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P122: Trends in OPDP Enforcement: Warning and Violation Letters in Two Different Eras





Poster Presenter

      Phillip Reveal

      • Consultant
      • Reveal Regulatory LLC
        United States

Objectives

The purpose of this assessment was to compare the number of enforcement letters issued by DDMAC/OPDP and the number of violations cited in the letters from two different eras (2004-2013; E1) vs (2014 - Present; E2).

Method

We examined the enforcement letters [Untitled (UL) and Warning (WL)] found on the FDA web site from the years 2004 to the Present. Our primary interest was to compare the number of enforcement letters, the types of letters and the number of violations cited to determine any observable differences.

Results

Insights into current interpretation of the regulations applicable to drug promotion can be gained from the review of issued enforcement letters from the Division of Drug Marketing and Communication (DDMAC) and later Office of Prescription Drug Promotion (OPDP). Previously, we investigated violations found in Warning vs. Violation Letters from the years 2004-13 (E1) and which suggested that on average, 1) more violations were found in Warning Letters than Violation Letters and, 2) that the most common primary violations in Warning Letters were safety violations (i.e. lack of balance or contextual elements). This current evaluation focused on the same parameters as the original evaluation but also sought to understand any observable differences in the the number of enforcement letters, the types and the number of violations per letter between the two eras (2004-2013; E1) vs. (2014- Present; E2). In comparison with E1, an observable difference is suggested in the number of enforcement letters (-73%) and the number of violations cited per letter (-27%) in E2. In addition to those findings, the number of violations per WL vs UL were found to be more equitable with the E1 cohort than previously observed. Consistent with findings from the original E1 cohort, enforcement via Warning Letter were found to be more commonly associated with primary violations that are safety-related.

Conclusion

Our findings indicate a comparative decrease in the number of enforcement letters issued and the number of cited violation per letter from 2 time periods (2014- Present vs 2004-2013). The comparative differences suggest improvements in the quality of materials submitted to FDA via Form 2253 or perhaps a change in the way OPDP is evaluating enforcement of pharmaceutical manufacturer materials.