FDA: Safety language needs to be easy to understand

Prescription drug advertising has increased year after year, but are THE ads really effective? The FDA is requiring a statutory requirement that in human prescription drug advertisements presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads), the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner.

“This final rule complements the longstanding requirements for including risk information in prescription drug ads, setting standards for the manner of presentation of the major statement of side effects and contraindications in DTC TV/radio ads to help ensure that this risk information is presented effectively–that is, in a way that helps consumers notice, attend to, and understand the drug’s risks.”

Let’s take a step back for a moment and ask some basic questions.

1ne: What do patients/consumers do due to exposure to a DTC ad?

The belief that patients ask about or ask for an advertised prescription drug is a canard. Google has continually shown that the number of online health seekers remains very high.  According to the International Telecommunication Union (ITU), 56% and 79% of users get health information online in the United States. At the same time, CDC research has shown that 74% of all U.S. adults use the Internet, and 61% have looked for health or medical information.

I have been involved in qualitative/quantitative research for over five years on what consumers do when they are interested in an advertised prescription drug. The results from this research clearly show they go online for more health information. They then rely on their HCP to help determine if a medication is right for them.

2wo: What do online health seekers want in researching side effects?

Our research has indicated that they want to understand the side effects better online, but they also want context. For example, what percentage of patients using the drug got GI side effects?

When we presented various focus groups with drug fair balance statements on websites, the overwhelming majority said they read like “a medical journal” and could not understand all the language in the fair balance. They also want updated side effect information based on ongoing clinical trials.

The FDA says, “the measures required by the final rule help ensure that DTC TV/radio ads convey a truthful and non-misleading net impression about the advertised drug, including its risks.” I would ask why. Does the FDA believe consumers will decide based upon exposure to these ads without asking a lot more questions and doing research?

I have suggested to clients that any complicated terms in fair balance or safety information contain “roll-overs” that lead to a pop-up with a clear and 8th grade-reading level definition.

When online health seekers research a prescription drug, they are most interested in the following information:

  • The drug’s uses and benefits. This includes information about what the drug is used to treat, how it works, and how effective it is.

  • The drug’s side effects and potential risks. This includes information about the common and rare side effects of the drug, as well as the potential for interactions with other medications or supplements.

  • The drug’s dosage and administration. This includes information about how often to take the medication, how much to take, and how to take it safely.

  • The drug’s cost. This includes information about the brand-name and generic versions of the drug and the cost of refills.

  • Patient reviews. This includes information about other people’s experiences with the drug, both positive and negative.

Consumers’ attention to side effects in prescription drug ads varies depending on several factors, including the individual consumer’s health literacy, level of trust in the pharmaceutical industry, and the advertised drug.

Studies have shown that many consumers do not pay enough attention to side effects in prescription drug ads. A 2011 study by the Kaiser Family Foundation found that only 44% of consumers believe that prescription drug ads provide enough information about side effects. Another study published in the journal JAMA Internal Medicine in 2015 found that only 25% of consumers can correctly identify the most common side effects of a widely advertised prescription drug.

There are several reasons why consumers may not pay enough attention to side effects in prescription drug ads. One reason is that the ads are often concise and only have a few seconds to convey information about side effects. Additionally, the ads may use technical language difficult for consumers to understand. Furthermore, the ads often downplay the severity of side effects or focus on the positive benefits of the drug, making it difficult for consumers to assess the risks.

The FDA is taking a good step here but more needs to be done. Talk to patients as people and when you do make it easy to understand.