Major FDA Public Meeting on Early Access, Accelerated Approval, September 12-13

A two-day public meeting of the FDA Antiviral Advisory
Committee is shaping up as one of the important AIDS policy
and community meetings of the year. It is important to let
the FDA and the pharmaceutical industry know that the AIDS
community insists on early access to new treatments, and
strongly supports accelerated approval. The meeting location
is not set as we go to press, but it will be in the
Washington D.C. area.

The following is from a fax we received from the FDA on
August 17; we have edited it slightly for clarity:

"The meeting is the 12th and 13th of September. Since there
are going to be three other meetings within a month on
surrogate markers, we are going to focus more on early access
and accelerated approval at the two-day meeting. It will also
be different in format, with much more time for public
comment, and several times scheduled for comments. There will
be a fax mailing announcing details soon through the AIDS
coordination office.

"In brief, the meeting will start with a history of making
drugs available early for life-threatening conditions, in
particular looking at the oncology experience. We will review
parallel track and treatment INDs as they have been used in
HIV drugs. There will be a point on the agenda here for
comments on access issues, standards for widespread use, and
the effects of widespread use on clinical trials and drug
approval. Hopefully both the community and industry will
share their perspectives. I think since d4T was approved that
this is the first time in many years that there hasn't been
an active parallel track or treatment-IND program in effect.

"Second, the meeting will look at the historical examples of
the use of accelerated approval: ddI (accelerated approval in
practice, although not in name), ddC/AZT, clarithromycin for
MAC treatment, and d4T. We will look at the evidence
available at the time of approvals, the pace of confirmatory
trials, what we have learned from each of these examples.

"Third, we will look for specific proposals to improve the
process of early access and accelerated approval. This would
be a time, for example, when TAG or anyone else who would
like to present the LST [large simple trial], or any other
proposal, could put it on the table. There have also been
some suggestions about bringing accelerated approval drug
candidates to the Advisory Committee early in their
development to get consensus on a reasonable portfolio of
trials, and proposals to strengthen the confirmatory trial
requirement process. I am sure there are others.

"The Advisory Committee will not be asked to formally vote on
any specific issue. The emphasis instead will be on open and
wide-ranging comments on how to best use these tools in the
future (including dealing with products still under
accelerated approval). We will try to develop a document with
points for a sponsor to consider when developing a drug that
is a candidate for early access.

"Anyone wishing to speak for longer than 5-10 minutes should
send us a request, including the topic, so we can arrange an
agenda. There will be time for comments not scheduled, but
they will need to be brief. Requests to speak can be sent
through Lee Zwanziger, FDA, CDER, HFD-9, 5600 Fishers Lane,
room 8B-45, Rockville, MD 20857."

Note: Persons who want to send a written statement to the
Antiviral Advisory Committee should also send it to Lee
Zwanziger at the above address. She is the executive
secretary of the Committee.

Note: The three other meetings on surrogate markers [such as
HIV RNA tests], mentioned above, include:

(1) "Surrogate Markers of HIV: Strategies and Issues for
Selection and Use," October 12-14, at the Sheraton National
Hotel in Alexandria, Virginia. The organizer is Cambridge
Healthtech Institute, Waltham, Massachusetts, 617/487-7989,
or fax 617/487-7937. The press is invited.

(2) "FDA Accelerated Approval: Dealing with Uncertainty,"
Friday, September 23, at the American Academy of Arts and
Sciences, near Harvard Square in Cambridge, Massachusetts.
This meeting is sponsored by the Tufts Center for the Study
of Drug Development, ML Strategies, Inc., Project Inform, and
Gay Men's Health Crisis. The organizer is ML Strategies,
Inc., Boston, Massachusetts, 617/542-6000. We could not reach
the person in charge before going to press.

We could not find out about the third meeting by press time.