34251 - Direct-to-Consumer Advertising A Dangerous Game of...

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Direct-to-Consumer Advertising: A Dangerous Game of Pitching Products to Parents Lynne Wells Graziano Department of History Case Western Reserve University
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Graziano March 2009 2 Direct-to-Consumer Advertisements (DTCA) Pharmaceutical DTCA are used in newspapers, magazines, internet websites and on television. Nearly one-third of Americans asked their doctors about an advertised medicine, and 82% of those who ask say their physician recommended a prescription. -USA Today, Julie Appleby, March 4, 2008
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Graziano March 2009 3 STUDIED PRODUCTS Vyvanse – a medication to control Attention Deficit/Hyperactivity Disorder (ADHD) Gardasil – a vaccine designed to prevent certain types of Human Papillomavirus (HPV) that can cause cervical cancer and genital warts Both contain hidden dangers which parents and caregivers may not know
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Graziano March 2009 4 THESIS The best interests of the American public are not being protected with current drug approval and advertisement practices. Parents are not always aware of hidden pharmaceutical dangers. Changes are needed in both the approval process of new drugs and the advertisement procedures related to pharmaceutical products.
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Graziano March 2009 5 Who oversees advertisements? United States Food and Drug Administration (FDA) Pertinent Legislation 1938 FDCA Act: medications proven safe prior to marketing 1962: medications “safe and efficacious” prior to advertising 1992: Prescription Drug User Fee Act (PDUFA) - $300,000 fee for new drug application before review 1997: advertisements in broadcast and electronic media no longer require “brief summary;” “adequate provision” needed met
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Graziano March 2009 6 2002/2007 Best Pharmaceuticals for Children Act During a one year period beginning on the date a drug receives pediatric exclusivity, all adverse event reports associated with the use of the drug will be reviewed by the FDA and reported to a Pediatric Advisory Committee in a public forum.
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