New Drug Approvals in 1992

NEW DRUG APPROVALS

Presented by the Pharmaceutical Manufacturers Association
January 1993

merica's pharmaceutical
research companies in 1992
on approval from the Food
and Drug Administration for 26 new
drugs, the second highest number
approved in the past decade. The most
approvals occurred in 1991 and 1985,
when 30 new drugs were cleared by FDA.
These new medicines represent significant advances in several therapeutic
categories. Many are for serious and
life-threatening diseases, including 4
new medicines for heart diseases, 2 for
cancers, and 4 for AIDS and AIDSrelated conditions. Other important
approvals were a drug for enlarged
prostate, an arthritis medication and an
asthma treatment. Also available are
4 neuropsychiatric drugs: a new treatment for migraine headaches, an antidepressant, a sleep aid and a diagnostic
for central nervous system disorders.
Two drugs were approved for use in
surgery-an anesthetic and a skeletal
muscle relaxant. Another 5 medicines
were approved for infectious diseases.
In addition, a treatment for skin damage
due to long-term exposure to the sun
and an oral contraceptive were cleared.
More details on these new drugs begin
on page 2 of this report.
Additional approvals included 6
important biologics-4 therapeutics and
2 vaccines. This is an increase of 1 over
FDA's 1991 biologics approvals, when
3 therapeutics and 2 vaccines were
cleared. Three of the 6 new biologics
are biotechnology medicines and are
developed using genetic engineering.
Two of the 3 approved biotechnology
medicines are for cancer. The other is
for hemophilia. More information on
the new biologics is provided on page 5
of this report.
Statistics from FDA show that other
important approvals include 53 efficacy
1992 NEW DRUG APPROVAL TIMES
Months Drugs Approved
Under 6 1
6-12 4
13-18 5
19-24 4
2 5 or more 12

Mean Approval Times for New Drugs, 1983-1992
Mean approval
time (months)
48

39.1

34.1

36
24
12
0

3234 31.3 32.5 30.3
28.5 277 3.3 29.9

"""2I'M1 232

11111 ENNUi.

m

4 Total number
of new drugs
_ approved in
each year
SNote:
A six-month
review time
is the statutory
standard

I I flUE1E1f1RE

m

1983 1984 1985

1986 1987 1988
Year

1989 1990 1991 1992

Source: U.S. Food and Drug Administration

supplements, 36 of which are for new
uses for already approved medicines.
Another 942 manufacturing supplements
were approved. Manufacturing supplements are for changes in manufacturing
specifications, methods or plant sites
of a marketed drug. More information
on efficacy and manufacturing supplements is given on page 7.
FDA required an average of 29.9
months to review the new drugs
approved in 1992, slightly less than the
30.3 months required in 1991. FDA's
continuing efforts to reduce the backlog
of long-pending new drug applications
is contributing significantly to the length
of the average approval time. Among
the long-pending applications approved
by FDA in 1992 were: a drug for
arthritis that took 122 months; an
asthma medication, 70 months; a
therapy for arrhythmia, 52 months;
and a treatment for angina and hypertension, 55 months.
The table titled "1992 New Drug
Approval Times" gives a breakdown of
the number of new drugs approved
within 12, 18 and 24 months, as well
as those that took more than 2 years.
Among those approved in under 12
months were drugs for AIDS, cancer
and malaria.

New user fee legislation is expected
to make prescription medicines available
sooner. The estimated $327 million in
user fees that pharmaceutical companies will pay FDA over the next 5
years will be used for improvements to
the new drug approval process. With
these additional resources, FDA says
that, over the next five years, it can
reduce review times for drugs for lifethreatening and serious diseases to an
average of six months and all other
new drugs to 12 months. The Senate
and House leadership, FDA and the
PMA worked cooperatively on the user
fee program. This legislation is discussed
further in an article on page 9.
The PMA annual year-end survey
results show that America's pharmaceutical research companies will invest
a record $12.6 billion to discover and
develop new medicines in 1993. Their
investment in 1992 was estimated at
$11.1 billion, more than double the $5.5
billion invested by the pharmaceutical
industry 5 years before that in 1987.
Gerald J. Mossinghoff
President
Pharmaceutical Manufacturers Association