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Articles 1 - 24 of 24
Full-Text Articles in Law
A Hot Topic: Is The Fda’S Approach To Sunscreen Regulation Failing Consumers?, Haley Westman
A Hot Topic: Is The Fda’S Approach To Sunscreen Regulation Failing Consumers?, Haley Westman
Seattle University Law Review
This Note suggests a better balance between allowing sunscreen innovation and protecting the public from unsafe products. Part I of this Note will review the factual background of the public’s attention to sunscreen, explain the current sunscreen issues in the news, and highlight the different actors involved in the growing discourse surrounding sunscreen. Part I will also show that the actors involved in the sunscreen industry—scientific researchers, social media influencers, and the public at large—have considerable influence on consumers’ trust in sunscreen, their buying habits, and the FDA’s approach to sunscreen regulation. Part II of this Note will outline the …
Making Executioners Out Of Pharmacists: Why South Carolina Should Not Adopt A Lethal Injection Secrecy Statute, Elizabeth T. French
Making Executioners Out Of Pharmacists: Why South Carolina Should Not Adopt A Lethal Injection Secrecy Statute, Elizabeth T. French
South Carolina Law Review
No abstract provided.
Antiquated Relics Or Misunderstood Mess, Why South Carolina Liquor Laws Are Ripe For Restructuring, Annie Day Bame
Antiquated Relics Or Misunderstood Mess, Why South Carolina Liquor Laws Are Ripe For Restructuring, Annie Day Bame
South Carolina Law Review
No abstract provided.
Reforming Regenerative Medicine Regulation, Sarah Duranske
Reforming Regenerative Medicine Regulation, Sarah Duranske
Georgia State University Law Review
Regenerative medicine is defined as the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells or tissues. It includes a variety of approaches, such as transplanting cells to promote healing, editing genes in cells to attack cancer, and even building organs from biological materials. Regulating regenerative medicine therapies is no easy task. Finding a balance between competing interests–enabling timely access for needy patients while simultaneously ensuring a positive benefit/risk profile and promoting the development of beneficial innovations–is hard enough at any given point in time. But add in constantly advancing scientific knowledge and increasing …
Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski
Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski
Michael J. Malinowski
All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …
Where Babies And Death-Row Inmates Intersect: Is Arbitrary Agency Decision-Making Supported Under Existing Law?, Lisa C. Blanton Bs., Mj.
Where Babies And Death-Row Inmates Intersect: Is Arbitrary Agency Decision-Making Supported Under Existing Law?, Lisa C. Blanton Bs., Mj.
Lisa C. Blanton BS., MJ.
The Food and Drug Administration (FDA) is the executive branch regulatory agency primarily responsible for protecting the nation’s drug products.[1] The FDA recently made highly inconsistent decisions surrounding a new drug for the prevention of pre-term birth, Makena™ (hydroxyprogesterone caproate). During a lengthy approval process, FDA made laudatory public announcements and demonstrated high programmatic preference to expedite approval of Makena by assigning orphan status[2] and granting accelerated “fast-track” approval time-frames.[3] Despite these actions, within weeks of the approval, the FDA issued aggressive public statements against the product’s efficacy and safety and made supportive comments about a non-FDA …
A Decade’S Quest For Safer Drugs: Congressional Committee Green Lights Regulation Of Drug Supply Chains And Compounding Manufacturers, Mary Ann Chirba, Alice Noble
A Decade’S Quest For Safer Drugs: Congressional Committee Green Lights Regulation Of Drug Supply Chains And Compounding Manufacturers, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment). Congressional efforts to enact comprehensive legislation to improve drug safety and secure the nation’s drug supply chain have lingered for over a decade. The lack of federal uniformity has allowed a patchwork of state legislation to emerge, attracting the less scrupulous to those states with the lowest security. The issue finally gained traction among HELP Committee members when 55 people died …
A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
Michael J. Malinowski
This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.
A Failure To Consider: Why Lawmakers Create Risk By Ignoring Trade Obligations, David R. Kocan Professor
A Failure To Consider: Why Lawmakers Create Risk By Ignoring Trade Obligations, David R. Kocan Professor
David R. Kocan Professor
The U.S. Congress frequently passes laws facially unrelated to trade that significantly impact U.S. trade relations. These impacts are often harmful, significant, and long-lasting. Despite this fact, these bills rarely receive adequate consideration of how they will impact trade. Without this consideration, Congress cannot properly conduct a cost-benefit analysis necessary to pass effective laws. To remedy this problem, the U.S. Trade Representative should evaluate U.S. domestic law to determine whether it is consistent with international trade obligations. Moreover, the U.S. Congress committee structure should be amended so that laws that might impact trade are considered within that light. In the …
Local Health Agencies, The Bloomberg Soda Rule, And The Ghost Of Woodrow Wilson, Paul A. Diller
Local Health Agencies, The Bloomberg Soda Rule, And The Ghost Of Woodrow Wilson, Paul A. Diller
Paul Diller
Local health agencies are often leaders in public health regulation. Despite the significance of this phenomenon, scant scholarship has assessed the interesting doctrinal and normative questions that local agency rulemaking raises. This paper uses local health agency rulemaking, and the New York City portion-cap rule for sugar-sweetened beverages ("the Bloomberg soda rule"), in particular, as a prism through which to analyze local agency rulemaking. The article first explains why it is important -- both doctrinally and practically -- to determine whence local agency power flows. If agencies are created directly by state law, then their powers should be circumscribed by …
Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns
Brooke Burns
This Casebrief recognizes the current division developing among courts concerning whether PSRs have been wrongly misclassified as exempt from overtime pay since the World War II era. Despite the Second Circuit’s more recent decision in In re Novartis Wage and Hour Litigation, this Casebrief identifies the Third Circuit’s jurisprudence in Smith v. Johnson & Johnson as providing controlling guidance for practitioners navigating the current legal landscape.
Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin
Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin
Keren F. Bisnauth
The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In …
The Transatlantic Gmo Dispute Against The European Communities: Some Preliminary Thoughts, David A. Wirth
The Transatlantic Gmo Dispute Against The European Communities: Some Preliminary Thoughts, David A. Wirth
David A. Wirth
Any day now, a World Trade Organization panel is expected to rule in a dispute between the U.S. and the EU concerning market access for genetically-engineered foods and crops. This piece, written before the release of the WTO panel's report, analyzes novel systemic issues concerning the impact of WTO law on regulatory design, at both the national and international levels, that are raised by this dispute. These include (1) the application of WTO disciplines to regulatory schemes that require prior governmental approval to protect the environment and public health from newly-introduced products and substances; (2) the role of precaution as …
The “California Effect” & The Future Of American Food: How California’S Growing Crackdown On Food & Agriculture Harms The State & The Nation, Baylen J. Linnekin
The “California Effect” & The Future Of American Food: How California’S Growing Crackdown On Food & Agriculture Harms The State & The Nation, Baylen J. Linnekin
Baylen J. Linnekin
For several decades, California has served as the epicenter of the American food scene. California produces one-third of the nation’s food, is home to one in eight American consumers, and boasts a staggering 90,000 restaurants. California is also where eating trends are born, and where fast food, organic food, and Napa Valley wines became durable icons of American culinary culture.
The state’s place atop the national food chain, though, is in jeopardy. In recent years, California legislators have pursued regulations that negatively impact many important agricultural and culinary trends. State and local governments have banned or severely regulated a veritable …
A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski
Journal Articles
This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.
The Deregulatory State, Lawrence O. Gostin
The Deregulatory State, Lawrence O. Gostin
O'Neill Institute Papers
Public health can be achieved only through collective action, not through individual endeavor. Collective goods are essential conditions for health, but can be secured only through a well-regulated society. Yet, successive governments have eroded health and safety protections, with serious consequences. Think about the death of miners, lead in children’s toys, industrial solvents in toothpaste, salmonella in peanut butter, e-coli in spinach, and unsafe or ineffective pharmaceuticals such as COX-2 inhibitors or non-statin cholesterol medications.
Conservatives have waged a campaign against the administrative state that has created and reinforced deep-seated concerns about over-bearing government, particularly at the national level. The …
Hemp ... Why Not?, Jared B. Kahn
Hemp ... Why Not?, Jared B. Kahn
ExpressO
Hemp ... Why Not?
By: Jared Kahn
(Abstract)
Industrial hemp has been utilized as a commodity crop for centuries in the United States, and for millennia throughout the world. Today, the crop is cultivated for industrial uses in thirty countries, but not the United States. United States citizens may import hemp, eat hemp, wear hemp, and do whatever they please with a manufactured hemp product, but nobody grows the valuable crop in the U.S. Several states have legalized industrial hemp cultivation, however, the federal Drug Enforcement Agency (DEA) interprets the Controlled Substances Act (CSA) to prohibit the growing of hemp …
A Complete Property Right Amendment, John H. Ryskamp
A Complete Property Right Amendment, John H. Ryskamp
ExpressO
The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.
Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp
Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp
ExpressO
This brief comment suggests where the anti-eminent domain movement might be heading next.
Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor
Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor
ExpressO
No abstract provided.
Securing Truth For Power: Informational Strategy And Regulatory Policy Making, Cary Coglianese
Securing Truth For Power: Informational Strategy And Regulatory Policy Making, Cary Coglianese
ExpressO
No abstract provided.
Judicial Review Of Fda Preemption Determinations, Amanda Frost
Judicial Review Of Fda Preemption Determinations, Amanda Frost
Articles in Law Reviews & Other Academic Journals
No abstract provided.
International Decisions. European Communities - Measures Concerning Meat And Meat Products, David A. Wirth
International Decisions. European Communities - Measures Concerning Meat And Meat Products, David A. Wirth
David A. Wirth
No abstract provided.
Anatomy Of A Regulatory Program: Comment On 'Strategic Regulators And The Choice Of Rulemaking Procedures', Jeffrey Lubbers
Anatomy Of A Regulatory Program: Comment On 'Strategic Regulators And The Choice Of Rulemaking Procedures', Jeffrey Lubbers
Articles in Law Reviews & Other Academic Journals
Besides being a very interesting, cogent, and even a tidy study, "Strategic Regulators" sheds some bright light on agency behavior and on the important issue of whether agency rulemaking may be "ossifying."
The study design employed by Hamilton and Schroeder is attractively simple. They started with all of the Environmental Protection Agency's ("EPA's") hazardous waste regulations under the Resource Conservation and Recovery Act ("RCRA") appearing in the Code of Federal Regulations ("CFR"), counting each decimal point CFR number as a separate rule. This yielded 697 rules. They then examined all EPA/RCRA guidance documents issued since the inception of the program …