Number of violation letters issued by FDA hits all-time low
- The FDA's Office of Prescription Drug Promotion (OPDP) issued only nine enforcement letters, an all time low, according to the Eye on FDA blog. The OPDP issued 11 letters last year. Over the last ten years, an average of nearly 26 letters have been issued each year.
- This year's all-time low could be part of a steadily declining trend in the rate at which violation letters are issued. At its peak, in 1998, the OPDP issued 156 such letters.
- Most of the violations cited were committed by smaller, lesser-known companies. The most common infraction cited was a lack of appropriate risk disclosure in prescription drug marketing.
The OPDP monitors prescription drug advertising and promotional labeling to ensure the information provided is accurate and doesn't mislead consumers. BioPharmaDive covered a warning letter this office sent to the drugmaker Duchesnay back in August for an ad featuring Kim Kardashian. The ad promoted a morning sickness drug and did not sufficiently display the risk information associated with the medication.
The overall declining trend may indicate companies are committing fewer infractions than in the 1990's when the FDA was issuing 100-plus letters per year, right after the FDA expanded the purview of DTC advertising.
However, as the Eye on FDA blog points out, this trend instead could be due to the significant increase in the amount of digital communications produced by pharma companies. Furthermore, the FDA still is in the process of formulating guidelines for digital media.
"The small amount of guidance put out by FDA on the topic fails to address the breadth and depth of the questions the agency asked in 2009 when it held a two day public hearing on the Internet and social media," explains Mark Senak, a lawyer at FleishmanHillard and author of Eye on the FDA.
According to a statement from the FDA provided to Stat, OPDP relies on a resource-allocation process to balance risk and the desire to have the most positive public-health impact. The spokesperson quoted emphasized one year does not represent a complete picture of the work OPDP does.