FDA's Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.
An FDA study looking at the power of background visuals to distract viewers from the often-ominous risk info read in the "major statement" section of TV drug ads found no evidence that consumer understanding of risk info is affected by the "emotional (affective) tone of images.
The FDA is weighing shifting to a prescription drug brief summary format more like that of the "Drug Facts" design used for OTC products, based on a study showing that it led to higher risk comprehension.
Covidien launched a patient safety organization - the Collaborating & Acting Responsibly to Ensure Safety (CARES) Alliance - today, featuring tools and resources for patients, physicians and pharmacists.
Reformulations of prescription pain drugs designed to reduce abuse potential are arriving on the scene, and the FDA is grappling with the best way to encourage manufacturers to communicate risks vs. benefits and ensure safety.
The FDA scolded GlaxoSmithKline over a disease-awareness ad that failed to mention side effects but alluded to newly approved cancer treatment Arzerra. It's a sign the agency is construing the exemption for disease-awareness promotions quite narrowly.
The FDA said side-effect related statements in consumer drug ads should be presented in a clear, conspicuous and neutral manner and, in a proposed rule issued this week, allowed for flexibility in determining whether these criteria are met.
Consumers tend to block out risk info in TV and print ads for prescription drugs -- particularly those over age 55 -- according to a study by ORC Guideline.
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