The US Food and Drug Administration (FDA) is advising the makers of medications and medical devices to avoid misleading consumers with marketing strategies that deemphasize the risks of these products.
Promotional materials that omit or minimize risk information are the most frequent reason the agency issues enforcement letters to companies, and the FDA says it has received requests from industry for clarification about what it considers a violation. In the new guidance (http://www.fda.gov/cder/guidance/7427dft.pdf), the agency emphasizes that simply including risk information is not enough to satisfy its requirements; rather, the agency weighs whether marketing materials leave consumers or clinicians with a balanced impression of a product's risks and benefits.
In addition to providing physicians with the information they need to know to safely prescribe medical products, appropriate risk disclosures in advertisements help consumers decide whether a product may be appropriate for them. Such disclosures also inform patients . . . [Full Text of this Article]
