FDLI Publications: Food and Drug Law Journal 52-4

Volume 52 Issue 4

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> The Application of the Patent Laws to the Drug Approval Process
> The Cosmetic/Drug Dilemma: FDA Regulation of Alpha-Hydroxy Acids
> Should Combat Troops Be Given the Option of Refusing Investigational Drug Treatment?
> Overview of FDA Regulation of Human Cellular and Tissue-Based Products
> The Regulation of Human Tissue in the United States: A Regulatory and Legislative Analysis
> He’s All Heart . . . and a Little Pig Too: A Look at the FDA Draft Xenotransplant Guideline
> Biobusiness on Campus: Commercialization of University-Developed Biomedical Technologies
> FDA Software Policy and Regulation of Medical Device Software
> FDA Regulation of Telemedicine Devices
> Implementation of the Food Quality Protection Act
> Update on Issues Before the Codex Alimentarius
> The Organic Foods Production Act of 1990 and Its Impending Regulations: A Big Zero for Organic Food?

The Application of the Patent Laws to the Drug Approval Process
Authors: Brian D. Coggio and Francis D. Cerrito
Issue: 52 Food and Drug Law Journal 345-355 (1997)

Under title 35 of the United States Code, section 271(e) of the patent laws, the use of an invention does not constitute patent infringement if that use is "reasonably related" to obtaining federal approval to market pharmaceutical products, veterinary products, or medical devices. One of the purposes of this section is to encourage research and speed new drugs to market. To achieve this goal, this section creates a "safe harbor" that has been used to insulate precommercial activities from actions by patentees. Thus far, the protection afforded by this safe harbor has been construed broadly by the federal courts that have had to decide the vast array of issues that involve the interplay between the Food and Drug Administration’s regulations and the patent laws (particularly the Waxman-Hatch Act). This article outlines the activities that have been found to fall within the safe harbor provision and addresses issues that can arise once a choice has been made to leave the protection of that provision.

The Cosmetic/Drug Dilemma: FDA Regulation of Alpha-Hydroxy Acids
Author: Laura A. Heymann
Issue: 52 Food and Drug Law Journal 357-375 (1997)

The legislators who enacted the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) almost certainly did not anticipate the development of what are now commonly known as "cosmeceuticals," cosmetic products with drug-like effects. Perhaps the most popular of these products on the market are skin-care preparations containing alpha-hydroxy acids (AHAs), an ingredient that exfoliates the top layer of the skin to reveal "newer" skin cells underneath. The popularity of AHAs has focused attention on the potential dangers of the product, including increased susceptibility to sun damage. Under current interpretations of the FDCA, however, products containing AHAs are regulated as cosmetics as long as their label claims remain relatively benign. Because cosmetics are not as stringently regulated as drugs, cosmetics manufacturers often escape premarket regulatory review simply by their choice of label language. The effectiveness of AHAs calls into question the ability of the Food and Drug Administration (FDA) to ensure consumer safety, given the agency’s current statutory authority in this matter. This article argues that FDA’s authority is too narrowly drawn, and proposes the creation of a cosmeceutical product category to enable FDA to regulate AHA-containing products more aggressively.

Should Combat Troops Be Given the Option of Refusing Investigational Drug Treatment?
Author: Robyn Pforr Ryan
Issue: 52 Food and Drug Law Journal 377-400 (1997)

Pyridostigmine bromide pills were administered to U.S. troops in Operation Desert Storm under a sharply criticized landmark wartime emergency protocol that had been issued by the Food and Drug Administration (FDA) only weeks before the ground war in Iraq began. Under this protocol, FDA allowed the Department of Defense (DOD) to compel troops to take experimental drugs without first getting their informed consent. The DOD believed these drugs provided the best prophylactic protection against the effects of nerve gas attacks. Until the Persian Gulf War, FDA allowed the use of such investigational drugs only with the fully informed consent of the subjects, except in narrowly conscribed emergency situations. FDA currently is considering a DOD request to make this emergency protocol permanent. This article examines the implementation of this protocol, which has implications for future wars and engagements, and the ethics of forced administration of investigational drugs during wartime. This article also suggests that the protocol be implemented only after sufficient consideration for the troops’ autonomy and health.

Overview of FDA Regulation of Human Cellular and Tissue-Based Products
Author: Martha A. Wells
Issue: 52 Food and Drug Law Journal 401-408 (1997)

This article reviews current regulatory requirements for human cellular and tissue-based products, and discusses the proposed strategy published recently by the Food and Drug Administration (FDA) that describes a more uniform approach to regulation of such products. FDA will regulate a wide range of products under this new approach (such as bone, heart valves, corneas, hematopoietic stem cells, sperm, embryos, and oocytes) based on the potential or actual risk to the public health. Some of these products have been used for years, and safety and efficacy has been established; others are novel therapies currently under development, for which little is known concerning safety and efficacy. The article also reviews the present state of knowledge concerning communicable disease transmissions from these products, as well as what is known regarding the number of cell and tissue establishments and the extent of transplantations. Concerns with the proposed approach and FDA’s current thinking regarding implementation of the proposals are assessed.

The Regulation of Human Tissue in the United States: A Regulatory and Legislative Analysis
Author: Mark O. Williams
Issue: 52 Food and Drug Law Journal 409-428 (1997)

Prior to 1993, human tissue banking and transplantation practices were largely unregulated in the United States. To the extent that federal regulatory controls were in place before that time, they represented a piecemeal approach that left most of the industry untouched by the Food and Drug Administration (FDA). In response to growing concern over such issues as the transmission of communicable disease through tissue transplants and the safety of tissue imported into the United States, FDA promulgated an interim rule that covered the industry in a more sweeping manner. In addition, Congress has several times attempted to craft a legislative solution. This article traces the history of FDA’s regulation in the human tissue area, discusses the current regulatory scheme, and analyzes various congressional efforts to impose a regulatory framework.

He’s All Heart . . . and a Little Pig Too: A Look at the FDA Draft Xenotransplant Guideline
Author: Jodi K. Fredrickson
Issue: 52 Food and Drug Law Journal 429-451 (1997)

This article reviews the events leading up to the Food and Drug Administration’s (FDA’s) creation of the Draft Guideline on Infectious Disease Issues in Xenotransplantation, with a focus on justifications for regulatory oversight and a brief look at FDA’s jurisdiction. The article then reviews the draft guideline and examines the implications of the proposed agency oversight with respect to informed consent and source animals. Finally, it suggests that the informed consent requirements are sufficient to afford protections to xenotransplant recipients. While no measure is certain to eliminate the risk of zoonoses, the guideline’s requirements provide reasonable protections without overburdening the industry, and foster the structured progression of medical technology.

Biobusiness on Campus: Commercialization of University-Developed Biomedical Technologies
Author: Kenneth Sutherlin Dueker
Issue: 52 Food and Drug Law Journal 453-509 (1997)

The university has been the locus of the vast majority of significant biomedical invention. This creative force combined with a competitive industrial setting for pharmaceuticals and other health-related products has facilitated a nexus between the academy and the commercial world. The Bayh-Dole Act aligned the incentives of the university with those of industry, setting off a transformation of old commercialization paradigms and prior university-corporate relationships in the two decades since its enactment. Old impediments to technology transfer, both regulatory and systemic, largely have been removed. A new profession has been born to manage the process: university technology transfer.

FDA Software Policy and Regulation of Medical Device Software
Authors: E. Stewart Crumpler & Harvey Rudolph
Issue: 52 Food and Drug Law Journal 511-516 (1997)

Many observers are concerned about the Food and Drug Administration’s (FDA’s) development of a new software policy, and are curious as to the agency’s motives for developing such a policy. This article provides some background on FDA’s regulation of software as a medical device, and describes the agency’s progress toward developing a new risk-based software policy.

FDA Regulation of Telemedicine Devices
Authors: Peter S. Reichertz & Naomi Joy Levan Halpern
Issue: 52 Food and Drug Law Journal 517-523 (1997)

Telemedicine involves the application of information management and telecommunications technologies to the provision of health care services. Some telemedicine systems, such as videoconferencing, are in use already, and many other applications are being developed. Persons involved in, or interested in the prospect of, providing telemedicine services may not be aware that the hardware and software that makes telemedicine possible may be regulated by the Food and Drug Administration (FDA). This article describes the status of FDA’s efforts to develop appropriate regulatory policies and practices to deal with this emerging field.

Implementation of the Food Quality Protection Act
Author: Stephen L. Johnson
Issue: 52 Food and Drug Law Journal 525-529 (1997)

On August 3, 1996, President Clinton signed into law the most significant piece of pesticide and food safety legislation enacted in many years, the Food Quality Protection Act (FQPA) of 1996. The new law calls for major changes in pesticide regulation and affords the Environmental Protection Agency (EPA) unprecedented opportunities to provide greater health and environmental protection, particularly for infants and children. Since the FQPA was passed, EPA’s Office of Pesticide Programs has applied the new safety standard to all pesticide registration and reregistration activities. This includes reviewing applications for new active ingredients, new uses, emergency exemptions under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act, and decisions regarding the eligibility of active ingredients in the reregistration process. While it is too early to determine the full effects of the FQPA, there are some areas in which it already has made a difference. The law has generated new policies in several scientific areas and fostered significant discussion in others, challenged regulators and regulated alike to reconsider traditional risk assessment methods, and increased the visibility of minor uses and antimicrobials. The FQPA’s ultimate impact will be revealed through future activities such as tolerance reassessment.

Update on Issues Before the Codex Alimentarius
Author: H. Michael Wehr
Issue: 52 Food and Drug Law Journal 531-536 (1997)

The Codex Alimentarius has gained renewed importance as a result of its position as the international reference organization for food safety under the General Agreement on Tariffs and Trade Uruguay Round Sanitary and Phytosanitary Trade Agreement. This new position has resulted in significant changes, or proposed changes, affecting the policies and operation of Codex. While the precise impact of these changes awaits the interpretations of certain policies, including the adoption of specific food safety standards/guidelines and the findings of World Trade Organization trade panels that involve the work of Codex, this article attempts to assess the present role of the Codex in standard setting.

The Organic Foods Production Act of 1990 and Its Impending Regulations:
A Big Zero for Organic Food?
Author: Kenneth C. Amaditz
Issue: 52 Food and Drug Law Journal 537-559 (1997)

In recent years, organic food has gained prominence with food growers, retailers, and consumers, but differing state standards for organic food production and labeling has been a source of confusion. In 1990, Congress passed the Organic Foods Production Act (OFPA) with the goals of alleviating consumer confusion over organic foods, creating a uniform standard for organic claims, and promoting interstate commerce in organic foods. Whether OFPA can meet these goals has been difficult to gauge because the U.S. Department of Agriculture (USDA) has yet to issue implementing regulations. Now that the National Organic Standards Board (NOSB) has sent its recommendations to USDA and a proposed rule is finally in the works, the time is ripe for an examination of the OFPA scheme. This article examines the provisions of OFPA and the NOSB recommendations, and various pitfalls therein, concluding that the OFPA regulatory scheme is unlikely to meet the congressional goals set out for it. The author suggests several steps USDA might take to achieve Congress’ OFPA objectives.