FDLI Publications: Food and Drug Law Journal 58-1

Volume 58 Issue 1

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> Challenging Food and Drug Administration Interpretations of the Federal Food, Drug, and Cosmetic Act
by Richard M. Cooper, Partner in the law firm of Williams & Connolly LLP, Washington, D.C. As counsel for one of the challengers to FDA's interpretation, he argued FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), and Granutec, Inc. v. Shalala, 139 F.3d 889 (Table), 46 U.S.P.Q.2d (BNA) 1398, 1998 WL 153410 (4th Cir. 1998).

> Underdeveloped: FDA's Authority to Take Photographs During an FDA Establishment
Inspection Under Section 704
by Frederick H. Branding, R.Ph., J.D., Member of the law firm of Bell, Boyd & Lloyd, L.L.C., and Chair of the firm's Food and Drug Practice Group, Chicago, IL and Washington, D.C. He is a former Assistant U.S. Attorney and a registered pharmacist.

James M.Ellis, Associate in the Litigation Group of the law firm of Bell, Boyd & Lloyd, L.L.C., Chicago, IL

> CFSAN's Program Priorities: From Food Safety to Food Security
by Joseph A. Levitt, Director of the Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration, College Park, MD. This article is based on a number of public presentations made over the past year

> Direct-to-Consumer Marketing: The Food and Drug Administration Is Not Alone
by Paul E. Kalb, Partner in the law firm of Sidley Austin Brown & Wood LLP and head of the firm's Health Care Group, Washington, D.C.

Karen O. Dunlop, Partner in the law firm of Sidley Austin Brown & Wood, Chicago, IL

Diane C. McEnroe, Counsel to the law firm of Sidley Austin Brown & Wood LLP, New York, NY

Scott D. Stein, Associate in the law firm of Sidley Austin Brown & Wood, Chicago, IL

> The Legal Status and Regulatory Context of "Health Foods" in the European Union
by Nicole Coutrelis, Attorney at the Paris Bar, COUTRELIS & ASSOCIES, Paris-Brussels. This article is an updated version of a speech that was presented at FDLI's 45th Annual Educational Conference, Washington, D.C. (Apr. 16-17, 2002).

> The Drug Price Competition and Patent Term Restoration Act of 1984: Fine-Tuning the Balance Between the Interests of Pioneer and Generic Drug Manufacturers
by Holly Soehnge, Ph.D., who is with Adler & Associates, Houston, TX and is a May 2003 J.D. candidate at the University of Houston Law Center, Houston, TX.

> Regulating the Fate of Pharmaceutical Drugs: A New Prescription for the Environment
by Christopher T. Nidel, third-year law student at the University of Virginia, Charlottesville, VA. A previous version of this article won first place in the 2002 H. Thomas Austern Memorial Writing Award Competition sponsored by the Food and Drug Law Institute.

> How Pharmacogenomics Will Impact the Federal Regulation of Clinical Trials
and the New Drug Approval Process
by Barbara Ann Binzak, Ph.D., who joined the law firm of Buchanan Ingersoll P.C. in Washington, D.C. in March 2003 as an Associate, pending bar passage. A previous version of this article won second place in the 2002 H. Thomas Austern Memorial Writing Award Competition sponsored by the Food and Drug Law Institute.

Challenging Food and Drug Administration Interpretations of the Federal Food, Drug, and Cosmetic Act
Author: Richard M. Cooper
Issue: 58 Food and Drug Law Journal 1-8 (2003)

Chevron, U.S.A. Inc. v. Natural Resources Defense Council, Inc. (467 U.S. 837 (1984)) is commonly viewed as overwhelmingly favorable to the upholding of agency interpretations of the statutes they administer. Chevron's step one, however, offers a party challenging an agency's statutory interpretations a better opportunity to prevail than did a standard pre-Chevron approach. Full exploitation of that opportunity commonly requires vigorous use of the traditional tools of statutory interpretation. Where an agency's statutory interpretation is expressed in a document not resulting from the exercise of delegated law-making authority, the interpretation is tested not under Chevron, but under Skidmore v. Swift & Co. (323 U.S. 134 (1944)). Skidmore should be applied in a two-step analysis parallel to that under Chevron. The first step should be identical to that under Chevron: whether, with the aid of the traditional tools, the statute can be found to have a clear meaning. The second step should differ from that under Chevron: not whether the agency's interpretation is "reasonable," but whether it is "persuasive."

Underdeveloped: FDA's Authority to Take Photographs During an FDA Establishment
Inspection Under Section 704
Authors: Frederick H. Branding & James M. Ellis
Issue: 58 Food and Drug Law Journal 9-18 (2003)

This article analyzes the Food and Drug Administration's (FDA's) establishment inspectional authority, particularly the scope of FDA's authority to take photographs during administrative establishment inspections. The discussion of this subject necessarily begins with a review of FDA's statutory authority to inspect under the Federal Food, Drug, and Cosmetic Act (FDCA), followed by an analysis of the case law interpreting the scope of FDA's authority to take photographs during establishment inspections. Neither the FDCA nor existing case law clearly answer the question of whether FDA is authorized to take photographs during administrative establishment inspections.

CFSAN's Program Priorities: From Food Safety to Food Security
Author: Joseph A. Levitt
Issue: 58 Food and Drug Law Journal 19-24 (2003)

Historically, the Food and Drug Administration's (FDA's) food program has been directed at ensuring the safety of the U.S. food supply. After the terrorist attacks of September 11, 2001, the priorities of the foods program expanded to emphasize the security of the food supply as well. Given that food is a possible vehicle for harmful contaminants, FDA and the food industry agreed on the need to substantially increase its preparedness to handle possible threats against the food supply. This article provides an overview of FDA's role in food security and preventing the intentional introduction of pathogens or harmful chemicals into the food supply. Because many of the systems designed to improve food safety also address food security, this article describes the major food safety systems currently in place and outlines new efforts meant to bolster security even further.

Direct-to-Consumer Marketing: The Food and Drug Administration Is Not Alone
Authors: Paul E. Kalb, Karen O. Dunlop, Diane C. McEnroe & Scott D. Stein
Issue: 58 Food and Drug Law Journal 25-34 (2003)

Direct-to-consumer marketing efforts implicate not just the Food and Drug Administration's rules, but also federal prohibitions on unfair and deceptive trade practices, the Anti-Kickback statute's prohibition on payments by a manufacturer "to arrange for or recommend" the purchase of product, and federal and state privacy laws. The agencies responsible for enforcing these laws, including the Federal Trade Commission and the HHS Office of Inspector General, increasingly are focusing on these efforts. Manufacturers that engage in direct-to-consumer marketing must be aware, and plan for, the full array of enforcement concerns.

The Legal Status and Regulatory Context of "Health Foods" in the European Union
Author: Nicole Coutrelis
Issue: 58 Food and Drug Law Journal 35-50 (2003)

"Health Foods" in the European Union, including food supplements, are clearly classified within the food sector, even though they are on the borderline between food and drugs. In order to solve trade problems resulting from this situation, the European Commission (EC) has proposed several pieces of legislation, which are currently under discussion in an attempt to harmonize all the rules and allow free circulation within the Member States. This article addresses the current legal status of the various categories of products (traditional foods with health claims; functional foods; fortified foods; foods for particular nutritional uses or food supplements) and details the regulations currently under discussion and the most recent case law of the EC Court of Justice.

The Drug Price Competition and Patent Term Restoration Act of 1984:
Fine-Tuning the Balance Between the Interests of Pioneer and Generic Drug Manufacturers
Author: Holly Soehnge
Issue: 58 Food and Drug Law Journal 51-80 (2003)

Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act), to address an imbalance between the patent protection interests of pioneer drug developers and the need of American consumers for lower-cost generic alternatives to pioneer drugs. Although the Act appears to be accomplishing its basic objectives of increased competition in the drug marketplace and increased innovation in new drug development, recent case law indicates the balance is being disturbed by some actions in the drug industry. Proposed legislation, as well as rules proposed by the Food and Drug Administration, address problems encountered under the Hatch-Waxman Act; however, legislative changes may be needed to restore the balance. This article seeks to provide both a comprehensive review of the Hatch-Waxman Act and related statutory and case law and an analysis of how legislative and regulatory changes may be needed to thwart the undermining of the Act's objectives by the drug industry.

Regulating the Fate of Pharmaceutical Drugs: A New Prescription for the Environment
Author: Christopher T. Nidel
Issue: 58 Food and Drug Law Journal 81-102 (2003)

Increasing international attention has been given to the impact of pharmaceutical drugs on the environment. This paper focuses on the scientific realizations that have been made over the last twenty years documenting the widespread contamination of the environment by human and animal drugs. Next, this paper presents the risks that may be associated with the prevalence of these compounds in the environment. Combined, these provide a basis for the argument that changes are needed to alter the current course of the pharmaceutical contamination of the environment. Three approaches to this problem are presented: a laissez-faire market solution, rethinking and redesigning sewage treatment, and relying on government regulation. The discussion of regulation begins with an overview of the Food and Drug Administration's (FDA's) approach to environmental assessment and suggests changes that may be made in response to new science. The final focus is on the availability of judicial review of FDA's action or inaction; issues of standing, ripeness, and the ultimate reviewability of the agency's action are addressed.

How Pharmacogenomics Will Impact the Federal Regulation of Clinical Trials
and the New Drug Approval Process
Author: Barbara Ann Binzak
Issue: 58 Food and Drug Law Journal 103-128 (2003)

The use of knowledge about pharmacogenomics—or how human genetic variations lead to different responses to drug products—appears by recent industry evidence to be the "next wave" in the pharmaceutical industry. The Food and Drug Administration (FDA) heavily regulates the approval of new drugs through the new drug approval (NDA) process. It is argued that FDA should be quick to recognize the increasing use of pharmacogenomics in drug design, and should change the NDA process, including how drug sponsors conduct—and FDA reviews-human clinical trials. Toward this end, it is critical 1) that FDA and the industry reconceptualize what it means to be "healthy" in a genetic sense versus in an external, or outward-appearing, sense; and 2) that new drug sponsors and FDA allow only those persons who are likely to respond to the drug, based upon this new definition of "healthy," to participate in the appropriate clinical trial phase. It is argued that FDA would be wise to make prospective changes in the NDA process for pharmacogenomic drugs, before the crest of the pharmacogenomics wave reaches the front doors of the agency.