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Date Posted: 21:27:53 04/27/02 Sat
Author: Susie
Author Host/IP: bgp425870bgs.union01.nj.comcast.net / 68.36.197.75
Subject: Letter From HAAC on Pegasys Approval

LET FDA KNOW YOU WANT PEGASYS APPROVED

Dear Community members:

As we will all welcome new options in HCV treatment choice, I hope you will
consider using the following sample letter as a template to send your own
request that the FDA approve Pegasys at the earliest possible date. You are
also welcome to post it where you like for others to use.

Keep your letter to one page maximum. Adding a few sentences on how access
to this treatment could affect you personally will give your letter more
meaning and can really influence the FDA.

Please note that there are no mentions of the supply, cost, or other market
issues in this letter. As serious as those issues are, the FDA only has
jurisdiction to act on approval of a product based on its proven clinical
safety and efficacy. So it's best to stick to those issues.

The FDA contact person listed is a liaison to HCV and HIV communities. He
will pass these letters on to the review committee so they will know how
important this is for people living with HCV.

Thank you,
Brian Klein
HAAC-SF
--------------------------------------------------------------------------------------------------------------------

Richard Klein
Office of Special Health Issues
U.S. Food and Drug Administration
5600 Fishers Lane, HF-12
Rockville, MD 20857

Fax: 301-443-4555


RE: REQUEST EARLIEST POSSIBLE REVIEW AND APPROVAL OF PEGASYS AND
PEGASYS/RIBAVIRIN COMBINATION THERAPIES

Dear Mr. Klein and Members of the FDA Application Review Panel for Pegasys,

As a person living with hepatitis C (HCV), I ask FDA to give the earliest
possible review and approval to Pegasys (pegylated interferon alfa-2a)
monotherapy and to Pegasys/ribavirin combination therapy. There is great
medical need for improved treatment and individual treatment choice. Recent
clinical data show these treatments to have safety and efficacy that is some
of the strongest seen for any HCV therapy, even for harder to treat groups
such as genotype 1, high viral load patients - the majority of Americans who
have HCV.

Pegasys data also show reductions in the incidence of depression and
flu-like symptoms so common to interferon treatments. In addition to its
effectiveness, this improved side effect profile will give people like me
better quality of life on treatment and a better chance for successful
completion of treatment.

I hope you will review and approve Pegasys and Pegasys/ribavirin combination
at the earliest possible date. Thank you for your consideration in this
matter.

Sincerely,

[YOUR NAME and CONTACT INFO]

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Replies:

[> I like this as a template...maybe I'll send another! -- terry, 23:54:46 04/28/02 Sun (NoHost/66.84.232.130)


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