FDLI Publications: Food and Drug Law Journal 49-4

Volume 49 Issue 4

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> Unapproved Uses of Drugs: An Analysis and Some Proposals
> Pre-Approval Promotion of Medical Devices
> I've Got You Under My Skin—And I Can't Get Redress: An Analysis of Recent Case Law Addressing Preemption of Manufacturer Liability for Class III Medical Devices
> FDA Enforcement Initiatives in the United States and Abroad
> Certificates of Free Sale
> Some Major Issues in Direct-to-Consumer Advertising
> Orphan Products—Ten Years Later and Then Some
> ISO 9000 and HACCP Systems
> Regulation of Pesticide Residues in Foods:
Proposed Solutions to Current Inadequacies Under FFDCA and FIFRA
> The States' Role in Regulating Food Labeling and Advertising: The Effect of the Nutrition Labeling and Education Act of 1990

Unapproved Uses of Drugs: An Analysis and Some Proposals
Author: Richard M. Cooper
Issue: 49 Food and Drug Law Journal 533-540 (1994)

This article examines some of the policy considerations that will enter into the legal analysis, and that are independently important, surrounding off-label uses of previously approved drugs. The issues it raises can be identified at the intersection of five distinct missions of sets of values and interests: the Food and Drug Administration's dual mission of protecting public health and preventing consumer deception; the scientific community's mission to determine scientific truths; individual physicians' mission to provide patients with good medical care; pharmaceutical manufacturers' mission to produce quality products at an acceptable profit; and the First Amendment's mission to preserve the freedoms of speech and the press. Each of these missions is explored to ascertain how they bear on the issue at hand.

Pre-Approval Promotion of Medical Devices
Author: Michael D. Petty
Issue: 49 Food and Drug Law Journal 541-552 (1994)

Medical device promotion is an area of changing regulatory interpretation and increased enforcement. This is true not only for the promotion of marketed devices, but for investigational devices as well. Because the existence of an investigational device exemption is confidential, Food and Drug Administration action against device companies for promotional activity prior to clearance/approval often does not receive the same publicity as actions for marketed devices. Thus, the importance of compliance can be underestimated. This article reviews the pre-approval promotional requirements for devices and cites regulatory trends in this area. The article also encourages greater public input into this process--a policy area with unique medical information concerns.

I've Got You Under My Skin--And I Can't Get Redress: An Analysis of Recent Case Law Addressing Preemption of Manufacturer Liability for Class III Medical Devices
Author: Gail H. Javitt
Issue: 49 Food and Drug Law Journal 553-574 (1994)

Federal courts, with few exceptions, recently have interpreted the Medical Device Amendments of 1976 (MDA) as preempting state tort law claims involving Food and Drug Administration (FDA)-approved Class III medical devices, including claims of manufacturer fraud on the FDA. These decisions arguably will have the effect of denying those injured by medical devices (such as heart valves and other implantable devices approved after 1976) any recovery for their injuries. This article argues that these decisions contravene the traditional balance between state and federal authority over health and safety issues, misconstrue both statutory language and congressional intent, and are contrary to Supreme Court authority that clearly supports a narrow reading of preemption provisions such as that contained in the MDA. Further, the article argues that these decisions represent a dangerous and ill-conceived policy choice in light of the FDA's inability to regulate devices adequately. The author recommends congressional amendment of the MDA to clarify the scope of preemption intended.

FDA Enforcement Initiatives in the United States and Abroad
Author: Arvin P. Shroff
Issue: 49 Food and Drug Law Journal 575-580 (1994)

The winds of change have been sweeping the Food and Drug Administration (FDA) since Dr. David Kessler became the Commissioner of Food and Drugs. The needle on the enforcement compass, which was stuck on "business-as-usual," has been spinning and pointing in a new direction ever since. Since December 1990 Commissioner Kessler's message has been that FDA enforcement would be revitalized, and it has become apparent to the agency and to the regulated industry that he is a man of his word. Enforcement has been and continues to be Dr. Kessler's number one priority. Over the last few years, the FDA has branched out both in domestic and international arenas that are discussed in this article. In addition, the European Union, the Pacific Rim countries, and the North American Free Trade Agreement will play large roles in the future; this article discusses how the FDA plans to deal with these new developments.

Certificates of Free Sale
Author: Emalee G. Murphy
Issue: 49 Food and Drug Law Journal 581-588 (1994)

A Certificate of Free Sale (CFS) is an assurance by public or private U.S. organizations to the importing country that products identified in the Certificate are produced in the United States, are within the jurisdiction of specified regulatory agencies, are lawfully on the U.S. market, and are not restricted for export. Certificates usually are notarized; authenticated by a government agency, such as the U.S. State Department; and consularized by the importing country. The final document often is sealed and bound with ribbons.

Unlike export permits issued for products not yet authorized for sale in the United States, Certificates are available only for products already approved or permitted in the United States and, although Certificates may be prepared by U.S. government agencies, they are not required by those agencies as a condition of export but rather, they are required by the importing country as a condition of import. For this reason, U.S. regulatory organizations such as the Food and Drug Administration (FDA) have in the past viewed preparation of Certificates as generally outside their normal duties, and FDA staff charged with fulfilling Certificate requests historically have been reluctant to promote or advertise the Certificate programs. In the absence of centralized direction, each FDA Center developed its own procedure for issuing Certificates. This article discusses those procedures.

Some Major Issues in Direct-to-Consumer Advertising
Author: Wayne L. Pines
Issue: 49 Food and Drug Law Journal 589-592 (1994)

The Food and Drug Administration's policy of approving in advance all product-specific direct-to-consumer (DTC) advertising removes enforcement issues, but larger issues about DTC advertising remain. Should such advertisements be permitted on television? What kind of "brief summary" information is needed? What role should DTC advertising play as the health care system changes? These issues warrant national debate, especially as managed care becomes more prominent and that industry seems to oppose any communication that drives patients into their physicians' offices.

Orphan Products--Ten Years Later and Then Some
Author: Marlene E. Haffner
Issue: 49 Food and Drug Law Journal 593-602 (1994)

During the first ten years of Orphan Drug Act implementation, drug sponsors have introduced many original ideas to the Food and Dug Administration's Office of Orphan Product Development. Innovative and unique ways of fulfilling the purpose of the Act have brought about an ever-changing regulatory program. This article discusses that program, as well as some of the events in the last decade that have contributed to the current status of orphan product regulation.

ISO 9000 and HACCP Systems
Author: Catherine E. Adams
Issue: 49 Food and Drug Law Journal 603-608 (1994)

Understanding the ISO 9000 quality systems, the Hazard Analysis Critical Control Point (HACCP) program, and their interrelationship is important, but they often are misperceived. ISO 9000 is well recognized as a tool for certifying quality management programs in Europe and in many U.S. industries other than food. ISO 9000 also is becoming a requirement in some sectors to compete successfully in the international trading marketplace. HACCP is employed by the U.S. regulatory community as a tool for ensuring food safety.

The ISO 9000 Standard was designed as a generic tool to ensure the consistent manufacture of a product as designed. Its requirements describe the building blocks of a sound management program. ISO 9000 does not address food safety or food manufacturing specifically, but food safety can be controlled through the application of ISO quality system requirements and HACCP programs for specific food products. These two systems are compatible because they emerged from a common philosophy of quality management. The food industry increasingly recognizes that a combination of ISO 9000 quality systems and HACCP food safety control programs is an optimal management tool that can target product consistency and food safety as manufacturing objectives. For regulators, the combined management program ensures that both food safety and regulatory compliance goals are met.

Regulation of Pesticide Residues in Foods:
Proposed Solutions to Current Inadequacies Under FFDCA and FIFRA
Author: Carol S. Curme
Issue: 49 Food and Drug Law Journal 609-648 (1994)

This article examines and provides solutions to the inadequacies of the statutes presently governing the registration and regulation of food-use pesticides. Government and private groups have called for the reform of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Amendments of 1988 and the Federal Food, Drug, and Cosmetic Act (FFDCA). The centerpiece of debate is the inconsistent treatment of pesticides in raw and processed foods. The inconsistency arises from the application of the Delaney Clause of section 409 of the FFDCA. The current statutory scheme has resulted in the "Delaney Paradox," whereby inconsistent standards applied to raw and processed foods actually increase the risk of cancer. The removal of pesticide residues beyond the reach of the Delaney Clause, and a consistent standard for all pesticide residues, would eliminate the Delaney paradox.

Reforms under FIFRA should result in the reduction of pesticide use without jeopardizing the ability to produce inexpensive fruits and vegetables. This can be accomplished by providing farmers with incentives to use safer farming techniques, and by providing manufacturers with incentives to register or reregister the more valuable pesticides. FIFRA also should provide a fixed expiration date for all pesticide registrations so that the Environmental Protection Agency can remove "old pesticides" from the market efficiently.

The States' Role in Regulating Food Labeling and Advertising:
The Effect of the Nutrition Labeling and Education Act of 1990
Author: Michele M. Bradley
Issue: 49 Food and Drug Law Journal 649-674 (1994)

In 1990, Congress enacted the Nutrition Labeling and Education Act (NLEA), which amended the Federal Food, Drug, and Cosmetic Act. The NLEA significantly changed the contents of food packaging labels, particularly the mandatory nutrition information and the types of health and nutrition claims permitted. The NLEA also altered substantially the role of the states in regulating food labels. In an effort to foster nationally uniform labeling requirements, the NLEA expressly preempts many state labeling laws that are inconsistent with the federal statute. To encourage greater state participation in enforcement activities, the statute permits states to enforce the NLEA in federal court. The NLEA is likely to increase uniformity in labeling requirements from state-to-state, although perhaps not as much as some had hoped. It also is likely to spawn conflicts between federal and state agencies as they determine what role each should play in enforcing the NLEA. This article examines the factors that led to the enactment of the NLEA and discusses the likely effects of the NLEA's preemption and state enforcement provisions on the regulation of food labeling and advertising.