This is a multi-part message in MIME format.
--------------97D2BF76B4E4E4D30EC19467
Content-Type: text/plain; charset=us-ascii
Content-Transfer-Encoding: 7bit
--
The following is an e-mail letter I received from Hank Malinowski of the
FDA regarding Pramipexole. It certainly makes a difference whether the
NDA was filed in Jan 1996 or 1997. The time is certainly not inordinate
if the application was filed Jan 1997 but there is a problem if it was
Jan 1996 unless there was a major disagreement between the manufacturer
and the FDA in which case I would support the FDA's efforts as doing
their job. I think it is important for us to understand the process and
advocate for eliminating unnecessary waiting time- especially for
significant additions to the drug armamentarium. At the same time as a
physician I have seen a number of initially promising medications that
were pulled from the shelves because of safety or efficacy questions or
were promising in the initial research and rightfully kept off the
market when a major safety question emerged.
The FDA is a double edged sword. It can and often does inordinately slow
valuable drugs from getting to market- but it also can protect us from
the well-meaning drug companies who have inadequate data as well as the
unethical companies who try to sneak questionable drugs onto the
market. AS much as I hate the delays and bureaucracy of the FDA I trust
them infinitely more than a lot of the drug companies whose corporate
ethics rival those of Philip Morris and RJR Nabisco and to whom the
bottom line is more important than our welfare.
I thank Dr. Malinowski for his time in responding. Becoming educated
about the process will help us become informed consumers and keep (make)
the FDA responsive to our needs.
If anyone knows authoritatively the date of the filing of the NDA please
let me (and Dr. Malinowski) know.
Charlie
**********************************************************
CHARLES T. MEYER, M.D.
MADISON, WISCONSIN
[log in to unmask]
**********************************************************
--------------97D2BF76B4E4E4D30EC19467
Content-Type: message/rfc822
Content-Transfer-Encoding: 7bit
Content-Disposition: inline
Received: from DONALD.CDER.FDA.GOV ([150.148.27.213])
by mail.tds.net (8.8.5/8.8.5) with ESMTP id GAA13889
for <[log in to unmask]>; Wed, 14 May 1997 06:40:24 -0500 (CDT)
Received: from mr.cder.fda.gov by fdaserv.cder.fda.gov (PMDF V5.0-8 #9595)
id <[log in to unmask]> for [log in to unmask]; Wed,
14 May 1997 07:37:58 -0400 (EDT)
Received: with PMDF-MR; Wed, 14 May 1997 07:33:34 -0400 (EDT)
MR-Received: by mta DONALD; Relayed; Wed, 14 May 1997 07:33:34 -0400
Alternate-recipient: prohibited
Date: Wed, 14 May 1997 07:33:36 -0400 (EDT)
From: Henry Malinowski 301-594-2567 FAX 301-480-3212 <[log in to unmask]>
Subject: Re: Pramipexole
To: "Charles T. Meyer" <[log in to unmask]>
Message-id: <E49IVM1MT49*/R=A1/R=DONALD/U=MALINOWSKI/@MHS>
MIME-version: 1.0
Content-type: TEXT/PLAIN; CHARSET=US-ASCII
Content-transfer-encoding: 7BIT
Posting-date: Wed, 14 May 1997 07:33:37 -0400 (EDT)
Importance: normal
Priority: normal
Sensitivity: Company-Confidential
UA-content-id: E49IVM1MT49
X400-MTS-identifier: [;43337041507991/1689019@FDACD]
A1-type: MAIL
Hop-count: 1
>Dear Dr. Malinowski,
>
>Again, thank you for your prompt reply regarding my question about the
release of pramipexole. I had chosen not to ask you any further
questions since you had been more than courteous and I felt that you had
more important things to do than to answer my e-mail.
>
>However a question came up which I do need to bounce off you. I was
reviewing information on Pramipexole on the clinical pharmacology
section of Physicians on Line and it appears that the pramipexole NDA
was submitted Jan 1996. That puts action on the application ant well
over your 12 month goal. What is going on? Also what occurs during the
6-12 + months. I recognize that data can not be reviewed and acted on
instantaneously but what happens in that year that adds knowledge about
a drugs safety and/or efficacy. Again thank you for your time.
Dr. Meyer,
I've seen a date of Jan 1997, not 1996. I don't know the
details, but sometimes, in discussions with the sponsor, major
amendments need to be submitted and reviewed and this can add to the
allowed review time. Please be aware that we have more NDAs to review
then review teams, so reviews are scheduled in sequence. All reviews
can't be started on the day that the NDA is accepted. During the 6-12
months, a review Team will evaluate various aspects of the submission,
including clinical safety and efficacy, clinical pharmacology and
biopharmaceutics (I'm involved here), animal pharmacology, and
chemistry. Labelling is also reviewed. Issues arising during these
reviews are discussed with the sponsor during this time period. A
decision is made as to the need for an Advisory Committee. Final
processing occurs within the reviewing Office. Then, a decision is made
for the NDA. Every drug in submitted NDAs is thought to be safe and
effective by the sponsor. Our role is to be sure that this is correct.
Not every drug involved in submitted NDAs is determined to be safe and
effective. This is the important knowledge that is added by our review
process. I hope that this information is useful...Hank Malinowski
--------------97D2BF76B4E4E4D30EC19467--
