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From Health Law Daily, June 10, 2014

Final rule finalizes electronic submission of postmarketing reports

By Michelle L. Oxman, JD, LLM

The FDA has finalized the requirements for electronic submission of postmarketing reports of adverse events involving prescription and nonprescription drugs, vaccines, and other biologicals. Effective June 10, 2015, reports of adverse events involving any of these products must be submitted to the FDA electronically in the form of an individual case safety report (ICSR) with electronic attachments (Final rule, 79 FR 33072, June 10, 2014).

Reports subject to the regulation. The ICSR requirements will apply to post-marketing 15-day alerts, periodic adverse experience reports, and reports under federal Food Drug and Cosmetic Act sec. 760, concerning nonprescription drugs marketed without an approved application. It does not apply to investigational new drug safety reports, safety update reports, approved annual reports for NDAs and BLAs, or certain adverse event reports related to blood collection or transfusion or to human cells or tissue.

Packers, distributors, or sellers who submit reports to the manufacturer may use whatever format the manufacturer will accept, but if they submit the report directly to the FDA, they must do so in an electronic format acceptable to the FDA. Entities that make frequent reports will enter the information directly into the Adverse Event Reporting System.

Specific requirements. As the FDA stated in the 2009 Proposed rule, the specifications will be made available as separate guidance. Notice of the availability of the draft guidance was published in the June 10, 2014, edition of the Federal Register at 79 FR 33200Entities that make reports infrequently would be expected to use the Safety Reporting Portal (SRP) at

Waivers. The agency declined to exempt small entities from the requirements. It considers the SRP to be about as complex as making an online purchase. However, it anticipates granting waivers in unusual circumstances, such as natural or human-made disasters.

Data elements. The Final rule and regulations list the required elements of the report, which include a patient identifier that protects the patient’s identity. However, if the patient is the reporter, the name and contact information should be listed as the reporter. The information remains confidential. Additional requirements, including the patient’s identity, apply to reports involving vaccines.

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