[ACVM] Discussion topic: Pharmacovigilance

[Fulton, Robert]

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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