[ACVM] Discussion topic: Pharmacovigilance

[Tim Frana]

The main difference between this proposal and the previous one is in the
details of the submitted reports. This proposal is more closely aligned
with VICH guidelines so they will be more harmonized for submission to
other regulatory authorities around the world. Not just APHIS. The VICH
guidelines have definitions about what constitutes an adverse event and
what data fields should be included in an adverse event report, etc. There
are also some other differences in this proposal around timelines for
submitting reports and a few other details. Mostly the difference is in
harmonization with VICH as I read it.

The information should allow APHIS better monitor product performance more
closely and take actions as necessary, but this proposal, like prior ones,
did not have any specifics about how information from adverse event reports
would be provided to the public. So not sure how that part will play out.
You can get adverse event report information from APHIS with a FOIA
request, but that's not the most user-friendly process.

I do think that providing information to the public is an important APHIS
consideration but is not simple or cheap. So a statement from ACVM might be
welcomed. I did work at CVB for a number of years and was involved with
adverse event reporting and now have a similar role in industry. So I see
the issue from both sides and think there's actually quite a bit of mutual
interest. It's just that adverse event data can be quite messy, so it is
hard to sort out what's real and actionable. I think that is what everyone
wants. The devil, as always, is in the details.

Hope that helps!
Tim





On Tue, Jan 12, 2016 at 1:30 PM, Fulton, Robert <robert.fulton at okstate.edu>
wrote:

> Dr. Frana,
>
> What is different in this new proposed rule from Sept 2015 that is
> different from the prior rules? I assumed that anything  about purity,
> safety , potentcy, or efficacy was an adverse event. We have been told
> before there was an adverse reporting mechanism. Regarding adverse reports
> to CVB, are these a matter of public record? Is it left up to the
> manufacturer to notify the public of adverse events or recalls?
>
> Having been involved in one of these prior "adverse events" from a
> producer's standpoint, becoming aware of the such events is problematic,
>
> Robert Fulton
>
>
> ________________________________________
> From: ACVM_diplomates <acvm_diplomates-bounces at lists.osu.edu> on behalf
> of Tim Frana <timfrana at gmail.com>
> Sent: Monday, January 11, 2016 5:58 PM
> To: ACVM - The American College of Veterinary Microbiologists Listserv
> Subject: [ACVM] Discussion topic: Pharmacovigilance
>
> Hi all,
>
> Would like to pose the following for discussion:
>
> In September 2015, the USDA APHIS published a proposed rule in the Federal
> Register regarding standards for pharmacovigilance.  In essence, the
> proposal would require veterinary biologics companies to record and submit
> reports concerning adverse events associated with the use of biological
> products, primarily vaccines. Currently, veterinary biologics companies are
> required notify APHIS if there are indications that raise questions
> regarding the purity, safety, potency, or efficacy of a product. However,
> there is no specific guidance related to adverse event reports. These
> requirements would align APHIS with guidelines outlined by the
> International Cooperation on Harmonization of Technical Requirements for
> Registration of Veterinary Medicinal Products (VICH). While the comment
> period for this proposal has closed, there will likely be opportunities for
> public input on pharmacovigilance for veterinary biological products in the
> future. Should ACVM provide comment on the need for the proposed
> requirements? If so, how should that be done? Examples: through AVMA
> Council on Biologics and Therapeutic Agents (COBTA), writing a position
> paper, supporting workshops or meeting presentations.  Issues related to
> the proposal but not specifically addressed include how to analyze and use
> data from adverse event reports and how to convey the information to the
> public. Is this area of vaccinology one in which ACVM can/should be
> involved or considered outside our area of expertise?
>
> Appreciate any comments.
>
> Thanks,
> Tim Frana
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