Food and Drug Law Commons^™

My Paper Makes Ssrn Top Ten List, Gabriela Steier

Gabriela Steier

My paper, "THE WTO'S BLIND SPOT: DISPUTE RESOLUTION IN THE INTERNATIONAL FOOD INDUSTRY", was recently listed on SSRN's Top Ten download list for: Food Law & Policy eJournal, PSN: Politics of the WTO (Topic), PSN: Politics of the WTO (Topic), SRPN: Agribusiness (Topic), SRPN: Biotechnology (Topic), SRPN: Politics of Food (Topic) and SRPN: World Trade Organisation (Topic).

Food Defense Among Meat Processing And Food Service Establishments In Kentucky, Morgan Webb-Yeates

Masters Theses & Specialist Projects

Agroterrorism is the deliberate introduction of a plant or animal disease with the
goal of causing fear, economic instability, illness, or death. After the 2002 terrorist
attacks on the World Trade Center, the security of the food supply is of increasing
concern to the United States. A major incidence of agroterrorism or food tampering would have far reaching impacts on the economy and public health. The first objective of this project was to determine knowledge and concern of agroterrorism in meat processing facilities in Kentucky, and to determine knowledge and concern of food tampering and food defense in food service ...

Drug Induced Insanity And Unconsciousness - A Clarification Of California Law, Jerome Bleiweis

Pepperdine Law Review

No abstract provided.

A Prescription Warning, Carlton Lee Harpst

Pepperdine Law Review

No abstract provided.

Stemming The Global Trade In Falsified And Substandard Medicines, Lawrence O. Gostin, Gillian J. Buckley, Patrick W. Kelley

Georgetown Law Faculty Publications and Other Works

Drug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and the problem is far more common and serious in low- and middle-income countries with weak drug regulatory systems. An Institute of Medicine consensus committee report identified the causes and possible solutions to the problem of falsified and substandard drugs around the world.

The vocabulary people use to discuss the problem is itself a concern. The word counterfeit is often used innocuously to ...

Book Reviews, David J. Agatstein

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Drugs And Alcohol In The Workplace , Venable, Baetjer & Howard, Esqs.

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan

Scholarly Works

This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to ...

Environmental Regulation And The Doctrine Of Scientific Uncertainty: A Case Study Of The Epa's Cancellation Of 2, 4, 5-T, Wendy Wagner

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Utica Packing Co. V. Block, 781 F.2d 71 (6th Cir. 1986), David J. Agatstein

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Food Ordinances: Encouraging Eating Local, Mia Shirley

William & Mary Environmental Law and Policy Review

No abstract provided.

Jurisdiction Of The Food And Drug Administration To Regulate Tobacco Products Under The Food, Drug, And Cosmetic Act: Food And Drug Administration V. Brown & Williamson Tobacco Corporation Et Al., Alison J. Lezak

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

What Is The Best Way For Manufacturers And Physicians To Apply Sunscreen To Avoid Being Burned By The Final Sunshine Act Regulations?, Abraham Gitterman

Student Articles and Papers

This [article] explains the requirements under the Patient Protection and Affordable Health Care Act’s Physician Payment Sunshine Act that all medical product manufacturers report to Health and Human Services (HHS) any payment or transfer of value made to physicians and teaching hospitals. Author Abraham Gitterman ... warns that manufacturers may face adverse consequences of public access to payment data, including fraud and abuse investigations and private litigation actions. He recommends that manufacturers begin training employees to ensure compliance with the statute and reduce the likelihood of further investigations. He further suggests that the Center for Medicare & Medicaid Services (CMS) include ...

Insights In Enforcement, Litigation & Compliance For Pharmaceutical And Medical Device Manufacturers At Fdli's Enforcement, Litigation And Compliance Conference, December 12-13, 2012, Thomas Sullivan, Abraham Gitterman

Student Articles and Papers

No abstract provided.

Executives Should Think Twice Before Accepting Pleas 'Related To Fraud': The Expansion Of Exclusion Under The Park Doctrine, Abraham Gitterman

Student Articles and Papers

No abstract provided.

California And Uncle Sam's Tug-Of-War Over Mary Jane Is Really Harshing The Mellow, Daniel Mortensen

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Pharmageddon: A Statutory Solution To Curb Ohio's Prescription Abuse Problem, Ed Woodworth

Journal of Law and Health

Prescription abuse in Ohio continues to be a serious and complex issue that should be addressed. Accordingly, Part II of this Note examines the background of prescription drug abuse generally. It identifies the dangers of prescription drug abuse, the cost drug abuse places on society, some reasons for prescription drug abuse, sources of prescription drugs, and discusses the current state and federal laws regarding prescription drug abuse and prescription reporting. Part III discusses the positive and negative aspects of H.B. 93 and Medical Rule 4731-11-11 and then offers proposals to more effectively prevent prescription drug abuse. Part IV discusses ...

Undue Process At The Fda, Lisa Heinzerling

Georgetown Law Faculty Publications and Other Works

For over 40 years, the Food and Drug Administration has been collecting evidence that the routine administration of antibiotics to animals destined for the food supply contributes to the development of antibiotic-resistant infections in the human population. For all these years, the FDA has put off acting with any force on this health risk. The agency’s explanation has been that the Food, Drug and Cosmetic Act requires it to hold time- and resource-intensive formal hearings before it can withdraw approvals for antibiotics used for the purposes of promoting growth and preventing infection in food animals. In so arguing, the ...

California Expands Tort Liability Under The Novel Market Share Theory: Sindell V. Abbott Laboratories, N. Denise Taylor

Pepperdine Law Review

The California Supreme Court, in the novel and unprecedented case of Sindell v. Abbott Laboratories, eliminated the plaintiffs burden of identification of a negligent party, and thus the causation requirement, in a multiple party tort action. In the course of this decision, the court adopted the "market share" theory of liability which dictated in Sindell that nonidentifiable defendant-manufacturers of the generic drug DES would be liable for the damages in proportion to their share of business in the market. The author thoroughly examines various theories of recovery, such as "alternative liability," "concert of action" and "enterprise liability," which the court ...

Fixing The Vaccine Act's Structural Moral Hazard, Brandon L. Boxler

Pepperdine Dispute Resolution Law Journal

The article presents information on the Vaccine Injury Compensation Program. It discusses the U.S. Federal circuit case Hazlehurst v. Sec'y of Health & Human Servs., in which lawsuit against the defendant was filed by the plaintiff who sought claims against the liability of product to recover damages for alleged injuries which his son had received from vaccines. It also provides information on the structural moral hazard of the program which devolves it into a litigious adjudicatory process.