From: Arellano, Felix M [R&D/0001] [felix.m.arellano@pharmacia.com]
Sent: Tuesday, April 15, 2003 3:32 PM
To: fdadockets@oc.fda.gov
Cc: Perez, Susana [R&D/0439]; Zurlo, Mariagrazia [R&D/0425]
Subject: Comments on Risk Management guidance document. docket number
02N- 0528


The following are comments on behalf of Pharmacia Drug Safety Surveillance:

		We think the proposed guidelines are a very good first draft
and the following a suggestions to tighten its focus on increasing patient's
safety and focus on proactive risk management:

		However, a lecture of the level 1 program as currently
defined in the concept paper 2, leaves open for interpretation what would be
the very minimum requirements for a level 1 program. We do not believe that
monitoring of spontaneous reports is, in general, sufficient.  

		We suggest that all products launched will require the
preparation of a formal document (pharmacovigilance plan) including what is
known from the safety profile of the drug during development, what is known
of the patient population expected to receive the drug, what is the expected
safety profile of the drug and what would be done to monitor it (i.e. what
MR. program level).

		We think it would be useful to characterize the very minimum
requirements for a level 1. This would ensure some clarity and diminish the
interpretation by different sponsors.  We suggest that these minimal
requirements are:

*	A patient characterization/drug utilization study.
*	Periodic monitoring of spontaneous reports including medical
assessment of safety profile of the drug and electronic signal detection via
PRRs or similar.
*	Specific epidemiological studies for any safety issues identified
pre-marketing or during the monitoring of safety profile.

		We suggest that the TIMING of these is what would be
negotiable with the sponsor (i.e. depending on patient exposure), rather
than what needs to be done. Any further risk intervention technique would be
added to this "level 1" as described in the FDA guidelines (level 2-4).

		We found reading the EURO risk management summary document
in a perspective focusing on pharmacovigilance plans elaborating according
to specific characteristics (NME, switch to OTC, etc.) rather than baseline
profile at launch. http://www.heads.medagencies.org/summary.org

		We would be happy to discuss this further at your
convenience.

		Felix Arellano, MD
		Chief Safety Officer
		Pharmacia Corporation
		100 Route 206 North, MS 135
		Peapack, NJ 07977
		(908) 901-8614


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