The Impact of Direct-to-consumer Drug Advertising on Seniors' Health and Health Care Costs: Hearing Before the Special Committee on Aging, United States Senate, One Hundred Ninth Congress, First Session, Washington, DC, September 29, 2005 |
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adjustment disorder adver advertised drugs advertising of prescription Agency American Medical Association antidepressant ANTONY appropriate April 27 asked AstraZeneca BEHRMAN billion brand-specific request brief summary Chairman clinical Consumer-Directed Broadcast Advertisements consumers cost Crestor DDMAC depressed mood Differin direct-to-consumer advertising disease doctors Drug Administration DTC ads DTC advertising DTC communications DTC promotion DTC television advertisements DTC-advertised drugs educate patients effects of DTC ensure FDA's Food and Drug guidelines Guiding Principles health care health care professionals healthcare increase issue Kravitz RL labeling Lurie Medicaid misleading office of accountability overall paroxetine Paxil Peter Lurie pharmaceutical industry PhRMA potential prescription drug advertising prescription medicines primary care physicians print advertisements programs questions regulations reported risk information risks and benefits role Senator KOHL Senator TALENT Senator WYDEN specific spending SPs portraying major standardized patients sumer survey television advertisements Thank tion treatment untitled letters Vioxx visits Warning Letters
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Page 31 - US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER...
Page 33 - Electronic Records; Electronic Signatures" and provides that agency decisions on whether or not to pursue regulatory actions will be based on a case by case evaluation. The CPG does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulation, or both.
Page 12 - The regulations further require that broadcast advertisements either contain a brief summary of "all necessary information related to side effects and contraindications" or make adequate provision for dissemination of the product's FDA-approved labeling (and the risk information it contains) in connection with the ad. FDA generally cannot require that prescription drug advertisements be reviewed and approved prior to their use. Prior FDA review of advertisements occurs only in very narrow circumstances,...
Page 12 - The regulations specify, among other things, that prescription drug advertisements cannot be false or misleading, cannot omit material facts, and must present a "fair balance" between benefit and risk information. Further, for print advertisements, the regulations specify that every risk addressed in the product's approved labeling also must be disclosed in the brief summary. For broadcast advertisements, however, the regulations require ads to disclose the most significant risks that appear in the...
Page 11 - DDMAC's mission is to protect the public health by insuring that prescription drug information is truthful, balanced, and accurately communicated. This is accomplished through a comprehensive surveillance, enforcement, and education program, and by fostering optimal communication of labeling and promotional information to both health care professionals and consumers.
Page 9 - DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 STATEMENT BY DOUGLAS L.
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Page 10 - Biopharmaceutics (OCPB) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) utilize CTS as a review tool to assess the results of clinical studies or to test different "what if" scenarios related to drug dosing and/or dosing regimen adjustments in special populations.
Page 41 - Patient and physician attitudes and behaviors associated with DTC promotion of prescription drugs: Summary of FDA survey research results.