Browsing by Subject "FDA"

Now showing 1 - 5 of 5
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    Building a Central Repository for Research Ethics Consultation Data: A Proposal for a Standard Data Collection Tool
    (ACTS, 2015-08-01) Cho, Mildred K.; Taylor, Holly; McCormick, Jennifer B.; Anderson, Nick; Barnard, David; Boyle, Mary B.; Capron, Alexander M.; Dorfman, Elizabeth; Havard, Kathryn; Reider, Carson; Sadler, John; Schwartz, Peter H.; Sharp, Richard R.; Danis, Marion; Wilfond, Benjamin S.; Department of Philosophy, IU School of Liberal Arts
    Clinical research ethics consultation services have been established across academic health centers over the past decade. This paper presents the results of collaboration within the CTSA consortium to develop a standard approach to the collection of research ethics consultation information to serve as a foundation for quality improvement, education, and research efforts. This approach includes categorizing and documenting descriptive information about the requestor, research project, the ethical question, the consult process, and describing the basic structure for a consult note. This paper also explores challenges in determining how to share some of this information between collaborating institutions related to concerns about confidentially, data quality, and informatics. While there is much still to be learned to improve the process of clinical research ethics consultation, these tools can advance these efforts, which, in turn, can facilitate the ethical conduct of research.
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    The FDA’s Graphic Tobacco Warnings and the First Amendment
    (2013) Orentlicher, David
    In the past, the government enjoyed broad authority to regulate tobacco or pharmaceutical advertising. Protection for commercial speech was weak, and state power to protect the public health was strong. But the U.S. Supreme Court has changed course. Corporate speech rights have become robust, and the justices exhibit less deference when the state exercises its public health authority. As a result, government is much more susceptible to challenge when it tries to regulate the promotional activities of cigarette manufacturers or pharmaceutical companies. This "Perspective" piece illustrates the evolution of First Amendment doctrine for public health regulations with a discussion of the Food and Drug Administration's graphic warnings for cigarette packages. Even though textual warnings for cigarettes have been upheld, and even though the U.S. Court of Appeals for the Sixth Circuit recognized a role for some color image warnings, the U.S. Court of Appeals for the D.C. Circuit rejected the FDA's actual graphic warnings (which were developed pursuant to a graphic warnings mandate from Congress). Rather than seek Supreme Court review, the FDA decided to revise its graphic warnings. In the meantime, we are left with some important questions about the factors that distinguish between permissible and impermissible graphic warnings.
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    An Interactive User Interface for Drug Labeling to Improve Readability and Decision-Making
    (AMIA, 2015) Abedtash, Hamed; Duke, Jon D.; Department of BioHealth Informatics, School of Informatics and Computing
    FDA-approved prescribing information (also known as product labeling or labels) contain critical safety information for health care professionals. Drug labels have often been criticized, however, for being overly complex, difficult to read, and rife with overwarning, leading to high cognitive load. In this project, we aimed to improve the usability of drug labels by increasing the ‘signal-to-noise ratio’ and providing meaningful information to care providers based on patient-specific comorbidities and concomitant medications. In the current paper, we describe the design process and resulting web application, known as myDrugLabel. Using the Structured Product Label documents as a base, we describe the process of label personalization, readability improvements, and integration of diverse evidence sources, including the medical literature from PubMed, pharmacovigilance reports from FDA adverse event reporting system (FAERS), and social media signals directly into the label.
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    A qualitative analysis of calorie menu labeling: Point of sale conversations with cashiers at fast-casual retsaurants
    (2015-05) Bechtel, Kimberly; Parrish-Sprowl, John; Goering, Elizabeth M.; Sandwina, Ronald M.
    The study was conducted to examine the communication between the customer and the cashier at the point of purchase in the process of determining the impact of the labeling laws. This study used an inductive qualitative design for data collection and data analysis. Data from this study suggest that calorie counts on menu labels are discussed frequently between the customer and the cashier at the point of sale at fast-casual restaurants. The data found gives us a framework and rationale as to why previous research on the effectiveness of the calorie labeling law in the Affordable Care Act have yet to make a significant impact in reducing consumer’s total daily caloric intake when eating food away from the home and found three specific reasons as to why the calorie labeling law may not be working the way the government intended it to. First, consumers at fast-casual restaurants rely on the cashiers as calorie guides because they are not aware or knowledgeable about the recommended daily caloric intake and often underestimate the total calories in their meals. Secondly, the study’s findings indicate that when restaurants offer lower calorie choices and downsizing options like a “small pita” at Pita Pit instead of a “regular pita”, many consumers buy the downsized item or smaller portion but food chains are not downsizing their signature items. Third, the study examined if the cashiers are trained in any way to discuss new regulations and calorie count/nutritional value and not one cashier was trained specifically about the calorie labeling law and why certain foods on the menu have more calories than others even though they are influencing decision making. Conversations at the point of sale have been routinely ignored in research about the calorie labeling law and this research helps to understand the choices consumers are making with the newly implemented calorie labeling regulation. The results from this study helps us further advance our understanding as to why consumers make the food choices they do while eating at restaurants.
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    Using Structural Docking for Drug Repurposing
    (Office of the Vice Chancellor for Research, 2011-04-08) Sanders, Philip
    Recently the FDA has increased restrictions making it very difficult to get a new drug out. Therefore it is desirable to repurpose a drug already in use, one which has passed clinical studies and has few side effects. For this reason we created a method to repurpose existing drugs to treat diseases other than their known targets. In this study we chose to demonstrate our method on colorectal cancer. CRC is an interesting disease for this approach, as known CRC chemotherapy drugs are ineffective in curing this kind of cancer. To find repurposed drugs for CRC we first use a structural algorithm to identify probable CRC gene targets for a specific set of in market cancer drugs. After prioritizing these targets, the relationships between the gene targets and the potential drugs are validated and scored using Autodock. We can then identify which drugs have the greatest potential of being repurposed to treat CRC. It is our hope that this method will be able to aid in finding new treatments for diseases without the cost and risk of developing new drugs.