A new chapter in drug advertising begins Monday when a federal transparency rule takes effect requiring commercials to clearly spell out potential side effects and when a person should avoid the medicine.
Why it matters: The effort, more than a decade in the making, could demystify those rapid-fire disclaimers at the end of TV and radio ads through steps like simultaneous text that is displayed long enough to be read easily.
- It marks a major update of a 2007 law that expanded the Food and Drug Administration’s authority in areas including advertising — a multibillion-dollar business for U.S. prescription drugs. The agency proposed updating its standards in 2010 but didn’t finalize new guardrails until last November.
Driving the news: 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.”
- The “major statement” of an ad, where the known risks are enumerated, also has to be clear and conspicuous, by limiting distracting audio or visual elements, like a person dancing to an upbeat song.
Yes, but: The new rule doesn’t address the flood of potentially misleading social media content promoting prescription drugs, including new weight-loss treatments like Wegovy, that’s prompted calls in Congress for updated enforcement.
- It also only covers prescription drugs — not over-the-counter drugs, dietary supplements and other products that are policed by the Federal Trade Commission.
Context: Direct-to-consumer drug ads are only allowed in the United States and New Zealand and can influence whether consumers seek out more information about a drug, visit a doctor to discuss an advertised product, or skip a medical visit.
- DTC promotions exploded during the pandemic, exposing the shortcomings of marketing standards developed when the only businesses that advertised were drug companies, and the main outlets were print and broadcast media, per Johns Hopkins’ Bloomberg School of Public Health.
Caveat: Drugmakers have six months to come into full compliance with the new rule, and it’s unclear how aggressively the FDA will enforce the requirements, per Ropes & Gray.
- Nor is it clear how how the FDA will interpret “television and radio format” given the rise of streaming services and the way some messages can be recycled or adapted on social media platforms.
What we’re watching: Senators led by Dick Durbin (D-Ill.) and Mike Braun (R-Ind.) are pressing the FDA to go further and crack down on dangerous or misleading content touting prescription drugs on social media.
- They’ve cited findings from a Wall Street Journal investigation of how online advertising drove patients with ADHD, anxiety and other conditions to certain telehealth companies whose marketing led to the abuse of controlled substances.