Law Commons^™

Speech Regulation And Tobacco Harm Reduction, Jonathan Adler, Jacob James Rich

Faculty Publications

Regulation of commercial speech is a major component of federal regulation of tobacco products. Since adoption of federal tobacco legislation, the Food and Drug Administration has asserted regulatory authority over ENDS and other vaping products as “tobacco products,” subjecting them to the same regulatory regime as traditional tobacco products even though such projects appear to pose less of a threat to public health. Such regulation, and the restriction on truthful speech in particular, may be having negative consequences for public health. Barring producers from informing consumers about the relative risks of vaping products and their potential to reduce smoking eliminates …

The Patient's Voice: Legal Implications Of Patient-Reported Outcome Measures, Sharona Hoffman, Andy Podgurski

Faculty Publications

In recent years, the medical community has paid increasing attention to patients' own assessments of their health status. Even regulatory agencies, such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services, are now interested in patient self-reports. The legal implications of this shift, however, have received little attention. This Article begins to fill that gap. It introduces to the legal literature a discussion that has been ongoing in the health care field.

Patient-reported outcome measures (PROMs) are reports of patients’ symptoms, treatment outcomes, and health status that are documented directly by patients, typically through electronic …

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Faculty Publications

The past several decades have seen the creation of transformative new technologies that are being used to design innovative consumer product ingredients never seen before in nature. Examples include the use of nanotechnology and genetic modification, and, right around the corner, cloning and lab grown meat. These innovative technologies are harbingers of more pioneering consumer product ingredients to come. The remarkable pace of the development of ground-breaking new technologies means that the population is being steadily exposed to novel ingredients with unknown health risks.

Optimally, the Food & Drug Administration ("FDA") should be regulating these innovative, novel ingredients in consumer …

Drug-Drug Interaction Alerts: Emphasizing The Evidence, Sharona Hoffman, Andy Podgurski

Faculty Publications

Many analysts and users of contemporary clinical decision support ("CDS") systems have expressed grave concerns about the technology’s efficacy and functionality. Alerts generated by CDS systems are often inaccurate, and an excess of alerts leads some physicians to experience "alert fatigue" and to turn off CDS altogether. This article formulates recommendations to improve drug-drug interaction (DDI) alerts.

The paper comments upon a proposal by Susan Ridgely and Michael Greenberg, who call for the development of a consensus-based "clinically significant drug-drug interaction list" that could generate limited liability protection for users. We argue that instead of creating a list of always-contraindicated …

The Drugs Stop Here: A Public Health Framework To Address The Drug Shortage Crisis, Sharona Hoffman

Faculty Publications

Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend …

Finding A Cure: The Case For Regulation And Oversight Of Electronic Health Record Systems, Sharona Hoffman, Andy Podgurski

Faculty Publications

In the foreseeable future, it is likely that the familiar, paper-based patient medical files will become a thing of the past. On April 26, 24, President George W. Bush announced a plan to ensure that all Americans' health records are computerized within ten years and to establish a National Health Information Network. Many advocates are enthusiastically promoting the adoption of health information technology (HIT) and electronic health record (HER) systems as a means to improve U.S. health care.

HER systems often not only serve as record-keeping systems, but also have multiple capabilities, including drug ordering, decision support, alerts concerning patient …

The Use Of Placebos In Clinical Trials: Responsible Research Or Unethical Practice?, Sharona Hoffman

Faculty Publications

Developments in medical research have been occurring at a rapidly increasing rate during the past two decades. Expanding budgets, augmented computer capabilities, and new research tools have all dramatically enhanced research technology. Accompanying the proliferation of medical research are increasing concerns about research risks. This article focuses on placebo-controlled clinical trials. The use of placebos enables clinical investigators to compare results from subjects taking an experimental intervention to results from a group that is receiving an inactive substance, such as a sugar pill, in order to determine the efficacy of the new medication. In recent years, some surgeons have also …