ADVERSE EVENT REPORTING
The FDA published the “Draft Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act” for comment on Oct. 15.
The guidance provides industry with five minimum data elements for a reportable event: identifiable injured person, identifiable initial reporter, identity and contact information for the responsible person (i.e., the manufacturer, packer, or distributor submitting the serious AER to FDA), a suspect dietary supplement and a serious adverse event or fatal outcome. Included in this requirement is at least one way of contacting for follow-up the initial person reporting the event. The 15 business day time clock does not start until all five elements have been collected. Additionally, FDA “encourages responsible persons to use trained health care practitioners to elicit information from reporters.” There is still debate as to whether the language of the act requires firms have healthcare professionals to make “reasonable medical judgment” when collecting reports. Also notable, FDA says if a report involves multiple supplements from more than one responsible person, the first manufacturer should send a copy of the form to the other manufacturer(s). The additional manufacturers do not need to submit a separate report unless a manufacturer has information about the serious adverse event.