
 
 
HICNet Medical News Digest      Mon, 01 May 1995        Volume 08 : 
Issue 18
 
Today's Topics:
 
  [MMWR] Progress Toward Global Poliomyelitis Eradication, 1985-1994
  [MMWR] Increasing Incidence of Gonorrhea -- Minnesota, 1994
  [MMWR] Adult Blood Lead Epidemiology and Surveillance -- US 4th Qtr
  [MMWR] Notifiable Diseases/Deaths in Selected Cities Weekly 
Information
  Remarks by David A. Kessler, M.D., Commissioner of Food and Drugs at 
FDLI
 Annual Meeting (Dec. 13, 1994)
 
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----------------------------------------------------------------------
 
To: hicnews
1994
 
        Progress Toward Global Poliomyelitis Eradication, 1985-1994
        ===========================================================
        SOURCE: MMWR 44(14);273-275,281   DATE: Apr 14, 1995
 
     In 1985, the Pan American Health Organization (PAHO)
established as a goal the elimination of poliomyelitis from the
Western Hemisphere by 1990; the last confirmed case of paralytic
polio caused by wild poliovirus occurred in 1991 in Peru (1). In
1988, the World Health Assembly established the objective of global
polio eradication by the year 2000 (2). Substantial progress toward
this goal has resulted from the use of four strategies recommended
by the World Health Organization (WHO): 1) maintenance of high
vaccination coverage levels among children with at least three
doses of oral poliovirus vaccine (OPV); 2) development of sensitive
systems of epidemiologic and laboratory surveillance, including use
of the standard WHO case definition * ; 3) administration of
supplementary doses of OPV to all young children (usually those
aged less than 5 years) during National Immunization Days (NIDs) 
to rapidly interrupt poliovirus transmission; and 4) "mopping-up"
vaccination campaigns -- localized campaigns targeted at high-risk
areas where wild poliovirus transmission is most likely to persist
at low levels (3). This report summarizes progress toward global
polio eradication from 1985 through 1994 based on data submitted to
WHO as of March 20, 1995.
     Worldwide. From 1985 through 1990, routine vaccination
coverage levels increased from 47% to 85% and stabilized at 80%-81%
during 1991-1994 (|Figure_1b|). From 1985 through 1994, the number of
cases reported annually decreased 84%, from 39,361 to 6241
(|Figure_1b|). The number of countries reporting polio cases decreased
steadily, from 1985 (99 {51%} of 196) to 1988 (88 {45%} of 196) and
1994 (51 {24%} of 214) (|Figure_2b|). In addition, the number of
countries reporting zero polio cases increased from 1985 (84 {43%})
to 1988 (104 {53%}) and 1994 (145 {68%}) ***. The number of
countries with endemic polio that conducted NIDs each year
increased from 15 in 1988 to 37 as of April 14, 1995; 24 additional
countries have scheduled their first NIDs for later in 1995.
     A total of 94 countries have implemented surveillance for
acute flaccid paralysis (AFP) to detect all cases of polio that
meet the standard WHO case definition and to monitor the
circulation of wild polioviruses. WHO has certified 12 regional
reference laboratories and 60 national laboratories as members of
the Global Polio Laboratory Network and has designated six
geographic areas as emerging polio-free zones ****: the Western
Hemisphere, Western and Central Europe, North Africa, Southern and
Eastern Africa, the Middle East, and the Western Pacific.
     African Region. Polio remains endemic in most countries of
West and Central Africa. In 1994, a total of 448 cases were
provisionally reported from 20 countries, a decrease of 73% from
1993 (1636 cases) and 98% from 1988 (4564 cases); 12 countries have
not yet reported to WHO for 1994; seven countries did not report in
1993. The number of countries reporting zero polio cases increased
from eight in 1988 to 16 in 1994; most are island nations or
located in southern Africa.
     Region of the Americas. The last case of indigenous polio in
the Americas was reported from Peru in 1991. In September 1994, an
international commission convened by PAHO certified that indigenous
transmission of wild poliovirus had been interrupted in the
Americas (1).
     Eastern Mediterranean Region. From 1988 through 1994, reported
cases of polio decreased 58%, from 2342 to 973. In 1994, the 520
cases reported in Pakistan accounted for 53% of the regional total,
although the number of cases within Pakistan declined 71% from 1993
(1803 cases). Pakistan conducted its first NIDs in April and May
1994. Coordinated NIDs are scheduled to be held during March-May
1995 in seven countries (Afghanistan, Iran, Iraq, Jordan, Lebanon,
Pakistan, and Syria) and in Gaza, Jericho, and the West Bank (4).
These countries reported 669 (69%) of the 973 cases reported in the
region during 1994 (4).
     European Region. The number of reported polio cases in the
region has been stable during the 1990s: during 1994, a total of
211 cases were reported, compared with 202 cases in 1993 and 204
cases in 1988. NIDs are scheduled to be held during March-May 1995
in 10 countries (Armenia, Azerbaijan, Bulgaria, Georgia,
Kazakhstan, Kyrgyzstan, Tajikistan, Turkey, Turkmenistan, and
Uzbekistan) (4). These countries accounted for 200 (95%) of the 211
cases reported in the region during 1994.
     Southeast Asian Region. From 1988 through 1994, the number of
reported cases of polio decreased 84%, from 25,711 to 4184. The
number of cases reported in India in 1994 (3867 cases) accounted
for 93% of the regional total and 62% of the global total.
     Western Pacific Region. From 1988 through 1994, the number of
reported polio cases decreased 80%, from 2126 to 425. In 1994,
polio was reported by five of 35 countries in the region (Cambodia,
People's Republic of China, the Lao People's Democratic Republic,
Philippines, and Vietnam). The number of cases reported by China
(158 cases) was a 71% decrease from 1993 (538 cases) and a 97%
decrease from 1990 (5065 cases); WHO-recommended strategies for
polio eradication were implemented in China in 1991.
Reported by: Expanded Program on Immunization, Global Program for
Vaccines and Immunization, World Health Organization, Geneva.
International Health Program Office; Div of Viral and Rickettsial
Diseases, National Center for Infectious Diseases; Polio
Eradication Activity, National Immunization Program, CDC.
 
Editorial Note: Major achievements in the coordinated global
campaign to eradicate polio include the substantial reduction in
the global incidence of paralytic polio, the complete elimination
of polio from the Region of the Americas, and the widespread
implementation of NIDs and other WHO-recommended strategies. In
particular, the number of reported cases declined dramatically in
countries that conducted NIDs in late 1993 or the first half of
1994 (including China, Pakistan, Sudan, and Vietnam). In addition,
during March-May 1995, coordinated NIDs targeting 56 million
children aged less than 5 years will be conducted in 18 contiguous
countries in Europe, Central and South Asia, and the Middle East
(4).
     The implementation of AFP surveillance is a critical element
of WHO's eradication strategies. Eradication of disease requires a
surveillance system that can detect a single case. Polio-endemic
countries have implemented a system in which any AFP case in a
person aged less than 15 years is reported as a suspected polio
case. Two stool specimens are collected from each suspected
case-patient at an interval of 24-48 hours to determine the
presence of poliovirus; however, the standard WHO case definition
permits an AFP case to be confirmed as polio if it meets any of
four criteria, including the isolation of poliovirus from a stool
specimen. Accurate and timely surveillance information about wild
poliovirus transmission enables the targeting of supplementary
vaccination activities toward remaining known reservoirs of
poliovirus through intensive, localized vaccination campaigns
(i.e., mopping-up vaccination). AFP surveillance also is being used
to certify eradication at the national, regional, and global
levels.
     In 1994, the contiguous countries of Bangladesh, India, and
Pakistan accounted for 73% of the global total of polio cases.
Since 1988, importation of wild poliovirus from these polio-endemic
countries of Southeast Asia has accounted for many of the outbreaks
or sporadic cases of polio in previously polio-free countries of
Europe, the Middle East, and North America. Because Southeast Asia
remains a major global reservoir of polioviruses, full
implementation of the WHO-recommended polio eradication strategies
in these countries is a high priority.
     The global eradication of polio by the year 2000 will require
that all polio-endemic countries implement NIDs and other
WHO-recommended strategies by 1997. Implementation of these
strategies is especially important in the African Region, which has
the largest number of countries not reporting polio surveillance
data; the African Regional Office of WHO is assisting countries in
strengthening polio surveillance and planning for NIDs. Although
global routine vaccination coverage levels remained stable during
1990-1994, reported polio cases declined substantially, largely
because of an increase in the number of countries conducting NIDs.
     Despite substantial progress toward global eradication of
polio, several challenges remain, including 1) increasing
vaccination levels in unvaccinated subpopulations; 2) preventing
the reintroduction of wild poliovirus into polio-free areas by
eliminating reservoirs in polio-endemic countries (particularly in
the Indian subcontinent); 3) increasing the awareness of donor
agencies and governments in industrialized countries of the
substantial financial and humanitarian benefits of global
eradication of polio, thus engendering support from unaffected
countries beyond that already provided by organizations such as
Rotary International; 4) encouraging all countries that remain
polio-endemic to make polio eradication a priority activity,
including the implementation of NIDs and the initiation of AFP
surveillance; and 5) providing support to vaccination program
managers for training to develop managerial skills for implementing
and maintaining effective vaccination and surveillance programs in
all countries. The success of the polio eradication initiative will
depend on finding solutions to these financial, managerial,
political, and technical challenges.
 
References
1. CDC. Certification of poliomyelitis eradication -- the Americas,
1994. MMWR 1994;43:720-2.
2. World Health Assembly. Global eradication of poliomyelitis by
the year 2000. Geneva: World Health Organization, January 1995.
3. Hull HF, Ward NA, Milstien JB, de Quadros C. Paralytic
poliomyelitis: seasoned strategies, disappearing disease. Lancet
1994;343:1331-7.
4. CDC. Mass vaccination with oral poliovirus vaccine -- Asia and
Europe, 1995. MMWR 1995;44:234-6.
 
* A confirmed case of polio is defined as acute flaccid paralysis
(AFP) and at least one of the following: 1) laboratory-confirmed
wild poliovirus infection, 2) residual paralysis at 60 days, 3)
death, or 4) no follow-up investigation at 60 days.
 Mass campaigns over a short period (days to weeks) in which two
doses of OPV are administered to all children in the target age
group, regardless of prior vaccination history, with an interval of
4-6 weeks between doses.
* The difference between the number of countries reporting polio
cases or zero cases and the total number of countries reflects
those not submitting reports.
** Geographic areas where wild poliovirus either has disappeared
or is at such a low level that eradication could be rapidly
achieved.
 
 
------------------------------
 
To: hicnews
 
             Increasing Incidence of Gonorrhea -- Minnesota, 1994
             ====================================================
               SOURCE: MMWR 44(14);282-286   DATE: Apr 14, 1995
 
     In the United States, gonorrhea is an important cause of
urethritis in men and cervicitis in women; reproductive
complications include infertility and ectopic pregnancy. During
1981-1993, the annual incidence rate of gonorrhea in Minnesota
declined; the average annual change in the rate of infection was -
8.5% (|Figure_1c|). However, in 1994, the incidence rate increased 32%
(from 56 cases per 100,000 persons in 1993 to 74 cases per 100,000
in 1994). No corresponding increases occurred in rates of other
reportable sexually transmitted diseases (STDs), including
chlamydial infection and early syphilis. To elucidate possible
explanations for the increased rate of gonorrhea in Minnesota in
1994, the Minnesota Department of Health (MDH) analyzed
surveillance data for 1994 and compared it with data for 1993. This
report presents the findings of the analysis.
     In 1994, a total of 3346 gonorrhea cases * were reported to
MDH, compared with 2543 cases in 1993. From 1993 to 1994, the
incidence rate of gonorrhea increased at least 30% in Minneapolis
and St. Paul and in the remainder of the seven-county
Minneapolis-St. Paul metropolitan area; in rural areas of the
state, the rate increased 17% but remained low (i.e., less than 10
cases per 100,000) (|Table_1c|). Six urban zip code areas accounted
for 49% of all gonorrhea cases but represented only 5% of the
state's population.
     From 1993 to 1994, the rate of gonorrhea in Minnesota
increased 14%-44% for all racial/ethnic groups; the rate was
highest for non-Hispanic blacks (|Table_1c|). Sex-specific rates
increased approximately 30% and were similar for men and women.
Age-specific rates increased 20%-86% for all age groups except 10-
14-year-olds; rates were highest among adolescents (i.e., 15-
19-year-olds).
     From 1993 to 1994, the increase in reported cases varied by
reporting source. During this period, the number of gonorrhea cases
reported by STD clinics increased 28% (from 1120 to 1430,
respectively) and by all other sources increased 34% (from 1423 to
1916, respectively). In addition, the related increase in positive
cultures for gonorrhea varied by laboratory testing source. At the
two STD clinics in Minneapolis and St. Paul that accounted for most
(43%) cases during 1993 and 1994, all clients were tested for
gonorrhea. These clinics submitted 18,032 culture specimens to the
Minnesota Public Health Laboratory (MPHL) in 1994. Although
specimen collection, handling procedures, and volume of tests were
unchanged at the two clinics, the percentage of cultures in 1994
that were positive for Neisseria gonorrhoeae increased 24% (from
6.7% to 8.3%) and 28% (from 6.0% to 7.7%). Of the five clinics that
each submitted greater than or equal to 1500 gonorrhea cultures to
the MPHL in 1994, the proportion of positive cultures increased
substantially for only one clinic. For 16 private and
hospital-based laboratories, the proportion of all tests (i.e.,
culture and nonculture) that were positive increased from 1.7% (409
of 24,531) during the fourth quarter of 1993 to 1.9% (491 of
26,231) during the fourth quarter of 1994. From 1993 to 1994, the
proportion of gonorrhea patients who were interviewed by health
department staff (30%) to identify and treat sex partners remained
constant.
     Testing for antimicrobial resistance was performed on every
fourth N. gonorrhoeae isolate identified at the MPHL; in 1994, a
total of 433 isolates were tested. All were susceptible to
ceftriaxone and ciprofloxacin, two of the recommended therapies for
gonorrhea (1).
Reported by: EA Belongia, MD, J Besser-Wiek, J DeBoer, KL
MacDonald, MD, MT Osterholm, PhD, State Epidemiologist, Minnesota
Dept of Health; K Henry, MD, St. Paul Public Health, St. Paul; M
Simpson, MD, Hennepin County Medical Center, Minneapolis.
Epidemiology Research Br, and Surveillance and Information System
Br, Div of Sexually Transmitted Diseases and HIV Prevention,
National Center for Prevention Svcs, CDC.
 
Editorial Note: Gonorrhea is a major cause of pelvic inflammatory
disease and may play a role as a cofactor in human immunodeficiency
virus transmission (2,3). During 1975-1993, the rate of reported
gonorrhea decreased 65% in the United States, from a peak of 467.7
cases per 100,000 persons to 165.8 per 100,000 (4). Despite the
decline, gonorrhea rates in the United States remain the highest
 



among developed countries (5).
     The surveillance findings in Minnesota probably reflect a real
increase in the incidence of gonorrhea because reported cases
increased in all age and race groups without apparent change in
program activities, reporting practices, or laboratory procedures.
In addition, the proportion of positive cultures increased at the
MPHL. Rates remained highest for adolescents, non-Hispanic blacks,
and residents of urban areas. National surveillance data also
indicate high incidence in these groups (4). Adolescents and young
adults are at increased risk for gonorrhea because they are more
likely to have multiple sex partners, to have unprotected sex, and
to select partners at increased risk (6). In 1993, 81% of the total
reported cases of gonorrhea in the United States occurred among
blacks (4); although explanations for the high rates among blacks
are undetermined, race may be a marker strongly associated with
risk factors for STDs, such as low socioeconomic status, access to
health care, health-care seeking behavior, illicit drug use, and
residence in communities with high prevalences of STDs. In
Minnesota, the concentration of gonorrhea cases in some zip code
areas suggests the disease is highly focal, and intervention should
be targeted geographically.
     Preliminary national surveillance data suggest that rates of
gonorrhea may have increased in other states during 1994. Following
the implementation of national gonorrhea screening programs in
1975, the national incidence of gonorrhea had decreased every year
except two (1978 and 1985) (4). From 1990 to 1993, the national
incidence decreased an average of 14.4% annually. However, during
the first three quarters of 1994, the rate decreased only 0.9%
compared with the same period in 1993. Of the 35 states reporting
greater than or equal to 1000 gonorrhea cases annually, 18 states
(including Minnesota) reported an increase during the first three
quarters of 1994 (|Figure_2c|); only three states reported increases
in 1992 and 1993.
     The increases in reported cases in many states may reflect
stabilization or slowing of the long-term decline in gonorrhea in
the United States. Although sporadic cases of fluoroquinolone
resistance have been reported, there is no evidence of widespread
clinical resistance in the United States to currently recommended
gonorrhea therapies (7); therefore, treatment failure probably is
not a cause of the slowing decline in rates of gonorrhea.
     In response to the recent increased incidence of gonorrhea in
Minnesota, MDH is collecting standardized information from a sample
of patients with STDs to assess demographic, behavioral, and
geographic factors contributing to transmission. Other state health
departments, especially those in areas with increasing rates in
1994, should assess trends in the occurrence of gonorrhea in local
areas and communities with an emphasis on groups that have
traditionally been at highest risk for gonorrhea.
 
References
1. CDC. 1993 Sexually transmitted diseases treatment guidelines.
MMWR 1993;42(no. RR-14).
2. Laga M, Manoka A, Kivuvu M, et al. Non-ulcerative sexually
transmitted diseases as risk factors for HIV-1 transmission in
women: results from a cohort study. AIDS 1993;7:95-102.
3. Wasserheit JN. Epidemiological synergy: interrelationships
between human immunodeficiency virus infection and other sexually
transmitted diseases. Sex Transm Dis 1992; 19:61-77.
4. CDC. Sexually transmitted disease surveillance, 1993. Atlanta:
US Department of Health and Human Services, Public Health Service,
CDC, December 1994.
5. Piot P, Islam MQ. Sexually transmitted diseases in the 1990s:
global epidemiology and challenges for control. Sex Transm Dis
1994;21(suppl 2):S7-S13.
6. CDC. Premarital sexual experience among adolescent women -- United
States, 1970-1988. MMWR 1991;39:929-32.
7. CDC. Decreased susceptibility of Neisseria gonorrhoeae to
fluoroquinolones -- Ohio and Hawaii, 1992-1994. MMWR 1994;43:325-7.
 
* A written report of gonorrhea submitted by a physician and
confirmed by a positive laboratory test for Neisseria gonorrhoeae.
 
 
------------------------------
 
To: hicnews
Qtr
 
        Adult Blood Lead Epidemiology and Surveillance -- United States,
                        Fourth Quarter 1994
        ================================================================
                  SOURCE: MMWR 44(14);286-287   DATE: Apr 14, 1995
 
     CDC's National Institute for Occupational Safety and Health
(NIOSH) Adult Blood Lead Epidemiology and Surveillance (ABLES)
program monitors elevated blood lead levels (BLLs) in adults in the
United States. Blood lead data from laboratory reports are
transmitted to state-based lead surveillance programs and are
compiled by NIOSH for quarterly reporting (1).
     The total number of elevated blood lead reports for 1994
increased 4% over 1993; this increase is attributed to the
participation of two additional states (North Carolina and
Oklahoma) (|Table_1d|). The number of reports in 1994 increased 5% at
lower BLLs (25-39 ug/dL and 40-49 ug/dL) and decreased 18% at
higher BLLs (50-59 ug/dL and greater than or equal to 60 ug/dL),
compared with the number of reports in 1993.
     Since 1988, the number of states with legislation requiring
laboratories and physicians to report elevated BLLs in adults to
state health departments has increased from four to 32. As of this
report, 22 of these 32 states contribute to quarterly national
reporting; 10 others are developing their capacity to report.
Aggregation of state-specific data began in 1992 with 12 states
providing quarterly data (4).
     ABLES data have improved understanding of the magnitude of
this public health problem; identified workplace-specific clusters
of overexposures to lead; and resulted in follow-up investigations
leading to either remedial activities by employers (5),
identification of new sources of exposures (6-8), or enforcement
actions by the Oc-cupational Safety and Health Administration (9).
Reported by: JP Lofgren, MD, Alabama Dept of Public Health. C
Fowler, MS, Arizona Dept of Health Svcs. S Payne, MA, Occupational
Lead Poisoning Prevention Program, California Dept of Health Svcs.
BC Jung, MPH, Connecticut Dept of Public Health and Addiction Svcs.
M Lehnherr, Occupational Disease Registry, Div of Epidemiologic
Studies, Illinois Dept of Public Health. R Gergely, Iowa Dept of
Public Health. E Keyvan-Larijani, MD, Lead Poisoning Prevention
Program, Maryland Dept of the Environment. R Rabin, MSPH, Div of
Occupational Hygiene, Massachusetts Dept of Labor and Industries.
A Carr, MBA, Bur of Child and Family Svcs, Michigan Dept of Public
Health. L Thistle-Elliott, MEd, Div of Public Health Svcs, New
Hampshire State Dept of Health and Human Svcs. B Gerwel, MD,
Occupational Disease Prevention Project, New Jersey State Dept of
Health. R Stone, PhD, New York State Dept of Health. S Randolph,
MSN, North Carolina Dept of Environment, Health, and Natural
Resources. E Rhoades, MD, Oklahoma State Dept of Health. M Barnett,
MS, State Health Div, Oregon Dept of Human Resources. J Gostin, MS,
Occupational Health Program, Div of Environmental Health,
Pennsylvania Dept of Health. R Marino, MD, Div of Health Hazard
Evaluations, South Carolina Dept of Health and Environmental
Control. D Perrotta, PhD, Bur of Epidemiology, Texas Dept of
Health. D Beaudoin, MD, Bur of Epidemiology, Utah Dept of Health.
L Toof, Div of Epidemiology and Health Promotion, Vermont Dept of
Health. J Kaufman, MD, Washington State Dept of Labor and
Industries. V Ingram-Stewart, MPH, Wisconsin Dept of Health and
Social Svcs. Div of Surveillance, Hazard Evaluations, and Field
Studies, National Institute for Occupational Safety and Health,
CDC.
 
References
1. CDC. Surveillance of elevated blood lead levels among adults --
United States, 1992. MMWR 1992;41:285-8.
2. CDC. Adult blood lead epidemiology and surveillance -- United
States, fourth quarter, 1993. MMWR 1994;43:246-7.
3. CDC. Adult blood lead epidemiology and surveillance -- United
States, 1992-1994. MMWR 1994;43:483-5.
4. CDC. Elevated blood lead levels in adults -- United States, second
quarter, 1992. MMWR 1992;41:715-6.
5. CDC. Control of excessive lead exposure in radiator repair
workers. MMWR 1991;40:139-41.
6. CDC. Lead intoxication associated with chewing plastic wire
coating -- Ohio. MMWR 1993; 42:465-7.
7. CDC. Lead poisoning among sandblasting workers -- Galveston,
Texas, March 1994. MMWR 1995;44:44-5.
8. CDC. Controlling lead toxicity in bridge workers -- Connecticut,
1991-1994. MMWR 1995;44: 76-9.
9. CDC. Lead poisoning among battery reclamation workers -- Alabama,
1991. MMWR 1992; 41:301-4.
 
 
 
------------------------------
 
To: hicnews
Information
 
        Notifiable Diseases/Deaths in Selected Cities Weekly Information
        ================================================================
               SOURCE: MMWR 44(14);276-280   DATE: Apr 14, 1995
 
(|Figure_Ie|)  Notifiable Disease Reports, Comparison of 4-week Totals
              Ending April 8, 1995, with Historical Data -- United 
States
(|Table_Ie|)   Summary -- Cases of Selected Notifiable Diseases,
              United States,
              for the Weeks Ending April 8, 1995 and April 9, 1994
(|Table_IIe|)  Notifiable Diseases of Low Frequency,
              Cumulatives for the Year 1995
(|Table_IIIe|) Cases of Selected Notifiable Diseases,
              United States, by Reporting Area,
              for the Weeks Ending April 8, 1995 and April 9, 1994
(|Table_IVe|)  Deaths in 121 U.S. Cities,
              Week Ending April 8, 1995  (14th Week)
 
 
 
------------------------------
 
To: hicnews
Drugs at
 FDLI Annual Meeting (Dec. 13, 1994)
0100000@conciliator.acsu.buffalo.edu>
 
Remarks by David A. Kessler, M.D., Commissioner of Food and Drugs
 
FDLI Annual Meeting
Washington, D.C.
December 13, 1994
 
 
NOTE: THIS TEXT IS THE BASIS FOR COMMISSIONER KESSLER'S
ORAL REMARKS.  IT SHOULD BE READ WITH THE UNDERSTANDING THAT
SOME MATERIAL MAY HAVE BEEN ADDED OR OMITTED DURING THE
PRESENTATION.
 
Editor's note:  To preserve the flow of the speech, text indicators of
slides used during the presentation were saved (ie:  Slide 1).
 
     Good morning.
 
        I'm here today to focus on the workings of FDA. I'm going to 
focus on
things that I believe are vital to the Agency's future but which, for 
the most
part, often haven't received widespread visibility.
        I am going to give you a lot of details, show you a lot of 
numbers,
a lot of slides. At the risk of being a little long,  I hope the 
information I
convey this morning leads to a better understanding of this vitally 
important
Agency.
        Five FDLI speeches ago I stood before you and set forth my 
initial
agenda for the Food and Drug Administration.  On that cold December 
morning, I
acknowledged that my first priority was the most difficult to discuss. 
It was
difficult because I knew then, as I know now, that the commitment of FDA
employees to their Agency is unmatched anywhere.
        My first priority upon arriving at the FDA in December 1990 was 
to
rebuild the Agency's credibility after the generic drug scandal. This is 
what
I said:  "The most important thing we can do to rebuild the credibility
of the Agency is to ensure the integrity of its processes."
        Today I want to take a moment to tell you something about the
integrity
of this Agency and its employees.
        Over the past two years, six FDA field staff have been offered 
bribes
for special treatment. The products involved ranged from spices and 
seafood to
surgical instruments and foodstuffs.  Six attempted bribes.  Six 
different FDA
field employees.  One attempt on the West coast, five on the East coast.
        In every case, the FDA people did what our bribery awareness 
training
had taught them:  They reported the criminal activity to the appropriate
authorities and cooperated with the Inspector General's Office.
        In subsequent meetings with those who offered the bribes, each
employee
pretended to accept the bribe.  As a result, I can tell you today that 
seven
arrests have been made.  Three of those arrested have pleaded guilty, 
the
other
four cases are still pending.
        The exemplary performance of these six employees speaks for 
itself.
Make no mistake, these individuals, who put their own safety at risk, 
are
heroes in the eyes of this Agency.
 
        Let me move on to the focus of my remarks today: some of the 
work we
have done over the last year, and some of what we plan to do in 1995. 
And I
need to underscore that I am going to be talking about only some, not 
all.
        A good place to begin is the Prescription Drug User Fee Act of  
1992
--
what has come to be known as PDUFA.  As many of you know, the Act
authorizes the Agency to use fees collected from the pharmaceutical 
industry
to
expedite review of applications for new drugs and biologics.  There has 
been a
tremendous push at FDA to get this program up and running.  Today I want 
to
show you some of the progress we have seen so far.
        Perhaps the most important early goal of PDUFA is elimination of 
the
user-fee defined backlog. (slide 1)
        The Agency committed to clearing a backlog of 696 overdue drug 
and
biologic submissions by July 2, 1995 -- about six and a half months from
today.
As of November 30, 1994, only 9 of those 696 remain.  We are way ahead 
of
schedule.  We will meet this goal.
        When it comes to new applications for NDAs, PLAs and ELAs, or
applications for manufacturing supplements, the performance goals are 
set for
twelve months or six months respectively after the submissions are 
received
and
filed by FDA.  As a result, we cannot yet accurately measure our review
performance for applications received in fiscal year 1994.
        However, we now have performance figures for new applications 
and
manufacturing supplements filed in fiscal year 1993. (slide 2)
        A second PDUFA goal is to have 55% of NDAs, PLAs, and ELAs
received in fiscal year 1994 reviewed in 12 months. We won't be able to
analyze
how we've done on the FY 94 cohort until 12 months after the last 
application
is submitted -- probably Fall 1995. So the FY 1994 cohort is still work 
in
progress.
        But as you can see on this slide, if you look at the 
applications that
came in during fiscal year 1993, we exceeded our 55% goal set for the 
fiscal
year 1994 cohort with the 1993 cohort.  So that, too, is good news. This 
slide
also shows the improvement in on-time actions over 1990-91 when no user 
fee
program was in place. (Slide 3)
        As the next graph shows, our performance in reviewing the 1,252
manufacturing supplements received in fiscal year '93 also represents
substantial improvement over previous years.  Our goal for manufacturing
supplements that is set for applications received during fiscal year 
1994 is
to have 55% reviewed within six months. Final analysis is going to have
to wait until six months after the last supplement in that cohort is
submitted.
        Yet I can announce today, that as of November 30, 1994, -- two 
weeks
ago -- we already reached the 55% goal for the fiscal year 1994 cohort. 
The
final percentage of supplements completed within six months in the 1994 
cohort
can only be higher, and in all likelihood will be somewhere between 55 
and
70%.
(Slide 4)
        The final PDUFA graph illustrates another important achievement:
substantial improvement in approval times.  In the FY '93 cohort, 20 
NDAs and
PLAs were approved within 14 months compared to only 12 in the years 
preceding
PDUFA.  Six of these faster approvals followed the second review cycle, 
and
the
sponsor turnaround time between review cycles averaged less than 60 
days.  FDA
review time on these second cycles averaged less than three months.
        This confirms a basic assumption of the user fee program; 
cutting
review times means quicker approval times for approvable applications.
        These improvements in the drug approval process are very 
important and
very heartening and I am enormously proud of the FDA staff who have 
worked so
hard to make them happen.  Safe and effective products are getting to 
market
sooner.  But a lot of hard work remains to fully realize the goals of 
the
program. We aren't fooling ourselves.  We aren't resting on our laurels. 
It
will take an enormous, sustained effort to reach performance levels 
mandated
in
upcoming fiscal years.
 
        I want to move on to medical devices where an efficient review 
process
is also a high priority. And today I want to show you some significant
progress
in the area of medical devices, too.
 
(Slide 5)  This slide shows that we have reduced the backlog of 510(k)
applications by 75% percent from its peak of 2,000 just one year ago.  
We are
also concentrating our resources on 510(k) devices requiring the most
intensive
review.  (Slide 6)
        Last week -- on December 7 -- we published a final rule 
exempting an
additional 148 generic types of class I "low risk" devices from 510(k)
premarket notification requirements. This makes a total of 441 or 65% of 
all
class I devices that are now exempt from review. We expect this to 
decrease
the number of 510(k) applications by about 600 a year.
        In the coming year, we plan to propose additional low-risk 
products
for
exemption. This enables industry to market devices more quickly and FDA 
to use
its resources more efficiently. With the reduction of our 510(k) 
backlog, we
are now intensifying our efforts to improve review times on PMAs.
        We have also been successful in cutting our time to process
certificates for exports and export permits, as these next slides show.
 
(slide 7)  In calendar year 1993 the average time required for a permit 
to
export unapproved devices was 65 days. In 1994, it was only 16 days.
 
(Slide 8)  We have made similar gains with export certificates for 
approved
products -- a drop from an average of 52 days in 1993 to only 10 days in 
1994.
        And most importantly, the improvements that you've seen in 
drugs,
biologics and medical devices have been accomplished without lowering 
the high
standards that the American people have come to expect.
 
        This is welcome news, but I would be remiss if I didn't also add 
a
note
of caution.  The progress I have shown you results from management
improvements
and shifts in resources.  However, these internal improvements can take 
us
only
so far. The number of applications and their complexity continue to 
increase
at
a phenomenal rate, pushing our resources beyond their limits.  To 
achieve the
kind of expedient, effective review process that all of us want, I 
continue to
believe that we need a user fee program for medical devices.
        Another very important initiative out of the Center for Devices 
and
Radiological Health is, of course, implementation of the Mammography 
Quality
Standards Act -- MQSA.   This is one very important part of the Agency's
commitment to improving women's health.
        High quality mammography can save lives from breast cancer.  But 
high
quality mammography is technically demanding. Two years ago Congress 
passed
the MQSA to ensure that every mammogram in this country is of the 
highest
quality. We have been working very hard over the past year to make that 
a
reality.
 
(Slide 9)  We met our October 1 deadline, announcing on that day that 
more
 



 
95% of the approximately 10,000 mammography facilities have been 
certified.
Today, I can report that about 99% of the facilities have been 
certified. Some
have full accreditation and others have been provisionally certified, 
meaning
their staff and equipment meet quality standards and they have six 
months to
meet other requirements.
        Mammography, I want to add, is a user fee program.
 
        Another important area where we have taken steps may be less 
familiar
to many of you. It concerns the regulation of imported products.
 
(Slide 10)  The volume of imports into this country has been growing
exponentially.  Currently, FDA-regulated products account for one out of 
every
three products offered for entry into this country--a robust 3 million 
entries
a year and growing.  We simply cannot cope effectively with this kind of
volume
without an automated system, and that is what FDA, together with the 
U.S.
Customs Office and the import industry, have been putting in place over 
the
past two years.
        We now have 55 ports of entry on this automated system, 
accounting for
80% of the FDA-regulated products coming into the country.  By the end 
of next
year, every port will be on the system.
        This system has transformed turnaround time from days to
minutes...days
to minutes.  At the same time, the system enables us to do a better job 
of
screening for volatile products --  we are seeing higher detention rates 
in
participating ports -- and it also generates data that help us analyze
long-term trends.
 
        On the international front, I also want to note the 
accomplishments
over the course of the past year on international harmonization of drug
regulations and development of international standards for devices, 
foods, and
veterinary medicine products.
        FDA has been a very active participant in the International 
Conference
on Harmonization (ICH), the International Organization for 
Standardization,
Codex Alimentarius Commission, and other efforts that are helping to 
create a
unity and order where once a cacophony of differing standards and 
requirements
was the order of the day.
        These cooperative ventures will mean that manufacturers do not 
have to
comply with a host of different and sometimes incompatible standards and
regulations depending on where on the map they want to market their 
products.
In an increasing number of areas, we are all reading off the same page.
 
(Slide 11)  In 1994 in the drug area, for example, FDA published four 
final
ICH
guidelines covering reproductive toxicity, stability testing, geriatric
testing
and dose response studies.
 
(Slide 12)  We will be publishing another seven guidelines developed in 
1994
in
early 1995.
        In the device area, international standards were developed 
covering
biocompatibility of implants, ethylene oxide and moist heat 
sterilization, and
heart valves to name but a few.
 
        I've spent the last few minutes reviewing some of our activities 
over
the past year.  Let me now turn to the present and two announcements.
        First, I want to announce a new policy on pediatric drug 
labeling. I
have had a strong personal interest in this initiative because, as a
pediatrician, I know just what a difference it can make in the medical 
care of
children.
        When I first came to the FDA I began to ask why it is that drug 
labels
have so little to say about the proper use of drugs in children.  The 
fact is,
drug companies usually don't test drugs for safety and efficacy in 
pediatric
populations. They collect data on adults. Pediatricians are left to
extrapolate,
guess a little, prescribe based on experience, what is in the pediatric
literature, or what is known about the drug's effects in adults.
        But children are not just miniature adults.  You can't simply
calculate
the pediatric dose based on the dose that is safe and effective in 
adults.
Relying only on information about adults is simply not good enough.
        I'm pleased to announce that today we are publishing in the 
Federal
Register a final rule to make it easier for drug companies to include
information about pediatric use in the labeling.
 
(Slide 13)  This slide shows the various ways a company should now 
convey
information -- or a lack of information -- about pediatric use.  Notice
especially the second one here. If the course of a disease is similar in
adults
and children, and the sponsor provides supporting pediatric information, 
such
as pharmacokinetic or safety studies, FDA now will consider approving 
the
product for pediatric use.
        Let me repeat: If the disease behaves the same in adults and 
children,
adequate and well-controlled trials to show efficacy may not need to be
repeated in children. All that may be necessary under the new rule is
information on the appropriate dose and perhaps additional safety 
information
for children.  We hope this provides an incentive for manufacturers to 
submit
pediatric information to us.
 
(Slide 14)  This rule is part of a broader FDA initiative to focus 
sponsors
and
FDA on obtaining more information on pediatric data throughout the drug
development period and in labeling.
        One personal note: Much of the credit for this rule goes to a 
number
of
folks within FDA.  But credit also goes to a brave and courageous woman 
who
died earlier this month -- Elizabeth Glaser, the co-founder of the 
Pediatric
AIDS Foundation. Several years ago, she and I met and discussed the need 
for
more information about the proper use of drugs in children.  During that
conversation, I promised her that we would move forward.  This rule is 
only a
first step.  We have launched discussions with members of the 
pharmaceutical
industry, as well as the pediatric community on next steps.
 
(Slide 15)  The new food label is here. It is on literally billions of 
food
packages across this country.  The food industry has done a remarkable 
job.
        It is enormously satisfying to see those new food labels and we 
are
gratified by the overwhelmingly positive response to them from consumers 
and
health professionals.  A recent survey of dietitians, for example, found 
that
almost 70 percent of their clients and nearly two-thirds of the 
dietitians
changed what food they buy as a direct result of the new label.
        The second announcement that I would like to make today has to 
do with
compliance with the new food labeling requirements.  Since last August, 
FDA
inspectors have been in food stores and in factories. And today I want 
to
share
with you what we have found.
 
(Slide 16)  We have examined more than 5,000 products.  Less than 1% did 
not
have the new label when they should have had it.  We have had to issue 
only 28
warning letters for failure to display the new label.  Scoring better 
than 99%
is an A+ in any grading system.
 
(Slide 17)  Today I am also releasing the results of a survey of 300 
food
products off store shelves.  The Agency received the final report last 
week,
and the news here is also good.  Ninety four percent of the analyses 
done on
fat content found the numbers on the label indeed accurately reflected 
what
was
in the package.  For calories, it was 93%.  Overall, 87 percent of the
analyses
done on a dozen nutrients found the numbers on the label were accurate.  
These
results show that consumers can trust what it says on the new food 
label.
        In addition to labels consumers can trust, we also want to make 
sure
they are easy to read.
 
(Slide 18)  This is what the new food label should look like on the vast
majority of food products. We have been meeting cooperatively with 
companies
to make sure that it does.
 
        Next, I want to move on to the future and the Agency's plans and
priorities for the next year.
        The starting point for any talk about the future has to be the
announcement just a few days ago of FDA's future home.  The Montgomery
County site selected is Clarksburg.
 
(Slide 19)  If all goes as planned, by the year 2003 the Centers for 
drugs,
biologics, medical devices and radiological health as well as the office 
of
regulatory affairs and office of the commissioner will be together at 
the
Clarksburg site.  This site was chosen by a panel of five experts -- 
three
from
GSA and two from FDA -- who worked for nine months exploring every 
aspect of
the three sites that were under consideration.
        The panel weighed the suitability of each site according to a
carefully
defined point system, considered the results of a detailed environmental
impact
study, and discussed each potential choice in public meetings with the
residents who would be affected by the construction.
        Some have questioned why GSA has proposed that we move out so 
far.
While many factors came into play, there are not many parcels of land in
Montgomery County that can accommodate 350 buildable acres. This site 
stood
out because the land is continguous and it is the only one of the sites 
where
FDA's buildings would not have to be needlessly broken up by existing or
proposed roads.  This site will allow us to be housed so that we can 
encourage
cross-center collaboration in a way that none of the others would.
        The process of choosing a new site was independent and rigorous, 
and
confidentiality about the selection was maintained until the end.  I 
received
word of the choice in an official phone call Friday morning at 8 a.m., 
just
before the public announcement. I want to express my personal thanks and 
the
gratitude of the Agency for the truly outstanding work of those involved 
in
making this decision.
        The new consolidated site is still several years away. Our 
immediate
focus needs to be on our program priorities for the coming year.
 
        Let me set out the top program priorities for 1995, center by 
center.
One caveat: The list is not meant to be all-inclusive. These are 
programmatic
priorities.  In a moment, I will some back to some more specific policy
initiatives for the coming year.
 
(Slide 20)  Our Center for Veterinary Medicine will be instituting 
changes to
strengthen its product approval system--making it more flexible and 
decreasing
the time and cost required without sacrificing standards of safety, 
efficacy,
and quality. It will also be removing from the market unapproved animal 
health
products that compete with FDA-approved products.  A third priority for 
CVM is
to improve the safety of animal-derived foods through increased 
enforcement.
 
(Slide 21)  HACCP -- the Hazard Analysis Critical Control Points program-
-will
be a top priority for CFSAN next year.  So will implementation of the 
dietary
supplement regulations. You will also see management improvements in 
1995,
consistent with the National Performance Review and recommendations of 
the
Food Advisory Committee.
 
(Slide 22)  CDER has listed four priorities: meet or exceed PDUFA goals, 
make
progress in information technology initiatives, implement Good Review 
Practice
Initiatives, and continue the Agency's efforts on international 
harmonization
of drug regulations.
 
        Let me say a few words about what to expect in the area of
international harmonization in 1995.  I mentioned earlier that we will 
be
publishing seven additional ICH guidelines.  In addition, work will 
continue
on
another 14 documents that are at various stages of drafting. Many of 
these
will
be completed by the ICH III meeting in Japan in November 1995.  
Additional
topics will also be launched in 1995, on biotechnology, clinical trials,
medical terminology, and electronic standards for the transfer of 
regulatory
information.
        In 1995 we will also be reaching more Mutual Recognition 
Agreements
with other countries to ensure that their standards for safety are 
equivalent
to ours, with the promise of both freer trade for American food and drug
manufacturers and safer products for American consumers.
 
(Slide 23)  CBER is working with CDER on the same list of priorities.  
CBER
also is looking to implement tissue regulations and establish a gene 
therapy
registry.
 
(Slide 24)  Our Center for Devices will continue to improve the review 
and
approval process.  One priority is to be able to approve most IDE's by 
30
days.
CDRH will also exempt and down classify products where 510(k)s don't add
significant consumer protection.  It will implement the mammography 
standards
under MQSA, as I mentioned earlier, and also move forward on design 
controls
as
the cornerstone of good manufacturing practices.
 
(Slide 25)  The National Center for Toxicological Research provides a 
critical
scientific base for our efforts and in the coming year it will be 
focusing on
scientific issues that bear on food safety and drug toxicity.  NCTR 
plans to
develop better analytical methods to identify microbial and chemical
contamination of foods and other products, expand knowledge on the
relationship
between dietary modulation and susceptibility and expression of 
chemical/drug-
induced toxicity, and continue to develop new test models to improve our
ability to predict and identify toxicity.
 
        Those are some, and I underline the word "some," of our program
priorities for 1995.  Let me next set out some of the policies that we 
expect
to be working on in the upcoming year.
 
(Slide 26)  Perhaps our most important initiative in foods is applying 
the
Hazard Analysis Critical Control Points to food safety.  Our final HACCP
regulations for seafood will be out early next year, and we'll be 
working
closely with the food industry on extending HACCP, as appropriate, to 
other
commodities.  HACCP not only gives American consumers greater assurance 
of
food
safety; adoption of HACCP as the standard for assuring quality will also 
help
American food producers market their products overseas.
        We will continue to fine-tune our food labeling initiative in 
1995.
We
particularly want to address concerns we've heard about how the 
regulations
might inhibit the use of valid health claims on foods.
        And, of course, Congress has made changes in the way we regulate
dietary supplements.  We'll be preparing the regulations to implement 
that new
legislation as well, I hope in a way that improves a relationship that 
has
often been too adversarial.  Related rulemaking--to protect children 
from
toxic
doses of iron-containing supplements--has received widespread support in 
its
proposal form, from the industry and the public, and will be finalized 
next
year.
        We're continuing to promulgate the many medical device 
regulations
required by Congress in recent years.  One of the most difficult, user
facility
reporting of adverse events, is almost ready, and a proposal on the new
requirements for mammography facilities and practices will be announced 
in the
Spring.
        In the drug and biologics areas, we are working with 
pharmaceutical,
pharmacy and consumer groups on how to get drug information to patients.
        We averted a problem last year when we uncovered attempts to 
import
into this country potentially infectious tissue for transplantation.  
The
regulations we published then will be followed this year with a more 
thorough
proposal on human tissue handling, processing, and storage.
        And finally, this year Congress made a needed change in the law
governing animal drugs by giving veterinarians greater authority to use 
such
drugs outside their labeled indications.  We'll be doing the 
implementing
regulations during 1995.
        As you can tell, there will be no shortage of activity.  We have 
a
very
full plate.
        The Prescription Drug User Fee Program has made it possible for 
us to
do our job better.  But for the most part in the coming year we are 
going to
have to do our job in an environment of limited resources.
        Budget constraints are very real. We have to find ways to do 
more with
less.  One way we are trying to make that possible is by streamlining 
and
automating our administrative and support functions throughout the 
Agency.  A
very important focus over the past year and in the upcoming year will be 
on
developing appropriate information systems for the Agency.
 
(Slide 27)  The most ambitious undertaking is the development of what we 
call
the SMART information system, which will in a standardized way allow us 
to
receive and review applications for new drugs and biologics.  This 
system will
allow us to support and better manage the entire review process.  Four 
modules
of this SMART system will be piloted in the upcoming year.
        A full plate. A limited budget. But in the end what gives me
confidence
about the future is the leadership we have in place at this Agency.
        Today, I am pleased to announce a new appointment: Sharon Smith
Holston as our new Deputy Commissioner for External Affairs.  Sharon has
served this Agency for 22 years, most recently as Associate Commissioner 
for
Management.  Her knowledge of FDA is invaluable.  She brings to her task 
an
outstanding record as a manager.  Sharon has earned the respect and 
admiration
of her colleagues and we all welcome her to this new position. In a 
moment,
she
will say a few words to you.
        I can also report today that we have selected a new Deputy
Commissioner
for Policy.  I expect to be able to announce that appointment soon.  
These two
deputy commissioners join a leadership team that I depend on in 
everything I
do.
 
        Make no mistake: We have in place at FDA a new generation of 
Center
Directors.  Over the last several years, there has been new leadership 
for
Biologics, Devices, Veterinary Medicine, NCTR and Drugs.  The real 
future of
this Agency lies less in any particular policy, less in any particular 
system
than it does in these Center Directors.  For in the end, they are the 
ones who
make the decisions.  They are the ones with the final say in their 
areas.
They
are this Agency's future. They are smart, tough, creative and committed
leaders
who know who to get things done.
        Three new Center Directors have been appointed since I last 
spoke
here,
one year ago.  It is important that you get a sense of them and of our 
new
Deputy Commissioner for Policy first hand and so I have asked each of 
them to
make a few brief comments.
        Ms. Holston will begin, followed by Dr. Bernard Schwetz, 
Director of
the National Center for Toxicological Research and Associate 
Commissioner for
Science, Dr. Steve Sundloff, the Director of the Center for Veterinary
Medicine,
and Dr. Janet Woodcock, Director of the Center for Drug Evaluation and
Research.
 
------------------------------
 
End of HICNet Medical News Digest V08 Issue #18
*********************************************
 
 
---
Editor, HICNet Medical Newsletter
Internet: david@stat.com                 FAX: +1 (602) 451-6135
 

