Allan M. Joseph

Hoping to increase the number of drugs tested in children, Congress and FDA have placed a set of incentives for and requirements on drug manufacturers, notably through sections 505A and 505B of the Food, Drug, and Cosmetic Act. Using publicly-available data, I demonstrate that many drugs still lack pediatric study, and that many pediatric studies provide only weak evidence. I also show that requirements have been more important than incentives in encouraging these trials. Finally, I recommend steps Congress and FDA can take to improve the evidence available to pediatric prescribers to ensure drugs are used safely and effectively in children.

Rita-Marie Cain Reid

In May 2016, the Organic Trade Association (OTA) petitioned the United States Department of Agriculture (USDA) to establish a federal research and promotion program for organic products. This paper discusses the statutory basis for agricultural marketing under USDA. The paper explains some of the legal issues inherent in organic marketing, including free speech concerns. The paper analyzes specifics of the proposed organic marketing program. The paper concludes with recommendations and future research opportunities.

Lee Kennedy-Shaffer

A prominent feature of statistical reasoning for nearly a century, the p-value plays an especially vital role in the clinical testing of new drugs. Over the last fifty years, the U.S. Food and Drug Administration (FDA) has relied on p-values and significance testing to demonstrate the efficacy of new drugs in the premarket approval process. This article seeks to illuminate the history of this statistic and explain how the statistical significance threshold of 0.05, commonly decried as an arbitrary cutoff, is a useful tool that came to be the cornerstone of FDA decision-making.

Eric Lindenfeld

Over the past half-decade, the Supreme Court has issued a succession of opinions that have preempted all product liability claims made against the manufacturers of generic pharmaceuticals. While plaintiffs have attempted to evade these rulings through innovative legal theories, to date, they have been largely unsuccessful. As a result, lawsuits against brand name manufacturers have increased dramatically. Despite these developments, the implementation of clear preemption principles with regards to brand name products has lagged. While the Supreme Court has, on one occasion, attempted to clarify brand name preemption, the guidance was vague, cryptic and has led to a hodgepodge of conflicting judicial decisions. This confusion has led legal experts, academics, and practitioners to call upon the Court to revisit the field of brand name preemption.

This Article is an attempt to assemble, centralize, and clarify the most misunderstood areas of brand name preemption. It is also an attempt to forecast the future of some of the most uncertain areas underlying the field. It is cautioned that this Article does not attempt to offer a solution to the growing judicial inconsistencies concerning brand name preemption. Nor should this Article be read to endorse either side of the preemption debate. Rather, it is the hope of the author that the Article generate greater interest in the field of pharmaceutical product liability litigation and stimulate a deeper discussion into its ultimate fate. At the very least, the investigation conducted herein should function as a useful starting point for the academic, judge, or practitioner who has found themselves in the marsh that is brand name preemption.

David E. Paul and Catherine Clements

Biomarkers are essential tools in expediting the development of new drugs, particularly Precision Medicines. While an innovator biopharmaceutical company often utilizes biomarkers to support developing their own drug, innovators may also seek to have biomarkers “qualified” by FDA. “Qualification” is an FDA determination that within an approved, specific context of use (COU) the qualified biomarker can be relied upon to have a specific use or interpretation to support drug development. That is, the biomarker will be publicly available for its COU to support any innovator’s applicable drug development program and application, without the need for FDA reviewers or the innovator to reconfirm the validity of the biomarker for its COU.
Recognizing the need to help accelerate biomarker qualification, Congress, in passing the recent 21st Century Cures Act, effectively statutorily codified FDA’s biomarker qualification process and included provisions for FDA to utilize external experts at the agency’s discretion. This paper argues the agency should follow historical precedent, fully utilizing an external expert consortium to conduct first substantive reviews and to make recommendations to FDA on biomarker submissions. We recommend the agency pilot this approach to explore further considerations such as application of its conflict of interest rules, process timelines, and costs involved.

Council for Responsible Nutrition, Healthcare Nutrition Council, and Infant Nutrition Council of America