FDA finalizes guidance on field alert reports
The US Food and Drug Administration on Thursday finalized guidance on its expectations for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) in submitting field alert reports (FARs) for potentially defective drugs. It contains only minor changes from the draft.The final document supersedes a draft guidance that was issued in July 2018. (RELATED: Field Alert Report Submissions: FDA Offers Draft Q&A, Regulatory Focus 19 July 2018).
FDA requires NDA or ANDA applicants to submit FARs within 3 working days of receiving information that the drug product or its labeling may be mistaken for another product. Additionally, FARs must be submitted when applicants receive any information on bacterial contamination; any significant chemical, physical, or other change or deterioration in the distributed drug product; or any failure of a distributed batch to meet the specification established for it in the application.
To determine whether a chemical, physical, or other change or deterioration in the distributed product is significant, manufacturers should evaluate the potential impact of the change on the identity, strength, purity and stability of the product, and also consider potential impact on efficacy. This assessment should be based on the product’s intended use, route of administration, dosage, length of treatment and patient population.
The FAR reporting requirements only apply to products that have been distributed, so the guidance clarifies that if a batch failed specifications but has not yet been distributed, manufacturers do not have to submit a FAR.
The reach of the FAR reporting also applies not only to finished drugs but to packaging components as well. For example, FARs must be submitted for stopper vials if manufacturers receive information that vials “could result in contamination of a distributed batch.”
Manufacturers still must submit a FAR even if a root cause of a problem related to a distributed drug product is identified and corrected within 3 working days.
The final guidance also covers, in question-and-answer format, such issues as when a recall will trigger the requirement for a FAR submission, who holds responsibility for the FAR submission, and details of when and how to submit a FAR.
The guidance also recommends that applicants file follow-up and final FARs, although these reports are voluntary. “We use the information in these reports to assess the problem, risk to public health, and status and adequacy of your corrective action, or your determination that there was no actual defect as initially suspected,” explains FDA in the guidance.
The final guidance is very similar to the draft, and only has a few revisions. One change clarifies that the FAR requirements apply to positron emission tomography drugs, designated medical gases and combination products containing a drug constituent under an approved NDA or ANDA. The change was requested by Philadelphia-based Avid Radiopharmaceuticals.
Another clarifies that FAR reporting requirements apply to drug products marketed under an approved NDA or ANDA, whether the products are distributed domestically or abroad. Products produced domestically “that are only marketed abroad pursuant to a foreign label, with non-US labeling” and do not carry an approved NDA or ANDA are not subject to FARS reporting. The clarification was sought by the International Society for Pharmaceutical Engineering and Sanofi who said that the draft did not address global manufacturers that have multiple facilities for the same product, with some of these facilities located in the United States.
FDA rejected calls from GSK and Perrigo to change the 3-day reporting timeframe, saying that change would be inconsistent with federal regulations. (RELATED: Drugmakers Raise Issues With FDA’s Field Alert Report Submissions Guidance, Regulatory Focus, 20 September 2018).
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FDA’s Final Guidance On Field Alert Reporting
