Medications under FDA review face significant scrutiny on their printed materials

WASHINGTON — The FDA’s Office of Prescription Drug Promotion uses many methods to assess the validity of a potential medication’s print advertising, labels and other such materials for a particular medication before the agency can clear the materials for public marketing, an employee within the agency’s office that oversees that variable process said.

“FDA regulations require that prescription drug advertisements be fair and balanced, both in terms of the content and the presentation of the information,” Kathryn Aikin, PhD, research team lead at the FDA Office of Prescription Drug Promotion, told attendees of the Rising Leaders Conference on Healthcare Policy.

“We protect the public health by ensuring information about prescription drugs is accurate, balanced and truthful. We help identify goals [of the medication], try to recognize behavioral or cognitive barriers to achieving those goals and test the effectiveness of these messages and verify the effectiveness of the messages once they are out in the public domain,” Aikin said. “We can definitely do better in this area, but we are always trying to pay attention.”

She said a workday often consists of reviewing studies and conducting research that considers factors that affect how risk and benefit information is conveyed to the public, targeting populations for specific medications, and assessing the quality of the research they use as the basis for their decision.

Much of this is done by consulting a variety of sources, such as cognitive interviews, pretesting, literature reviews, content analyses, interviews and focus groups, surveys and experiments, Aikin said, noting that the process can potentially be seen as the first benefit-risk analysis done on a medication outside of the company that is overseeing the drug’s development.

Examples of the office’s findings include some consumers interpreting precautions on prescription drug websites as potential adverse events, a few websites had drug risk information in a location that did not benefit the consumer, suggesting that the information would be better suited on the websites’ homepages, and some wording such as “important safety information” or “important risk information” does not “differentially affect consumer risk perception,” according to Aikin.

“We don’t want consumers to be misled by potentially false hopes stemming from misleading claims. At the end of the day, we want consumers to have accurate and truthful information about the efficacy and risks of a product to help them make the best decision,” she said, adding that, sometimes, research can lead to new publications, guidance, rulemaking or other regulatory actions. – by Janel Miller

Reference: Aikin K. Social service in prescription drug promotion. Presented at: Rising Leaders Conference on Healthcare Policy; May 21-22, 2019; Washington.

Disclosure: Healio Primary Care could not confirm Aikin’s relevant financial disclosures at the time of publication.