AHPA Comments to FDA on Adverse Event Reporting Guidances

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The American Herbal Products Association (AHPA) has submitted comments to the FDA that seek to improve and clarify the agency’s guidance on submitting serious adverse event reports associated with dietary supplements and OTC drugs.

FDA published two draft guidance documents on October 15, 2007, intended to assist the dietary supplement and nonprescription (over-the-counter, or OTC) drug industries in complying with the adverse event reporting (AER) and recordkeeping requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which goes into effect on Saturday, December 22, 2007.

One request by AHPA is that FDA use the terms “patient” or “subject” instead of the term “injured person,” which would make AER guidance documents consistent across all products — prescription or OTC drugs, supplements or medical devices.

Further, AHPA challenges the agency’s encouraging the use of healthcare practitioners to elicit information from reporters, except as an option. AHPA has already created a targeted questionnaire that ensures that responsible persons will gather thorough AER information — the minimum data elements as well as all of the other information identified on MedWatch Form 3500A, and any additional relevant information. AHPA believes that properly trained staff using well-designed computer-assisted interview technology or targeted questionnaires can serve as an option to, rather than an adjunct to, the use of trained healthcare practitioners to obtain complete SAER information.

AHPA requested that the two guidance documents describe “inpatient hospitalization” based on the instructions for MedWatch Form 3500A in order to avoid erroneous AER submissions by emergency room medical personnel treating patients who are not admitted to the hospital. Seeking treatment at a hospital emergency room for a minor adverse event does not meet the definition of a serious adverse event.

AHPA also notes that FDA’s estimate of the number of AERs associated with dietary supplements expected to be submitted annually is entirely speculative.


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