FDA Publishes New Field Alert Reporting Draft Guidance

Earlier this month, FDA published a Notice of Availability for its Draft Guidance entitled, Field Alert Report Submission, Questions and Answers. We have previously blogged about Field Alert Reporting (FAR) requirements here and here.

The draft guidance makes recommendations to NDA and ANDA holders regarding the submission of information to FDA during a FAR. The FAR is described in the guidance as part of “…an early warning system to protect patient health.”

What follows are a few potentially useful nuggets of information from the draft guidance:

• To determine whether a chemical, physical, or other change or deterioration in the distributed drug product is “significant” as per the regulatory requirements, the applicant should evaluate the potential impact of the change or deterioration on the drug product’s identity, strength, purity, stability, and efficacy, and how that change or deterioration could impact an individual using the product.
• Information about “packaging or components” used in the manufacture of the distributed drug product that meet the criteria outlined in the FAR regulation (i.e., not just the drug product itself or its labeling) necessitate the submission of a FAR.
• Although the submission of a follow-up FAR and a final FAR are recommended, they are not required. Only the initial FAR is required. The information in the follow-up and final FAR is used by FDA to assess the risk to public health and the adequacy of the firm’s response.
• Aseptic process simulation failures for a distributed drug product require a FAR when the failure indicates a potential problem related to sterility assurance that requires an investigation, including an assessment on the impact of distributed drug product that has been produced since the last successful media fill.
• Even if the root cause of a problem related to a distributed drug product is identified and corrected within three working days, the applicant must still submit a FAR if the problem had originally met the criteria under 21 CFR 314.81(b)(1).
• The undertaking of a recall does not absolve the applicant of the responsibility to perform a FAR, if the issue with the drug product which led to the recall meets the criteria for a FAR under 21 CFR 314.81(b)(1).
• FARs associated with multiple NDAs/ANDAs need to be submitted on separate Forms (Form FDA 3331a), one for each NDA/ANDA.
• Ultimate responsibility for submitting the FAR rests with the NDA/ANDA holder, even if certain steps in the manufacturing, holding, packaging, labeling or distribution of the drug product in question are contracted out to other parties.
• Failing to submit a required FAR within the three working day timeframe is not only a violation of 21 CFR 314.81(b)(1), but also a violation of section 505(k) of the Federal Food, Drug and Cosmetic Act (FDCA) as well as section 301(e) FDCA.

We will keep you posted on any interesting comments posted to the docket for this draft guidance, as well as the publication of any revised or final guidance documents by the agency.