The Food and Drug Administration (FDA) has published their report on the performance of industry organisations in fulfilling their drug safety reporting requirements.
In summary of their annual report, the FDA has outlined that Pharma Companies can have either a post-marketing requirement (PMR) or a post-marketing commitment (PMC) in place. Additionally, the report went into further detail for the reasons why and circumstances where the FDA can require applicants and license holders to conduct clinical and post-marketing activities, in the interest of ensuring both patient and subject safety.
Within their overview for reporting requirements, the FDA provided key considerations for the topics of: timescales of new drug applications (NDA), abbreviated new drug applications (ANDA) and biologics license applications (BLA); PMR and PMC status categories; and additional requirements involved with post-marketing reporting requirements.
In addition to reporting requirements, the FDA also provided information on their internal PMR/PMC databases, with accompanying insight into the publicly available PMR and PMC data, as well as providing their summary for reporting information collected in 2019 – with key considerations in number of applicants; number of open PMRs and PMCs; applications where an ASR is expected but not submitted within the outlined time-frame; verified status for open reports; status of closed reports; and year to date comparison of PMR and PMC information.
In summary of the data provided for fiscal year 2019, the key findings that can be found are that, of total annual status reports expected, 79% were received on time and only 7% not received during this period. For open PMRs, only 79% could be classified as currently progressing on schedule; similar to open PMCs, showing 75% of reports to be progressing on schedule.
Furthermore, when reviewing the year to date data comparison for both PMRs and PMCs, using 2013 as the FDA’s outlined establishment date for PMRs and PMCs, it can be seen that, in 2019, there is a substantial percentage rise for pending PMRs (94%) and pending PMCs (94%) when compared to 2013 – which showed pending PMRs at 2% and pending PMCs at 0%. These findings are further highlighted by the status of fulfilled PMRs and PMCs for 2019 showing as 1% and 3% respectively – compared to 2013’s 43% fulfilled PMRs status and 69% fulfilled PMCs status.
PharSafer Comment
The FDA, in publishing these results, continue to remind both Companies that are clinical trial sponsors and license holders of their responsibilities in both performing post marketing activities, which can result in license suspension if not performed on time, as well as submissions for clinical trials.
With the advent of COVID-19 and the constraints placed upon Companies as a result, it will be interesting to see whether compliance continues to rise as it has been, or there will be an impact upon compliance assessment.
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