Pharmacy and Pharmaceutical Sciences Commons^™

An Integrative Review Of The Absorption Of Fda-Approved Chemical Sunscreen Filters Into The Blood, Srinidhi Banala, Samrat Gollapudi, Abhiram Gollapudi, Bhaumik Patel

Rowan-Virtua Research Day

Introduction: This integrative review examines the absorption of FDA-approved chemical sunscreen filters, specifically avobenzone and oxybenzone, into the bloodstream. The study aims to compare the levels of absorption and potential health effects of systemic exposure to these sunscreen ingredients in the United States.

Methods: The researchers conducted a literature search of 57 articles, of which 15 were used for the review. Inclusion criteria focused on studies discussing absorption levels of avobenzone and oxybenzone, as well as methods of absorption into the bloodstream. Exclusion criteria included sunscreen ingredients not approved in the United States, non-English studies, and studies on methods to …

The High Cost Of Pharmaceutical Acquisitions: Increasing Social Welfare Or Furthering Inequality?, Timothy J. Haltermann

Notre Dame Journal on Emerging Technologies

This note will argue that government and regulatory authorities should focus on easing access to downstream innovation by broadening research exemptions to patent infringement. Part I of this note will focus on the current state of patent protection and exclusivity afforded to pharmaceutical companies. Part II will discuss incentives created that lead rational actors to engage in M&A instead of through internal R&D. Part III will address the development of innovation as a standalone theory of harm in merger review, and the fallacies associated with labeling certain transactions as “killer acquisitions.” Finally, Part IV of the note will look at …

Leveraging Technology In Risk Evaluation And Mitigation Strategy Programs, Sondra Davis, Katie Reynolds, Charles Ulrich

HCA Healthcare Journal of Medicine

Medication safety is improved through REMS programs. Multidisciplinary teams and frontline staff are vital in setting up a REMS program and should be included in any discussions surrounding REMS programs. Certain components of the REMS requirements may be replaced with CDS screens. Utilizing technology can help advance patient safety and aid in regulatory compliance.

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 …

Delirium Associations With Antibiotics: A Pharmacovigilance Study Of The Fda Adverse Event Reporting System (Faers), Chengwen Teng, Christopher R. Frei

Faculty Publications

Background Ertapenem, cefepime, imipenem, ofloxacin, ceftazidime, clarithromycin, cefaclor, levofloxacin, linezolid, moxifloxacin, azithromycin, piperacillin-tazobactam, trimethoprim-sulfamethoxazole, metronidazole, ciprofloxacin, and cefuroxime are known to be associated with delirium. Other antibiotics may also lead to delirium, but no study has systemically compared delirium associations for many available antibiotics.

Objective The objective of this study was to evaluate the association between delirium and antibiotics using the FDA Adverse Event Reporting System (FAERS).

Methods FAERS reports from January 1, 2004 to December 31, 2018 were included in the study. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (95% CI) for the association between antibiotics and …

“Holistic Risk-Based Site Surveillance – A Data-Based Approach To Site Quality Risk Identification And Assessment In The Pharmaceutical Industry”, Matteo Bernasconi, Thomas Friedli, Nuala Calnan (Editor)

Level 3

Effective quality risk management is fundamental in guaranteeing the development and manufacture of high-quality drugs, reducing drug shortages, and avoiding harm to patients’ health. The ability to accurately assess the actual risk environment, predict potential product quality or supply disruption issues and act to eliminate, prevent, reduce or mitigate them is key to improvements in quality management maturity. This paper illustrates a just-launched research project aimed at developing a comprehensive framework for how to assess and predict risks by leveraging a range of diverse factors.

A Brief Review Of Fda’S Novel Tools For Ensuring Pharmaceutical Quality In The Human Drug Supply Chain, Heather R. Campbell, Robert A. Lodder

Pharmaceutical Sciences Faculty Publications

Purpose

Pharmaceutical manufacturers execute quality control operations and Good Manufacturing Practices (GMP) to provide safe drugs. The Federal Drug and Food Administration (FDA) is tasked with ensuring manufacturers are performing such procedures. Faced with limited resources the FDA has developed novel tools to aid pharmaceutical manufacturing oversight. This paper briefly reviews these tools.

Methods

Current inspection approaches employed by the FDA are identified by searching the FDA’s guidances, the Code of Federal Regulations, public reports and other online resources.

Outcomes

Industry

A risk-based site selection model (SSM) is used to prioritize on-site inspections for FDA investigators. Theoretically, the SSM allows …

Does It Get Any Worse Than Acne? It Does, Actually. An In-Depth Review Of Accutane’S Regulatory History., Bridget A. Betts

Honors Theses

Isotretinoin, most often recognized by the brand name Accutane®, is regarded by many patients and prescribers as the miracle cure for acne. Its unsurpassed efficacy is paired with serious risk of adverse events and birth defects, which poses ethical questions regarding its safety and necessity. Its regulatory history established precedent in Food and Drug Administration Risk Evaluation and Mitigation Strategies and brought awareness to the sharp dangers of teratogenic drug use.

This medication came as a breakthrough solution to patients that suffered years of unsuccessful regimens for the treatment of acne vulgaris. Some question the risk-benefit evaluation of such a …

The Landscape Of Cellular And Gene Therapy Products: Cost, Approvals, And Discontinuations, Vaishali Shukla, Enrique Seoane-Vazquez, Souhiela Fawaz, Lawrence M. Brown, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

Background The past 10 years witnessed a significant increase in the approval of cellular and gene therapy products worldwide. The US Food and Drug Administration (FDA) approved 3 gene therapy products within the last 4 months of 2017. The objective of this study was to examine the approval characteristics, discontinuations and cost of all cellular and gene therapy products approved worldwide. Data and Methods We conducted an electronic search of approved cell and gene therapy products from the databases of the main drug regulatory agencies including the US Food and Drug Administration, the European Medicines Agency (EMA), the Korea Ministry …

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 …

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 …

Exploring The Potential For Using Drug Indications To Prevent Look-Alike And Sound-Alike Drug Errors, Enrique Seoane-Vazquez, Rosa Rodriguez-Monguio, Saad Alqahtani, Gordon Schiff

Pharmacy Faculty Articles and Research

Background: Look-alike, sound-alike (LASA) drug names are a cause of medication errors with resulting patient harm and healthcare costs. This study assessed to which extent the use of the generic drug name, therapeutic class, health problem, and the U.S. Food and Drug Administration (FDA)-approved indications might be used to differentiate LASA drug pairs.

Research design and methods: We collected information about LASA drug pairs reported by the FDA to have look-alike sound-alike similarities. To assess potential for differentiating LASA drug pairs, we compared the following drug characteristics: generic name, therapeutic class, health problem, and FDA-approved indication.

Results: …

Data-Driven Design Of An Ebola Therapeutic, Robert A. Lodder

Pharmaceutical Sciences Faculty Publications

Formulation is very important in drug delivery. The wrong formulation can render a drug product useless. The amount of preclinical (animal and in vitro) work that must be done before a new drug candidate can be tested in humans can be a problem. The cost of these cGxP studies is typically $3-$5 million. If the wrong drug product formulation is tested, new iterations of the formulation must be tested with additional costs.

Data-driven computational science can help reduce this cost. In the absence of existing human exposure, a battery of preclinical tests must be performed in at least two species …

Ethical Imperatives Of Timely Access To Orphan Drugs: Is Possible To Reconcile Economic Incentives And Patients’ Health Needs?, Rosa Rodriguez-Monguio, T. Spargo, Enrique Seoane-Vazquez

Pharmacy Faculty Articles and Research

Background

More than 6,800 rare diseases and conditions have been identified in the US, which affect 25–30 million Americans. In 1983, the US Congress enacted the Orphan Drug Act (ODA) to encourage the development and marketing of drugs to treat rare diseases and conditions. This study analyzed all orphan designations and FDA approvals since 1983 through 2015, discussed the effectiveness of incentives for the development of treatments for rare diseases, and reflected on the ethical imperatives for timely access to orphan drugs.

Methods

Study data were derived from the Food and Drug Administration (FDA) Orange Book and the Office of …

Moseying Along At The Fda, Rodney Richmond

College of Pharmacy Faculty Research ​and Publications

No abstract provided.

Keeping An Eye On The Fda, Rodney Richmond

College of Pharmacy Faculty Research ​and Publications

No abstract provided.

Fda Has A Banner Quarter To Finish Out 2016, Rodney Richmond

College of Pharmacy Faculty Research ​and Publications

No abstract provided.

The Impact Of The Sentinel Initiative And Faers Surveillance System On Consumer Safety, Sonia Batra

Walden Dissertations and Doctoral Studies

The U.S. Food and Drug Administration (FDA) uses the FDA Adverse Event Reporting System (FAERS) to monitor adverse events resulting from pharmaceutical drug use. However, this system has limitations such as not allowing real-time data collection. To address these limitations, the FDA launched the Sentinel Initiative in 2008. This comparative case study was conducted to describe perceptions of investigating the efficacy of the Sentinel Initiative compared with the FAERS. The study was based on the theory of preemption as it emphasized the need for efficient means for providing unquestionable proof that consumers suffered adverse drug effects. The sample included interivews …

Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters

Indiana Law Journal

Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened.

This Article analyzes two examples of FDA inertia and compares …

Fda Approves 18 New Molecular Entities/Biologics, Rodney Richmond

College of Pharmacy Faculty Research ​and Publications

No abstract provided.

Orphan Drug Development: Incentives Under The Orphan Drug Act, Sara H D Smith

Senior Theses and Projects

After describing the intellectual property and regulatory environment for orphan drugs in the United States, this thesis compares the investment decisions in the orphan drug market with the larger pharmaceutical industry. A series of case studies trace the development paths of different orphan products using information collected through the Food and Drug Administration (FDA) Approved Drug Product and Orphan Drug Product Designation Databases. In addition to this analysis, difference-in-differences estimates calculated using annual revenues compare the relative success of different orphan products under the current incentive system. This study finds that partial orphan drugs are associated with larger revenue growth. …

Fda Approves A Wide Range Of New Drugs And Biologicals This Quarter, Rodney Richmond

College of Pharmacy Faculty Research ​and Publications

No abstract provided.

The Fda Funding Crisis, Judith Alphonse, Sireesha Bellam, Marlene Fernandez, Anishka Gilbert, Lauren Roper, Antonia Zapantis, Robert C. Speth

HPD Articles

The role of the Food and Drug Administration (FDA) is to ensure the safety of prescription and nonprescription drugs, dietary supplements, and the food supply, representing more than 20% of US consumer spending. The increased need to monitor imported drugs, drug products and foods, drug shortages, and compounding pharmacies bring the adequacy of FDA funding into question. Performing even at status quo cannot be accomplished if responsibilities increase without equitable funding increases: both from the federal government and fees imposed on FDA-regulated industries. Additionally, scientific advancement, new legislation, and new industries are continually increasing the FDA workload, necessitating commensurate budget …

Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, Michael Mccann

Law Faculty Scholarship

There exists increasing concern that the Dietary Supplements Health and Education Act (DSHEA) has proven ineffective. Much of the concern regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Namely, while pharmaceutical drugs must undergo years of costly pre-market testing, most supplements, like foods, can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (FDA) remove them. Such a framework appears to belie both consumer expectations and marketing strategies, as supplements tend to be most perceived for their apparent medicinal qualities. This philosophy of waiting for a …

Nudging The Fda, W. Nicholson Price Ii, I. Glenn Cohen

Law Faculty Scholarship

[Excerpt] "The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients and the health care system holds high the value of consumer choice. Patients should get all the information and the drugs they want; the FDA should do what it can to enforce some basic standards but should otherwise get out of the way. On the other hand, a paternalist view values the FDA’s role as an expert agency standing between patients and a set of potentially dangerous drugs and potentially unscrupulous or …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Pharmaceutical Counterfeiting And The Rfid Technology Intervention, Alberto Coustasse, Cody Arvidson, Phil Rutsohn

Alberto Coustasse, DrPH, MD, MBA, MPH

Both nationally and internationally, pharmaceutical counterfeiting has become a problem that is threatening economic stability and public health. The purpose of the present research study review was to analyze the scope and severity of pharmaceutical counterfeiting and to establish if the implantation of the Radio Frequency Identification Device (RFID) model can more efficiently be used within the pharmaceutical supply chain to reduce the problem counterfeit drugs impose on public health and international economic stability. Results indicated that implementing the RFID model for tracking drugs at the item level in the pharmaceutical supply chain has potential to alleviate the scope of …

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

Jonathan R. K. Stroud

No abstract provided.

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

IP Theory

No abstract provided.

Pharmaceutical Counterfeiting And The Rfid Technology Intervention, Alberto Coustasse, Cody Arvidson, Phil Rutsohn

Management Faculty Research

Both nationally and internationally, pharmaceutical counterfeiting has become a problem that is threatening economic stability and public health. The purpose of the present research study review was to analyze the scope and severity of pharmaceutical counterfeiting and to establish if the implantation of the Radio Frequency Identification Device (RFID) model can more efficiently be used within the pharmaceutical supply chain to reduce the problem counterfeit drugs impose on public health and international economic stability. Results indicated that implementing the RFID model for tracking drugs at the item level in the pharmaceutical supply chain has potential to alleviate the scope of …