Risky Business

The FDA’s latest draft Industry Guidance paper addresses how drug companies should present risk information in ads for prescription drugs and medical devices. It is meant to illustrate factors the FDA considers when evaluating ads and labeling for drugs and devices for compliance to relevant regulations. It delves into the mind of the consumer and provides examples on how companies should present risk information.

Risk information is critical to both health professionals and consumers and needs to be clearly communicated to its target audience. According to the FDA, omission or minimization of risk information is the most common violation of regulations for product advertising and promotion. They also claim research in Direct to Consumer (DTC) prescription drug advertising has shown that:

• “60 percent of patients believe ads directed at them do not provide enough information about risks”
• “60 percent of physicians believe that patients have little or no understanding from these ads about what the possible risks and negative effects of the products are” and
• “72 percent of physicians believe that patients have little or no understanding from these ads about who should not use the product”

To comply with regulations ads cannot be false or misleading, they must reveal facts about the product and consequences from its use and they must present benefits and risks in a balanced manner. In other words, you can’t play up the drug’s benefits while downplaying its risks.

When evaluating a promotional piece, the FDA evaluates the net impression communicated by all the elements of the piece. It does so using “well-developed social science principles supported by decades of scientific research.” They use science to figure out how we understand best.

For example, the FDA explains how research indicates when people process a list of text they are better able to recall items at the beginning or end of the list. So ads should not insert important risk information in the middle of reams of text.

They also discuss how cognitive load, or the mental effort required to take in information, is affected by the amount of information presented and in what way. Word choice, loud colors and busy graphics can be distracting or put more emphasis on one piece of information versus another.

The bottom line from the guidance paper is that drug and device communications need to present risk and benefit information in a balanced manner and in language that is clear for its target audience.

A Wall Street Journal article reported that drug makers “remain committed to producing responsible, balanced promotional materials” and have adopted voluntary guidelines that say risks “should be presented in clear, understandable language without distraction.” via a PhRMA spokesperson.