JIM@AUVM.AUVM.EDU (Jim McIntosh) (06/21/89)
P89-26 Food and Drug Administration
For Immediate Release Brad Stone (301) 443-3285
June 5, 1989 (Home) (703) 440-6042
The Food and Drug Administration, which requires blood banks
to test for AIDS and hepatitis, today proposed that these blood
establishments and affiliated testing laboratories participate in
FDA-approved proficiency testing programs to ensure testing
accuracy.
While most blood establishments already participate in such
a proficiency testing program, FDA's proposed regulation is
designed to make sure participation is universal and standard.
FDA, which licenses and inspects blood establishments, has
required that they test for the presence of AIDS antibody and
hepatitis B surface antigen in all donated blood. Consequently,
the risk of AIDS and hepatitis B contamination in the blood
supply has been greatly diminished.
The new rule is designated to build upon this success by
requiring blood establishments and laboratories that conduct the
testing for blood establishments to demonstrate their proficiency
through FDA-approved evaluation programs.
In proficiency testing programs, sets of samples that have
been pre-tested are sent for retesting. The results from this
retesting are compared by the proficiency testing program center
to the original results to detect any discrepancies in the
participating blood bank's or laboratory's results.
Under today's proposal, the proficiency testing programs
would be performed in accordance with standards established in a
recent Health Care Financing Administration proposal for ensuring
the proficiency of clinical laboratories.
The proposed FDA regulation complements the HCFA regulation
by extending proficiency testing standards to blood
establishments and laboratories that might be exempt from HCFA's
authority. Both regulations are part of an HHS effort to improve
the overall performance of the nation's testing laboratories.
In the event of such a failure, FDA would work closely with
the blood establishment or laboratory to improve the quality of
its performance. If the blood establishment or laboratory is
unable to meet an adequate level of proficiency, the agency would
take regulatory action.
The proposal will be published in the June 6 Federal
Register. Comments may be sent for 30 days to the FDA Dockets
Management Branch (HFA-305), Room 4-62, 5600 Fishers Lane,
Rockville, MD 20857.JIM@AUVM.AUVM.EDU (Jim McIntosh) (06/21/89)
Current Releases
Thursday June 15, 1989
Approval of Aerosolized Pentamidine
P89-29 Food and Drug Administration
FOR IMMEDIATE RELEASE Brad Stone -- (301) 443-3285
June 15, 1989 (Home) -- (703) 892-0468
HHS Secretary Louis W. Sullivan, M.D., today announced Food
and Drug Administration approval of aerosolized pentamidine -- a
drug inhaled into the lungs to help prevent a form of pneumonia
that frequently threatens the lives of AIDS patients.
Although many patients have already been receiving
aerosolized pentamidine treatments through a special pre-approval
distribution program, a large number of these patients have not
been able to get medical insurance reimbursement for it. But
today's approval, Dr. Sullivan said, will make the drug
affordable to more patients since it is likely most private
insurance providers will now pay for an approved drug.
"Today's approval will help many of those infected with the
AIDS virus avoid one of the most deadly opportunistic infections
associated with AIDS," said Secretary Sullivan. "It may help an
estimated 100,000 or more individuals who are at risk of
developing first or subsequent episodes of Pneumocystis carinii
pneumonia and will, therefore, significantly improve the quality
of their lives."
Dr. Sullivan noted that the cost of using aerosolized
pentamidine to prevent Pneumocystis carinii pneumonia would
probably represent only a fraction of the cost of treating
patients who have developed this pneumonia, "but, most important,
it should improve the quality of life for those at highest risk
from this infection." The FDA, which approved the product, is a
part of the U.S. Public Health Service and Dr. Sullivan's
department.
Today's action coincides with the Public Health Service's
publication of guidelines for prophylaxis against Pneumocystis
carinii pneumonia in persons infected with the AIDS virus. The
guidelines, which appear in the June 16, 1989 issue of the
Centers for Disease Control's Morbidity and Mortality Weekly
Report, are the recommendations from a panel composed of medical
experts from the Public Health Service and leading medical
centers. The use of aerosolized pentamidine to help prevent
Pneumocystis carinii pneumonia is prominently recommended in the
guidelines.
Aerosolized pentamidine will be labeled for use in patients
who have had at least one episode of the pneumonia or who have
greatly diminished immunity, as indicated by CD4 helper
lymphocyte cell counts of 200 or less. CD4 helper cells are white
blood cells that are critical components of the body's immune
system and which are destroyed by the AIDS virus. Healthy
individuals normally have CD4 helper cell counts of about 1,000
or more.
FDA Commissioner Frank E. Young, M.D., Ph.D., said his
agency's approval was based largely upon clinical data from a
community-based study conducted by the San Francisco Community
Consortium. "The approval of this vital drug heralds a new era
of close cooperation among FDA, industry and those community
physicians who are on the front line of dealing with this
terrible disease," Dr. Young said.
This is the first new drug approval emanating from a clinical
trial sponsored jointly by a community research initiative and a
pharmaceutical company. The trial, conducted by the San
Francisco Community Consortium, a group of physicians with
experience treating people infected with the AIDS virus, compared
three dosages of the drug to determine which dose would be most
effective. In this study, headed by Bruce Montgomery, M.D.,
David W. Feigel, M.D., M.P.H., and Gifford Leoung, M.D.,
individuals infected with the AIDS virus who were at high risk of
developing the pneumonia had a lower incidence of infection when
treated with this drug administered via the Respirgard II
nebulizer at a 300 milligram dose every four weeks than similar
patients treated with lower doses.
In November 1988, LyphoMed Inc. of Rosemont, Ill., which
partially underwrote the San Francisco Community Consortium
study, filed the new drug application that was approved today.
Clinical data from this study continued to be collected through
December 1988, and its final results were submitted to FDA in
April 1989. In May 1989, FDA's Anti-Infective Drugs Advisory
Committee unanimously recommended that FDA approve the drug. The
company will market the approved drug under the trade name
NebuPent.
The Respirgard II nebulizer, the filtered system specified in
the drug's approved labeling, is manufactured by the Marquest
Corp. of Engelwood, Colo. and is available through home health
care retailers and hospital pharmacies.
Since February 1989, aerosolized pentamidine has been made
widely available to patients under the agency's "treatment IND"
regulations -- a plan for the use of an investigational new drug
(IND) in selected patients facing serious or life-threatening
conditions. Despite this status, many eligible patients were
unable to receive reimbursement for the costs of this therapy
from private or government health insurance providers. Although
some companies have provided reimbursement, others were reluctant
to pay until the drug was fully approved.
Injectable pentamidine, as distinct from aerosolized
pentamidine, was approved in 1984 for the treatment of those
already suffering from Pneumocystis carinii pneumonia.
Aerosolized pentamidine can provoke severe wheezing and
coughing at the time of administration, as well as other adverse
reactions. The long-term risks associated with its use are
unknown.