
issues.
| Back to top |
The Role of the State as a Drug Purchaser
Author: Francis B. Palumbo
Issue: 56 Food and Drug Law Journal 267-280 (2001).
In light of the absence of federal action on a Medicare drug benefit, states are undertaking a number of activities on their own. As the federal government continues to grapple with coverage for the elderly, states find themselves pressured to do something to improve access to drugs for their citizens. States are examining a number of options, and this article examines the major points of focus in the following categories: programs designed to provide broad access to state residents with financing principally from the pharmaceutical manufacturers through rebates to the states; programs designed to provide broad access to state residents with financing principally through pharmacies which are expected to provide discounts at the point of sale; and the state acting as a direct or bulk purchaser.
| Back to top |
The Vulnerability of HIPAA Regulations to First and Fourth Amendment Attack:
An Addendum to "Evolving Constitutional Privacy Doctrines Affecting Healthcare Enterprises"
Author: Andrew S. Krulwich & Bruce L. McDonald
Issue: 56 Food and Drug Law Journal 281-304 (2001).
This addendum supplements the article presented in Volume 55, Issue 4 of the Food and Drug Law Journal, that analyzed the evolving constitutional law background potentially guiding or limiting federal regulators' "privacy" initiatives designed to affect healthcare enterprises. After the article was published, the Department of Health and Human Services (DHHS) finalized its comprehensive privacy regulations under the Health Insurance Portability and Accountability Act (HIPAA), and, thereafter, the Supreme Court announced its important decisions in Ferguson v. City of Charleston and Bartnicki v. Vopper, which, respectively, addressed Fourth and First Amendment issues having direct implications for privacy rights and regulation. This addendum discusses DHHS' approach to constitutional privacy rights as reflected in the HIPAA privacy regulations, and analyzes the related implications of Ferguson, Bartnicki, and other recent decisions. The analysis reveals significant doubts concerning whether the HIPAA privacy regulations make sufficient provision for the Fourth Amendment privacy rights of patients or adequately take into account the First Amendment implications of restraints placed on marketing and fundraising use of information about patients gathered by healthcare enterprises. The regulations could well prove vulnerable to judicial challenge on both grounds.
| Back to top |
Federal Regulation of Single-Use Medical Devices: A Revised FDA Policy
Author: John J. Smith & Jennifer A. Agraz
Issue: 56 Food and Drug Law Journal 305-316 (2001).
The reprocessing and reuse of medical devices intended for single-use has been part of the U.S. healthcare community since the introduction of single-use products. Largely due to the cost savings associated with the practice, reprocessing and reuse expanded over the years to become commonplace in many healthcare settings. For years, hospitals engaged in this practice were essentially unregulated by the Food and Drug Administration (FDA), while third-party reprocessors were effectively exempt from agency marketing regulations. FDA recently has revised its regulatory policy, subjecting hospitals and third-party reprocessors to all regulations imposed on original equipment manufacturers for the first time. The rationale behind this policy and its impact on single-use device reprocessing has a variety of implications for industy, healthcare institutions, and FDA.
| Back to top |
The Evolution of Substantial Equivalence in FDA's Premarket Review of Medical Devices
Author: Benjamin A. Goldberger
Issue: 56 Food and Drug Law Journal 317--338 (2001).
Although it is doubtful that Congress originally intended it to have such significance, the 510(k) process has become the primary path by which manufacturers shepherd new medical devices to market. Springing from the enigmatic "substantial equivalence" language of the Medical Device Amendments of 1976 (MDA), 510(k)s outnumber premarket approval (PMA) applications by a ratio of 10 to 1. This article traces the evolution of substantial equivalence in the Food and Drug Administration's (FDA's) premarket review of medical devices and examines how FDA's application of this standard impacts medical device manufacturers, consumers, and tort victims. To better understand the origins of this standard, the article begins by examining federal control over medical devices before the MDA and how the amendments transformed the premarket review process. The article continues by recounting how FDA developed the substantial equivalence doctrine in the 1980s and how Congress made some modifications to the scheme in the 1990s. After examining how premarket review of medical devices operates today, the article concludes by suggesting how changes to the current paradigm might benefit public health.
| Back to top |
PMA Primacy: Synthesizing the 35 U.S.C. §156 Patent Term Extension, 35 U.S.C. § 271(e)(1) Patent Infringement Exemption as Currently Applied to Medical Devices, and Medical Device Preemption Jurisprudence to Yield a Cohesive Solution Regarding Scope of Coverage
Author: James M. Flaherty, Jr.
Issue: 56 Food and Drug Law Journal 339-350 (2001).
One of the primary methods by which the United States' patent law system rewards inventors of patentable inventions is by granting a 20-year period of exclusive rights. During this 20-year patent term, patentees can bar others from making, using, offering to sell, or selling the patented invention. To maintain the integrity of this patent term, Congress occasionally has granted exceptions to the normal patent process. Two such exceptions are related to the federal premarket regulatory process outlined in the Federal Food, Drug, and Cosmetic Act (FDCA).
The patent term extension outlined in 35 U.S.C. § 156 and the related patent infringement exemption found in 35 U.S.C. § 271(e)(1) operate to maintain the 20-year patent term. These provisions accomplish this goal by granting extensions to those inventors who were prevented from exploiting their patents because of the federal premarket regulatory process outlined in the FDCA and by granting limited infringement exemptions to competitors to meet the requirements of the FDCA. The primary focus of this article is the relationship of these two provisions to medical devices.
The text of 35 U.S.C. § 156 limits the scope of this patent term extension to medical devices that have undergone the premarket approval (PMA) process. The types of devices subject to the 35 U.S.C. § 271(e)(1) infringement exemption, however, is unclear. This article contends that the current case law extending the 35 U.S.C. § 271(e)(1) exemption to all medical devices is incorrect. Furthermore, it argues that a more proper interpretation of this provision would limit the exemption to PMA devices, thereby mirroring the scope of the 35 U.S.C. § 156 extension. Next, the article proposes a scheme in which medical devices undergoing the PMA process will gain the benefit of the 35 U.S.C. § 156 patent term extension and the 35 U.S.C. § 271(e)(1) patent infringement exemption, while devices not undergoing the PMA process will not derive these benefits. Finally, the article advocates expanding this scheme to incorporate current medical device preemption law that contains similar scope ambiguity, specifically arguing that only those devices that have undergone the PMA process should gain the benefit of preemptive effect, thereby providing consistency with the patent-related proposals and predictability to the interaction between medical device regulations, patent, and preemption law.
| Back to top |
The National Childhood Vaccine Injury Act Turns Fifteen
Author: Elizabeth C. Scott
Issue: 56 Food and Drug Law Journal 351-366 (2001).
The discovery and widespread use of vaccines against many infectious diseases represents one of the greatest public health developments of the 20th century, eradicating some diseases and drastically reducing mortality from others. Vaccines, however, are capable of causing injuries in a small percentage of recipients, victims who often incur high medical costs and require compensation. Because compensation through the traditional tort system was complicated and unsuccessful for several reasons, Congress created a no-fault mechanism for compensating victims of vaccine-related injuries, the National Childhood Vaccine Injury Act of 1986 (NCVIA). Fifteen years later, this article examines the current state of the NCVIA in light of Congress' objectives in enacting the NCVIA and today's public health and political landscape, and the article proposes improvements to the NCVIA.
| Back to top |
Compensation Versus Colonization:
A Common Heritage Approach to the Use of Indigenous Medicine in Developing Western Pharmaceuticals
Author: John L. Trotti
Issue: 56 Food and Drug Law Journal 367-384 (2001).
Recently, pharmaceutical companies have turned to the abundant and diverse plant life of developing countries in search of natural compounds with powerful healing properties. To cut costs and streamline research, these companies rely increasingly on indigenous peoples and their remedies to locate naturally occurring medicinal compounds. This valuable cooperation, however, often goes unrewarded. Critics argue that the lack of patent protection for indigenous remedies under the Trade Related Aspects of Intellectual Property agreement (TRIPS) fosters this dynamic. As such, these critics view TRIPS as an imperialistic codification of Western notions of property rights and technology. Thus, some advocate reforms for patent regimes. Instead of uncritically accepting patent rights as the solution to compensation for use of indigenous medicine in Western drug development, the international community should develop a common heritage approach similar to Part XI of the 1982 United Nations Convention on the Law of the Sea.
| Back to top |