After marketing tactics resulted in $1.2 billion fines, the 2002 PhRMA Code attempted to standardize marketing and sales practices. Self-regulation had varied success by other industries and by pharmaceutical industries in other countries. Similarly, the Code addressed negative responses about pharmaceutical's practices but had no provisions for monitoring violations. Representative's (reps) perspectives were assessed using an 18-item instrument with 72 reps from 25 companies. Analyses indicated that reps from bigger companies, PhRMA and non-PhRMA, adhered better. The way reps adhered was split between adhering reluctantly and following faithfully. Two thirds felt it was more difficult to do their jobs, resulting from prior entertainment-based relationships with physicians.
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http://dx.doi.org/10.1080/07359683.2010.519992 | DOI Listing |
BMJ Evid Based Med
December 2020
Centre for Evidence-Based Medicine, University of Oxford, Oxford, UK.
Purpose: Trustworthy reporting of quadrivalent human papillomavirus (HPV) vaccine trials is the foundation for assessing the vaccine's risks and benefits. However, several pivotal trial publications incompletely reported important methodological details and inaccurately described the formulation that the control arms received. Under the Restoring Invisible and Abandoned Trials initiative (RIAT), we aim to restore the public record regarding the content and rationale of the controls used in the trials.
View Article and Find Full Text PDFHealth Mark Q
October 2010
The Erivan K Haub School of Business, Saint Joseph's University, Philadelphia, Pennsylvania 19131-1395, USA.
After marketing tactics resulted in $1.2 billion fines, the 2002 PhRMA Code attempted to standardize marketing and sales practices. Self-regulation had varied success by other industries and by pharmaceutical industries in other countries.
View Article and Find Full Text PDFPharmacogenomics
January 2009
Medco Health Solutions Inc., 14401 Falling Leaf Drive, Gaithersburg, MD 20878, USA.
The 4th US FDA/Industry workshop, in a series on Pharmacogenomics, was on 'Biomarkers and Pharmacogenomics in Drug Development and Regulatory Decision Making' and was held on December 10-12, 2007 in Bethesda, MD, USA, with clear objectives to continue the dialogue that began in 2002 for enabling the use of biomarkers and pharmacogenomics in drug development and regulatory decision-making. This brief commentary will highlight the major topics and outcomes discussed at this meeting that was jointly sponsored by the FDA, The Pharmacogenomics Working Group (PWG), The Pharmaceutical Research and Manufacturers of America (PhRMA), The Biotechnology Industry Organization (BIO) and The Drug Information Association (DIA).
View Article and Find Full Text PDFJ Biopharm Stat
May 2004
Statistical Research and Consulting Center, Ann Arbor Laboratories, Pfizer Inc., Ann Arbor, Michigan 48105, USA.
An industry survey was conducted by a PhRMA/FDA Working Group on Active Control Trials in the summer of 2002 in preparation for a non-inferiority workshop sponsored by the Pharmaceutical Research and Manufacturers Association (PhRMA). Its objective was to understand the industry practices in the design and analysis of active control studies and to identify areas where regulatory guidances are most needed. The survey was sent to all major research-based pharmaceutical companies that were members of PhRMA in April 2002, and results were presented at a PhRMA workshop, held in Washington, D.
View Article and Find Full Text PDFPharmacoepidemiol Drug Saf
September 2002
Division of Metabolic and Endocrine Drug Products, Center for Drug Evaluation and Research, FDA, HFD-510, 5600 Fishers Lane, Rm. 14-B-04, Rockville, MD 20857, USA.
Purpose: Risks and benefits of marketed drugs can be improved by changing their labels to optimize dosage regimens for indicated populations. Such postmarketing label changes may reflect the quality of pre-marketing development, regulatory review, and postmarketing surveillance. We documented dosage changes of FDA-approved new molecular entities (NMEs), and investigated trends over time and across therapeutic groups, on the premise that improved drug development methods have yielded fewer postmarketing label changes over time.
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