Risk Information

Merz web-copy shortcuts don't sit well with OPDP

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FDA's Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.

FDA study casts doubt on danger of "distracting visuals"

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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

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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

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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

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

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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

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

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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

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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

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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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MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.