by
Mark I. Schwartz, Associate Chief Counsel for Biologics, Food and Drug Administration, Rockville, MD

63 Food and Drug Law Journal 1-34 (2008)

In September 2006, the Institute of Medicine, part of the National Academy of Sciences, released a report on drug safety, commissioned by the Food and Drug Administration, arguing that the agency be given the power to impose a two-year moratorium on direct-to-consumer (DTC) advertisements.  In 2007, bills were introduced in both houses of Congress empowering the Secretary of Health and Human Services to impose moratoria on DTC advertising for certain newly approved drugs.

Although these bills were not incorporated into the Food and Drug Administration Amendments Act of 2007, there remains significant support for a new-drug moratorium on Capitol Hill, and among interest groups, medical organizations, a majority of physicians and at least one presidential candidate.

The United States remains one of only two countries in the Organization for Economic Cooperation and Development that allows DTC advertising of prescription drugs.  As a result, there is a real possibility that a future Congress will pass, and a president will sign, legislation imposing some sort of moratorium on DTC drug advertising.  This article considers whether these, or any similar bills, would be constitutionally valid under the First Amendment.

by
Julia Ariel Miller, Attorney-at-Law

63 Food and Drug Law Journal 35-74 (2008).

In contrast with the numerous regulations enforced by the Food and Drug Administration (FDA) and the U.S. Department of Agriculture on food processors, manufacturers and distributors, there are relatively few rules governing the sanitary transport of food.  In the past two decades, transport-related safety incidents have prompted interest in additional rules and regulations.  However, these efforts largely have been hampered for many reasons, from misdelegation of responsibility to lack of agency resources.

Some sectors of industry have responded independently and undertaken safety measure voluntarily.  Some new food safety rules also address food transport concerns, although often as an afterthought.  Recently, responsibility for regulating food transportation has been reassigned to FDA, which, although perhaps well-suited for the job, lacks the necessary funds.  Yet, while some concerns have been addressed tangentially, this central fact remains: The law remains largely the same as it was in 1990.

This article highlights the technical and logistical considerations involved in transporting food, reviews the history of the regulation of food transportation in the United States and provides an analysis of current law.

by
Shana Campbell Jones, Adjunct Professor, Old Dominion University, Norfolk, VA
Joseph McMenamin, Partner, McGuireWoods LLP, Richmond, VA
David C. Kibbe, Senior Advisor, American Academy of Family Physicians, Leawood, KS

63 Food and Drug Law Journal 75-88 (2008).

Interoperability allows for digitized data collected from two or more different sources to be exchanged and compared.  In the effort to develop a nationwide health information technology infrastructure, the interoperable electronic health record (EHR) has been the focus of much discussion and debate.

EHRs are touted as providing clinicians access to patients’ complete medical histories, physical findings, and lab and imaging data; allowing for electronic reminders and alerts; reducing errors; and improving quality of care by improving communication between patients and providers.

Although EHR advocates, EHR vendors, policymakers and standards-setting organizations will undoubtedly play important roles in defining how EHRs are adopted and implemented for years to come, the legal system also looms large as a factor.

This article discusses potential legal issues surrounding EHRs, particularly with respect to their interoperability.  This article posits that the legal issues associated with the widespread interoperable EHR fall into these areas:  the doctor-patient relationship; the standard of care; statute of limitations; new theories of causation; product liability issues; exposure to fraud; and privacy.

The article recommends that liability should be limited for health care providers adopting EHRs so that the promise of interoperable information exchange may be realized.

by
Brian Wilhelmi, Student, Arizona State University, Tempe, AZ

63 Food and Drug Law Journal 89-112 (2008).

Nanotechnology is the science of small where particles are broken down to a minute size, and where quantum physics often replaces Newtonian physics and materials possess novel chemical and physical properties.  Researchers have speculated about the use of this “room at the bottom” of material engineering and product development for years, but harnessing the technology is just now beginning to bear fruit.

In this calm before the “nano-storm,” the Food and Drug Administration (FDA) is staring at a limitless incorporation of natural and engineered nanotechnologies into the full breadth of the products under their regulatory jurisdiction within a handful of years.  The question at this point is whether the FDA will have the resources and expertise to fulfill its mission of promoting beneficial technology while protecting the public’s safety under these circumstances.

Silver, a product of almost universal human familiarity, is a material that takes on an antimicrobial property at the nanoscale.  As an antimicrobial it has found a calling in providing greater sanitation, hygiene, and health in an ever expanding array of products.  It is this multitude of utilities that has made human contact with silver nanoparticles inevitable.
Due to its broad array of applications and rich history of FDA regulation, silver becomes an excellent case study for the application of existing FDA expertise and statutory authority to a sentinel product of nanotechnology.  By analyzing the FDA’s reaction to silver, all involved can further understand the needs of the agency and the future regulatory path for other nanotechnologies through an experience with a  real-life example.

by
Jon Felce, Associate, Jones Day, London, EU

63 Food and Drug Law Journal 113-130 (2008).

Since July 1, 2007, European Union (EU) legislation on nutrition and health claims has applied in the EU, with the aim of harmonizing such claims across the current 27 EU member states and providing a framework to ensure consumers are not misled.

This has been merely part of the desire for increased consumer information, driven as much by regulations as by food producers, retailers and consumers themselves.  In the EU, there is now an extensive food labeling regime, covering not just the information necessarily required to be present on labels, but rules for information voluntarily provided and the way information is presented.  This area of law is continuing to evolve and is currently the subject of a review by the European Commission.

This trend toward increased labeling and information for consumers has been mirrored by potentially conflicting moves to curb excessive packaging and packaging waste.  EU legislation has established various targets and objectives with the aim of reducing the impact of packaging and packaging waste on the environment, in particular in connection with its impact on landfill.

In recent months, various further initiatives have been proposed and the desire for a more environmentally-friendly society shows no signs of abating.  This article looks at these concurrent movements, in particular with the reference to the United Kingdom, and suggests that a delicate balance needs to be maintained between them.

by
Jon F. Murphy, Associate, Woodcock Washburn LLP, Philadelphia, PA

63 Food and Drug Law Journal 131-150 (2008).

The Cloned Food Labeling Act, introduced in Congress in 2007, requires that foods produced from cloned animals and their progeny bear labels indicating this fact.  The only type of cloning to which the label applies is the new form of cloning that was used to produce Dolly the sheep, who was a copy of another adult sheep.  The b ill was introduced shortly after the Food and Drug Administration (FDA) announced its conclusion that foods from animals cloned by this new process are as safe as foods from conventional animals, and animals cloned by existing techniques.

There is a strong scientific consensus that cloned foods are safe, and an even stronger one that food from the progeny of cloned animals is safe.  Nevertheless, the vast majority of the American public favors a labeling requirement, and a significant fraction of the public finds animal cloning immoral, and believes it should be illegal.

This paper attempts to make some sense out of the collision of food safety and food morality by showing that the legislation is premised upon a belief that it is beneficial to America for consumers to know the process by which their food is made.  After exploring this premise and its consequences for cloned food, the paper offers the key flaws of the Act and how they can be corrected.

by
Krista Hessler Carver, Associate, Covington & Burling LLP, Washington, DC

63 Food and Drug Law Journal 151-216 (2008).

This article examines how recent First Amendment case law affects the food and drug regulatory system.  Since 1997, three prominent cases have demonstrated that the First Amendment limits the ability of the Food and Drug Administration (FDA) to regulate labeling, advertising, product claims, off-label promotion and other speech.

This article investigates this food and drug case law, governing First Amendment doctrine, and responses to FDA’s Request for Comment on First Amendment Issues.  In light of these relevant sources, it analyzes the constitutional propriety of the current food and drug regulatory regime and suggests reform where appropriate.

63 Food and Drug Law Journal 217-256 (2008).

When a serious medical emergency strikes, the hope is that the individual will receive life-saving treatments, physical and neurological functioning will be restored and there will be few, if any, long-lasting, adverse effects.  To achieve this positive outcome, controlled clinical trials of new and existing drugs and devices must be conducted in subjects experiencing life-threatening conditions, such as cardiac arrest, stroke or traumatic injury.
These clinical trials present special challenges because subjects often are incapable of providing informed consent, medical intervention must be provided within a brief therapeutic window and a legally authorized representative may not be available to provide consent for the individual to participate in a research study.

In 1996, the Food and Drug Administration (FDA) amended the informed consent regulations to allow clinical emergency research to be conducted with waiver of informed consent under very restricted conditions.  Although initial use of this regulation was rare, ongoing emergency research studies plan to enroll tens of thousands of subjects without obtaining informed consent form the subjects or their legally authorized representatives.

In this paper, the emergency research regulations are reviewed, with emphasis on the special protections afforded to non-consenting subjects.  Regulations from the HIPAA Privacy Rule that are applicable to non-consenting subjects participating in emergency research studies are discussed.  The paper also reviews completed and ongoing emergency research studies, evaluates the outcome of key assumptions made by FDA when the regulation was enacted in 1996 and provides recommendations for addressing shortcomings in the implementation of the regulation.

by
Roseann B. Termini, Attorney-at-Law, Wynnewood, PA
Leah Tressler, Student, Widener University School of Law, Wynnewodd, PA

63 Food and Drug Law Journal 257-274 (2008).

Today, more people are using cosmetics on a daily basis.  What was once nothing more than a small-scale, door-to-door sales operation has become a multi-million dollar industry.

Concerns for cosmetic safety first arose in the early 1900s, as consumers faced adverse health effects from dangerous ingredients in product formulations.  Along with the growth of cosmetic sales has come an increase in public requests for safety measures to prevent cosmetic hazards.

Public concerns influenced Congress to include cosmetic regulation in the Food, Drug, and Cosmetic Act of 1938.  to date, there has not been substantial change in cosmetic regulation.  More recently, consumers have expressed desires for the adoption of more stringent regulation.

This paper reviews the history of cosmetic regulation, provides a critique of the effectiveness of current regulations and highlights important issues concerning globalization, consumer demand, and the resulting impact on industry manufacturers.

by
Michael Enzo Furrow, Associate, Fitzpatrick, Cella, Harper & Scinto, New York, NY

63 Food and Drug Law Journal 275-320 (2008).

The period of new drug market exclusivity finely balances the incentives to innovate against the deadweight loss consequent to the monopoly pricing paradigm.  Legal equilibrium has been maintained in recent years, at a point that enables ample drug discovery and generic competition, due to strong lobby representation from the drug innovators on one side, and from the generic drug manufacturers and consumers on the other.

The recent decision by the Supreme Court in KSR v. Teleflex threatens to disrupt the present balance, as pharmaceutical innovators may be at risk of losing some of the essential patent tools by which to maintain market exclusivity long enough to recoup the costly drug discovery and development investment.

The court in KSR was motivated by the basic normative considerations that underlay the patent right in this country―promoting the progress of science and the useful arts.  While the decision may serve that purpose for some industries, the effect experienced by the innovator drug industry appears to be just the opposite.

This paper provides background on some of the technological, legislative, and judicial forces that play upon the pharmaceutical industry, and reviews the KSR decision and a few pharmaceutical patent decisions of lower courts.  The discussion illustrates how the present paradigm of technology-blind patentability jurisprudence can be complicating, rather than clarifying.  The industries that are reliant upon the patent grant are tremendously diverse, and the courts should consider evaluating industry differences in future jurisprudential adjustments.

63 Food and Drug Law Journal 321-374 (2008).

Gene therapy clinical research in the United States is regulated by FDA, and to a lesser degree, by NIH.  During the period between 1999 and 2001, both of these agencies separately went about modifying their regulations to explicitly deny confidential status to gene therapy safety reports submitted to the respective agencies, or in the case of the Food and Drug Administration, to affirmatively require public disclosure of such information over the Internet.

The Biotechnology Industry Organization (BIO) responded with comments to the proposed changes of each agency.  Although these proposals were modified or withdrawn before the dispute ever elevated into litigation, statements made by the agencies and by BIO indicate the postures that the parties would have taken if they ultimately resorted to court.  This paper provides history and background on the regulation of gene therapy by FDA and the NIH, and describes the body of law (reverse FOIA) that would have governed the dispute had it gone to trial.

Finally, the paper discusses the regulations proposed by NIH and FDA, the reverse FOIA arguments offered in support of and against such regulations, analyzing these arguments and evaluating additional arguments that had not been discussed by the parties.

63 Food and Drug Law Journal 375-390 (2008)

This paper presents a basic argument for the creation of a third class of behind-the-counter (BTC) drugs in the United States.

Part I discusses the approval of the Plan B emergency contraceptive as a potential paradigmatic shift in the Food and Drug Administration’s two-class system of prescription (Rx) and nonprescription (OTC) drug products.  Part II discusses the history of the two-class system and several contemporary trends that lend support to the creation of a BTC class.  Part III enumerates several viable BTC product categories, including some that are already sold BTC as mandated by state and/or federal law.

The paper then addresses two potentially viable approaches to the creation of a BTC class: an administrative rulemaking, and a congressional amendment to the Food, Drug, and Cosmetic Act.  The paper concludes that to give the agency the power to compel BTC switches, an amendment may be necessary to create a federally regulated BTC class.