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US FDA to probe drug ads to evaluate need for more targeted risk disclosures

In an effort to better understand if patients and doctors are benefiting from the U.S. Food and Drug Administration's policies over drug companies' promotions of their prescription medicines, the agency is undertaking new social science research, including a study examining if low- to non-internet users are being adequately informed about risks and benefits.

FDA Commissioner Scott Gottlieb said the agency's research on how drug risks are presented in television commercials has suggested that a more targeted presentation may lead to better retention about the potential side effects that consumers should weigh as they consider their treatment choices.

"As a result, we've been exploring new guidelines that would recommend more focused disclosure of risk information in TV ads, to better emphasize potential side effects that are severe, serious and actionable," Gottlieb said in a March 12 statement. "I'm committed to continuing to invest in this critical research to help ensure we're making informed, science-based decisions."

The FDA has long been engaged in research evaluating advertising features, including content and format, target populations and research quality.

The agency's regulations require that broadcast advertisements containing product claims present major side effects and contraindication information in the audio or audio and visual portion of the commercial — the major statement.

Broadcast ads must also contain a brief summary of all necessary information related to side effects and contraindications or ensure that adequate provision be made for dissemination of the approved package labeling in connection with the broadcast.

The requirement for adequate provision is generally fulfilled when a drugmaker gives consumers the option of obtaining FDA-required labeling or other information via a toll-free telephone number, through print ads or product brochures, in information disseminated at healthcare provider offices or pharmacies and through the internet.

Through the evaluation of advertising features, the FDA said it assesses how elements such as graphics, format and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits.

The FDA's Office of Prescription Drug Promotion is charged with protecting public health by helping to ensure that prescription medicine information is truthful, balanced and accurately communicated.

The office is also responsible for guarding against false or misleading advertising and promotion through comprehensive surveillance, enforcement and educational programs and fostering better communication of information to help patients and healthcare providers make informed decisions about treatment options.

Study details

The FDA plans to conduct new research involving focus groups, surveys and experimental studies, the agency said during a recent slide presentation which it posted online March 12.

In one new study, the FDA plans to look at the potential differences in perception that may arise by presenting the same information to healthcare professionals in sales materials versus the peer-reviewed journals.

In two other studies, the FDA is expected to examine the impact of perceptual similarity between direct-to-consumer, or DTC, targeted ads, like disease awareness and product promotion, and the distance between those promotions over the course of programming, also looking at exposure frequency and delay.

The FDA also plans to conduct a survey of healthcare professionals about their opinions, attitudes, beliefs and intentions about pharmaceutical promotion directed at them.

In addition, the agency plans to convene eight focus groups to examine consumer understanding of information about the FDA's accelerated approval process.

In another study, participants will view a website for a fictional oncology prescription medicine and then complete a questionnaire that assesses their attention to, and understanding of, the product's accelerated approval information.

The FDA also expects to conduct in-person interviews with healthcare professionals to evaluate how they process risk information for newly promoted prescription drugs.

Internet accessibility

For its study evaluating how low- to non-internet users gain access to information, the FDA plans to use a telephone survey to examine the value of including a toll-free number and print ad as part of the agency's adequate provision requirement in broadcast DTC drug commercials, according to a notice published online March 12 in the Federal Register.

The FDA will also investigate the ability and willingness of low- to non-internet users to make use of internet resources if other options are not available.

The agency noted that some older adults or Americans with low socioeconomic status have reported that they do not have easy access to online resources to view additional information about prescription drugs, and so a website alone may not adequately serve all potential audiences.

Some of those consumers may also prefer to consult sources other than a healthcare provider to conduct initial research, for privacy reasons or otherwise.

So, the toll-free number and print ad may provide special value to consumers who are low to non-internet users or those who value privacy when conducting initial research on a medication, though not necessarily unique value relative to one another.

In the study, regulators want to specifically know if risk perceptions are influenced by an ad's opening statements, which may be used to introduce risks in DTC prescription drug commercials.

Opening statements may also be used to frame risk information that follows, the FDA said.

"As such, consumers may interpret the likelihood, magnitude and duration of risks differently depending on how those risks are introduced," the agency said.