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Articles 1 - 28 of 28
Full-Text Articles in Health Law and Policy
Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales
Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales
University of Miami Law Review
Cosmetics only first became regulated after a series of tragic events where users were seriously harmed from the use of cosmetic products. These tragic events prompted legislators to enact the Food, Drug, and Cosmetics Act of 1938. Before then, law makers feared that regulating the cosmetic industry would lower the tone of legislation because they considered the cosmetic industry to be inconsequential. At present, the regulatory system in place to protect vulnerable cosmetic consumers is nearly identical to when it was enacted over eighty-six years ago—even though the cosmetic market looks nothing like it did back then. The consumer base …
Death By Detox: Substance Withdrawal, A Possible Death Row For Individuals In Custody, Dorothea R. Carleton
Death By Detox: Substance Withdrawal, A Possible Death Row For Individuals In Custody, Dorothea R. Carleton
Journal of Law and Health
Suffering through substance withdrawal is a major problem for the majority of individuals in custody, yet there are no guidelines or standards to ensure their safety. Instead, individuals in custody are having their Constitutional rights violated and many die at the hands of the justice system. When their families seek accountability for the lack of adequate care provided by correctional facilities and employees, families are faced with a lack of consistency from one circuit to the next for knowing as to the correct standard to have a successful claim. Strain v. Regalado was a chance for the Supreme Court to …
Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous
Improving Access To Emerging Lifesaving Drugs: Solving The Disclosure Problem Within The Patent Dance, Michael J. Schellhous
Saint Louis University Journal of Health Law & Policy
Biologics are a growing class of pharmaceutical drugs and are associated with a significant portion of major medical breakthroughs over the past fifty years. However, in comparison with traditional small-molecule drugs, biologics are vastly more complex, more difficult to manufacture, and extremely expensive. Congress passed the Biologics Price Competition and Innovation Act (BPCIA) in an effort to increase the availability of biosimilars—the generic versions of biologic drugs—but the BPCIA has been largely ineffective. This is due, in part, to the lack of a standard regarding initial information disclosures required at the outset of the BPCIA process, leading to a cumbersome …
Mistakes Were Made: Applying Lessons Learned From The Tobacco Master Settlement Agreement To The Opioid Settlement Agreement, Elizabeth Orrick
Mistakes Were Made: Applying Lessons Learned From The Tobacco Master Settlement Agreement To The Opioid Settlement Agreement, Elizabeth Orrick
Mitchell Hamline Law Journal of Public Policy and Practice
No abstract provided.
The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman
The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman
Michigan Law Review Online
In late 2019 and early 2020, a new strain of coronavirus, a family of pathogens causing serious respiratory illness, began infecting populations across the globe. A quick uptick in COVID-19, the disease caused by the novel pathogen, prompted the World Health Organization to declare the outbreak a Public Health Emergency of International Concern on January 30, 2020. By mid-February 2020, with 26 countries reporting cases of COVID-19 infection, the global case count had surpassed 50,000, and had resulted in over 1,500 deaths. The World Health Organization elevated the status of the outbreak to a pandemic in mid-March. As of early …
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Michigan Telecommunications & Technology Law Review
Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …
Improving Generic Drug Approval At The Fda, Kathleen Craddock
Improving Generic Drug Approval At The Fda, Kathleen Craddock
Michigan Journal of Environmental & Administrative Law
Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …
Informing Consent: Medical Malpractice And The Criminalization Of Pregnancy, Laura Beth Cohen
Informing Consent: Medical Malpractice And The Criminalization Of Pregnancy, Laura Beth Cohen
Michigan Law Review
Since the early 1990s, jurisdictions around the country have been using civil child abuse laws to penalize women for using illicit drugs during their pregnancies. Using civil child abuse laws in this way infringes on pregnant women’s civil rights and deters them from seeking prenatal care. Child Protective Services agencies are key players in this system. Women often become entangled with the Child Protective Services system through their health care providers. Providers will drug test pregnant women without first alerting them to the potential negative consequences stemming from a positive drug test. Doing so is a breach of these providers’ …
Trying And Dying: Are Some Wishes At The End Of Life Better Than Others?, Oliver J. Kim
Trying And Dying: Are Some Wishes At The End Of Life Better Than Others?, Oliver J. Kim
Dalhousie Law Journal
In the United States, efforts to create a "rightto try," or to provide access for the terminally ill to try experimental drugs, have seen overwhelming success in passing state legislatures. This success provided the foundation for advocates' long-term goal of a federal right to try. Yet proposals ranging from very modest advance-care-planning consultations to the "rightto die,"or medical aid in dying, face steep political challenges despite seeming public support. This paper discusses the legal underpinnings of both "rights" and the current political and policy debate over each. More often than not, these "rights" are grantedthrough legislation rather than judicial decisions, …
Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
Michigan Law Review
The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …
Shifting Our Focus From Retribution To Social Justice: An Alternative Vision For The Treatment Of Pregnant Women Who Harm Their Fetuses, April L. Cherry
Shifting Our Focus From Retribution To Social Justice: An Alternative Vision For The Treatment Of Pregnant Women Who Harm Their Fetuses, April L. Cherry
Journal of Law and Health
The ways in which society responds to pregnant women whose behavior purportedly harms their fetuses can be explored from a variety of legal vantage points. This article argues that the criminal law model currently used is ineffective. The assignment of criminal liability to pregnant women is often rooted in fetal personhood and maternal deviance discourse. Criminal law solutions fail because they fail to take into account the fact that maternal behavior is often the result of a myriad of the social and economic conditions over which pregnant women have little or no control. The criminal law model, therefore, simply punishes …
Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
Seattle University Law Review
Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …
The Case For Flexible Intellectual Property Protections In The Trans-Pacific Partnership , Matthew E. Silverman
The Case For Flexible Intellectual Property Protections In The Trans-Pacific Partnership , Matthew E. Silverman
Journal of Law and Health
The United States and eleven other countries are currently in the end stages of negotiating the Trans-Pacific Partnership (TPP)—the largest free trade agreement (FTA) in U.S. history—which incorporates a range of trade topics, including the protection and enforcement of intellectual property rights (IPRs). Although the negotiations have been highly secretive, negotiating texts of the agreement leaked as recently as November 2013 have suggested that the United States is proposing IPR provisions, specifically relating to patent protection, that are stronger and less flexible than IPR provisions included within three of the four most recent U.S. FTAs. This paper addresses and analyzes …
Introducing Patient Scope Of Care: Psychologists, Psychiatrists, And The Privilege To Prescribe Drugs, Rachel P. Berland
Introducing Patient Scope Of Care: Psychologists, Psychiatrists, And The Privilege To Prescribe Drugs, Rachel P. Berland
Saint Louis University Journal of Health Law & Policy
No abstract provided.
Independent Clinical Trials To Test Drugs: The Neglected Reform, Marc A. Rodwin
Independent Clinical Trials To Test Drugs: The Neglected Reform, Marc A. Rodwin
Saint Louis University Journal of Health Law & Policy
No abstract provided.
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
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 …
Litigating Against An Epidemic: Hiv/Aids And The Promise Of Socioeconomic Rights In South Africa, Nathaniel Bruhn
Litigating Against An Epidemic: Hiv/Aids And The Promise Of Socioeconomic Rights In South Africa, Nathaniel Bruhn
Michigan Journal of Race and Law
With one of the highest incidence rates in the world, the HIV/AIDS epidemic has taken a large toll on South Africa. Despite medical advances that have made the disease more manageable, many South Africans still do not have access to the medicines needed to control the disease. At the same time, the Constitution of South Africa grants individuals far-reaching socioeconomic rights, including the right to access health care. This Comment explores the intersection of the socioeconomic rights and the HIV/AIDS crisis. Although the Constitutional Court has developed a deferential approach to enforcing socioeconomic rights, substantial room remains to litigate on …
Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang
Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang
University of Michigan Journal of Law Reform
Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …
How The Rise Of Federal Bureaucratic Powers Challenges The Role Of Courts In Adjudicating Claims Of Injury Inflicted By Prescription Drugs, Denise K. Top
Golden Gate University Law Review
This Comment uses the recent Paxil litigation as an example of how the rise of federal bureaucratic powers, specifically those exercised by the FDA to administer the Food Drug and Cosmetic Act (hereinafter "FDCA"), increasingly challenge the role of courts in adjudicating tort claims of injury inflicted by prescription drugs. Part I explains the current labeling requirements for prescription drugs. Part II describes product liability law regarding claims involving prescription drugs. Part III analyzes the drug manufacturers' and FDA's defenses to state tort claims, specifically preemption and primary jurisdiction. Part IV discusses the current law as it applies to the …
Danger Or Resort To Underwear: The Safford Unified School District No. 1 V. Redding Standard For Strip Searching Public School Students., Joseph O. Oluwole
Danger Or Resort To Underwear: The Safford Unified School District No. 1 V. Redding Standard For Strip Searching Public School Students., Joseph O. Oluwole
St. Mary's Law Journal
Safford Unified Sch. Dist. No. 1 v. Redding (Redding III) represents a pivotal decision in school search and seizure jurisprudence, specifically regarding strip searches of students. Redding III establishes constraints specific to strip searches on the search and seizure authority of school officials. Redding III is intended to provide a uniform test for the judiciary and school officials when evaluating the reasonableness of strip searches of students. The Court explicitly interposed a “reliable knowledge” element requiring: (1) the degree to which known facts imply prohibited conduct; (2) the specificity of the information received; and (3) the reliability of its source. …
Pdufa And Initial U.S. Drug Launches, Mary K. Olson
Pdufa And Initial U.S. Drug Launches, Mary K. Olson
Michigan Telecommunications & Technology Law Review
In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review …
Pursuing The Perfect Mother: Why America's Criminalization Of Maternal Substance Abuse Is Not The Answer- A Compartive Legal Analysis, Linda C. Fentiman
Pursuing The Perfect Mother: Why America's Criminalization Of Maternal Substance Abuse Is Not The Answer- A Compartive Legal Analysis, Linda C. Fentiman
Michigan Journal of Gender & Law
In this Article the author will examine not only the substantive legal differences between the United States, Canada, and France, but will also explore how these legal rules fit within a broader social, political, and religious setting. This Article will pursue four lines of inquiry. First, it will briefly chronicle the history of criminal prosecution of pregnant women in America and show how these prosecutions have become markedly more aggressive over the last twenty years. Second, it will situate these prosecutions in the full context of American law and culture, demonstrating how the fetus has received increasing legal recognition in …
Fear Of Prescribing: How The Dea Is Infringing On Patients' Right To Palliative Care, Ashley Bruce Trehan
Fear Of Prescribing: How The Dea Is Infringing On Patients' Right To Palliative Care, Ashley Bruce Trehan
University of Miami Law Review
No abstract provided.
Health Care Law, Michael C. Guanzon
Health Care Law, Michael C. Guanzon
University of Richmond Law Review
No abstract provided.
Drug Regulations And The Constitution After Western States, Margaret Gilhooley
Drug Regulations And The Constitution After Western States, Margaret Gilhooley
University of Richmond Law Review
No abstract provided.
Cybermedicine And Virtual Pharmacies, Ronald L. Scott
Cybermedicine And Virtual Pharmacies, Ronald L. Scott
West Virginia Law Review
No abstract provided.
The Charleston Policy: Substance Or Abuse?, Kimani Paul-Emile
The Charleston Policy: Substance Or Abuse?, Kimani Paul-Emile
Michigan Journal of Race and Law
In 1989, the Medical University of South Carolina (MUSC) adopted a policy that, according to subjective criteria, singled out for drug testing, certain women who sought prenatal care and childbirth services would be tested for prohibited substances. Women who tested positive were arrested, incarcerated and prosecuted for crimes ranging from misdemeanor substance possession to felony substance distribution to a minor. In this Article, the Author argues that by intentionally targeting indigent Black women for prosecution, the MUSC Policy continued the United States legacy of their systematic oppression and resulted in the criminalizing of Black Motherhood.
The Hardest Drug: Heroin And Public Policy, Michigan Law Review
The Hardest Drug: Heroin And Public Policy, Michigan Law Review
Michigan Law Review
A Review of The Hardest Drug: Heroin and Public Policy by John Kaplan