FDA Accepting Comments on Adverse Event Reporting

WASHINGTON, D.C., October 15, 2007 — The FDA today issued a draft guidance on complying with the adverse event reporting (AER) and recordkeeping requirements of dietary supplement manufacturers, packers and distributors by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. The agency has also separately released guidance for the OTC (over-the-counter) and human drug product aspects of the AER act.

A mandated element of the AER act, the guidance explains what is required for the reporting of serious AERs for dietary supplements. This includes guidance on how, when and where to submit a serious AER for a dietary supplement, as well as guidance on maintaining records and access for serious and non-serious adverse event reports and related documents.

Comments on the guidance must be submitted to the FDA in the next 60 days, or by Dec. 14. The AER law goes into effect on Dec. 22, leaving little time for compliance education for companies affected.

“Congress clearly intended businesses would have at least 90 days to digest FDA’s guidance and make any necessary changes to their staff or procedures in order be ready to comply with the law when it goes into effect,” said Michael McGuffin, president of the American Herbal Products Association, upon sending a request letter to the FDA on Oct. 4. “As of today, we’ve less than 80 days, and the clock is ticking.” He further asked the FDA if it would exercise discretionary enforcement, considering the delay in issuing this needed guidance. “Companies are already preparing to submit any serious AERs they receive,” he added. “However, it’s inefficient and confusing to establish a procedure that may change when guidance is finally produced.”

Daniel Fabricant, Ph.D., vice president of scientific and regulatory affairs for the Natural Products Association (NPA), said NPA expects to submit comments. “As the largest [natural products] trade association representing both retailers and manufacturers, we plan to submit comments on the draft to ensure that the final guidance is fair, clear and can be implemented by those it impacts.”

The Board of Citizens for Health is preparing comments as well, so check back soon for our thoughts. Meanwhile, you can send comments of your own to:

Division of Dockets Management (HFA-305),

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

Be sure to include Docket # 2007D-0388. The FDA website says electronic comments can be posted by going to http://www.accessdata.fda.gov/scripts/oc/dockets/comments/CommentSearch.cfm?CID=&AGENCY=FDA and searching for the above docket number; however, as of the posting of this story, the guidance was not yet listed for electronic comments.

Click here to read the guidance, or you can download a copy by clicking on the attachment below (Adobe Acrobat Reader required).