A New Vector for Reporting Safety Issues is Launched

Yesterday, the FDA and the NIH announced the availability of a new electronic portal that has been partially constructed to allow widespread reporting of safety concerns for a huge array of products.  It is a one-stop-site to report just about anything that is wrong with just about anything – at least when it is completed.  The site is named quite literally – the Safety Reporting Portal (SRP).  

At the current time, the portal is prepared to accept reports on food safety issues, matters related to clinical trials, pet foods and treats and adverse events related to drugs used on pets and animals. Eventually the vision is apparently to have the SRP be the go-to resource for reporting a problem even when the product is regulated outside of FDA.  For example, the current set up allows for the reporting of issues related to clinical trials in gene therapy, and the report goes to NIH.  

At this time, there does not appear to be a mechanism for reporting adverse events associated with the use of approved human drugs, outside of clinical trial experiences.  However, the information on the portal states that the purpose of the SRP is to eventually allow anyone with Internet access to report a safety problem with food or medical products, and presumably that will eventually include drugs as well as supplements.

It has always been surmised that adverse events associated with drug use are under reported.  Right now, there is an electronic capability for reporting adverse events associated with medical products on the FDA's MedWatch site, but the site is not consumer friendly, to say the least.  

With the advent of a new resource, and one that will presumably grow to include the reporting of adverse events associated with drugs, bi0logics, devices and supplements, one is forced to wonder whether or not a more user friendly means of reporting adverse events will consequently increase the number of reports, particularly those directly from consumers.  

That, in turn, leads to other questions – if there is an increase in the volume of reports, will there be capacity to handle and triage the reports in a timely manner?  Only last November, the GAO issued a report entitled "Drug Safety: The FDA Has Begun Efforts to Enhance Postmarket Safety, but Additional Actions Are Needed" (Don't you love the way GAO titles are so literal?) that outlined many steps that still needed to be taken for postmarket safety efforts, including the observation that the FDA had not defined the decision-making roles of the Office of New Drugs and the Office of Surveillance and Epidemiology.

The SRP is a neat idea.  But while it may increase accessibility for consumers to report problems, there may be more than was bargained for in the eventual response for FDA, requiring a whole new set of resources to provide support.  The agency will have its work cut out for it in addressing existing issues related to the handling of postmarketing safety, as well as ensuring that internal resources are beefed up to handle a possible increase, which may be a tall order in what might be a diminishing pool of resources in upcoming budgets.  

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1 Response to A New Vector for Reporting Safety Issues is Launched

  1. Paul Grant says:

    Mark, excellent commentary as usual.
    Your readers may also be interested in a post-workshop industry publication from 2007 which discusses the reporting of ADEs in the context of MedWatch – notably suggesting that a system such as the MHRA’s Yellow Card is more comprehensive and accessible for consumers. It also raises the question about what happens when ADEs are more accurately reported in proportion to the volume that they actually occur.
    Here is a comparison table directly from the publication: http://books.google.co.uk/books?id=AQL_N6w1joAC&lpg=PP1&pg=PA28#v=onepage&q&f=false

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