Pharmacy Administration, Policy and Regulation Commons^™

Promoting Scientific Impact At The Nih, Fred D. Ledley M.D.

CISI Publication

We are honored to offer our comments on Promoting Scientific Impact at the NIH in response to NOT-OD-26-087: Request for Information on Measuring and Rewarding Scientific Impact.

These comments are informed by my professional experience as the founding director of the Center for Integration of Science and Industry at Bentley University, which has a mission to “advance the translation of scientific discoveries for public value by engaging science, business, and policy in transdisciplinary dialogue, scholarship, and education.” Our approach is to bring together the perspectives of natural science, business, analytics, economics, law, and policy to better understand, and advance, the …

Comments Re: Medicare Drug Price Negotiation Program And Medicare Prescription Drug Benefit Program, Fred D. Ledley M.D., Edward Zhou Pharm. D.

CISI Publication

Thank you for the opportunity to provide written comments in response to the Medicare Drug Price Negotiation Program proposed rule published on June 16, 2026 in the Federal Register. [1] We are answering as academic researchers with experience in medicine, pharmacy, biomedical research, and the biopharmaceutical industry. Our perspective is informed by extensive, published research on the economics and finance of pharmaceutical innovation, the value created by new medicines, and the impacts of the Inflation Reduction Act (IRA).

We applaud the accomplishment of the IRA in establishing the precedent for the government to negotiate “fair market prices” for drugs on …

Comments Re: Commonsense Policy Options To Lower Drug Prices For Patients, Fred D. Ledley M.D., Edward Zhou Pharm. D.

CISI Publication

Thank you for the opportunity to provide written comment in response to the Senate Finance Committee Minority Staff’s “Request for Information: Commonsense Policy Options to Lower Drug Prices for Patients.” We are answering as academic researchers with experience in medicine and the biopharmaceutical industry. This comment will focus on sections I and III of the RFI.

We applaud the accomplishment of the Inflation Reduction Act (IRA) in establishing the precedent for the government to negotiate “fair market” prices for drugs on terms that address both patients’ needs for affordability and industry’s need for a reasonable return on investment. Our analysis …

Navigating The Gray Area: The Unregulated Surge Of Unique Glp-1 And Glp-1/Gip Products, Jordyn Belcourt, Amy Sapowadia, Charles Michael White

Honors Scholar Theses

Purpose: To identify unique compounded semaglutide and tirzepatide products that existed after the shortage grace period ended and to assess their characteristics.

Methods: Researchers searched for compounding pharmacies using specific terms on Google. They collected the formulation, ingredients, dosage, and monthly cost of products. Researchers also contacted compounding company websites with available information to ascertain further information about products.

Results: Researchers identified 26 sites selling a total of 86 semaglutide or tirzepatide products. Of the included products, 33 were unique, and 41 products were essentially copies of FDA-approved products. Unique formulations included sublingual solution (n=9), sublingual tablets (n=5), and orally …

3rd Place Contest Entry: "Examining Physicians’ Behaviors Regarding Buprenorphine Prescribing For Opioid Use Disorder", Khashayar Eshtiaghi

Eric M. Scandrett Graduate Library Research Prize

This is Khashayar Eshtiaghi's submission for the 2026 Eric M. Scandrett Graduate Research Prize, which won third place. It contains their essay on using library resources, a summary of their research project on physicians' behaviors regarding buprenorphine prescribing for opioid use disorde, and their bibliography.

Khashayar is a student in the Ph.D. in Pharmaceutical Economics and Policy program at Chapman University. Their faculty mentor is Dr. Marc Fleming.

Community Pharmacies Face Critical Sustainability Challenges In The United States: Academic Pharmacy Can Help, Karl M. Hess, Peter Lim

Pharmacy Faculty Articles and Research

Community pharmacies in the United States (US) face an increasingly unsustainable future due to declining third-party reimbursement (remuneration) and ongoing cash flow challenges following the elimination of retroactive direct and indirect remuneration (DIR) fees. These pressures have contributed to widespread pharmacy closures, the emergence of pharmacy deserts, and reduced access to care for millions of patients. Despite these challenges, community pharmacy remains the most common employment setting for pharmacy school graduates in the US. However, currently required community pharmacy Advanced Pharmacy Practice Experience (APPE) student rotations may offer limited exposure to business, management, and entrepreneurial activities, potentially leaving students underprepared …

Improving Hba1c And Diabetes Preventative Screening Measures In Spanish-Speaking Patients With Clinical Pharmacist Care: A Quality Improvement Initiative, Jennifer Ko, Tila P. Nguyen, Bonnie K. Chen, Richard Beuttler

Pharmacy Faculty Articles and Research

Purpose:

Methods:

Results:

Early And Sustained Improvements In Sense Of Smell With Tezepelumab Treatment In Patients With Chronic Rhinosinusitis With Nasal Polyps (Waypoint), Joaquim Mullol, Joseph K. Han, Tanya M. Laidlaw, Claire Hopkins, Anju T. Peters, Oliver Pfaar, Martin Desrosiers, Stella E. Lee, Andrew P. Lane, Claudia Chen, Yun Chon, Sandhia S. Ponnarambil, Andrews Foster, Andrew W. Lindsley, Christopher S. Ambrose

Department of Otolaryngology (ENT) Faculty Publications

Background

Loss of smell is a principal symptom of chronic rhinosinusitis with nasal polyps (CRSwNP), affecting health-related quality of life and posing a safety hazard.

Methods

WAYPOINT (NCT04851964), a phase 3, multicenter trial in adults with uncontrolled CRSwNP, randomized patients 1:1 to receive tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. Changes from baseline in biweekly mean Nasal Polyposis Symptom Diary (NPSD) loss of smell item, University of Pennsylvania Smell Identification Test (UPSIT), and 22-item Sino-Nasal Outcome Test (SNOT-22) loss of smell/taste item scores, as well as anosmia (UPSIT score ≤18) prevalence, were assessed over 52 …

Assessing Buprenorphine Treatment Utilization And Samhsa Data Waiver Provider Distribution In 2021: A Real-World Analysis In California, Yun Wang, Tao Hu, Chih-Hung Chang, Matthew Heshmatipour, Jeff Jianfei Guo, Moom R. Roosan, Karen A. Miotto

Pharmacy Faculty Articles and Research

Qualified clinicians previously required a practitioner waiver (i.e., “DATA-waiver” or "X-waiver") to offer buprenorphine, a medication for opioid use disorder (OUD). However, many counties in the US experience fewer buprenorphine prescriptions due to factors such as “DATA-waiver” providers underutilizing their buprenorphine prescribing ability. Our study aimed to compare the availability of active buprenorphine-prescribing clinicians in California to the Substance Abuse and Mental Health Services Administration (SAMSHA)-listed DATA waived prescribers under each 5-digit ZIP Code. This study utilized the buprenorphine prescription record data in 2021 from California’s Controlled Substance Utilization Review and Evaluation System (CURES). The list of the locators for …

Enhancing Holistic Patient Care Of Black Individuals Diagnosed With Hiv And Comorbid Chronic Conditions, Marc Fleming, Saharnaz Nejdat, Jon C. Schommer, Crystal K. Hodge

Pharmacy Faculty Articles and Research

Background

Pharmacists can play a crucial role in delivering the holistic care model. Research suggests that HIV-positive African American patients particularly benefit from this approach compared to other communities. Typically, pharmacists in community pharmacy settings are limited in their access to a patient's medical record, preventing holistic care delivery.

Objectives

This study addressed the impact of access to medical records on a holistic patient care approach among pharmacists engaged in medication therapy management.

Methods

This was a sub-analysis of a randomized controlled trial of the impact of community pharmacist access to medical records during MTM for African Americans diagnosed with …

Interprofessional Education And Collaboration In The Philippines: Current Landscape, Gaps, And Propositions, Arvie Vitente, Michael Sy, Reeva Ann Sumulong, Anna Causapin, Jocel Regino

Rehabilitation Sciences Department Faculty Articles

Interprofessional education (IPE) is a forward-looking strategy in healthcare education that unites students and professionals from various disciplines to enhance interprofessional collaboration (IPC). IPE is designed to prepare future health and social care professionals to navigate and address the complexities of modern healthcare systems. In the Philippines, despite being a developing country with a fragmented healthcare system, there have been efforts over the last 15 to 20 years to introduce and institutionalize IPE and IPC in both higher education and healthcare settings. However, significant challenges persist, including the dominance of medical professionals, inadequate regulatory mechanisms, and a lack of strong …

Strengthening The Paediatric Clinical Trial Ecosystem To Better Inform Policy And Programmes, James A. Berkley, Judd L. Walson, Glenda Gray, Fiona Russell, Zulfiqar Ahmed Bhutta, Per Ashorn, Shane A. Norris, Ebunoluwa A. Adejuyigbe, Rebecca Grais, Bernhards Ogutu

Institute for Global Health and Development

The first WHO Global Clinical Trials Forum was convened in November, 2023 to develop a shared vision of an effective global clinical trial infrastructure. The Paediatric Clinical Trials Working Group was formed to provide perspectives, identify challenges, and propose solutions to strengthen the paediatric clinical trials ecosystem. Participants represented paediatric disciplines, including infectious diseases, nutrition, neonatology, pharmacology, oncology, neurodevelopment, public health, and policy. Childhood diseases have profound lifelong effects on health, livelihoods, and societies. Investment in early childhood results in highly cost-effective changes to lifelong health, productivity, and human capital returns. Yet, there remain substantial gaps in knowledge on the …

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

Amicus Briefs & Court Filings

No abstract provided.

Blended Learning Course In Medical Affairs To Improve Exposure And Interest In Pharmaceutical Industry Careers, Nandini Manne, Gayle Brazeau, Craig Kimble

Pharmacy Practice & Administration

Objective: This study aimed to evaluate students’ knowledge and perceptions of career options and their knowledge of the pharmaceutical industry based on pre-post module quizzes, reflections, and team presentations in a hybrid medical affairs elective certification course.

Methods: A qualitative research design was used to analyze the reflections of 19 students enrolled in the Accreditation Council for Medical Affairs Pharmaceutical Industry Training Certificate elective at Marshall University during spring 2023. The course used 7 modules from the Medical Affairs Competency Certificate offered by the Accreditation Council for Medical Affairs. Students completed premodule and postmodule quizzes, engaged in discussions with industry …

Mergers And Acquisitions (M&As) In Pharmaceutical Markets: Associations With Market Concentration, Prices, Drug Quantity Sold, And Shortages, J. Daniel Mcgeeney M.S., Aylin Sertkaya Ph.D., Leah Ross M.A., Fred Ledley M.D., Cody Hyman Ph.D.

CISI Publication

In recent decades, the pharmaceutical industry has become increasingly concentrated in the United States, in part due to mergers and acquisitions (M&As) between drug manufacturers. This consolidation from M&As has been cited as a key factor affecting drug prices and drug shortages (U.S. Federal Trade Commission, 2022). In this study, we assessed trends in pharmaceutical M&As during 2010–2023 and evaluated the characteristics of drugs and companies involved in those M&As. We considered the effects of M&As on market concentration, drug prices, drug quantity sold, and drug shortages. We also considered how these associations vary by drug characteristics, including brand drugs …

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 …

Payment Disrupters And Opportunities: Key Trends That Impacted Pharmacy In 2024, Craig Kimble, Thomas Pile, Alberto Coustasse

Management Faculty Research

In 2023, the United States experienced the most significant increase in prescription drug spending (13.6%), totaling $89 billion.1 This was driven by higher utilization and the introduction of new, expensive specialty and biotech drugs. In 2024, other factors continue to drive costs and disrupt the pharmacy landscape, including the implementation of new business models, pharmacy benefit manager (PBM) practices, the rebate system, regulatory changes, advancements in provider status, and potential Federal Trade Commission (FTC) interventions.

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 …

Impact Of A Pharmacist-Led Hcv Treatment Program At A Federally Qualified Health Center, Jerika T. Lam, Sharon Xavioer

Pharmacy Faculty Articles and Research

Pharmacists are key players who can help to eliminate the hepatitis C virus (HCV) epidemic in the United States. This pilot retrospective study evaluated the impact of a pharmacist-led HCV treatment program in a federally qualified health center (FQHC) primary care clinic setting. The primary outcome was to assess sustained virologic response (SVR) rates 12 weeks after patients were initiated and completed their oral direct acting antiviral (DAA) treatment regimens. Methods: This pilot retrospective study included historical analyses of patients who received DAA treatment in the pharmacist-led HCV treatment program in a FQHC clinic between 1 January 2019 and 31 …

Comments Re: Draft Nih Intramural Research Program Policy: Promoting Equity Through Access Planning, Fred Ledley M.D., Edward Zhou Pharmd., Paula Chaves Da Silva Ph.D.

CISI Publication

We commend the NIH initiative to require that licensees of technologies that enable discovery or development of FDA-approved products arising from the NIH intramural program to include an Access Plan to promote “product affordability, availability, acceptability, and sustainability” and recognition that such protections are essential to ensuring a “return on taxpayers' investment in biomedical research.” Recognizing the complexity of anticipating appropriate terms for products that are in pre-clinical or early clinical development at the time of licensing, we also support the proposal that the Access Plan be submitted in late-stage clinical development, though we argue that …

Transitions Of Care Practice Models: Innovations Across Different Health Settings, Laressa Bethishou, Noah Fang

Pharmacy Faculty Articles and Research

"Being discharged from a hospital may be a joyous occasion for a patient with a long length of stay, but this process may also be riddled with medication issues. With a deluge of new medications, unclear instructions, and new costs that may be unaffordable, many patients face challenges that are all too common. Additionally, the medication list may be fraught with discrepancies of missing or inaccurate home medications, duplicate therapies of new medications prescribed, or drug-drug interactions of old and new medications.

Pharmacists and pharmacy personnel who support patients during transitions of care (TOC) are very familiar with the consequences …

The Role Of Pharmacy In Supporting Safe And Effective Transitions Of Care, Laressa Bethishou

Pharmacy Faculty Articles and Research

Goal To inform pharmacists and pharmacy technicians of the importance of and processes for conducting transitions of care when patients are moving among healthcare settings.
Summary A narrative review of recent events and research into transitions of care (TOCs) — the movement of patients from one healthcare setting to another. To be conducted safely and effectively, the entire patient care team must optimize patient care and communicate up-to-date information among its members. As the medication experts on the healthcare team, pharmacists are well poised to receive and share information that impacts medication use and patient safety. Pharmacy technicians can play …

Developing Public-Private R&D Consortia To Accelerate Alzheimer’S Disease Drug Development, Joel West, Paul Olk

Management: Faculty Scholarship

Efforts to accelerate Alzheimer's disease (AD) drug development have been spurred on by the creation of open science, public-private R&D consortia. An R&D consortium provides an improved structure for generating and disseminating AD knowledge across a range of organizations while also aligning their interests. Drawing from archival and interview data collected on 46 public-private R&D consortia focused wholly or in part on AD, we uncover two important innovations: the creation of novel consortium types that facilitate coordination beyond the individual consortium, and the practice of organizations joining multiple consortia. Collectively these innovations provide member organizations with different pathways for advancing …

Medicare Drug Price Negotiation Program Draft Guidance, Fred Ledley M.D., Edward Zhou Pharmd, Paula Chaves Da Silva Ph.D.

CISI Publication

This comment focuses on Section 50.1, provisions 1 & 3 of the draft guidance regarding the negotiation of a “maximum fair price” under the Inflation Reduction Act (IRA), research and development (R&D) costs of the primary manufacturer, and prior federal financial support for novel therapeutic discovery and development. Specifically, we argue that a negotiated, “maximum fair price” must consider both public sector (federal) and private sector (manufacturer) investments and provide returns to both commensurate with the scale and risk of their investments. This comment addresses three issues and makes specific recommendations regarding each:

1. In negotiating a “maximum fair price,” both …

Tech Note 2024-1 A Novel Framework To Estimate Social And Private Value Created Through Commercialization Of A Pharmaceutical Product, Paula Chaves De Silva, Fred D. Ledley

CISI Publication

This framework posits that the value created by a new medicine is embodied in the total health value (health benefit) provided to those using the products. This value is then distributed between social value and private value by the price paid for the product and how these revenues are expensed for different purposes. In this framework, the social value created includes the residual health value (net price paid) along with the scientific value, jobs creation, and social payments to public sector organizations. The private value created includes shareholder value (change in market capitalization plus cash distributions to shareholders) as well …

Kratom Safety And Toxicology In The Public Health Context: Research Needs To Better Inform Regulation, Jack E. Henningfield, Oliver Grundmann, Marilyn A. Huestis, Kirsten E. Smith

Institute of Emerging Health Professions Faculty Papers

Although kratom use has been part of life for centuries in Southeast Asia, the availability and use of kratom in the United States (US) increased substantially since the early 2000s when there was little information on kratom pharmacology, use patterns, and effects, all critical to guiding regulation and policy. Here we provide a synthesis of research with several hundred English-language papers published in the past 5 years drawing from basic research, epidemiological and surveillance data, and recent clinical research. This review of available literature aims to provide an integrated update regarding our current understanding of kratom's benefits, risks, pharmacology, and …

Pour Une Diffusion Éthique Des Connaissances De La Médecine Traditionnelle: L’Intersection De La Culture Yoruba Et Des Besoins Médicaux, Isabel Sala

CISLA Senior Integrative Projects

No abstract provided.

Factors Predictive Of Postgraduate Residency Placement: A Systematic Review, Hazel Billings-Chiu

Honors Scholar Theses

This systematic review aimed to identify pharmacy student and school characteristics that are associated with higher postgraduate residency placement. Studies had to be an observational or experimental investigation, analyze pharmacy students and/or pharmacy schools, and report the statistical association, correlation, MV regression, propensity score analysis or matched analysis between a student or school variable with match success. Only studies that utilized multivariate analyses were included. The NewsCastle-Ottawa Quality Assessment Form for Cohort studies was used to assess risk of bias in the included studies. Student and school-level factors were then collected and synthesized via full text review. In total, there …