Reserve Samples and Retains

The United States Food and Drug Administration (FDA) places a significant amount of emphasis on the need for pharmaceutical companies to develop an effective approach to complaint management, including the establishment of well-written procedures. In fact, the Agency believes that complaint management is such a salient element for drug manufacturers that 21 CFR 211 has a dedicated section for the management and retention of complaint files, 211.198. Additionally, 21 CFR 314 expands on the post-market surveillance process under 314.80 (post-marketing reporting of adverse drug experiences) and 314.81 (other post-marketing reports). Equally important is the reporting of adverse events through the use of the FDA Adverse Event Reporting System (FAERS). Although the management of complaint files and subsequent investigative process is distinctly different from the voluntary and, in some cases, mandatory reporting of adverse events through the use of FAERS, the two processes are linked.

Although FDA citation for failure to comply with 211.198 in a warning letter is a rare event, the Agency does occasionally cite such violations. More common is the citing of a failure to complete and/or document investigations pursued as a result of a complaint.

IMPORTANCE OF 21 CFR 314.80 AND 314.81

As part of the drug application process, FDA wants to reinforce the need for review and reporting of adverse drug experiences (that is, adverse drug event), post-marketing studies, periodic reporting requirements, annual reporting requirements, and the importance of record keeping. Similarly to medical devices, drug manufacturers are required to report adverse drug experiences through the use of form FDA 3500A. Once a drug manufacturer becomes aware of an adverse drug experience, it is required to perform a thorough investigation followed by the completion and submission of form 3500A. An exemption is noted for post-marketing studies. It is important to be aware of a 15-calendar-day window when reporting an adverse drug experience. Within 15 calendar days of initial receipt of information, the drug applicant is required to report every serious adverse drug experience and every unexpected adverse drug experience. The best practice is to notify FDA has soon as possible when such adverse drug experiences occur. Additionally, drug manufacturers are required to script procedures that delineate their processes for managing surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences to FDA, including the record keeping (10 years).

Additional reporting requirements delineated within 21 CFR 314 include periodic adverse drug experience reports and annual reports. Periodic adverse drug experience reports are required to be filed quarterly with FDA for a period of three years from the date the initial drug application was approved. These quarterly reports are due within 30 days after the close of the quarter. At the discretion of the Agency, the quarterly reporting requirement can be extended. Annual reports are due to the Agency within 60 days of the anniversary date of the application approval.

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