FDA requirements and standards.
The FDA requires that all drug ads contain information concerning side effects, contraindications and effectiveness. All risk information must be included in the labeling. Advertisements cannot be false or deceptive and cannot forget facts. There must be a balance between effectiveness and risk information. Appropriate communication of effectiveness information included important restrictions to the product use. The Federal Trade Commission is responsible for regulating over-the-counter (OTC) drug ads; the FDA regulates advertising for prescription drugs only. The FDA also oversees the advertising for certain types of medical devices. There is no law that states that drug companies have to summit ads for approval
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• Have unsupported claims.
• Misrepresent data.
• Overstate the benefits.
• Make claims that the drug works for people with specific traits when the drug has not been shown to work or to be safe for those people.
• Do not tell of a risk or to make the risk seem like nothing.
• Pretend to be an awareness advertisement but suggest a specific drug.
Mission and Purpose of PhRMA
PhRMA’s mission is to “conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical and biotechnology research companies.” (phrma.org/about) PhRMA believes that a strong biopharmaceutical research industry is critical to patients.
DTC Guiding Principles
PhRMA sets the following as guidelines for the DTC: Be truthful and not deceptive, make claims only when supported by evidence, reflect a balance between the risks and benefits and be consistent with the FDA-approved labeling. Advertisements should also me designed to educate the customer about the medicine and where and how it can be prescribed. The ad must state that it is a prescription drug to separate them and non-prescription products.
Direct-to-consumer