Law of Advertising and Public Relations - FDA
Law of Advertising and Public Relations - FDA JMC-40016-001
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This 2 page Class Notes was uploaded by Megan Angelo on Tuesday April 19, 2016. The Class Notes belongs to JMC-40016-001 at Kent State University taught by Timothy A. Roberts (P) in Spring 2016. Since its upload, it has received 10 views. For similar materials see LAW OF ADVERTISING AND PUBLIC RELATIONS in Culture at Kent State University.
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Date Created: 04/19/16
Food and Drug Administration - Approving new drugs, medical devices, and food additives for safety and effectiveness o Set standards for foods and labeling o Must meet via testing - Inspect production, manufacturing sites - Issue public warnings- take legal action if unsafe products threaten public welfare FDA and Commercial Speech Jurisdiction 1.)Regulating information about the contents and safety of prescription drugs as they are advertised and promoted 2.)Tobacco advertising - Content- based regulation of prescription drug information - Require detailed list and proportion of the ingredients must be prominent and readable - Generic equivalent must be listed as well Side effects: - “summary” of specified information about its safety and effectiveness - Suggesting new uses could re-classify it as a “new drug” Red Flags: Commercial speech on prescription drugs will be deemed false, unfair, or misleading if: 1.)Fails to indicate potential side effects 2.)Exaggerates the effectiveness of a drug 3.)Doesn’t specify the negative effect of long-term usage 4.)Claims a drug is more effective than a competitors without scientifically valid support 5.)“represents” … that a drug is better, or more effective or useful in a broader range of conditions or patients without at least two clinical trials indicating so Monitors- ensures 1.)Statistics are valid: sample sizes are appropriate 2.)There are no false or misleading interpretation of data Enforcement: - Seek injunctions to stop sales - Confiscate products - Can seek criminal penalties against companies and advertisers Graphic Tobacco Warnings- 2009 - Family Smoking and Prevention and Tobacco Control Act - They wanted more graphic warnings on cigarette packs - Show a non-smokers lung and a lung of someone that has smoked for 30 years R.J. Reynolds- sued – aimed at discouraging use- not purely factual Split appellate - District and 2 nd Circuit Courts ruled- Reynolds- Did not prove the third prong of the Central Hudson th - 9 Circuit Court- ruled for FDA FDA- bows out - No graphic warning labels
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