Today marks one year since the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an Untitled Letter. That letter, issued on June 2, 2022, to Althera Pharmaceuticals took issue with false or misleading claims and representations about the risks and efficacy of Roszet, a prescription drug for high cholesterol.
Untitled Letters are sent by government agencies as an initial notification that the Agency has taken notice of one or more violations. They typically allow the company time to come back into compliance to avoid further FDA regulatory action. OPDP has specifically been heavily reliant on Untitled Letters over the last decade.
However, last year, in all of 2022, OPDP only issued three Untitled Letters (and one Warning Letter). This marks the lowest number of Untitled Letters sent by OPDP since 2010 and is the continuation of the decline in volume of enforcement letters from the Agency. The three Untitled Letters last year all covered violations of false or misleading risk presentation and false or misleading benefit presentation.
Bad Ad Program
Many of the Untitled Letters sent by OPDP over the last decade were a result of the Bad Ad Program. The FDA OPDP started the Bad Ad Program in 2010 as a way to “ensure prescription drug promotion is truthful, balanced, and accurately communicated.” Prior to the Bad Ad Program, OPDP conducted some surveillance of promotional materials of drugs, including monitoring drug promotional materials sent directly to them, monitoring medical convention exhibit halls, monitoring drug promotion on the internet and social media, and reviewing complaints submitted by industry competitors.
However, the Bad Ad program sought to take surveillance a step further by educating health care providers about how they can help the FDA ensure that prescription drug advertising and promotion was truthful and not misleading. Once a provider submitted a complaint to OPDP, the Agency evaluated the complaint to determine whether compliance action was needed. If compliance action was needed, OPDP would take the next steps and stop the promotion. If compliance action was not needed, OPDP used the complaint as “valuable information in focusing” ongoing surveillance activities.
Most of the violations found through the Bad Ad program centered around: making claims that were not appropriately supported, misrepresenting data, overstating a drug’s benefits, omitting material facts about a drug, failing to present a “fair balance” of risk and benefit information, and misbranding investigational drugs.
What Next?
While it has been a year since OPDP issued an Untitled Letter, it may not mean the Bad Ad Program is dead. It could be that Agency resources are being consumed in another area, such as compliance with COVID-19 regulations. Therefore, while we acknowledge the lack of Untitled Letters coming from OPDP, it’s likely too soon to say that the Bad Ad Program is over.