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In July, the Journal of the American Medical Association printed a Research Letter and an on-line editorial on pharmaceutical companies’ late expedited (15 day) reports to the FDA. The article (behind a paywall) can be found here. and the editorial here and here. The study is from the University of Minnesota.  The findings were based on data available to the public from the FDA quarterly post-marketing FAERS safety data files from 2004 to 2014.

In a nutshell, the authors looked at over 1,600,000 reports and found that over 160,000 (10%) were not received by the FDA within the 15-calendar day time frame required by federal regulations. Apparently these are only initial reports with follow-ups not included.  Over 40,000 involved patient deaths. Three percent of the reports were three to six months late, and 3 percent were over 6 months late.  Adjusted rates of reports taking 16–90 days to reach FDA were 6.42% for events with patient death and 5.19% for events without patient death.

This received some press coverage in late July with a handful of stories in newspapers and on social media but it does not seem to have gone viral.  See for example, this article and this article.

Although the methodology may be criticized for some probably minor issues, the overall data and conclusions appear to be consistent with anecdotal reports and FDA inspection reports and Warning Letters.  Thus the article itself makes some very good points.

However, the editorial in JAMA is another story being a bit naïve and not aware or informed of how the PV system works in the US.  For example, here are some statements from the editorial:

According to the news reports found on-line, FDA did not comment on this report when asked.  One imagines they will at some point and hopefully will address some of these questions.

This is not the case.  The issue hinges on the definition of “disciplinary actions”.  FDA has issued Warning Letters and 483/EIRs which note late reporting and require a response within 15 days and often the implementation of corrective actions (CAPAs).  Whether there is a lack of deterrence is hard to determine based on this article; it is a separate issue.

In summary, this paper provides interesting and important information that, as always, produces more questions that need answering if we are to improve this situation. In the meanwhile, on a practical level, pharma companies and CROs should have a look at their on-time/late expedited reporting data and put in place procedures to minimize delays with the goal of no late reports. And, obviously, if you’re not tracking late reports, start to do so immediately!




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