America Living With AIDS

A M E R I C A Living With AIDS

Some of you
at, in the world:h and approval,
ie so quickly as
)S; I will tell you
neighborhoods
ry people have
often so young
's so ugly as
sis, of MAI, or of
ieuropathy...
day our daily
I forgive me,s sound bitter.
ace in my mind
LIDS-related
i describe to you,
es several faces,
face of a friend
Sor dead....:ess by which we
rove therapies
atingly slow,
quick relief from
kness and death
wcade now has
ommunity and
our culture
bly poorer.

quickly enough to
approve drugs for use in
treating HIV disease.
Much of this criticism has
come from people with
HIV disease. However,
there has long been criticism of FDA for the length
of the drug approval process by proponents of
deregulation who consider the drug lag to be evidence of excessive red
tape. In fact, recently the
National Committee to
Review Current Procedures for Approval of New
Drugs for Cancer and
AIDS (referred to as the
"Lasagna Committee"
after its Chairman Louis
Lasagna, M.D.) reviewed
FDA activities. In its
August 1990 report, the
Committee called for less
stringent criteria of effectiveness and recommended that FDA "be more
flexible and permit the use
of treatment earlier in the
[regulatory] process
where alternative therapies are unavailable."
There is a great deal of
debate over how much
and what kind of data
must be required before

has been hampered by a lack of
trained scientists, as well as by insufficient facilities and equipment needed
to review quickly the data submitted
by clinical researchers. Clearly, FDA
needs funds and personnel commensurate with its important mission to
safeguard the public health, and in the
context of HIV disease, to speed up
the pace of drug approval. The Commission strongly urges the Congress
and the Administration to review
FDA's budget and provide the funding
increases needed to meet the demands
placed on the agency.
EXPANDED ACCESS STRATEGIES
From the beginning of the modern era
of drug development regulation in the
early 1960s, there have been provisions for distributing potentially lifesaving drugs, not yet licensed for use,
to seriously ill individuals. Since that
time, it has been possible for physicians to gain access to drugs under
study through investigational new
drug (IND) applications ("compassionate use" INDs or investigator
INDs). The rules governing such
access were never completely codified;
the result was an informal process that
relied heavily on the ingenuity and
energy of individual physicians.
In 1987 the IND regulations for
drug trials in serious illnesses were

FDA will approve a drug for marketing; but not all of the roadblocks to
getting drugs to the marketplace
involve philosophical or scientific disagreements with FDA. FDA has been
grossly underfunded and as a result

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