FDLI Publications: Food and Drug Law Journal 52-1

Volume 52 Issue 1

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> Remarks by the Commissioner of Food and Drugs
> The Lohr Decision: FDA Perspective and Position
> Preparing America’s Food Safety System for the Twenty-First Century —
Who is Responsible for What When it Comes to Meeting the Food Safety Challenges of the Consumer-Driven Global Economy?
> What Every Food Manufacturer Needs to Know:
Realizing the Impact of Globalization on National Food Regulation
> A Legal Assessment of FDA’s New HACCP Regulations
> The Food Label and the Right-to-Know
> New Challenges for Medical Product Promotion and Its Regulation
> Enforcement of the Current Good Manufacturing Practices for Solid Oral Dosage Forms After United States v. Barr Laboratories
> A Whole New World?: Pharmaceutical Responses to the Managed Care Revolution
> Commentary on Payment and Reimbursement Issues Affecting the Marketing of Drugs, Medical Devices, and Biologics, with Emphasis on the Anti-Kickback Statute and Stark II
> The Need for Balancing the Regulation of Pharmaceutical Trademarks Between the Food and Drug Administration and the Patent and Trademark Office
> Execution of a Criminal Search Warrant by FDA — Effective Preparation and Response
> An Interpretive Guide to Chairing an FDA Advisory Committee

Remarks by the Commissioner of Food and Drugs
Author: David A. Kessler
Issue: 52 Food and Drug Law Journal 1-6 (1997)

In his seventh and last address as Commissioner of Food and Drugs at FDLI's Annual Educational Conference, Dr. Kessler focused on a fundamental question facing today's Food and Drug Administration (FDA): How well does the agency do in getting important new therapies that are safe and effective to patients who need them? The Commissioner relied heavily on data regarding FDA's processing, turn-around times, and approval rates for new molecular entities, new drug applications, priority versus standard drugs and biologics, efficacy and manufacturing supplements, and resubmissions and returned applications. U.S. data was compared to data from the new centralized drug approval process of the European Union (EU), and the FDA's median time for review and approval for fifteen common drugs was faster than the EU's. Dr. Kessler saluted the hard work and contributions of all of the employees of the FDA Centers, calling the FDA "the most important consumer protection agency in the world."

The Lohr Decision: FDA Perspective and Position
Author: Margaret Jane Porter
Issue: 52 Food and Drug Law Journal 7-12 (1997)

The Medtronic v. Lohr decision affirms the Food and Drug Administration's (FDA's) long-standing presumption against preemption in implementing section 521 of the Federal Food, Drug, and Cosmetic Act. The suggestion, therefore, that Lohr represents a significant shift is not reflective of the agency's history and practice. Rather, the Lohr decision is an important affirmation of FDA's historical approach. This article seeks to help put Medtronic v. Lohr in context from the agency's perspective, and to explain why FDA took the position it did and why FDA regards the Supreme Court's holding as an important victory for consumer protection.

Preparing America's Food Safety System for the Twenty-First Century —
Who is Responsible for What When it Comes to Meeting the Food Safety Challenges
of the Consumer-Driven Global Economy?
Author: Michael R. Taylor
Issue: 52 Food and Drug Law Journal 13-30 (1997)

The recent hazard analysis critical control point (HACCP)-based food safety reforms adopted by the Food and Drug Administration and the U.S. Department of Agriculture will improve food safety and help maintain America's worldwide food safety leadership. There remain, however, a number of challenges related to food safety that must be met to ensure the future success of the American food system in the consumer-driven global economy of the twenty-first century. These include: further reducing the risk of foodborne illness; successfully managing the introduction of new food technologies; overseeing and facilitating international trade; and maintaining public confidence in the food supply. Meeting these challenges will require forging new approaches to interaction between the food industry and the government, and addressing some of the problems of coordination and resource utilization within government that stem from the statutory and organizational fragmentation of the federal government's food safety program. This article identifies some of the specific questions that need to be addressed to prepare America's food safety system for the future.

What Every Food Manufacturer Needs to Know:
Realizing the Impact of Globalization on National Food Regulation
Author: John S. Eldred & Shirley A. Coffield
Issue: 52 Food and Drug Law Journal 31-38 (1997)

The food standards-setting activities of the Codex Alimentarius Commission have achieved enhanced importance and status with the advent of the World Trade Organization (WTO) and its dispute settlement provisions. Under the WTO's Sanitary and Phytosanitary Agreement, and the Agreement on Technical Barriers to Trade, if United States' or other national regulations on food differ from Codex requirements, it may amount to a WTO violation. One example of this is the definitions and standards of identity promulgated by the Food and Drug Administration (FDA). Codex is in the process of revising its commodities standards to make them more flexible. Unless the United States follows suit, FDA standards may be challenged before the WTO. FDA and the U.S. food industry have the opportunity to positively influence the revision of both Codex and U.S. food standards to benefit consumers and to avoid lengthy, costly, and unnecessary trade disputes.

A Legal Assessment of FDA's New HACCP Regulations
Author: Stephen H. McNamara
Issue: 52 Food and Drug Law Journal 39-48 (1997)

In December 1995, the Food and Drug Administration (FDA) published new final regulations for "Fish and Fishery Products." The regulations require the application of Hazard Analysis Critical Control Point (HACCP) principles to the processing of seafood. This article reviews these new HACCP requirements from a legal and practical perspective. In particular, the article comments on whether FDA has the authority to establish these new requirements for the seafood industry and flags particular legal considerations about which seafood companies and their legal counsel ought to be aware.

The Food Label and the Right-to-Know
Author: Frederick H. Degnan
Issue: 52 Food and Drug Law Journal 49-60 (1997)

While the European Union is struggling with the alleged conflict between the consumers right-to-know and the proliferation of biotechnology and genetically engineered foods, the Food and Drug Administration's (FDA's) regulation of the food label has remained unaffected by numerous consumer right-to-know initiatives. This article will focus on FDA's longstanding regulation of the food label and Congress' limitations on the agency's ability to require information to appear thereon. The premise of the article is that those limitations were the product of foresight and, over the years, have resulted in a rational system of food labeling that serves the interests of the public by guaranteeing that consumers have the essential information they need to choose foods wisely. Efforts to broaden the permissible scope of required information beyond what is essential represent a dramatic departure from a history of regulation dedicated to ensuring that consumers are meaningfully informed about the food they buy.

New Challenges for Medical Product Promotion and Its Regulation
Author: Wayne L. Pines
Issue: 52 Food and Drug Law Journal 61-66 (1997)

Current trends in today's health care system have resulted in many new challenges for pharmaceutical companies as well as the Food and Drug Administration (FDA). Companies face the challenge of complying with FDA regulations as they attempt to deliver their messages effectively through new communications technologies. FDA faces the challenge of establishing policies that permit full disclosure and relate useful information to consumers, without the communication of erroneous information. Although FDA's regulation of paid advertising and the communication of medical product information is now institutionalized, the agency will face continued challenges in its ability to control such information, by the need for companies to market products and educate consumers, and by the need for consumers to have more information available to them.

Enforcement of the Current Good Manufacturing Practices for Solid Oral Dosage Forms
After United States v. Barr Laboratories
Author: Freddy A. Jimenez
Issue: 52 Food and Drug Law Journal 67-82 (1997)

This article provides a general overview of the current good manufacturing practice (CGMP) regulations as they apply to solid oral dosage forms for human consumption. This is accomplished by describing the statutory framework as interpreted by the case law, and then presenting the Food and Drug Administration's (FDA's) enforcement practices, followed by selected consequences of industry noncompliance. Most importantly, this article presents the interpretation of the regulations as provided by the Barr decision. While the conclusions of law presented in the opinion were limited to the facts of the case, this article demonstrates that the decision profoundly changed the dynamics of CGMP enforcement, as is evidenced by enforcement patterns and recent proposed rulemaking by FDA.

A Whole New World?: Pharmaceutical Responses to the Managed Care Revolution
Author: David A. Balto
Issue: 52 Food and Drug Law Journal 83-98 (1997)

The managed care revolution has made its way to pharmaceuticals. Buyers, faced with increasing pharmaceutical costs, have tried to export innovations in controlling other health care costs to the pharmaceutical arena. Many managed care providers include pharmaceuticals as part of their benefit programs. This article generally addresses how an important group in the managed care environment — pharmacists — can respond to the managed care revolution. In particular, it looks at the development of pharmaceutical benefit managers (PBMs), which play an important role in controlling health care costs, and how the acquisition of PBMs by pharmaceutical manufacturers may raise competitive concerns.

Commentary on Payment and Reimbursement Issues Affecting the Marketing of Drugs, Medical Devices, and Biologics, with Emphasis on the Anti-Kickback Statute and Stark II
Author: John B. Reiss
Issue: 52 Food and Drug Law Journal 99-108 (1997)

This article focuses pharmaceutical and other manufacturers' attention to various rules governing the sales and marketing of their products. It summarizes three aspects of Medicare and other third-party payors' programs that affect the success of manufacturers' sales and marketing programs: 1) coverage decisions concern how payors determine which pharmaceuticals and medical devices will be included in the items provided to the beneficiaries of those programs; 2) payment decisions concern the amount that will be paid for covered items; and 3) restrictions relate to the federal anti-kickback statute, which prohibits remuneration in exchange for or to induce business, Stark II, which prohibits referrals for items or services by physicians who have a financial relationship with the entity to which the referral is made, with certain exceptions; and various state anti-fraud and consumer protection statutes and regulations. Included in this discussion is the Medicaid rebate statute. The article identifies various limitations on sales and marketing programs that, if violated, could lead a manufacturer to criminal sanctions and exclusion from federal and state health programs. It also suggests the development of internal compliance and enforcement programs by manufacturers.

The Need for Balancing the Regulation of Pharmaceutical Trademarks Between the Food and Drug Administration and the Patent and Trademark Office
Authors: Daniel Boring & Chris Doninger
Issue: 52 Food and Drug Law Journal 109-116 (1997)

The U.S. Patent and Trademark Office (PTO) and the U.S. Food and Drug Administration (FDA) exert dual regulatory control over pharmaceutical trademarks. The PTO examines trademarks for federal registration under the Lanham Act, while FDA evaluates pharmaceutical trademarks under the Federal Food, Drug, and Cosmetic Act as part of the official labeling for drugs. This dual system of review provides a high level of protection for the public from confusing pharmaceutical trademarks. There is, however, uncertainty over the basis for FDA's role in trademark usage. This article discusses the trademarking process from both the PTO and FDA perspectives, and offers some constructive suggestions for improving this process.

Execution of a Criminal Search Warrant by FDA — Effective Preparation and Response
Author: Steven M. Kowal
Issue: 52 Food and Drug Law Journal 117-132 (1997)

Many FDA criminal investigations now being conducted by agents from the Office of Criminal Investigations (OCI). These agents have begun to use criminal search and seizure warrants, even when there is no apparent threat to public health or reason to believe that evidence will be destroyed if a less disruptive form of investigation is employed. When a search warrant is executed on a legitimate business, it can result in the seizure of the company's business records, its computer system, and even its product inventory. Such a process can disrupt the operation of the company, and even threaten its existence. Some of the harsher effects of the execution of a search warrant can be reduced by effective planning and a quick response on the company's part. Written procedures can be prepared that will provide information and guidance to a manager who must confront an unfamiliar and potentially hostile situation, thus avoiding decisions that will prejudice the company throughout the investigation. A rapid response could regain possession of, or secure access to vital information, without which a company may be deprived of this information for the duration of the investigation. Preparation and effective response could reduce the burden caused by the execution of the warrant, and help the company weather the storm of an ensuing criminal investigation.

An Interpretive Guide to Chairing an FDA Advisory Committee
Author: Randy P. Juhl
Issue: 52 Food and Drug Law Journal 132-140 (1997)

Food and Drug Administration (FDA) advisory committees provide independent expert scientific advice to the agency in open public forums. This system is a well developed interface between the scientific community and the agency that integrates broad participation into the agency's product approval and public policy setting processes. The intersection of scientific, capitalistic, and public interests, occasionally under the mindful eye of elected officials, constitutes a fascinating and sometimes challenging environment in which to hold a scientific discussion. Thus, the conduct of an advisory committee meeting must facilitate and not detract from this important mission. This article offers practical suggestions for advisory committee chairs, who bear the primary responsibility for ensuring that advisory committee meetings run smoothly and fulfill their public service mission.