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Jun 09 2010

FDA & NIH Launch Electronic Safety Reporting Portal

Biology will relate every human gene to the genes of other animals and bacteria, to this great chain of being.

– Walter Gilbert

The FDA and the NIH have announced a joint venture called the Safety Reporting Portal (SRP).  The SRP is a website for reporting safety data (pre- and post-market) in compliance with U.S. regulations.  It will eventually cover more (and maybe all) types of federally regulated safety reports, but for now four types of reports can be submitted through the SRP:

  1. Reportable Food Registry:  Industry can report problems with food that present a reasonable probability of harming humans or animals.
  2. Pets: Anyone can report product problems with pet foods and treats.
  3. Animal drugs: Manufacturers can report adverse drug events.

Finally, and most relevant to our work:

Clinical Trials: Biomedical researchers involved in human gene transfer clinical trials [emphasis added] can report an adverse event, indicating whether it might be an unanticipated consequence of the product being tested. Trial sponsors can use the portal to prepare a report, print it and send it to the agency to satisfy reporting requirements for investigational new drugs.

Only providing for human gene transfer trial reports may seem overly specific, but eventually more types of clinical trials will be able to use the SRP as the mechanism to submit safety reports.  As it expands, this portal will move the U.S. government one step closer to a unified electronic reporting system that could be shared by multiple agencies.

I’ve walked through the SRP a few times, and it seems fairly straightforward.  Maybe more importantly, it looks both faster and easier than the ol’ MedWatch 3500 forms.  If a user tries to report something not currently covered, they will be re-directed to the appropriate outlet.  Also, the SRP does not (yet) make the traditional modes of reporting obsolete; it is just another way of reporting.

Anything that codifies and streamlines safety reporting is certainly more than welcome.  The two obvious advantages to this kind of consolidation are:  1) Lessening the burden of reporting will increase compliance and 2) Having all safety reports for the U.S. in one location will facilitate more meaningful analyses.