FDA’s new drug ad requirement doesn’t go far enough

Starting today, a new rule requires drug commercials to clearly show the potential side effects and when not to take the medicine. This update to a 2007 law gives the FDA more control over drug advertising. Drugmakers have six months to comply with the new rule fully, and it’s unclear how aggressively the FDA will enforce the requirements, per Ropes & Gray. It’s a good step, but a lot more is needed.

The federal transparency rule takes effect, requiring commercials to spell out potential side effects and when a person should avoid the medicine. The rule lays out five standards for direct-to-consumer ads to be more upfront about possible pitfalls, including a requirement that the information be presented in “consumer-friendly language and terminology that is readily understandable.” But it’s not enough.

Do Consumers Understand Prescription Drug Side Effects in Ads?

Prescription drug advertisements are ubiquitous in the media landscape, aiming to inform potential patients about treatments for various health conditions. However, the effectiveness of these ads in conveying the necessary information, especially regarding side effects, is a topic of significant concern. Do consumers genuinely understand the side effects of the medications promoted to them? The answer is complex and multifaceted.

The Structure of Prescription Drug Ads

Prescription drug ads typically follow a structured format mandated by the Food and Drug Administration (FDA). They must include information about the drug’s intended use, benefits, and potential risks. This requirement includes side effects, often in a segment called the “fair balance” section. While this aims to ensure consumers are well-informed, the execution and reception of this information can vary.

The Comprehension Challenge

Several factors contribute to the difficulty consumers face in understanding prescription drug side effects from ads:

  1. Medical Jargon: Ads often use complex medical terminology that can confuse the average consumer. Phrases like “contraindicated,” “adverse reactions,” and “pharmacokinetics” may not be easily understood without medical knowledge.
  2. Presentation Speed: Side effects are usually listed rapidly and towards the end of the advertisement. The quick delivery and sometimes lower audio volume compared to the rest of the ad can make it challenging for viewers to catch all the details.
  3. Visual Distractions: Many ads show serene, engaging visuals of happy, healthy people while narrating the side effects. This contrast can distract from the severity of the potential risks.
  4. Length and Complexity: The lengthy and detailed list of side effects might overwhelm consumers, leading them to tune out or not fully process the information.

Studies on Consumer Understanding

Research highlights these issues. A study published in the Journal of Health Communication found that while 70% of participants recognized the risks mentioned in drug ads, only about half could recall specific side effects when asked shortly after viewing the ads. This gap suggests that while consumers know there are risks, they may not fully grasp the details.

Another FDA study revealed that consumers tend to remember the benefits of a drug more clearly than the risks, indicating an imbalance in what is retained from these advertisements. This phenomenon is partly due to the more prominent and engaging benefits presentation compared to the typically more clinical and rapid delivery of side effect information.

Regulatory and Industry Responses

The FDA has considered various strategies to improve the communication of side effects in ads in response to these concerns. These include using more straightforward language, uniform presentation speeds, and straightforward visual aids to highlight risks. Additionally, some industry experts advocate for “boxed warnings” within ads, similar to the prominent warnings seen on cigarette packages.

Consumer Responsibility and Advocacy

Consumers can take proactive steps to understand prescription drug side effects better. Essential practices include consulting with healthcare professionals, researching medications through reputable sources, and reading the full prescribing information. Moreover, patient advocacy groups often provide resources to help decipher the complex information presented in drug ads.

While prescription drug advertisements serve a crucial role in informing the public about available treatments, the current methods of presenting side effects often fall short of ensuring comprehensive consumer understanding. Simplifying the language, enhancing the clarity and prominence of risk information, and encouraging active consumer engagement are vital steps toward bridging this gap. As the pharmaceutical industry and regulatory bodies refine their approaches, fostering an informed patient population remains a critical goal.

But what exactly do consumers do when they see a DTC ad?

When consumers see a pharma drug advertisement, their responses can vary widely, but everyday actions and reactions include:

  1. Increased Awareness and Curiosity:
  • Research: Many consumers become curious about the drug and may research it online to learn more about its uses, benefits, and side effects.
  • Discussion with Healthcare Providers: Some consumers might mention the drug during their next doctor’s visit and ask if it suits their condition.
  • Discussion with Family and Friends: Consumers often discuss the drug with friends or family members, especially if someone they know has a condition that the drug treats.

2. Self-Diagnosis and Seeking Information:

  • Self-Diagnosis: Ads might prompt consumers to self-diagnose conditions based on the symptoms described, even if a doctor hasn’t formally diagnosed them.
  • Online Forums and Social Media: Consumers might seek opinions and experiences from others on online forums or social media platforms to see if the drug has been effective for others. Research has shown that the majority of people interested in an advertised drug go online to read about the drug and its potential side effects.

3. Behavioral Changes:

  • Requesting the Drug: The persuasive messaging of the ad may influence consumers to ask their doctors to prescribe it directly.
  • Changing Medications: If currently on a different medication, some consumers might consider switching to the new drug after consulting with their healthcare provider.

4. Emotional and Psychological Reactions:

  • Hope and Optimism: A positive portrayal of the drug’s benefits can create a sense of hope for those struggling with a particular health issue.
  • Anxiety and Concern: Conversely, ads that emphasize severe symptoms or complications might cause anxiety or concern, significantly if consumers recognize some of those symptoms in themselves.

5. Skepticism and Critical Evaluation:

  • Critical Evaluation: Some consumers remain skeptical and critically evaluate the ad, considering factors such as the pharmaceutical company’s reputation, potential side effects, and the necessity of the drug.
  • Comparing Alternatives: They might compare the advertised drug with other treatments or medications to gauge its effectiveness and safety.

6. Impact on Doctor-Patient Relationships:

  • Influencing Medical Consultations: Ads can affect doctor-patient interactions, with patients becoming more proactive in their healthcare decisions.
  • Trust Issues: Tension can arise if doctors feel that patients are overly influenced by advertisements rather than medical advice.

What’s missing is the context on side effects. Target patients want to know how many people have had specific side effects. How many people who took the drug had nausea compared to the placebo? How many people stopped taking the drug because of side effects?

The FDA has taken an excellent first step, but in an age when trust in pharma is at an all-time low, more must be done to clearly communicate the potential risks to patients.