FDLI Publications: Food and Drug Law Journal 51-1

Volume 51 Issue 1

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> Preemption and Medical Devices: A Response to Adler and Mann
> The Prescription Drug Marketing Act: A Solution in Search of a Problem?
> Drug Labeling and Promotion: Evolution and Application of Regulatory Policy
> Hints on Preparing Successful Orphan Drug Designation Requests
> Should the FDA Regulate Nicotine-Containing Cigarettes? Has the Agency Established a Legal Basis
and, If Not, Should Congress Grant It?
> Reinventing the Biologics Approval Process
> FDA Regulatory Review and Approval Processes: A Delphi Inquiry
> Industry View on the Regulation of Ancillary Reagents
> "The Article 30 Solution": An Alternative to Market Food Contact Materials in the European Union
> The International Tower of Babel: The Small Business Perspective
> The Regulation of Health Claims in Food Advertising: Have the FTC and the FDA Finally Reached a Common Ground?

Preemption and Medical Devices: A Response to Adler and Mann
Authors: Mark Herrmann and Geoffrey J. Ritts
Issue: 51 FOOD AND DRUG LAW JOURNAL 1-19 (1996)

The majority of courts that have considered the issue of federal preemption of state common law torts under the Medical Device Amendments have decided that the Amendments do preempt such claims. The only major differences in the case law concern the scope of that preemption. Contrary to this judicial authority, Professors Robert Adler and Richard Mann recently argued that the Medical Device Amendments should not be read as preempting state tort law. This article asserts that Adler and Mann's argument is flawed, by drawing on the language of the Amendments, other statutes, the legislative history, and the case law. The article concludes that the Medical Device Amendments broadly preempt state tort law.

The Prescription Drug Marketing Act: A Solution in Search of a Problem?
Author: Robert T. Angarola and Judith E. Beach
Issue: 51 FOOD AND DRUG LAW JOURNAL 21-55 (1996)

Despite a lack of support from the President and the Food and Drug Administration (FDA), Congress enacted the Prescription Drug Marketing Act (PDMA) in 1988. The PDMA is a comprehensive, complicated, costly law covering a broad spectrum of pharmaceutical industry activities: the reimportation of American-made prescription human drugs, the distribution of prescription drug samples, the licensing of wholesale drug distributors, and the resale of prescription drugs purchased by hospitals, health care entities, and charitable institutions. Although in 1992 Congress added a scienter requirement to the civil and criminal sanctions for violating the PDMA, the maximum penalties remain severe. Nevertheless, except for serious violations, the enforcement of the PDMA has been inconsistent, and most of the cases on record could have been prosecuted under other laws. This article concludes that, with the anticipated streamlining of the FDA and its laws, Congress ought to narrow the coverage of the PDMA.

Drug Labeling and Promotion: Evolution and Application of Regulatory Policy
Author: Thomas A. Hayes
Issue: 51 FOOD AND DRUG LAW JOURNAL 56-74 (1996)

Recent developments in health care delivery due to the rapid growth of managed care include fewer but more important "customers" purchasing prescription drugs, new marketing initiatives by the pharmaceutical industry, and renewed emphasis on cost containment. Through its labeling and advertising regulations, the Food and Drug Administration (FDA) continues to control drug promotion, directing additional enforcement efforts towards "switching" programs and nontraditional forms of promotion that occur in scientific and educational activities. First Amendment objections have been raised in response to the FDA's publication of a draft policy creating a "safe harbor" for qualifying continuing medical educational programs funded by the pharmaceutical industry. The FDA maintains that its approach to regulating product information is inherently congruent with its mission. This article examines the statutory basis for the agency's actions, which often seem to be novel applications of regulatory policy.

Hints on Preparing Successful Orphan Drug Designation Requests
Author: Paul V. Buday
Issue: 51 FOOD AND DRUG LAW JOURNAL 75-84 (1996)

The new drug regulations describe the format and substantive content of a formal request for orphan drug (pharmaceutical, biological, or biotechnological) designation for a product for the treatment or prevention of a rare (orphan) disease. The Food and Drug Administration (FDA), however, often finds that these requests are poorly prepared, which results in an unnecessary volley of questions and replies between the agency and the applicant. This paper enumerates the advantages in gaining orphan drug designation, where feasible, and provides recommendations as to how applicants can gain these advantageous designations in a more timely fashion.

Should the FDA Regulate Nicotine-Containing Cigarettes?
Has the Agency Established a Legal Basis and, If Not, Should Congress Grant It?
Author: Susan H. Carchman
Issue: FOOD AND DRUG LAW JOURNAL 85-138 (1996)

In August 1995, the Food and Drug Administration (FDA) proposed to regulate specific nicotine-containing tobacco products as combination drug/device products. The proposed regulations would permit the FDA to regulate the sale and distribution of tobacco products to children and adolescents, but also would allow the agency to take additional unspecified measures in the future. The FDA's reversal of its long-standing position that it did not have jurisdiction to regulate cigarettes unless the manufacturer made express health claims was based on two essential findings: (1) that the level of nicotine in nicotine-containing cigarettes was addictive and (2) that cigarette manufacturers intended their products to deliver levels of nicotine to keep smokers addicted. This article reviews several key issues regarding nicotine addiction, manufacturer intent, and public policy about smoking, and concludes that the FDA does not have jurisdiction to regulate nicotine-containing tobacco products, unless therapeutic claims are stated or implied, and that Congress should not grant such jurisdiction to the agency.

Reinventing the Biologics Approval Process
Author: John C. Petricciani
Issue: 51 FOOD AND DRUG LAW JOURNAL 139-142 (1996)

Bringing new medical products to market involves a series of long and expensive steps, not the least of which is the approval process. If viewed in isolation, the possibilities for change in the way approvals process are more limited than if the approval process is considered along with overall changes in the drug development and postmarketing process. This article looks at the approval process particularly as it operates in the Food and Drug Administration's (FDA's) Center for Biologics Research and Evaluation; notes the difficulties in categorizing and processing products that are combinations of drugs, biologics, and/or medical devices; and concludes that the FDA's current organizational structure is an impediment to the agency's fulfilling its mission in a world that is vastly more complicated than what was anticipated when that structure was instituted.

FDA Regulatory Review and Approval Processes: A Delphi Inquiry
Author: Bogdan Dziurzynski
Issue: 51 FOOD AND DRUG LAW JOURNAL 143-153 (1996)

For the past five years improving regulatory practices has been a recurring agenda item in meetings between industry and the Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER). Striving for change and improvement, however, has not been solely an industry-owned concept. CBER staff also have been instrumental in synthesizing policy and procedural improvements. The leadership of senior agency officials is exemplified in several innovative regulatory initiatives such as the Managed Review Process, Report Reduction, Use of Pilot Manufacturing Facilities, Cooperative Manufacturing Arrangements, and Alternatives to Lot Release.

Business and political leaders in the United States want to maintain global technological competitiveness. Overregulation may obstruct both the proliferation of new companies and the stability and growth of existing small, innovative enterprises. This article presents research data gathered using a Delphi inquiry to identify what, if any, are the regulatory problem areas. This Delphi inquiry confirms that additional regulatory changes are needed.

Industry View on the Regulation of Ancillary Reagents
Author: Richard S. Schifreen & Cynthia Louth
Issue: 51 FOOD AND DRUG LAW JOURNAL 155-159 (1996)

Ancillary products are used in the manufacture of agents for somatic cell and gene therapy. The same products also may be used in basic research and tissue and organ transplantation. Despite efforts to facilitate approval for an investigator to use ancillary products, manufacturers remain reluctant to make them available. A major impediment is the fact that the current regulations place responsibility on the manufacturer to prevent sales of these products to qualified practitioners in nonFDA-regulated tissue and organ transplant programs. Industry believes that this regulatory environment is placing at risk further progress in both somatic cell and gene therapy, as well as in tissue and organ transplantation.

"The Article 30 Solution": An Alternative to Market Food-Contact Materials in the European Union
Author: Jean-Philippe Montfort
Issue: 51 FOOD AND DRUG LAW JOURNAL 161-173 (1996)

Article 30 of the Treaty of Rome allows for the legal sale in one Member State of the European Union (EU) of goods that do not comply with the laws of that Member State provided, in essence, that these goods are lawfully marketed in another Member State. In areas where the laws of Member States remain different, and pending their harmonization at EU level, mutual recognition represents a valid alternative for companies that wish to sell their products lawfully throughout the EU. This article describes the concept of mutual recognition and discusses how, in practice, it can be used for marketing food contact materials in the EU. The article concludes that the use of this concept requires a tailored strategy that is designed on a case-by-case basis for a particular material or application and that takes into account the applicable EU and national legislation.

The International Tower of Babel: The Small Business Perspective
Author: Marsha A. Echols
Issue: 51 FOOD AND DRUG LAW JOURNAL 175-190 (1996)

This article focuses on nutrition labeling as a contributor to the international Tower of Babel, in which governments have used incongruous regulatory approaches and thereby imposed high costs on small businesses. It describes the role of the codex Alimentarius commission, whose guidelines provide the international standard against which labeling requirements will be measured. The article compares the differing regulatory approaches of Canada, the European Community, and the United States regarding voluntary versus mandatory nutrition labeling, product coverage, listing of nutrients, the reference unit, location of labels, and claims. As solutions for the problems identified, the article suggests that in the long term countries should be more willing to harmonize their requirements, including the development of a graphic or pictorial food label; in the short term countries should commit to using an international model as the basis of new regulations and consider accepting the equivalency of a foreign government's approach.

The Regulation of Health Claims in Food Advertising:
Have the FTC and The FDA Finally Reached a Common Ground?
Author: Douglas W. Hyman
Issue: 51 FOOD AND DRUG LAW JOURNAL 191-205 (1996)

This article discusses the practical results of the Federal Trade Commission's (FTC's) response to the Nutrition Labeling and Education Act of 1990 (NLEA), namely its May 13, 1994 announcement of policy to promote consistency in health claim standards for food advertising, which it regulates, and for food labeling, as regulated by the Food and Drug Administration (FDA). The article begins with an overview of health claims under the NLEA and a brief discussion on the regulatory authority of the two agencies in this area. The FDA's standard for regulating food label health claims is examined in contrast to the pre-May 13, 1994 FTC policy statement, and then the statement itself is specifically reviewed. Finally, the article argues in support of the FTC's efforts to coordinate regulatory approaches, and considers some new questions and repercussions that accompany the policy statement.