Volume 53 Issue 4
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Table of Contents
> Emerging Technologies and Their Implications:
Where Policy, Science, and Law Intersect
> First Amendment Limits on Regulating Information:
An Initial Reaction to the Washington Legal Foundation
Case
> "It’s Time to Make a Good Agency
Better": The Food and Drug Administration Modernization
Act of 1997
and the First Amendment
> The Key to Product Quality Assurance
> What Has Been Happening With Over-the-Counter
Drug Regulation
> Can the Safe Harbor of 35 U.S.C. § 271(e)(1)
Shelter Pioneer Drug Manufacturers?
> Direct-to-Consumer Broadcast Advertising:
Empowering the Consumer or Manipulating
a Vulnerable Population?
> Death by Apple Juice: The Problem of Foodborne
Illness, the Regulatory Response,
and Further Suggestions
for Reform
> Coordinated Food Systems and Accountability
Mechanisms for Food Safety:
A Law and Economics Approach
> Book Review: Fundamentals of Law and Regulation,
Volumes I and II
Emerging Technologies and Their Implications: Where
Policy, Science, and Law Intersect
Author: Frederick H. Degnan
Issue: 53 Food and Drug Law Journal 593-596 (1998)
This Open Forum article explores the growth and role of innovative technologies, such as nanotechnology, in food safety, and the friction these technologies produce in the regulation of food safety, which largely is based on long-standing statutory and regulatory schemes that never envisaged these startling new scientific techniques. Presenting specific examples of this science and policy struggle, the article acknowledges the difficulty that novel science can present for public health authorities, particularly from the perspective of regulatory efficiency. Noting some positive steps toward balancing the need to harness scientific advancements with institutional aims, the article calls on industry to inform agency decisionmaking and calls on public authorities to exercise creatively those regulatory tools at their command.
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First Amendment Limits on Regulating Information:
An Initial Reaction to the Washington Legal Foundation Case
Author: Jeffrey N. Gibbs
Issue: 53 Food and Drug Law Journal 597-602 (1998)
Over the years, various constitutional challenges have been raised to Food and Drug Administration (FDA) policies, but few have succeeded. On July 30, 1998, however, in Washington Legal Foundation v. Friedman, the court struck down several important agency policies on the dissemination of information for off-label uses in enduring materials and as part of continuing medical education programs for violating the First Amendment. Historically, FDA has allowed distribution of off-label information only under narrowly-defined circumstances and has restricted the dissemination of scientific journal articles that discuss off-label uses of approved therapeutic products. This article reviews the procedural posture of Washington Legal Foundation and Judge Royce C. Lamberth’s decision in the District Court for the District of Columbia, and discusses some of the case’s implications for companies.
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"It’s Time to Make a Good Agency
Better":
The Food and Drug Administration Modernization Act of
1997 and the First Amendment
Author: Ann Marie Murphy
Issue: 53 Food and Drug Law Journal 603-626 (1998)
The Food and Drug Administration Modernization Act of 1997 (FDAMA) contains a mission statement listing promotion of public health before protection of public health. This mission can transform the Food and Drug Administration (FDA) from gatekeeper to facilitator of public well-being. The controversial provisions regarding dissemination of off-label use information are consistent with this new image, but may be vulnerable to a First Amendment challenge, similar to that posed in Washington Legal Foundation v. Friedman. This article argues that the materials in question, namely scientific journal articles and medical texts, are pure, not commercial, speech. FDAMA provisions, nevertheless, may survive strict scrutiny because they arguably are "narrowly drawn" to satisfy the "compelling" government interest of public health protection. Prior to dissemination, a company must submit, or promise to submit, a supplemental new drug application (SNDA) covering the new use described in the materials. If, however, FDA deems the SNDA economically prohibitive, an exemption may be granted. In fact, waiving this requirement solely on economic grounds diminishes the argument that FDA’s interest in restricting the speech is compelling.
Even if the FDAMA provision survives a First Amendment challenge, the article argues, its implementation may remain tentative because Congress has delegated authority to FDA outside of its area of expertise, that is, it gave FDA the authority to deem that it is economically prohibitive for the manufacturer to conduct the additional clinical trials necessary for an SNDA.
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The Key to Product Quality Assurance
Author: William L. Schwemer
Issue: 53 Food and Drug Law Journal 627-632 (1998)
This article reviews the importance of identifying and resolving problems that occur in manufacturing regulated products. It also considers the role of change control in problem solving and product/process improvement. While consumer and medical products are expected to be manufactured within a state of control, human errors, equipment breakdowns, and other factors can result in worrisome trends or periodic failures. The article points out various weaknesses in the traditional approach of using stand-alone written procedures to investigate and correct problems and to control change. It then suggests that an integrated program of identifying and solving problems is superior to traditional methods and describes such a program in practice.
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What Has Been Happening With Over-the-Counter Drug
Regulation
Author: Stan Stringer
Issue: 53 Food and Drug Law Journal 633-642 (1998)
This article traces the history of over-the-counter (OTC) drug regulation, beginning with the Durham-Humphrey Amendment, which separated prescription and OTC drugs and provided a mechanism for switching approved new drugs to OTC status. The article briefly examines the role of the 1962 Kefauver-Harris Amendments and the drug efficacy review, as applied to OTC drugs and drugs grandfathered under the Federal Food, Drug, and Cosmetic Act of 1938. The article presents OTC review program methods with steps to OTC marketing, including a discussion of the Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research role and the categorization of drug ingredients by OTC review panels. A list of drugs approved for OTC marketing in the thirty-one months preceding October 1998 is included. The article summarizes modifications to investigational new drug and new drug application regulations, which complement the new OTC monographs and the OTC Review program. The article concludes with discussions of recent efforts to standardize OTC labeling and of the FDA Modernization Act’s effect on OTC drug regulation.
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Can the Safe Harbor of 35 U.S.C. § 271(e)(1) Shelter
Pioneer Drug Manufacturers?
Author: Courtenay C. Brinckerhoff
Issue: 53 Food and Drug Law Journal 643-660 (1998)
Section 271(e)(1) of title 35 of the United States Code was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984. This statute permits unauthorized use of patented inventions to obtain regulatory approval for products regulated under certain federal laws. The statute’s legislative history indicates that Congress intended to permit generic drug manufacturers to use patented drugs to obtain premarket approval for their generic drugs. The statutory language, however, is broad and does not limit its application to this narrow class of would-be infringers. Judicial interpretations of the provision consistently have broadened its applications. This article explores whether the statute can be invoked in situations falling within its plain language, but beyond the purposes described in its legislative history. The article considers three situations in detail, involving pioneer drug manufacturers’ use of: 1) a patented in vivo screening assay to identify potential drug candidates; 2) a patented computer program to analyze the statistical significance of its clinical data; and 3) an approved, patented drug to compare the efficacy of its drug with that of the approved drug. Although these three situations appear to fall within the plain language of the statute, equitable considerations may weigh against the application of the statute to at least the first two situations.
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Direct-to-Consumer Broadcast Advertising:
Empowering
the Consumer or Manipulating a Vulnerable Population?
Author: Kelly N. Reeves
Issue: 53 Food and Drug Law Journal 661-680 (1998)
In August 1997, the Food and Drug Administration (FDA) issued a draft guidance policy clarifying the requirement for the adequate provision of product labeling in its direct-to-consumer advertising regulations. Prior to the new guidance policy, it was not feasible for prescription drug manufacturers to advertise prescription drugs through broadcast media. Drug manufacturers now may reveal the name and indication of the drug in the same broadcast advertisement if adequate provision of the approved product labeling is ensured. The pharmaceutical industry’s approach to prescription drug advertising may prompt FDA to revisit the draft guidance policy before it issues its final guidance in 1999. FDA, however, should consider consumer needs for prescription drug information when analyzing the industry’s advertising response to the draft guidance policy. In fact, the pharmaceutical industry may be best suited to satisfy the prescription drug informational needs of consumers.
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Death by Apple Juice: The Problem of Foodborne
Illness, the Regulatory Response,
and Further Suggestions for Reform
Author: Chryssa V. Deliganis
Issue: 53 Food and Drug Law Journal 681-728 (1998)
This article provides a comprehensive overview of the problem of foodborne illness in the United States, past and current regulatory measures in response to the problem, and further suggestions for reform. Part I fully outlines the numerous, and often disparate, aspects of the foodborne illness problem, with special attention to several recent and highly publicized outbreaks. This part also provides a history of Food and Drug Administration (FDA) and other government regulation of food pathogens. Part II discusses recent efforts by the Clinton Administration to combat foodborne illness, including the National Food Safety Initiative and related efforts to increase the safety of imported food. Part III discusses problems with the current regulatory approach, including the government’s almost-exclusive reliance on Hazard Analysis and Critical Control Points methods to prevent foodborne illness. Suggestions for reform include increased funding for research in food chemistry and development of risk assessment methodologies.
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Coordinated Food Systems and Accountability Mechanisms
for Food Safety:
A Law and Economics Approach
Author: Jesse D. Lyon
Issue: 53 Food and Drug Law Journal 729-776(1998)
This article uses a law and economics analytical approach to compare food safety rules and institutions across legal systems and over time. Examinations of historical food systems include supply chain characteristics; locale, scope, and primary emphasis of exchange; and availability of market information. The article uses an understanding of the role of these factors in the evolution of food market and safety regulation to develop hypotheses regarding the present-day food safety debate. Supplemented with anecdotal evidence, the article provides a detailed quantitative analysis, correlating vertical coordination and food safety performance within certain food manufacturing industries. The article then considers ways to encourage market-driven food safety within vertically-coordinated food systems. Finally, the article employs an economic model of coordinated food production to identify incentives created under these alternative regimes for regulating five key aspects of the food industry, ranging from production contracts to antitrust and anticorporate farming issues.
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Book Review: Fundamentals of Law and Regulation,
Volumes I and II
Author: Joseph A. Page
Issue: 53 Food and Drug Law Journal 777-782 (1998)
Because of numerous amendments since its enactment in 1938, the Federal Food, Drug, and Cosmetics Act (FDCA) has burgeoned in its complexity and level of regulatory minutiae. Building on its past treatments of food, drug, cosmetic, and medical device regulation, FDLI’s new Fundamentals publication fills a pair of paperback volumes and expands its coverage to include not only FDCA, but also the Radiation Control for Health and Safety Act; advertising regulation by the Federal Trade Commission; reimbursement and fraud-and-abuse issues under Medicare and other public and private insurance programs; and FDA initiatives in international harmonization. With minor criticisms of the books, this review suggests that the Fundamentals treatises will appeal strongly to practitioners and succeed in providing an eminently useful, first-rate resource in this complicated and expanding area of the law.
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