From: Jean Masonek [jmasonek@BIOMARINPHARM.com]
Sent: Tuesday, April 01, 2003 7:51 PM
To: 'FDADockets@oc.fda.gov'
Subject: Comment on the "Active Query" Provisions of the Proposed Rule
on Safety Reporting

My name is Jean Masonek, and I am the Safety Clinical Research Associate at
BioMarin Pharmaceutical Inc. in Novato, CA.  I have been a Drug Safety
Associate at various biotechnology companies in the Bay Area for 5 years.

I am writing to comment on the proposal that "Active Query" be required for
gathering follow-up information on SADR reports, and that such query is
defined as "telephone or other interactive means."  It appears that
gathering information via e-mail has been specifically omitted, and I
believe that e-mail should be a valid means of "active query."

Telephone contact with initial reporters is a major hardship when the
pharmaceutical company and the initial reporter are in widely different time
zones.  As an example, I have reporters in both Austria and Australia, and I
cannot contact them by phone without substantial inconvenience to one party
or the other.  For this reason alone I believe e-mail should be a valid form
of "active query."

Also, any information obtained via telephone must be written up as a
Telephone Contact Report (TCR) for the case file.  TCRs cannot, by their
very nature, be a verbatim rendition of the information exchanged, so the
possibility for error and confusion in the transcribing of information
exists.  The dating of TCRs cannot be verified.  E-mails, on the other hand,
provide an exact record of what was said by each party, and are date and
time stamped automatically by the computer system.  Therefore the dates of
the request and reply are independently confirmed, and the information
gathered is recorded exactly for the case file.

It is certainly possible for reporters to ignore e-mail requests, but it is
equally possible for reporters to ignore voicemail messages or telephone
messages left with other staff persons at their sites (as I have experienced
on numerous occasions).  In fact, I believe that most people in a
professional setting today are more accustomed to checking and responding to
e-mails promptly than they are to checking and responding to voicemails
promptly.

I have had great success contacting reporters by e-mail, and appreciate the
accuracy of documentation that an e-mail print-out provides for the case
file.  Therefore I would respectfully request that e-mail be included as a
valid form of "active query" in the proposed rule.

Thank you.
Jean Masonek, RN
Safety CRA
BioMarin Pharmaceutical Inc.
415-506-6179
415-382-6075 (fax)