Pharmacy Administration, Policy and Regulation Commons^™

Fda Policy Shift On Clinical Efficacy Study Requirements For Monoclonal Antibody Biosimilars, Rileigh Rahrig, Madilyn Paphanchith, Allie Honigford, Daniella Egbujor, Haley Brown, Jenny Magana Figueroa, Connor Dains, Brenna Hissong, Kyle W. Parker

Pharmacy and Wellness Review

Biologic products are widely used in the treatment of various disease states, including rheumatoid arthritis, inflammatory bowel disease, cancers, and genetic diseases. These products are derived from proteins and genes produced by living organisms and are subsequently used to treat specific disease states. Due to the complexity of biological products, the costs of research and production are high. Currently, the United States approval pathway requires extensive testing for biologics to be designated as biosimilars, meaning there are no clinically meaningful differences in safety or purity of their active components. These required tests can be redundant, as biosimilars are developed using …

Health, Patents, And Path Dependence: India's Pharmaceutical Crossroads, Jacie Bissell

Michigan Technology Law Review

This paper examines how India’s historical commitment to affordable medicine and public health continues to shape its pharmaceutical patent regime, even as the country aspires to become an innovation-driven economy. Through the lens of path dependence, the paper explores how India’s legal and institutional frameworks have created structural constraints on policy reform. Focusing on key moments such as the Patents Act of 1970, the landmark Novartis decision, and India’s evolving stance on the TRIPS waiver during the COVID-19 pandemic, the paper analyzes the tensions between fostering pharmaceutical innovation and maintaining access to affordable medicines. While recent procedural reforms and judicial …

Study Of Laws And Regulations Related To The Management Of Florfenicol Detection Cases In Swine, Shinnawat Saengungsumalee

The Thai Journal of Pharmaceutical Sciences

Background: Florfenicol, an antibiotic permitted in veterinary medicine, currently lacks an established maximum residue limit (MRL) in meat products in Thailand, effectively mandating undetectable residue levels. In May 2024, Thailand Pesticide Alert Network reported florfenicol residues in swine, raising concerns about consumer safety, rational veterinary drug use, and the potential for antimicrobial resistance (AMR). Addressing these issues involves multiple laws, decrees, and regulations across various agencies. Objectives: To analyze laws and regulations managing florfenicol residue detection in swine. Materials and Methods: This documentary research examines relevant laws, regulations, and measures for florfenicol in livestock and compares Thailand’s regulations with those …

Brief Of 76 Scholars Of Law, Business, Economics, And Medicine As Amici Curiae, Charles Duan

Amicus Briefs & Court Filings

No abstract provided.

The Chemical Straightjacket: Institutional Over-Use Of Psychotropic Drugs On Children In Lieu Of Therapeutic Community Mental Health Services, Marisa Leib-Neri

Indiana Journal of Law and Social Equality

This Article argues that the abysmal state of children’s mental health in America is in part due to an overreliance on and over prescription of psychotropic drugs inside psychiatric residential institutions in lieu of community based mental health services. This overreliance on residential institutions and psychotropic drugs has allowed a new form of chemical restraint to flourish—the chemical straitjacket. This Article uses the medication lists of twelve children in seven different North Carolina psychiatric residential treatment facilities to demonstrate how the chemical straitjacket operates: the prescription of drugs not approved for pediatric populations, counter to evidence-based practices for particular diagnoses, …

Customary Corruption, Ani B. Satz, Liza Vertinsky

Faculty Articles

For over a hundred years, it has been well-accepted among tort scholars that physicians—as one of the legally recognized professions— determine their own customary practices. Within tort law, and medical malpractice more specifically, customary practice establishes whether physicians breach or uphold the required standard of care toward their patients. The results of our hand-coded examination of decided cases and statutes show a more complex picture. While some states have endeavored to shift the standard away from professional custom, it continues to play a critical, and in many cases a determinative, role in establishing physician liability in most states.

Using illustrative …

Defederalizing Opioid Addiction Care, Matthew B. Lawrence

Faculty Articles

Lack of access to evidence-based care for drug addiction is an urgent problem amid a decades-long overdose crisis that kills tens of thousands of Americans a year. Opioid addiction is the primary driver of overdoses today, and medicines exist to treat such addiction that can dramatically improve quality of life while reducing the risk of deadly overdose by more than half. Yet fewer than one in four of the nine million Americans who need such evidence-based medical care for their addiction receive it. Chief among barriers to access are restrictive and burdensome federal requirements limiting the use of narcotic medications …

Pharmaceutical-Telehealth Confederacies, Michael S. Sinha

All Faculty Scholarship

Access to prescription pharmaceuticals has historically been controlled by a physician’s pen. As a result, pharmaceutical companies spend billions of dollars on advertising and promotion to mitigate this barrier: first and primarily, to physicians and other prescribers, and more recently, to the general public through direct-to-consumer advertising. The success of these promotional efforts can be seen in greater prescribing of costly brand-name medicines, even in settings where lower-priced generic alternatives exist. Brand-name prescriptions now make up only 10% of all prescriptions written yet account for 87% of drug spending. Despite these substantial returns on investment, companies continue to seek opportunities …

A Tale Of Two Bills: Lessons Learned In Expanding Pharmacist-Led Hiv Pre-Exposure And Post-Exposure Prophylaxis, Jennifer M. Cocohoba, Jerika Lam, Maria Lopez, Betty J. Dong

Pharmacy Faculty Articles and Research

"In December 2023, JACCP published a content analysis of state legislative bills focused on expanding pharmacist scope of practice to provide human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).¹ All states permit pharmacists to prescribe under a collaborative practice agreement with approximately half of the states granting HIV PrEP and post-exposure prophylaxis (PEP) authority to prescribe either via legislation, standing orders, or statewide protocols.^2-4 New York was the first state to expand pharmacists' specific authority for HIV prevention in 2017; however, California was the first state to pass legislation with Senate Bill 159 …

Does Federal Preemption Inoculate Us Against The Alarming Prospect Of State Vaccine Bans?, Lars Noah

UF Law Faculty Publications

With growing resistance to vaccinations-premised, for instance, on misplaced fears of side effects or religious objections-it takes little effort to imagine that a state might act to prohibit some or all uses of a particular vaccine licensed by the federal government. Indeed, one year ago, legislators in a couple of states toyed with the idea of banning the primary vaccines against Covid-19, and, twenty years ago, half a dozen states effectively barred certain uses of one flu vaccine formulation. Although federal law should preempt at least some of these types of state restrictions, the Supremacy Clause of the U.S. Constitution …

President’S Address: Dr. Vince Benivegna, Vince Benivegna Dds

The Journal of the Michigan Dental Association

Dr. Vince Benivegna, the outgoing President of the Michigan Dental Association, addressed the House of Delegates, emphasizing the significant progress in enhancing Adult Dental Medicaid coverage and reimbursement in Michigan. He thanked the dedicated individuals who supported him during his tenure and shared his journey. Dr. Benivegna lauded Michigan's accomplishments in reducing opioid prescribing and highlighted the MDA's role as a model state society in advocacy, leadership, mentorship, continuing education, diversity, equity, and inclusion. He praised Michigan's achievements in improving Adult Dental Medicaid, encouraging Michigan dentists to participate and help address oral health disparities. Dr. Benivegna underscored how this aligns …

Dentistry And The Law: Accessing/Disclosing Prescription Information On Software Platforms, Dan Schulte Jd

The Journal of the Michigan Dental Association

This article discusses the access and disclosure of prescription information on software platforms like eScribe and MAPS. It highlights that HIPAA regulations govern such access, and as long as the information is obtained through business associate agreements and used for treatment purposes, specific patient consent may not be necessary. The article also mentions that the Michigan Automated Prescription System (MAPS) allows prescribers to access controlled substance prescription information without requiring patient consent.

Utah Pharmacists’ Qualitative Feedback Regarding Licensure Standards., Rebecca Howard

Annual Research Symposium

This project sought to understand current attitudes and perceptions of licensed pharmacists in the state of Utah to the existing occupational licensing standards which govern our profession. Qualitative feedback was gathered from Utah licensed pharmacists for a period of one month.

Pharmacy Law: Pharmacists Awareness Of Licensure Regulations, The Mpje And Nabp - A State-Wide Study, Andrew Holick

Annual Research Symposium

No abstract provided.

Redlining And Opioid Overdose Outcomes: Do Historical Housing Policies Still Impact Health Today?, Sahana Paravantavida

Honors Theses

This study examines the relationship between historical housing policies and current health outcomes, specifically the impact of redlining on opioid overdose rates. Using data collected from the state of New Jersey, neighborhoods with a history of redlining have higher rates of opioid overdose deaths. My findings suggest that historical housing policies, which systematically excluded certain populations from accessing affordable housing and resources, continue to impact health outcomes today.

Analyzing Factors Impacting Time To Full Approval Of Innovative Drugs Via An Accelerated Approval Pathway In The United States, Eleanor Panico

Seton Hall University Dissertations and Theses (ETDs)

Background and purpose of study: Pharmaceutical drugs are commonly used to treat various ailments and the pharmaceutical industry is increasingly leveraging expedited pathways to market, like the FDA’s accelerated approval pathway. Thus, these pathways are becoming more prevalent and thus more scrutinized for reliability. A consequence from this increased utilization is observed variability in time to reach full approval from the point accelerated approval was received. Variables that may impact time and ability to reach full approval should be further investigated. The purpose of this study was to explore, identify and predict variables that may influence time from accelerated approval …

Lessons Learned From The Hiv/Aids Pandemic And Access To Medicines For Covid-19 Treatment, Thalia Le

Independent Study Project (ISP) Collection

There is an imminent need to address the healthcare disparities in accessing all COVID-19 medicinal products in developing countries. While logistical issues like inadequate production facilities such as the lack of vaccines administration capacity, storage issues, gap between supply and demand as well as vaccine hesitancy can certainly play a part in impeding COVID19 medicines distribution, patent monopolies and intellectual property protection laws further exacerbated the problem, especially when vaccines were at its early stages of authorization. Historical and contemporary case studies of efforts to challenge patents on HIV AVRs treatment provide a useful lens through which we may glean …

J Mich Dent Assoc July 2021

The Journal of the Michigan Dental Association

Every month, The Journal of the Michigan Dental Association brings news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200+ members. No publication reaches more Michigan dentists!

In this issue, the reader will find the following original content:

• A cover story on “Measuring Outcomes to Improve the Quality of Clinical Care”.
• A feature article, “Is Your Office Winning or Losing the Race? You Won’t Know Without Measurement”.
• The feature article, “The DQA and Quality Measurement in Dental Programs and Plans”.
• News you need, Editorial and regular department articles on MDA Foundation activities, Dentistry …

Effect Of Free Trade Agreements On Pharmaceutical Market Competition: The Case Of The 2009 Us-Peru Free Trade Agreement And Its Implementation As National Drug Policy, Lita Araujo, Enrique Seoane-Vazquez, Michael Montagne

Pharmacy Faculty Articles and Research

Free Trade Agreements (FTA) are controversial for threatening essential aspects of health, especially access to affordable medicines. The US-Peru FTA required changes in the Peruvian pharmaceutical legislation that resulted in the implementation of the National Drug Policy (NDP) of 2009. The NDP included more robust technical requirements for registration, a Peruvian Good Manufacturing Practices certificate, a longer timeline for drug registration, and an increase in registration fees. This study evaluated the impact of the FTA on the number of registrations and competition in the Peruvian pharmaceutical market.

Data for the period January 2005 to April 2014 were provided by the …

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Faculty Articles

One thing we have seen today that we talk about in health law all the time is how the policy, the laws and institutions up at the 10,000 foot level, can so dramatically influence the personal, people’s lived experiences. Our speakers today have done a really great job of drawing out abstract institutional questions and also showing us how those questions have influenced the lives of real people in often tragic ways. Another thing we have seen that we talk about in administrative law all the time is the importance of expertise, especially given how hard it is to trace …

Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser

St. Mary's Law Journal

Abstract forthcoming

Legislation Across The Nation And The Impact On Pharmacy Practice, Sabrina Hamman, Hannah Lamb, Jennifer Harklerode, Elizabeth Kramer, Steven Martin

Pharmacy and Wellness Review

Pharmacy legislation is constantly being updated, giving pharmacists a larger role in the health care field. In the past 20 years, pharmacists have seen expansions to legislation involving contraceptive authority, medical marijuana, vaccines and provider status. There is a greater pharmacist impact from legislation passed on the state level in comparison to the national level. As a result, pharmacists have different opportunities to provide new and advanced services to patients based on the state in which they are practicing. Comparing these various laws across the nation allows the profession to determine which sections of the law are problematic and which …

Drug Prices, Dying Patients, And The Pharmaceutical Marketplace: A New Conditional Approval Pathway For Critical Unmet Medical Needs, Robert A. Bohrer

Faculty Scholarship

Prescription drugs have been a major topic in the news for much of the past year. There are two issues which appear often: first, the very high prices of new drugs, particularly the "specialty" drugs developed for serious diseases; and second, the time required for FDA approval in relation to the perceived need for earlier access to new therapies for critically ill patients. Much less in the news, but lurking behind both issues, is the need for better information for physicians and patients to use in making decisions about prescribing and taking drugs, and for insurance companies and the government …

Direct-To-Consumer Ads Are Misleading: Concise Statements Of Effectiveness Should Be Required, Robert A. Bohrer

Faculty Scholarship

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals has been the subject of much criticism and the issue has become even more pressing with the Trump administration’s proposal to require the disclosure of prices in DTC ads. In this article I argue that a more powerful approach to the problem of DTC ads would require the disclosure of the effectiveness of the advertised drugs, at least as found in the clinical trials submitted for FDA approval. To support the need for an effectiveness disclosure, I describe the problem of DTC ads and examine representative ads to illustrate the potential of such ads …

Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker

Publications

This book is designed to appeal to anyone who is at all interested in topics related to making life better and safer—for all us consumers. Our current approach to consumer protection is extremely flawed; sometimes costing lives rather than saving them. There are better ways to protect ourselves and the people we love.

Regulatory Gaps In Drug Compounding: Implications For Patient Safety, Innovation, And Fraud, Joanna Shepherd

Faculty Articles

Drug compounding is the practice of mixing, combining, or altering drug ingredients to create a product that meets the medical needs of a patient whose needs cannot otherwise be met with commercially-available products. Compounding is essential for patients that are allergic to certain ingredients or cannot tolerate the route of administration or dosage form of a commercially-available drug. Compounding may also enable pharmacists to supply medications when there is a shortage of commercially-available drugs. For example, amid the nationwide shortage of generic liquid Tamiflu and growing flu deaths in early 2018, pharmacists around the country used Tamiflu capsules to compound …

Pharmacy-Based Travel Health Services In The United States, Keri Hurley-Kim, Jeffery Goad, Sheila Seed, Karl M. Hess

Pharmacy Faculty Articles and Research

The aim of this paper is to review pharmacy laws and regulations, pharmacist training, clinic considerations, and patient care outcomes regarding pharmacy-based travel health services in the United States. Pharmacists and pharmacies in the United States are highly visible and accessible to the public, and have long been regarded as a source for immunization services. As international travel continues to increase and grow in popularity in this country, there is a pressing need for expanded access to preventative health services, including routine and travel vaccinations, as well as medications for prophylaxis or self-treatment of conditions that may be acquired overseas. …

Multiple Sclerosis Drugs Have Been Getting A Lot More Expensive, Ben Jay

Capstones

Multiple Sclerosis is a very expensive disease. According to a 2016 study in the American Journal of Managed Care, treating it can cost patients anywhere from $30,000 to $100,000 per year, which can meet or even exceed the average US household median income, depending on how severe your case is. For a disease that has no known cure, and requires frequent medical attention to manage symptoms that can completely debilitate a person if left untreated, that can mean spending $4.1 million over the course of a lifetime, according to the same study. However, in the last 20 years, that …

Radical Social Ecology As Deep Pragmatism: A Call To The Abolition Of Systemic Dissonance And The Minimization Of Entropic Chaos, Arielle Brender

Student Theses 2015-Present

This paper aims to shed light on the dissonance caused by the superimposition of Dominant Human Systems on Natural Systems. I highlight the synthetic nature of Dominant Human Systems as egoic and linguistic phenomenon manufactured by a mere portion of the human population, which renders them inherently oppressive unto peoples and landscapes whose wisdom were barred from the design process. In pursuing a radical pragmatic approach to mending the simultaneous oppression and destruction of the human being and the earth, I highlight the necessity of minimizing entropic chaos caused by excess energy expenditure, an essential feature of systems that aim …