A new rule governing direct-to-consumer prescription drug advertisement takes effect on Monday, requiring commercials to articulate potential side effects clearly and reasons why a person with certain conditions should avoid the medication.
The new rule from the Food and Drug Administration follows more than a decade of advocacy work and marks the first major update in pharmaceutical advertising since 2007.
The finalized rule, which the FDA announced in November, has five explicit guidelines for the orientation of prescription drug advertisements, including the use of “consumer-friendly language and terminology that is readily understandable.”
Specifically, the rule requires that the major statement that outlines the side effects and reasons not to take the drug must be presented in both audio and visual format, a method known as dual modality.
All text presented on the stream must be in an “easy-to-read format” and be shown “long enough for the text to be read easily,” according to advertising firm Ropes and Gray.
Firms will have six months to come into full compliance with the new rule, but it is unclear how aggressively the FDA will enforce the new requirements.
The United States and New Zealand are the only developed countries that allow for direct-to-consumer prescription drug advertising, also referred to in the medical community as DTC.
DTC came under fire during the height of the opioid epidemic when the addictive properties of OxyContin were minimized in commercial advertisements and the drug was heavily marketed.
The FDA’s new rule also comes amid significant controversy over how to regulate advertisements for prescription drugs on social media and streaming services. The agency specifically outlines that the rule is intended to govern “television and radio format,” but it does not elaborate on how advertisements on new technology platforms are to be classified.
Supporters of tighter regulation cite studies and journalistic investigations finding that telehealth companies have been marketing products on social media platforms such as Instagram and TikTok without adhering to federal regulations that govern marketing for radio and television broadcasting.