Background
In a 3 June 2013 posting on FDA’s Voice blog, FDA Commissioner Margaret Hamburg recounted how the program has grown in the last two decades. Since being started by then-Commissioner David Kessler in 1993, MedWatch has grown over the years, both in the number of products it tracks and the requirements placed upon it. At the core of those requirements, Hamburg explained, is that reporting forms need to be easy to use and understand while still allowing FDA to obtain actionable intelligence from the reports. But until now, FDA has largely focused on two reporting forms known as 3500 and 3500A, used respectively by medical professionals and the sponsors, distributors, importers and manufacturers of a product.
Now FDA is adding a third form to the mix, known as 3500B.
News of the form’s impending release was broken by Regulatory Focus last month in an interview with James Valentine, a program analyst with FDA’s Office of Health and Constituent Affairs, an office focused on incorporating patient views into FDA’s regulatory process. “One of the things being worked on is an actual consumer form for reporting,” Valentine said. “That’s something that has never existed before. Right now, there’s the generic MedWatch adverse event reporting form (FDA Form 3500), which isn’t consumer-friendly.” “We’re in the process of developing a consumer-friendly form that will eventually be featured on our website, as we think our audience will be the largest user of this form,” he added.
Meeting 3500B
FDA gave the public the first glimpse of that form on 3 June 2013, and added further explanations regarding the importance of the change. Consumers, they said, had found the reporting form “too technical” and wanted something “more consumer-friendly.” The 3500B form uses relatively plain language in asking for patient feedback. For example, a segment that asks, “Did any of the following happen?” lists options such as hospitalization, disability, birth defect, and death, among other options. There is also a section for the patient to explain the problem in a narrative format, the results of any laboratory data, extensive product information, and information about the patient or caregiver.
Compared to the 3500 submission process, the five-page form is relatively straightforward, though consumers could potentially become confused between Section B (“About the Products”) and Section C (“About the Medical Device”), especially if the problem involves a combination product or a patient with a poor understanding of the distinction between the two. In an attempt to mitigate confusion, FDA said it has launched MedWatchLearn, a new web-based training tool it hopes will educate consumers on how to use the MedWatch system and report adverse events. The website already has a number of case studies, including ones for drug quality problems and therapeutic failures.
The one thing consumers won’t find friendly about the form, however, is the submission process. While the 3500/3500A form can be submitted online, the 3500B form requires submission either by mail or by fax, potentially to cut down on false or malicious reporting. What remains to be seen is how FDA will actually use the reports to inform its safety investigations. The agency noted in an announcement that consumers will not be expected to provide proof that a problem was caused by a particular product. In addition, a patient or caregiver’s lack of medical knowledge could lead to erroneous reports.
So while FDA says that “Every report counts,” consumers may well find that their reports count less.
REFERENCE: Alexander Gaffney, RF News Editor; 4 June 2013; RF Regulatory Focus