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Adverse Event Reports - Draft Proposal 1

View PDF of the Adverse Event Reports Section (72 KB)


Summary of Public Comments


View All Adverse Event Reports Draft Proposals

View Comments for this Proposal

Average Rating for this Proposal (Based on 8 Ratings):  

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Draft Proposal 

FDA should expand the areas in which it provides the public with online access to public information from adverse event reports about FDA-regulated products submitted to FDA, in a format that is searchable and allows users to generate summary reports of this information, including, if known and as applicable, the trade name and/or established name of the product, dosage, route of administration, description of the adverse event, and the health outcome.  Adverse event report information should continue to be disclosed with a clear disclaimer about the limits of the information.

Reasoning: Individuals using, or who have an interest in using, an FDA-regulated product have a particular interest in receiving information about the safety of that product as soon as possible.  For medical products, for example, this information can be used by prescribers, patients, public health officials, and consumers to inform decisions about the use of such products, and may help those who use the product to identify and report additional adverse events. 

Public access to adverse event reports can provide industry with more complete information that can be used to assess the safety profile of products and may help industry determine more quickly whether additional actions are required to ensure the safe use of a product. 

FDA is likely to have the most complete database of adverse event reports about a particular product because of the reporting systems described above.  Making adverse event report information about FDA-regulated products more accessible to the public provides a window into FDA’s post-marketing surveillance system.  Disclosing some of the data FDA uses to monitor FDA-regulated products once they are on the market may lead to better understanding of the post-marketing surveillance system. 

FDA has some experience providing the public with online access to adverse event report information quickly, as discussed in section 1 above.  But in many circumstances, members of the public only have access to information from adverse event reports by submitting a Freedom of Information Request (FOIA) request to FDA.  This method does not provide broad access to the information nor is it efficient for Agency employees to provide this public information on a piecemeal basis.

FDA should provide adverse event reports for all FDA-regulated products in a similar manner.  There is no compelling reason for providing differential access to adverse event reports for FDA-regulated products.  FDA should aim to provide the public with increasing availability and accessibility of adverse event report information for all FDA-regulated products.  Increased availability of this information can arm the public with information relevant to the safe use of products, free up Agency resources for other activities that improve public health, and further the goals of the Administration in achieving more transparent government.

Comments for this proposal 

(Total Received: 9)

Comment: The current Med Watch database is about as archaic as it can get. Even more to the point all data prior to 1996 is maintained on another database and is not being made available to the general public. The FDA needs to combine ALL the previous as well as current drug safety databases into ONE ONLINE database that is easily accessable and searchable without resorting to specialized software. The current system, as well as the system that was replaced in the mid nineties, is pathetic and all but useless when it comes to generating meaningfull data. But considering how antiquated the FDA's computer systems are, this may not even be possible.
Date Submitted: 5/22/2010

Comment: The access to adverse events proposal is critical to make sure the public is made aware of any problems with a given medication or medical device. The information needs to be accessible to disabled persons many of whom need to take medications for their conditions and/or use medical equipment. The website for adverse events information should be accessible to electronic card readers, be in large print and picture exchange communication formats.
Date Submitted: 5/22/2010

Comment: This idea is a wonderful way of expanding the amount of information available to patients and health care providers. I think a good way of incorporating this into the existing structure already available is through the www.accessdata.fda.gov websites. I order for the information to be best understood, I think there should be an option to filter AER results by various criteria. This would allow users to see AERs not only for their specific drug but also their therapeutic equivalents. It could also allow for comparisons between different drugs in the class of drug they belong, ultimately allowing the FDA to be a liaison for information sharing between patients, doctors, manufacturers, and regulatory agencies.
Date Submitted: 5/24/2010

Comment: I think that this is an excellent proposal! I would also suggest that this should apply to allergic reactions caused by food labeling that is not in compliance with the Food Allergen Labeling and Consumer Protection Act or caused by the failure to follow Current Good Manufacturing Practice regulations. My understanding is that when a consumer reports a reaction to FDA, an investigation is conducted, and FDA sometimes independently confirms the undeclared presence of an allergen. In these situations, this is actionable material that should be shared with the public, perhaps targeted to the food allergy community, just as other information might be targeted to other groups of vulnerable consumers such as pregnant women. This is information that, if shared, might prevent serious harm or death to other consumers. The sharing of this information is especially important since FDA does not have the current authority in most cases to order mandatory recalls of products.
Date Submitted: 7/15/2010

Comment: CRN supports the expansion of the current system that makes adverse event reports publicly available to include a format that is searchable and allows users to generate summary reports with a clear disclaimer about the limitations of the information. In addition to the disclaimer the agency should provide the public with information on how it analyzes and uses adverse event data internally. CRN would like to emphasize that any modifications of the current system aimed to speed up the process should not compromise the time the agency has to properly review cases for quality control and redact non-public information. Because the public currently has access to adverse event reports through the Freedom of Information Act (FOIA) Draft Proposal 1 should have a low priority.
Date Submitted: 7/19/2010

Comment: Note: This part precedes CRN's comment on 7/19/10. CRN recognizes the potential public health benefits to providing the public with timely information about adverse events reported about FDA-regulated products. Timely Information about adverse events can be especially valuable to health care practitioners who have the knowledge and training to understand the limitations of adverse event reports that have not been carefully reviewed and assessed. CRN shares the agency’s concerns that the general public may draw inaccurate conclusions based on the incomplete information provided by adverse event reports
Date Submitted: 7/20/2010

Comment: I strongly support this proposal
Date Submitted: 7/20/2010

Comment: Adverse event reporting awareness is critical
Date Submitted: 7/20/2010

Comment: We believe adverse event reporting is critical to ensure public awareness of issues with devices/medications
Date Submitted: 7/20/2010