Editor’s note: Kathleen Dunn and Dean Cirotta presented the basics of SAERs in earlier posts, but this exhaustive overview on AERs from Robin C. Koon is a culmination of what was written before and provides insights into what the FDA requires of manufacturers in this situation. We hope you use all four posts as a blueprint.
Since the GMPs (Good Manufacturing Practices) for dietary supplements became law in 2007, the industry has continued to evolve with the continued regulatory changes. One recent area of that focus, in which the regulatory auditors have started paying particular attention to, is with AER reporting. MedWatch is the FDA’s Safety Information and Adverse Event Reporting Program and was founded in 1993. Any person can use the FDA’s MedWatch system to report: serious adverse outcomes, product quality problems, product use errors, etc. to the FDA for all human healthcare products except vaccines. The
MedWatch system collects reports of adverse reactions and quality problems (defects/malfunctions/safety) for FDA-regulated products [cosmetics, drugs, nutritional (dietary supplements, food, medical foods, infant formulas), and medical devices].
The database is designed to support the FDA's post-marketing safety surveillance program for these regulated products.
The supplement law governing Adverse Event Reporting (AER)—the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) —was passed by the 109th U.S. Congress in December 2006 and required compliance one year later (December 2007) after its enactment.
The act requires dietary supplement manufacturers (the manufacturer, packer, or distributor whose name appears on the package), to file serious adverse event reports (AERs) of their products with the Food and Drug Administration (FDA). Failure to report can result in FDA enforcement action against any company that violates the law. Retailers whose names appear on the label may designate the manufacturer or packer to submit reports on the retailer’s behalf. Note that reported submissions are not an admission that the dietary supplement involved caused or contributed to the adverse event being reported.
Under the law, a manufacturer, packer, and distributor (whose name in appears on the package) of dietary supplements or nonprescription drugs is deemed to be the “responsible person” and must submit to FDA serious adverse event report (SAER), as defined in section 761(a)(2) of the FD&C Act (21 U.S.C. 379aa-1(a)(2)), within 15 business days that result in the following:
- Life-threatening experience
- In-patient hospitalization
- Persistent or significant disability or incapacity
- Congenital anomaly or birth D\defect
- Requires, based on reasonable medical judgement, a medical or surgical intervention to prevent an outcome as listed above
Such reports must be kept for six years, and firms have an obligation to submit to FDA new medical information related to the AERs. These AER records are to be made available during FDA inspections. The law does not require reporting of more mild and transient adverse events such as fatigue, headaches, nausea, etc..—although consumers, manufacturers, and medical professionals still have that option.
Prior to this law taking effect, consumers, doctors, and other healthcare providers were already reporting serious adverse medical events (SAME) to the FDA thru MedWatch and CAERS programs.
FDA Reporting Forms
Form FDA 3500 - Voluntary Reporting
For use by healthcare professionals, consumers, and patients.
Form FDA 3500B - Voluntary Reporting for Consumers
A consumer-friendly version of the 3500 reporting form.
Form FDA 3500A - Mandatory Reporting
For use by IND reporters, manufacturers, packers, distributors, importers, user facilities’ personnel.
For dietary supplement manufacturers, packers, and distributors: only use the form FDA 3500A
Use the correct form & fill out the form accurately
The five basic minimum data elements the FDA requires for submission of a safety report are:
- an identifiable injured person (patient)
- an identifiable initial reporter
- the identity and contact information for the responsible person (the manufacturer, packer or distributor) submitting the SAER
- a suspect dietary supplement (copies of label and related medical/laboratory documents recommended)
- a serious adverse event or fatal outcome, due to use of the suspect dietary supplement
The FDA in its Guidance for Industry recommends: "The responsible person should actively seek information on any minimum data elements that are not initially provided by the reporter and wait to submit a serious adverse-event report to FDA until the information is obtained. FDA recommends that the responsible person document [his or her] efforts to obtain the basic elements for a serious adverse-event report."
Any new medical information received within one year of the initial report must be submitted to the FDA within 15 days of receiving it. If any new data is received later (> 1 year), you are not required to submit it (but can), and you must keep it on file.
There are two FDA guidance documents:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm171383.htm (June 2009)
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm179018.htm (September 2009)
Read the conclusion of this post tomorrow.