Drug ads must be more upfront about side effects, FDA says
The Food and Drug Administration has finalized a long-running effort to require prescription drug ads on TV and radio to clearly lay out potential side effects and when a person should avoid a medicine.
Why it matters: While the number of drug ads has surged and they account for billions of dollars in direct-to-consumer marketing, experts say they primarily rely on emotional appeals and focus on a drug's benefits over potential risks.
- DTC drug ads, which are banned in all other developed countries besides New Zealand, can influence whether consumers seek out more information about a drug, visit a health care provider to discuss an advertised product, or skip a doctor's visit.
Driving the news: The FDA on Monday outlined five standards, including a requirement that the information be presented in "consumer-friendly language and terminology that is readily understandable."
- The key message in TV ads will have to include a concurrent text message displayed long enough that it can be read easily.
- "The measures in this rule join other longstanding requirements that help remedy the lack of business incentive for prescription drug firms to effectively communicate the risks of their products to consumers," the FDA wrote in the rule.
Yes, but: The requirements only apply to prescription drugs. Advertising for over-the-counter drugs, dietary supplements and other products is policed by the Federal Trade Commission.
The other side: The drug industry has said its DTC ads provide "accurate, accessible and useful health information to patients and consumers" and aim to encourage them to seek guidance from their providers.
- There's also evidence that presenting people with more information about a drug can overwhelm consumers and actually dilute each piece of information.
Catch up quick: Prescription drug marketing came under increased scrutiny during the opioid epidemic, when the addictive nature of prescription painkillers like OxyContin was downplayed. Before that, in the 1990s, risky weight-loss treatments like fen-phen were heavily marketed.
- Some studies have concluded federal regulators are so light-handed that many commercials violate federal guidelines and don't reveal the best course of treatment.
- Drug ads have long been required to have a statement of major side effects and contraindications — usually presented in a fast-paced list of potential risks at the end.
- But manufacturers aren't required to elaborate on how a drug works, or precisely which patients would benefit from taking it.
- Congress in 2007 expanded the FDA's authority and, among other things, required the agency to ensure the major message in ads is presented in a "clear, conspicuous and neutral manner."
- The FDA proposed updating its standards in 2010 but didn't finalize the effort until now.