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Full-Text Articles in Health Law and Policy

Federal Regulatory Responses To The Prescription Opioid Crisis: Too Little, Too Late?, Lars Noah Sep 2019

Federal Regulatory Responses To The Prescription Opioid Crisis: Too Little, Too Late?, Lars Noah

Utah Law Review

Part I of this Article suggests that the medical establishment shares more blame for the crisis than many commentators seem to appreciate. Part II canvasses a variety of ways in which the federal government has responded to the opioid problem during the last few years before delving more deeply into the FDA’s role in the mess, assessing the different tools that it has tried to use as well as some that it failed to employ. This Article concludes that the agency should have allowed only a narrowly defined subset of physicians to prescribe opioid analgesics, even though the medical ...


From Health Policy To Stigma And Back Again: The Feedback Loop Perpetuating The Opioids Crisis, Nicolas Terry Sep 2019

From Health Policy To Stigma And Back Again: The Feedback Loop Perpetuating The Opioids Crisis, Nicolas Terry

Utah Law Review

Between 1999 and 2017, almost 400,000 people died from opioid overdoses, and since 2001, the opioid crisis has cost the U.S. more than 1 trillion dollars. In late 2018, the Department of Health and Human Services (HHS) Secretary opined that the country was “beginning to turn the tide” in responding to the crisis. Secretary Azar’s positive statements were based on preliminary CDC data that showed a national decline of 2.7 percent in drug overdose deaths from October 2017 to May 2018. However, data still show over half the states posting an increase in overdose deaths with ...


Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan Jan 2019

Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan

Texas A&M Law Review

This Comment examines the extent to which Congress empowered the FDA to address the increase in petitions and the general accessibility of orphan drug remedies. Specifically, this Comment seeks to understand why the FDA’s interpretation of the purpose of the ODA seems to conflict with the statutory intent as interpreted by federal courts. This Comment considers a statute’s ultimate goal or social purpose to be the purpose of the statute, whereas the express mechanisms by which Congress seeks to bring about these goals is best understood as the statute’s intent. To understand the FDA and judiciary’s ...


Dying To Be Fresh And Clean? Toxicants In Personal Care Products, The Impact On Cancer Risk, And Epigenetic Damage, Katherine Drabiak Jul 2018

Dying To Be Fresh And Clean? Toxicants In Personal Care Products, The Impact On Cancer Risk, And Epigenetic Damage, Katherine Drabiak

Pace Environmental Law Review

The FDA does not conduct pre-market review of chemicals contained in cosmetics—which encompasses not only makeup but also numerous personal care products including shampoo, lotion, perfume, aftershave, and shaving cream. Every day, consumers use cosmetic products that contain a variety of synthetic ingredients, none of which the FDA has approved for safety but each of which are being ingested, absorbed, and inhaled into our bodies and accumulating in our tissue. Many of these products contain endocrine disrupting chemicals (“EDCs”), which emerging research links to an increased risk of cancer as well as immune and neurological dysfunction. This Article examines ...


Emerging Governance Of Mitochondrial Replacement Therapy: Assessing Coherence Between Scientific Evidence And Policy Outcomes, Katherine Drabiak May 2018

Emerging Governance Of Mitochondrial Replacement Therapy: Assessing Coherence Between Scientific Evidence And Policy Outcomes, Katherine Drabiak

DePaul Journal of Health Care Law

In the fall of 2016, media headlines reported news of several births of children born through “three parent IVF” or mitochondrial replacement therapy (MRT). MRT refers to an experimental procedure that entails removing the nuclear DNA from the mother’s egg or fertilized zygote and transferring it to a donor’s egg or fertilized zygote. This procedure constitutes a modification of the human germline, which has been prohibited by numerous declarations, directives, and laws promulgated by the United Nations, the Council of Europe, and other nations. In 2016, the Human Fertilisation and Embryology Authority in the United Kingdom was the ...


Patent Infringement In Personalized Medicine: Limitations Of The Existing Exemption Mechanisms, Jiyeon Kim Jan 2018

Patent Infringement In Personalized Medicine: Limitations Of The Existing Exemption Mechanisms, Jiyeon Kim

Washington University Law Review

Mr. X suffers from recurrent glioblastoma, a type of deadly brain cancer. One of his physicians reads a study reporting a novel immunotherapy, which uses the chimeric antigen receptor T cell (CAR-T) technology, leading to regression of glioblastoma in a small number of patients. Although the therapy has recently been approved by the U.S. Food and Drug Administration (FDA) and is now offered by two major pharmaceutical companies, it is only approved for certain hematological cancers. In addition, Mr. X’s cancer does not express the biomarker that is necessary for the CAR-T therapy used in the published glioblastoma ...


Securing The Internet Of Healthcare, Michael Mattioli, Scott J. Shackelford, Steve Myers, Austin Brady, Yvette Wang, Stephanie Wong Jan 2018

Securing The Internet Of Healthcare, Michael Mattioli, Scott J. Shackelford, Steve Myers, Austin Brady, Yvette Wang, Stephanie Wong

Articles by Maurer Faculty

Cybersecurity, including the security of information technology (IT), is a critical requirement in ensuring society trusts, and therefore can benefit from, modern technology. Problematically, though, rarely a day goes by without a news story related to how critical data has been exposed, exfiltrated, or otherwise inappropriately used or accessed as a result of supply chain vulnerabilities. From the Russian government's campaign to influence the 2016 U.S. presidential election to the September 2017 Equifax breach of more than 140-million Americans' credit reports, mitigating cyber risk has become a topic of conversation in boardrooms and the White House, on Wall ...


A Proposal For Fda Label Regulations And Uniform Certifications For Organic Non-Food And "Natural" Products, Allyson Bartolomeo Dec 2017

A Proposal For Fda Label Regulations And Uniform Certifications For Organic Non-Food And "Natural" Products, Allyson Bartolomeo

Barry Law Review

No abstract provided.


The Epipen Problem: Analyzing Unethical Drug Price Increases And The Need For Greater Government Regulation, Talal Rashid Dec 2017

The Epipen Problem: Analyzing Unethical Drug Price Increases And The Need For Greater Government Regulation, Talal Rashid

University of Miami Business Law Review

In recent years, some pharmaceutical companies have started increasing the price of their existing drugs to exorbitant levels. Often, these drugs are medically necessary for patients, who are left to take on the high costs of the medicine. One recent example is Mylan, who raised the price of the EpiPen by four hundred percent, solely for the profit of its own company and to the detriment of consumers who rely on the EpiPen. Similar patterns of drug price increases have occurred in the past and will likely happen again in the future. This Comment will seek to identify the common ...


The Recent Enactment Of National Mandatory Gmo Labeling Law: Superior To A Voluntary Labeling Scheme But Unlikely To End The Labeling Controversy, Nan Feng Apr 2017

The Recent Enactment Of National Mandatory Gmo Labeling Law: Superior To A Voluntary Labeling Scheme But Unlikely To End The Labeling Controversy, Nan Feng

Seattle University Law Review

Part I of this Note provides background information about the major controversies related to GM foods, including the debate about whether such foods should be labeled, and the history of GMO labeling laws in the United States. Part II compares S. 764 with H.R. 1599 and explains why a national mandatory labeling approach is superior to the voluntary labeling approach advocated by the House. Part III discusses the potential drawbacks and effect of S. 764 and finally concludes that the rulemaking process that will follow may create controversies and litigation.


Plain Tobacco Packaging’S Impact On International Trade And The Family Smoking Prevention And Tobacco Control Act In The U.S. And Drafting Suggestions, Sunil S. Gu Jan 2017

Plain Tobacco Packaging’S Impact On International Trade And The Family Smoking Prevention And Tobacco Control Act In The U.S. And Drafting Suggestions, Sunil S. Gu

Washington University Global Studies Law Review

Despite its legal status, tobacco products, due to the potential harmful effects on health, have never been free from various governmental regulations. However, it was easier said than done to regulate them as governments wished, and in fact there were numerous failed attempts. Thus, governments tried to come up with a better and more effective regulation that will reduce the tobacco consumption thereby promoting public health, under the name of public health of their citizens. And plain tobacco packaging measures are the latest solution suggested.

The introduction of the plain tobacco measures has stirred huge controversy (understandably so), since it ...


Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise Jan 2017

Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.


The Prescription For Rising Drug Prices: Competition Or Price Controls?, Joanna Shepherd Jan 2017

The Prescription For Rising Drug Prices: Competition Or Price Controls?, Joanna Shepherd

Health Matrix: The Journal of Law-Medicine

The article focuses on the implementing of reforms aimed at promoting competition or prohibiting anticompetitive practices in rising drug prices in the U.S.


Are We Adopting The Orphans, Or Creating Them? Medical Ethics And Legal Jurisprudential Guidance For Proposed Changes To The Orphan Drug Act, Lydia Raw Jan 2017

Are We Adopting The Orphans, Or Creating Them? Medical Ethics And Legal Jurisprudential Guidance For Proposed Changes To The Orphan Drug Act, Lydia Raw

Washington University Jurisprudence Review

This Note traces the subtle changes in the underlying purposes of the Orphan Drug Act, and evaluates those purposes from the perspectives of medical ethics and legal jurisprudence. Part I begins with the history of the Orphan Drug Act discussed issue by issue, to elucidate the subtle changes in the purpose of the Orphan Drug Act through its history. Part II explores the moral and ethical issues presented by the Orphan Drug Act to identify eleven guiding principles from medical ethics and legal jurisprudence. Lastly, Part III applies these guiding principles to the most common proposed amendments to the Orphan ...


The Statutory Case Against Off-Label Promotion, Nathan Cortez Jan 2017

The Statutory Case Against Off-Label Promotion, Nathan Cortez

Faculty Scholarship

The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA ...


International Reciprocity: If A Drug Is Good Enough For Great Britain, It Should Be Good Enough For The United States, Nicole C. Perez Dec 2016

International Reciprocity: If A Drug Is Good Enough For Great Britain, It Should Be Good Enough For The United States, Nicole C. Perez

University of Miami Business Law Review

The pharmaceutical industry is one of the largest, and most lucrative, industries in the world, worth about one trillion U.S. dollars. Specifically, the United States accounts for more than one-third of the global pharmaceutical market with about 340 million dollars in sales. Not only is the pharmaceutical industry one of the biggest industries profit-wise, but it is also an industry that affects almost every single person in the world. In a nation where healthcare issues are always on the rise, ensuring that American citizens benefit from pharmacology is essential to improving the nation’s healthcare system. The Food and ...


Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey Sep 2016

Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey

Georgia Journal of International & Comparative Law

No abstract provided.


Science, Public Bioethics, And The Problem Of Integration, O. Carter Snead Aug 2016

Science, Public Bioethics, And The Problem Of Integration, O. Carter Snead

O. Carter Snead

Public bioethics — the governance of science, medicine, and biotechnology in the name of ethical goods — is an emerging area of American law. The field uniquely combines scientific knowledge, moral reasoning, and prudential judgments about democratic decision making. It has captured the attention of officials in every branch of government, as well as the American public itself. Public questions (such as those relating to the law of abortion, the federal funding of embryonic stem cell research, and the regulation of end-of-life decision making) continue to roil the public square. This Article examines the question of how scientific methods and principles can ...


Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete Jun 2016

Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete

Catholic University Law Review

The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a ...


Regulating Healthcare Robots: Maximizing Opportunities While Minimizing Risks, Drew Simshaw, Nicolas Terry, Kris Hauser, M.L. Cummings Jan 2016

Regulating Healthcare Robots: Maximizing Opportunities While Minimizing Risks, Drew Simshaw, Nicolas Terry, Kris Hauser, M.L. Cummings

Richmond Journal of Law & Technology

Some of the most dynamic areas of robotics research and development today are healthcare applications. Robot-assisted surgery, robotic nurses, in-home rehabilitation, and eldercare robots' are all demonstrating rapidly iterating innovation. Rising healthcare labor costs and an aging population will increase demand for these human surrogates and enhancements. However, like many emerging technologies, robots are difficult to place within existing regulatory frameworks. For example, the federal Food, Drug, and Cosmetic Act (FD&C Act) seeks to ensure that medical devices (few of which are consumer devices) are safe, the HIPAA Privacy and Security Rules apply to data collected by health care ...


Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher Jan 2016

Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher

Scholarly Works

In this article, Professor Orentlicher explores free speech and federalism issues arising from FDA regulation of off-label uses and off-label marketing of drugs. In light of the FDA's desire to respect state government authority, together with other considerations discussed in this article, he argues for the rejection of the analysis of the Caronia court and to give the FDA significant leeway in its regulation of off-label marketing.


A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks Jan 2016

A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks

Articles

Although food safety is a significant and increasing global health concern, international economic law does not adequately address today’s global food safety needs. While most countries rely on a collection of formalized legal rules to protect food safety, these rules too often fall short. As fiscal constraints impede raising the number of border inspections, formal international commitments (treaties) frequently limit governmental efforts to raise food safety standards. Private companies, meanwhile, can readily adopt higher standards to meet consumer demands and supply chain needs, thus demonstrating more nimbleness and flexibility in adopting the highest food safety standards available. Can countries ...


The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi Jan 2016

The Scope Of Preemption Under The 2009 Family Smoking Prevention And Tobacco Control Act, Sam F. Halabi

Faculty Publications

The 2009 Family Smoking Prevention and Tobacco Control Act endeavored to alter the regulatory regime for tobacco products in the United States by allocating authority to regulate tobacco products to the U.S. Food and Drug Administration (FDA). While the law aims at greater transparency in the constituent components of cigarettes and non-combustible tobacco products, it also includes a provision which will bring FDA’s consumer protection and tobacco control mandates into tension: Section 911’s process for the approval of modified risk tobacco products. That provision allows tobacco manufacturers to submit applications to label products as “reduc[ing] the ...


Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher Jan 2016

Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher

Washington University Journal of Law & Policy

This article focuses on the unique nature of prohibited disclosures within the health care field. Specifically, this article details the relationship between restrictions on off-label drug use advertising and constitutionally protected free speech. Orentlicher explores the conflict between regulation of off-label drug use through direct prohibition versus regulation through indirect advertising restrictions. Ultimately, Orentlicher argues that pharmaceutical companies should not be able to invoke first amendment arguments against off-label advertising restrictions due to the potential for harm to the consumer.


A Natural Food Fight: The Battle Between The “Natural” Label And Gmos, Colleen Gray Jan 2016

A Natural Food Fight: The Battle Between The “Natural” Label And Gmos, Colleen Gray

Washington University Journal of Law & Policy

This note addresses the complex nature of food labeling in the United States, specifically in relation to the rise of “natural” products. Gray analyzes the history of food labeling, focusing on the use of the term “natural” in relation to products containing genetically modified organisms (GMOs). Gray then argues that due to a lack of regulation by the FDA on what the term “natural” means, consumers have a right to know that the “natural” product they are consuming may contain GMOs.


“Right To Try” Legislation And Its Implications For The Fda Drug Approval Process, Emily Hogan Jan 2016

“Right To Try” Legislation And Its Implications For The Fda Drug Approval Process, Emily Hogan

Washington University Journal of Law & Policy

This note analyzes the regulation of experimental drugs by the FDA within the context of “right-to-try” laws. Hogan explores the FDA’s drug approval process, highlighting the specific options for terminally ill patients to fast-track their access to potentially life-saving drugs. Hogan then turns to state “right-to-try” laws, addressing them in relation to federal preemption, pharmaceutical companies, and actual assistance to terminally ill patients. Hogan recommends a relaxation of the FDA’s drug approval process, specifically streamlining the “expanded access” program to give terminally ill patients access to experimental drugs.


Keep Out Fda: Food Manufacturers' Ability To Effectively Self-Regulate Front-Of-Package Food Labeling, Ellen A. Black Nov 2015

Keep Out Fda: Food Manufacturers' Ability To Effectively Self-Regulate Front-Of-Package Food Labeling, Ellen A. Black

DePaul Journal of Health Care Law

No abstract provided.


Trade Secret Rising: Protecting Equivalency Test Research And Development Investments After Momenta V. Amphastar, Hannah-Alise Rogers Nov 2015

Trade Secret Rising: Protecting Equivalency Test Research And Development Investments After Momenta V. Amphastar, Hannah-Alise Rogers

Journal of Intellectual Property Law

No abstract provided.


Prozac: Another Drug Wrongfully Attacked - What Can Be Done To Stop The Legal System From Driving Good Drugs Off The Market, While Protecting State And Federal Interests, Melinda M. Katz Jul 2015

Prozac: Another Drug Wrongfully Attacked - What Can Be Done To Stop The Legal System From Driving Good Drugs Off The Market, While Protecting State And Federal Interests, Melinda M. Katz

Akron Law Review

This Comment will examine the U.S. Food and Drug Administration (FDA) as a regulatory agency, and the status of pharmaceutical products liability. The Comment will describe Prozac, an antidepressant drug currently caught in the products liability dilemma; its compliance with FDA regulations; and opposition to the drug since FDA approval. The Comment will then review American problems with pharmaceutical products liability, and solutions that other commentators have proposed. Finally, the Comment will propose that Congress erect barriers to filing claims against manufacturers for drugs that meet or exceed a higher level of FDA approval, like Bendectin and Prozac, through ...


Pay No Attention To That Man Behind The Curtain: Concealment, Revelation, And The Question Of Food Safety, Denis W. Stearns Jul 2015

Pay No Attention To That Man Behind The Curtain: Concealment, Revelation, And The Question Of Food Safety, Denis W. Stearns

Seattle University Law Review

Despite knowledge that commerce in food is a profit-driven enterprise, the public has consistently put great faith in the wholesomeness and safety of the food being purchased. To some extent, such faith is necessary, even if not always justified. In making the decision to put a bite of food in one’s own mouth, or the mouth of a friend or family member, a form of faith or trust must accompany the act of eating. For who would knowingly eat food suspected to be unsafe? But that is precisely what millions of people do every year, with a great many ...