Law Commons^™

Covid-19 Pediatric Vaccine Authorization, Fda Authority, And Individual Misperception Of Risk, Joanna K. Sax, Neal Doran

Faculty Scholarship

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to …

Dangerous Interpretations Of The Precautionary Principle And The Foundational Values Of European Union Food Law: Risk Versus Risk, Miguel A. Recuerda

Journal of Food Law & Policy

In their ordinary lives, many people try to avoid any situation involving risk that could cause themselves harm. On the otherhand, others assume risk with greater facility because they are not sufficiently aware of it, or because they know that the probability of resulting damage is very low. Overwhelming worry in the face of any kind of risk would be paralyzing (we would not leave the house, eat in any restaurant outside of our home, drive, or fly). On the contrary, an attitude absolutely heedless of risks would end up causing innumerable damages, some of them irreparable. Common sense suggests …

Risk And Regulatory Calibration: Wto Compliance Review Of The U.S. Dolphin-Safe Tuna Labeling Regime, Cary Coglianese, André Sapir

All Faculty Scholarship

In a series of recent disputes arising under the TBT Agreement, the Appellate Body has interpreted Article 2.1 to provide that discriminatory and trade-distortive regulation could be permissible if based upon a “legitimate regulatory distinction.” In its recent compliance decision in the US-Tuna II dispute, the AB reaffirmed its view that regulatory distinctions embedded in the U.S. dolphin-safe tuna labeling regime were not legitimate because they were not sufficiently calibrated to the risks to dolphins associated with different tuna fishing conditions. This paper analyzes the AB’s application of the notion of risk-based regulation in the US-Tuna II dispute and finds …

Private Regulation And Foreign Conduct, Adam I. Muchmore

Adam I. Muchmore

Current U.S. policy on safety regulation for imported food is based largely on ex post measures. Several reform proposals seek to strengthen the ex ante component of this regulatory program. These proposals rely on one or more of three basic strategies: direct extraterritorial regulation; delegation of regulatory authority to private entities; and delegation of regulatory authority to foreign government agencies. This paper explores the ability of each strategy to respond to several principal-agent problems relevant to imported-food safety: the regulatory license problem; interest group capture; and the reality of bribery and threats in many food-exporting countries. Through the lens of …

Is The Turkey Halal? Genetically Modified Animal Feed Regulation Where East Meets West, Jennifer Spreng

Jennifer E Spreng

Turkey’s Biosafety Law (2010) imposes some of the world’s most stringent restrictions on the import, release and marketing of genetically modified foodstuffs. The Biosafety Board has not approved a single food event; the Council of State has suspended approval of MON 810; Turks have endured meat and milk price spikes; herders are going bankrupt for lack of affordable feed; and importers have been arrested and prosecuted for trace contamination with unapproved GMOs. It’s a pox an all their houses: Turks want nothing do with GM foodstuffs.

The culprit? The “precautionary principle,” which authorizes taking precautions in the face of scientific …

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …

Private Regulation And Foreign Conduct, Adam I. Muchmore

Journal Articles

Current U.S. policy on safety regulation for imported food is based largely on ex post measures. Several reform proposals seek to strengthen the ex ante component of this regulatory program. These proposals rely on one or more of three basic strategies: direct extraterritorial regulation; delegation of regulatory authority to private entities; and delegation of regulatory authority to foreign government agencies. This paper explores the ability of each strategy to respond to several principal-agent problems relevant to imported-food safety: the regulatory license problem; interest group capture; and the reality of bribery and threats in many food-exporting countries. Through the lens of …

International Harmonization Of Regulation Of Nanomedicine, Gary E. Marchant, Douglas J. Sylvester, Kenneth W. Abbott, Tara Lynn Danforth

Gary E. Marchant

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nanotechnologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether …

Crises, Congress, And Cognitive Biases: A Critical Examination Of Food And Drug Legislation In The United States, Sharon B. Jacobs

Publications

No abstract provided.

Improving Post-Approval Risk Surveillance For Drugs: Active Post-Market Risk Identification, Matthew Gordon

Michigan Telecommunications & Technology Law Review

Pre-approval clinical trials cannot possibly ensure that a drug will not have disastrous side effects once it arrives on the market. Post-approval drug safety data gathering was put in place to address this problem, but as implemented, it has not proven to be as effective as hoped. Congress recently overhauled the legislation regarding post-approval drug risk identification, and in doing so made a deliberate decision to put much of the burden of post-approval drug surveillance on the FDA through data mining. Further, the legislation gave the FDA the power to require post-approval clinical trials from drug makers only in limited …

From The Wrong End Of The Telescope: A Response To Professor David Bernstein, Margaret A. Berger, Aaron D. Twerski

Michigan Law Review

On the pages of this law review, in an article entitled Uncertainty and Informed Choice: Unmasking Daubert, the authors argued for the recognition of a new product liability cause of action when drug companies fail to warn about uncertain risks attendant to the use of non-therapeutic drugs whose purpose is to enhance lifestyle. We noted that in the post-Daubert era, plaintiffs have faced increasing difficulty in proving that a given toxic agent was causally responsible for the injuries suffered after ingesting a drug. That plaintiffs cannot overcome the barriers to proving injury causation does not mean that defendants have met …

Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein

Michigan Law Review

Margaret Berger and Aaron Twerski are among the leading scholars in their respective fields of Evidence and Products Liability. I have benefited from their work on many occasions. Precisely because of the deserved respect and esteem in which Berger and Twerski are held-not to mention the prominence of their forum, the Michigan Law Review-their proposal to create a new "informed choice" cause of action in pharmaceutical litigation is likely to receive sympathetic attention. Because I believe that their proposal is ill-conceived and dangerous, I feel compelled (with some trepidation) to write this response. Berger and Twerski propose that courts recognize …

Pesticide Residue Regulation: Analysis Of Food Quality Protection Act Implementation, Linda-Jo Schierow

RISK: Health, Safety & Environment (1990-2002)

Dr. Schierow discusses the effects of a recent statute on food safety.

Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green

University of Michigan Journal of Law Reform

Professor Green addresses the matter of the proper balance between the tort system and regulation in the context of prescription drugs and the FDA's vigorous oversight of the industry. He articulates several reasons why a regulatory compliance defense, in which tort law would defer to FDA regulation, is quite attractive. Despite the superior expertise of the FDA in assessing the benefits and risks of a drug, a regulatory compliance defense is considerably more problematical than might appear at first glance. Ascertaining compliance with FDA requirements could be a lengthy and complicated inquiry that would either replace or supplement the issues …

Products Liability Based Upon Violation Of Statutory Standards, Joseph H. Ballway Jr.

Michigan Law Review

Regulatory enactments controlling production and distribution can give rise in several different ways to civil liability on behalf of persons injured by non-conforming merchandise. For instance, if a statute codifies existing common-law rules of negligence, its effect is merely to place the weight of legislative authority behind ordinary negligence principles. Since an injured party's recovery under such a provision still depends largely upon his proving in the traditional manner that a defendant failed to exercise due care, this kind of statute merits no further discussion. On the other hand, if particular legislation expressly states that a violator may be subjected …