Ralph Hall

• J.D.
• Professor at University of Minnesota

Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and diagnostics subject to regulatory oversight by the United States Food and Drug Administration. At the same time, there is substantial basis for concern about the uncertainties of accurately assessing the human health...

Background The blood recall process is intended to remove from use products that may be harmful, but characteristics of recalls nationally have not been reported.Study Design and Methods We analyzed recalls of all blood products for 2010 and categorized the reason for the recall, the organizations producing the recalled products, and the Food and D...

The nanomedicine field is fast evolving toward complex, "active," and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures....

For fifteen years Courts and Litigants have cited to the Supreme Court case, Medtronic, Inc v. Lohr to find product liability preemption for 510(k) cleared devices. When the Supreme Court decided Lohr in 1996, the Supreme Court correctly assessed the 510(k) system as it existed in 1982 — the year the product in question in Lohr was cleared by FDA....

Biobanks and archived data sets collecting samples and data have become crucial engines of genetic and genomic research. Unresolved, however, is what responsibilities biobanks should shoulder to manage incidental findings and individual research results of potential health, reproductive, or personal importance to individual contributors (using “bio...

The Institute of Medicine (IOM) is increasing engaged in policy analysis and recommendations including a current project to assess medical devices and the 510(k) process. In addition to internal IOM policies and good practices, any IOM committee commissioned by a federal agency must abide by FACA Sec. 15. This paper expands upon an earlier paper by...

The Institute of Medicine (IOM) is increasingly engaged in policy analysis and recommendations including a current project to assess medical devices and the 51'6k) process. In addition to internal IOM policies and good practices, any IOM committee commissioned by a federal agency must abide by FACA Sec. 15. This paper examines the issues relating t...

Nanotechnology, as with many technologies before it, places a strain on existing legislation and poses a challenge to all administrative agencies tasked with regulating technology-based products. It is easy to see how statutory schemes become outdated, as our ability to understand and affect the world progresses. In this article, we address the reg...

Federal oversight of nanobiotechnology in the United States has been fragmented and incremental. The prevailing approach (at FDA, OSHA, and other key agencies) has been to use existing laws and other administrative mechanisms for oversight. However, this “stay-the-course” approach is inadequate for this complex and convergent technology and may ind...

The physiological effects of biphasic pacing have not been studied in compromised hearts. Myocardial infarction was induced in 12 sheep by high coronary artery ligation. Perioperative mortality was 33%. The surviving eight animals exhibited increased left ventricular volume and reduced percent fractional shortening. Two weeks after the infarction,...

Discussion of FDA regulation of social media tools (such as Facebook, Twitter, and blogs) through an analysis of enforcement actions and public hearings. Includes an analysis of First Amendment commercial speech as it applies to FDA regulation in general, and highlights areas where this may affect FDA regulation of social media.

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing...

For the past several years, commentators have predicted (or warned) that federal prosecutors were increasingly using deferred prosecution agreements (DPAs) and non-prosecution agreements (NPAs) when settling with companies accused of corporate wrongdoing. From 2002 (the year after Enron) through 2007, this prediction was accurate - DPAs increased b...

Oversight systems specific to nanotechnology have not yet been created; stakeholders, government, industry, academia, and the public are debating whether and how to craft such systems and address emerging safety, social, and ethical issues. The United States has no coordinated policy for oversight of the products and applications of nanotechnology...

The federal government has collected literally billions of dollars alleging, among other claims, that off-label promotion of drugs and devices violates the False Claims Act (FCA). The huge potential penalties in these cases have led to their settlement and no court has yet fully tested the viability of the legal theory linking off-label promotion t...