FDLI Publications: Food and Drug Law Journal 57-3

Volume 57 Issue 3

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> Bioterrorism: Defining a Research Agenda
by Anthony S. Fauci, M.D., Director of the National Institute of Allergy and Infectious Diseases (NAID) at the National Institutes of Health (NIH), Bethesda, MD. This article is an updated version of a speech that was presented at FDLI's Conference on Bioterrorism, Washington, D.C. (Feb. 20, 2002).

> The Development of Direct-to-Consumer Prescription Drug Advertising Regulation
by Francis B. Palumbo, Ph.D., J.D., Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy, Baltimore, MD
C. Daniel Mullins, Ph.D., Associate Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy, Baltimore, MD

> Financial Conflict of Interest in Medical Research: Overview and Analysis of Federal and State Controls
by Jennifer A. Henderson, J.D., M.P.H., Administrative Director and Senior Research Associate, Regulatory Affairs Program, Center for Integration of Medicine and Innovative Technology, Boston, MA
John J. Smith, M.D., J.D., Associate Radiologist, Massachusetts General Hospital; Associate Professor of Radiology, Harvard Medical School; and Director of Regulatory Affairs, Center for Integration of Medicine and Innovative Technology, Boston, MA

> Negotiating Reality: The Construction of Enforceable Pharmaceutical Standards
by Richard H. Parrish II, Ph.D., R.Ph., Assistant Professor, Department of Pharmacy Practice, Bernard J. Dunn School of Pharmacy, Shenandoah University, Winchester, VA

> Navigating the Hatch-Waxman Act's Safe Harbor
by Phillip B.C. Jones, who earned a Ph.D. in Physiology and Pharmacology at the University of California, San Diego. Since obtaining his J.D. in 1992, he has specialized in the protection of intellectual property covering biotechnology-based inventions.

> Exploring the Frontiers of Law and Science: FDAMA's Pediatric Studies Incentive
by Christopher-Paul Milne, D.V.M., M.P.H., J.D., Assistant Director of the Tufts Center for the Study of Drug Development, Tufts University, Boston, MA

> Pediatric Marketing Exclusivity as Altered by the Best Pharmaceuticals for Children Act of 2002
by Karena J. Cooper, May 2003 J.D. candidate, University of Maryland School of Law, Baltimore, MD

> What's in the Wine? A History of FDA's Role
by Elaine T. Byszewski, who earned her J.D. cum laude from Harvard Law School, 2002.

> "By Hercules! The More Common the Wine, the More Wholesome!"
Science and the Adulteration of Food and Other Natural Products in Ancient Rome
by James F. Bush, Associate at the law firm of Morgan & Finnegan, LLP, New York, NY

Bioterrorism: Defining a Research Agenda
Author: Anthony S. Fauci, M.D.
Issue: 57 Food and Drug Law Journal 413-422 (2002)

The September 11, 2001 attacks on the World Trade Center and Pentagon forever changed our collective thinking regarding the vulnerability of the United States to terrorists. Superimposed on those tragic events were the first recorded cases of anthrax in the United States to result from an intentional human act. These two events mobilized a new effort to bolster what has come to be known as Homeland Security, a multifaceted endeavor that includes, among many other components, defenses against and responses to bioterrorism. Our ability to detect and counter bioterrorism depends to a large degree on the state of biomedical science. This article will discuss the biodefense research agenda of the National Institutes of Health (NIH), and provide background into selected medical and public health aspects of bioterrorism.

The Development of Direct-to-Consumer Prescription Drug Advertising Regulation
Author: Francis B. Palumbo, Ph.D., J.D. & C. Daniel Mullins, Ph.D.
Issue: 57 Food and Drug Law Journal 423-444 (2002)

Direct-to-consumer (DTC) prescription drug advertising has grown from $12 million in 1989 to over $2 billion in 2001, an almost 200-fold increase. The authors trace the evolution of the laws and regulations that led up to today's DTC advertising. This article examines the interplay between the drug advertising laws administered by the Food and Drug Administration (FDA) and those administered by the Federal Trade Commission (FTC), and discusses the relative roles of the two agencies. Today, the FTC regulates advertising of over-the-counter drugs, while FDA, through its Division of Drug Marketing, Advertising and Communications, regulates prescription drug advertising, including DTC advertising. The article also addresses the regulation of DTC advertising in other countries, and explores the positions of the various stakeholders in DTC advertising. Finally, the article addresses new legislative and legal efforts in the DTC advertising arena.

Financial Conflict of Interest in Medical Research:
Overview and Analysis of Federal and State Controls
Author: Jennifer A. Henderson, J.D., M.P.H. & John J. Smith, M.D., J.D.
Issue: 57 Food and Drug Law Journal 445-456 (2002)

Over the past two decades, increasing academia-industry collaboration has given rise to exciting new opportunities for medical researchers and the medical technology community. These opportunities have in turn generated important medical advances and new policy challenges. Financial conflict of interest is among the key issues resulting from this new medical research environment. Current federal and state controls form an overlapping, incomplete, and occasionally conflicting message to investigators and institutions, creating the potential for considerable variation in application at the local level. To solidify existing collaborative paradigms and lay the foundation for future benefits from the academia-industry partnership, financial conflict of interest must be successfully addressed.

Negotiating Reality: The Construction of Enforceable Pharmaceutical Standards
Author: Richard H. Parrish II, Ph.D., R.Ph.
Issue: 57 Food and Drug Law Journal 457-474 (2002)

This paper examines the tensions surrounding the construction of enforceable standards for pharmaceutical
production and use, as negotiated by professional groups and the federal government from the time of the Pure Food and Drugs Act of 1906 to the Federal Food, Drug, and Cosmetic Act of 1938, two landmark federal food and drug acts. This "negotiated reality" for enforceable standards centered on the idea of allowable variations for therapeutic substances. Government could not enforce the descriptive "rubrics" of professional formulation, despite the elaborate system of local-state-federal cooperation that Harvey Wiley developed, and his successors expanded. Industry and practitioners alike exploited the vagaries of the law by inventing and producing therapeutic substances not covered under existing standards or statutes. Government scientists increasingly pressured pharmacy leaders to revise many aspects of the U.S. Pharmacopeia and the National Formulary, and recommended changes to standards to make enforcement of the 1906 Act more efficient. Over time, this negotiation shifted the content of drug standards from organoleptic qualitative "rubrics" to industrial quantitative monographs.

Navigating the Hatch-Waxman Act's Safe Harbor
Author: Phillip B.C. Jones, Ph.D., J.D.
Issue: 57 Food and Drug Law Journal 475-490 (2002)

Almost twenty years ago, Congress passed the Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act), a political compromise between competing economic interests of the pioneer research-based pharmaceutical industry and the generic pharmaceutical industry. One of the provisions of the Hatch-Waxman Act established a "safe harbor" from patent infringement liability for certain activities related to generating information for Food and Drug Administration approval. Over time, interpretations from district courts, appellate courts, and the U.S. Supreme Court arguably have transformed the contours of the safe harbor originally envisioned by Congress. This article steers the expanding scope and sounds the depth of the current safe harbor.

Exploring the Frontiers of Law and Science: FDAMA's Pediatric Studies Incentive
Author: Christopher-Paul Milne, D.V.M., M.P.H., J.D.
Issue: 57 Food and Drug Law Journal 491-518 (2002)

The industry, the Food and Dug Administration (FDA), Congress, and pediatric research advocates have wrestled for many years with the problem of how to incorporate the evaluation of drugs for pediatric use as a routine part of new drug development, as well as to generate clinical trial-based information for already marketed drugs commonly used in children. The Food and Drug Administration Modernization Act's (FDAMA's) pediatric studies provision, which established a voluntary program to provide incentives to the industry for assessing the pediatric use of both marketed and new drugs, has become the centerpiece of a uniquely successful pediatric research initiative. The implementation of FDAMA's incentive program has engendered a number of scientific and public health advances, in addition to serving as a model for novel regulatory approaches. Its success, however, has not been without controversy and challenge, as detailed by the findings of a survey of industry professionals who have "lived" the pediatric incentive program experience and as described in this article.

Pediatric Marketing Exclusivity as Altered by the Best Pharmaceuticals for Children Act of 2002
Author: Karena J. Cooper, J.D.
Issue: 57 Food and Drug Law Journal 519-544 (2002)

On January 4, 2002, President Bush signed the Best Pharmaceuticals for Children Act (BPCA) into law. The BPCA is legislation passed to reauthorize the pediatric exclusivity provisions of Section 111 of the Food and Drug Administration Modernization Act of 1997 (FDAMA). Pediatric marketing exclusivity is the process by which six-month marketing incentives are offered to the innovator pharmaceutical industry to conduct studies involving children. This article sets forth the provisions of the BPCA and discusses the similarities and differences between it and FDAMA Section 111. The article highlights the ways in which the process of pediatric exclusivity has been altered by the BPCA and how the BPCA strived to fill some of the gaps of FDAMA and attempted to address several outstanding issues, such as the testing of off-patent drugs, an important issue that the FDAMA was never intended to address. There is a brief discussion of the interface between BPCA and FDA regulatory actions, such as the 1979, 1994 and 1998 Pediatric Rules and FDA's authority to require pediatric studies. The article concludes with a discussion of unresolved issues with pediatric exclusivity in general and with BPCA specifically.

What's in the Wine? A History of FDA's Role
Author: Elaine T. Byszewski, J.D.
Issue: 57 Food and Drug Law Journal 545-572 (2002)

For those who wonder why wine bottles do not display ingredient labeling and nutrition facts, this article will explain the relevant jurisdictional conflict in which the consumer-friendly Food and Drug Administration lost to the industry-friendly Bureau of Alcohol, Tobacco and Firearms. In the Brown-Forman case, the judge refused to harmonize the Federal Food, Drug, and Cosmetic Act with the Federal Alcohol Administration Act, although congressional intent was to the contrary, as evident from this article's analysis of legislative history, contemporary whiskey politics, and court and regulatory decisions.

"By Hercules! The More Common the Wine, the More Wholesome!" Science and the Adulteration of Food and Other Natural Products in Ancient Rome
Author: James F. Bush, J.D.
Issue: 57 Food and Drug Law Journal 573-602 (2002)

Trade in foods, spices, drugs and aromatic perfumes brought natural products to Ancient Rome from the Mediterranean region and beyond. These commodities were often subject to adulteration, and many Romans recognized the economic and health dangers posed by such tampering. The Roman legal and scientific systems had ways of recognizing and addressing such adulterations. Although modern science has discarded many analyses the Romans used to detect adulterations, several ancient techniques remain useful today.