Risk Information

FDA study casts doubt on danger of "distracting visuals"

Matthew Arnold January 31, 2012

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.

FDA weighs brief summary format redesign

Matthew Arnold June 21, 2011

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 launches opioid patient safety alliance

Ben Comer September 08, 2010

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.

New pain meds pose tricky PR test, as FDA gaffe shows

Marc Iskowitz July 23, 2010

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.

GSK awareness ad for Arzerra a stealth product promotion, says FDA

Marc Iskowitz April 19, 2010

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.

FDA proposes standard for print, broadcast drug ads

Marc Iskowitz April 02, 2010

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.

Info overloaded, consumers tune out risk info, says survey

Matthew Arnold November 30, 2009

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.