News Along the Pike
August 31,
2004
Volume 10, Issue 3
Center for Drug Evaluation and Research
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By Jackie Barber Washington
At the Center’s Spring Honor Awards Ceremony, 56 individuals and
73 teams were recognized. Ten individuals and four teams from CDER
were recognized at the Agency-level ceremony. FDA’s 2004 scientific
achievement awards were presented to two individuals and one team
with CDER scientists at the annual Science Forum.
“In the three years that I have been at CDER, I have had the
opportunity to work with many of our employees, and I continue to be
impressed by their abilities,” said Acting Center Director Steven
Galson, M.D. “I am extremely proud to be associated with an
organization of such dedicated and highly competent professionals.”
Kevin Barber sang the national anthem, and the PHS Wind Ensemble
played the “PHS March.” The awards were announced by Eileen M.
Cole, who heads the Program Management Services Branch in the
Division of Management Services in the Office of Management. Dr.
Galson and members of the Center’s senior management presented the
awards.
Follow the links below to read the awards:
Jackie Barber Washington is the Center’s
incentive awards officer.
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By Patrick E. Clarke
CDER is involved in 41 partnerships to develop and disseminate
messages about the safe and wise use of medicines. Fifteen of the
agreements are with state pharmacists’ professional associations to
spread our message about the risks of buying medicines outside FDA’s
regulatory scope.
Some of the partnerships involve the co-development of messages
with other HHS agencies and independent, non-profit health and
consumer organizations. Other partnerships involve “co-branding” of
our messages with retail pharmacy chains, health care organizations,
insurers and health information providers. In co-branding, another
organization republishes our materials with their logo alongside
FDA’s logo.
“Tens of millions of Americans have been exposed to our public
health messages,” said Ellen Shapiro, director of the
Division of Public Affairs in the Office of Training and
Communications. “More importantly, our partnerships help ensure the
messages in our public health campaigns reach the right audience at
the right time. While our division coordinates the partnerships, our
Center’s experts in the Office of New Drugs and the Office of
Generic Drugs are key players in developing timely and relevant
messages.”
Some recent campaigns in which we partnered to develop the
messages and materials include:
Aging. The Council on Family
Health (now defunct) and the Administration on Aging. DPA
coordinator:
Ayse Hisim.
As You Age. The Substance Abuse and Mental
Health Services Administration and the Administration on Aging.
DPA coordinator: Ayse Hisim.
Antibiotics and Antibiotic Resistance. The
Centers for Disease Control and Prevention. DPA coordinator:
Sherunda Lister.
Over-the-Counter Pain Relievers. The National
Consumer’s League and the National Council on Patient Education
and Information. DPA coordinator: Mandy Eisemann.
Examples of campaigns that involve the “co-branding,” or the
authorized use of FDA’s logo with an other organization’s logo,
include:
Partners
included pharmacy benefit companies and major pharmacy chains. DPA
coordinator: Ayse Hisim.
Looks Can Be Deceiving
, which outlines the
risks of purchasing medicines outside of FDA’s regulatory scope.
Partnered with 13 state pharmacists’ associations and resulted in
distribution of 10 million pieces of information. DPA coordinator:
Cindi Fitzpatrick.
Some of the important placements for our public service
announcements include television, radio, national and specialty
publications, posters, pamphlets and even information attached to
prescription bags at retail pharmacies.
A leading provider of consumer medication information distributed
with prescriptions dispensed at 20,000 U.S. pharmacies frequently
includes our health promotion messages. “Our messages have been
included on information sheets stapled to nearly 180 million
prescription bags in the last two years,” Fitzpatrick said.
“From August through December of last year, our antibiotic
resistance television public service announcements were broadcast
more than 4,000 times in 108 markets,” Lister said.
“If we had to pay for that amount of coverage, it would have cost
more than $345,000.” Radio public service announcement was played
during that same time period in 213 cities at an estimated value of
more than $1.1 million.
Eisemann has coordinated the placement of several public service
announcements in national magazines. “The West Coast edition of one
national publication carried one of the OTC public service
announcements reaching a possible audience of almost 3 million
people,” Eisemann said. And 152 grassroots newspapers with a
projected readership of 7.3 million picked up a news release
explaining the campaign.
“We’re also working with the New York State Health Department on
a plan for them to use posters of one of the announcements in all
4,000 of their pharmacies and hundreds of hospital pharmacies,”
Eisemann said.
The Looks Can Be Deceiving campaign uses posters,
prescription bag inserts, fliers and tabletop displays to remind
pharmacy customers in straightforward language that imported drugs
pose a safety risk.
A major pharmacy benefit company, which represents more than 40
million Americans, has been using educational materials from the
Generic Drug Quality Awareness campaign. After using the items, the
company reported that generic drug use reached an all-time high.
Hisim also has a roster of pharmacy chains that use the generic
campaign material. “They often have monthly or bi-monthly
newsletters, and they’ll put an ad or article relating to our
message in them,” Hisim said. “We put out a good health message, and
they see additional value in associating with FDA.”
All CDER campaigns and co-sponsored campaigns are available on
the Center’s Web site at
http://www.fda.gov/cder/consumerinfo/DPAdefault.htm. At
the top of the page, there is a link to subscribe to a service that
will send you an e-mail when our campaigns are updated. The e-mail
address for more information about partnering is
dpapubs@cder.fda.gov.
Our educational materials are in the public domain and can be
used as they are by anyone. However, to co-brand or co-develop
items, organizations need a signed a co-sponsorship agreement.
“The agreement spells out that the product is in the public
domain and can be shared with interested organizations and
individuals,” Eisemann said. “The FDA Ethics Office reviews initial
agreements, which are usually good for two years.”
To foster partnerships, employees in the Division of Public
Affairs “take their show on the road.”
They set up and staff a display booth of educational materials at
different organizations’ annual meetings or conventions and make new
contacts who are interested in using some of the material or forging
a partnership.
The division also exhibits at medical professional events ranging
from the Association of Clinical Research Professionals to the
American Society of Consultant Pharmacists.
The division’s staff also attend some consumer meetings such as
those of the AARP or the National Urban League.
Shapiro, who recently received an FDA Leveraging/Collaboration
Award, is always looking for new partners and innovative ways to
disseminate CDER’s messages about the safe and wise use of
medicines.
“We don’t have a big promotional budget, so we have to find
creative ways to get these important messages out. Forming
partnerships is key to our success,” she said.
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FDA on Aug. 11 announced the approval of two intravenous
chelators for treating exposure to certain kinds of radiation
contamination.
The approvals of pentetate calcium trisodium injection (Ca-DTPA)
and pentetate zinc trisodium injection (Zn-DTPA) are part of our
ongoing effort to provide the American public the best available
protection against nuclear accidents and terrorist threats.
The FDA had previously determined that Ca-DTPA and Zn-DTPA would
be safe and effective for treating internal contamination with
plutonium, americium or curium when produced under conditions
specified in approved marketing applications. The drugs increase the
rate of elimination of these radioactive isotopes from the body.
“The approval of these two drugs is another example of FDA’s
readiness and commitment to protecting Americans against all
terrorist threats,” said Acting FDA Commissioner Lester M.
Crawford, DVM, Ph.D.
The two drugs have been used for several decades as
investigational drugs to treat patients in radiation contamination
emergencies.
In order to encourage manufacturers to submit new drug
applications for these products, we announced in September 2003
specific conditions and findings under which the two drugs could be
approved through new drug applications. Until these approvals, there
had been no approved drug products for the treatment of internal
contamination with plutonium, americium or curium.
Internal contamination with plutonium, americium or curium can
occur through a variety of routes including ingestion, inhalation or
direct contact through wounds.
The goal of treatment with the intravenous chelators is to
enhance the removal of these radioactive contaminants and,
therefore, reduce the risk of possible future biological effects
including the development of certain cancers, which may occur years
after exposure.
Release of plutonium, americium and curium could occur from
laboratory or industrial accidents; or through terrorist attacks
using a radiation dispersal device, commonly known as a “dirty
bomb.”
The chelators Ca-DTPA and Zn-DTPA should not be administered
simultaneously. If both products are available, Ca-DTPA should be
given as the first dose.
If additional treatment is needed, treatment should be switched
to Zn-DTPA. This treatment sequence is recommended because Ca-DTPA
is more effective than Zn-DTPA during the first 24 hours after
internal contamination. After the initial 24 hours, Zn-DTPA and Ca-DTPA
are similarly effective. Ca-DTPA and Zn-DTPA are usually
administered into the blood stream; however, in people whose
contamination is only by inhalation, Ca-DTPA or Zn-DTPA can be
administered by nebulized inhalation.
The main side effect of Ca-DTPA is the loss of certain essential
nutritional metals such as zinc, which can be replaced by taking
oral zinc supplements. Although Zn-DTPA may also decrease the levels
of certain nutritional metals, the effect is less than with Ca-DTPA.
More information about FDA’s efforts to
counteract bioterrorism is available on FDA’s website at
http://www.fda.gov/oc/opacom/hottopics/bioterrorism.html.
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By Robert King
The exciting new Critical Path Initiative and the ongoing
cGMPs for the 21st Century Initiative, which will reach its
second anniversary in September, were the major focus of
presentations and discussions at the July 20-21 meeting of the newly
formed Manufacturing Subcommittee of the Advisory Committee for
Pharmaceutical Science.
“In some ways I look at all these initiatives as a desire to
define a desired state, which is more efficient and which is more
effective in meeting the needs of the customer, that is, a patient,”
Ajaz Hussain, Ph.D., deputy director of the Office of
Pharmaceutical Science, told the subcommittee in his opening
remarks.
Topic areas for the meeting were:
-
Quality by design. Updates on International
Conference on Harmonization topics Q-8 on pharmaceutical
development, Q-9 on risk management for good manufacturing
practices and a proposed Q-10 on life cycle management for process
and system control.
-
ASTM E-55 Committee: Pharmaceutical
Applications of process analytical technologies (PAT). The
non-profit ASTM provides a global forum for the development and
publication of voluntary consensus standards for materials,
products, systems, and services.
-
Introduction to Bayesian approaches. These are
statistics that incorporate prior knowledge and accumulated
experience into probability calculations.
-
Research and training needs: The
industrialization dimension of the Critical Path Initiative
(July Pike).
-
Moving towards the “desired state”:
Manufacturing science and quality by design as a basis for
risk-based review of chemistry, manufacturing and controls (CMC).
-
Update on pharmaceutical industry practices
research study.
-
Pilot model for prioritizing selection of
manufacturing sites for cGMP inspection.
-
cGMPs for the production of Phase I
investigational new drugs.
-
Applying manufacturing science and knowledge:
Regulatory horizons-current steps relative to PAT, comparability
protocols and changes without prior approval.
On the first day of the meeting, discussions focused on the
evolving CMC review paradigm within the Office of New Drug Chemistry
and the Office of Generic Drugs. Each office provided its own
perspective. The meeting started with a lively debate on defining
the amount of production development data to be submitted with an
application that would assist the Agency in understanding the
manufacturing process. The members agreed that process
understanding, as additional pharmaceutical development information
becomes available, would lead to greater regulatory flexibility.
The subcommittee discussed establishing a working group to assist
in defining the level of developmental data to be submitted with
applications and to determine what incentives might be appropriate.
After an OGD presentation, the subcommittee expressed an interest in
seeing approval times shortened, while maintaining the quality of
review, which will benefit both the public health and the industry.
Both presentations discussed “gaps” in the knowledge of
manufacturing processes. The subcommittee suggested that another
working group could be formed to assist in developing an educational
program for both Agency and industry staff to strengthen their
knowledge of process understanding.
On the second day, the Office of Compliance presented its first
public rollout of a pilot model being developed to prioritize the
selection of manufacturing facilities for cGMP inspection. David
Horowitz, the office director, said that we wanted to “look at
determining whether FDA resources are being used most effectively
and efficiently to address the most significant public health
risks.” He also said that “in order to provide the most effective
public health protection, we should match the level of effort
against the magnitude of the risk.”
Discussion was centered on:
-
The suggestion to distinguish between different
risks associated with the products and the processing lines.
-
The suggestion to use a decision tree to
prioritize sites.
-
The recommendation that the distribution of
sites selected by the model should represent a balance between
generic and innovator sites and between biotech and conventional
manufacturing sites.
-
The concern that a high volume of production
should not be given too much weight as a criterion to prioritize
sites for inspection.
-
A suggestion that there should be a
“volume-risk index” that would fully take into account factors
that mitigate risks, some of which may be associated with
high-volume production.
-
The historical inconsistency among investigator
findings that might limit the use of such findings in prioritizing
sites for inspection. These inconsistencies should become less
problematic over time as the new Pharmaceutical Inspectorate
program is implemented.
-
Ensuring that the proposed model for selecting
cGMP inspection sites would promote the correct incentives to
encourage robust quality systems, continued availability of
medically important drugs and continuous improvement.
Full information on the meeting, including copies of the
presentations, is available at
http://www.fda.gov/ohrms/dockets/ac/cder04.html#PharmScience.
The subcommittee is part of FDA’s strong advisory committee
system which complements the Agency’s scientific expertise. This
system brings the latest research together with patient and
caregiver concerns, and industry and consumer advocacy viewpoints
for discussion, recommendation, and input to strategic planning
activities and decision-making processes.
Subcommittee members are: Judy Boehlert, Ph.D., (chair), Patrick
DeLuca, Ph.D. (also a member of ACPS), Daniel Gold, Ph.D., Kenneth
Morris, Ph.D., Thomas Layloff, Jr., Ph.D. [not in attendance],
Garnet Peck, Ph.D., Joseph Phillips, G.K. Raju, Ph.D., Nozer
Singpurwalla, Ph.D. (also a member of ACPS). Also in attendance as
non-voting industry members were Gerry Migliaccio, Ph.D., and Paul
Fackler, Ph.D.
Robert King is a special assistant for science in
OPS.
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The steering committee for International Conference on
Harmonization and its expert working groups met in Tysons Corner in
June.
The committee continued a discussion initiated in Osaka, Japan,
in November, on how to manage the ICH process in the future. It
focused on how to:
-
Streamline and optimize working practices.
-
Better monitor the implementation of existing
guidelines.
-
Better evaluate proposed new topics.
-
Improve transparency and communication.
The ICH Global Cooperation Group held its first meeting with
participants from six non-ICH regional harmonization initiatives:
the Asia-Pacific Economic Cooperation, the Association of Southeast
Asian Nations, the Gulf Cooperation Council, the Pan American
Network for Drug Regulatory Harmonization and the Southern African
Development Community.
Janet Woodcock, M.D., FDA’s acting deputy
commissioner for operations, updated the committee on the status
activities related to a risk-based approach to drug product quality
and good manufacturing practices for pharmaceutical products.
Collaboration and interaction with the ICH
process to harmonize product quality globally is one of FDA’s key
priorities, Dr. Woodcock said.
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By Dana Schuhly and Chris Benton
Starting Aug. 22, employees and visitors to CDER offices at
Corporate Boulevard will be required to display a CDER parking hang
tag in their vehicles from 9:30 a.m. to 3:30 p.m. on weekdays.
Between Aug. 22 and Sept. 22, warnings will be distributed. After
that, all vehicles without a hang tag risk being towed.
If you are visiting Corporate for a meeting,
conference or IT training, the person scheduling the meeting or
training will e-mail you a temporary hang tag good for the period of
your visit.
There is no designated visitor parking at Corporate II.
Government vehicles do not require a hang tag to park at the
building. We recommend that visitors to Corporate II use a
government vehicle whenever possible. Also, motorcycles do not need
a hang tag, but we ask that you provide us your license number.
Also, you will be able to borrow a Corporate II
parking hang tag from designated individuals in each of CDER’s
buildings.
Please contact us for any assistance.
Dana Schuhly and Chris Benton are coordinating
the parking hang tag program.
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By Ron Wilson
CDER now has a new Web page on laws and regulations governing
the import and export of human drugs and biologics.
The Web page was created for small pharmaceutical business so
there would be one place for clear and comprehensive information on
imports and exports. It is available by clicking on the Small
Business link at the bottom right of the Center’s home page or
directly at
http://www.fda.gov/cder/about/smallbiz/importExportInfo.htm.
Steven Silverman, Margaret O’Rourke and Ada Irizzary
in the Office of Compliance helped Small Business Assistance in the
creation of the Web page. In addition to information on imports and
exports, there are many links to various offices and people within
the Agency that can provide additional information.
Many will probably be surprised to learn that there are 19 import
program managers in the regional and field offices of FDA who are
available to provide assistance. The name of each is listed in the
Web page along with his or her location and phone number.
Links are also provided to several other federal agencies
involved in imports and exports, such as the Department of
Agriculture, the Drug Enforcement Administration, the U.S. Export
Assistance Centers and the Bureau of Customs and Border Protection.
Import and export issues can be challenging as they sometimes
involve coordination with more than one Federal agency.
Ron Wilson runs the Center’s Small Business
Assistance Program.
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By Tony Chite, P.D.
Match the numbered term with the lettered definition. One letter
does not have a number to match.
|
1. Parenchyma |
a. pain resulting from a non-noxious stimulus to
normal skin |
|
2. Lithotripsy |
b. designates the functional elements of an organ
as distinguished from its framework |
|
3. Dystocia |
c. having borne one or more viable offspring |
|
4. Nulliparous |
d. crushing of a calculus within the urinary
system or gallbladder, followed at once by the washing out of
fragments |
|
5. Phocomelia |
e. hyperpigmentation over cheeks and forehead,
also called the “mask of pregnancy” |
|
6. Melasma |
f. absence of the proximal portion of a limb |
|
7. Parous |
g. having never given birth to a viable infant |
|
8. Allodynia |
h. abnormal or difficult labor |
|
|
i. pertaining to the zygomatic bone |
Key: 1b; 2d; 3h; 4g; 5f; 6e; 7c; 8a
Tony Chite is a pharmacist and CSO with the
Division of Information Disclosure Policy.
Return to Index
Stephan Ortiz, R.Ph., Ph.D., has an invitation for you. He’s
the new publicity chair for the Parklawn Toastmasters Club that
meets every Tuesday from noon to 1 p.m. in Room 10-40.
“If you’re interested in improving your public speaking skills,
both prepared and extemporaneous, or just wish to learn more about
Toastmasters, come on by,” Stephan says.
Toastmasters International, founded in 1924, promotes itself as
the leading movement devoted to making effective oral communication
a worldwide reality. With over 8,000 self-help clubs, Toastmasters
International helps men and women learn the arts of speaking,
listening and thinking-vital skills that promote self-actualization,
enhance leadership potential, foster human understanding and
contribute to the betterment of mankind, Stephan notes.
“A Toastmasters charter club has existed in the Parklawn Building
since 1970,” Stephan says. “The mission of the Parklawn Toastmasters
Club is to provide a supportive and positive learning environment in
which every member has the opportunity to develop communication and
leadership skills, which in turn foster self-confidence and personal
growth.”
By the way, whatever skill I have in public speaking I owe to
Toastmasters, which a mentor early in my Army career recommended to
me. If, like me, you’re a product of the 20th century educational
system, you may be surprised to learn most colleges and universities
up until the late 19th century and early part of the last century
deemed competence in rhetoric and public speaking a requirement for
graduation. A pale remnant of that old system remains, at many
institutions, in oral exams for advanced degrees.
Toastmasters International’s success and growth is largely due to
the continued development of its educational programs that fill a
need unmet by the specialization of modern higher education. The
organization has come a long way since its first speech manual,
Basic Training, was developed more than 50 years ago. The
current manual, now called Communication and Leadership Program,
was most recently updated in 2003. After club members complete
all 10 speech projects in the manual, they may apply for a Competent
Toastmaster award and then choose from any combination of 15
advanced manuals.
Stephan, a reviewer in the Office of Clinical Pharmacology and
Biopharmaceutics, says he’ll be happy to answer any questions you
have about the program if you send him an e-mail. Better yet, stop
by Room 10-40 any Tuesday at noon. The club is having a pizza party
on Sept. 14 and a Speech-a-Thon in October.
Associate Editor Patrick Clarke notes that the Botanical
Review Team, which he reported on in last year’s spring issue of the
Pike, now has an external Web site.
The team developed the site as another tool to help accomplish
their mission of facilitating botanical drug development and the
review of new drug investigations under INDs and later as NDAs. The
Web site includes:
-
Descriptions of who the team members are and
what the team does.
-
A section with answers to the most frequently
asked botanical questions.
-
A link to the guidance for industry on
botanical drug products.
-
Other information useful to industry, consumers
and FDA staff.
The automatic email contact provided will ensure that all
botanical questions are answered promptly. According to Pat, the
Botanicals Team unanimously stated: “We are all very excited that we
are able to provide this additional service to our internal and
external constituents.”
The site can be found at:
http://www.fda.gov/cder/Offices/ODE_V_BRT/default.htm.
Return to Index
The Pike is published electronically approximately
monthly on the World Wide Web at:
http://www.fda.gov/cder/pike.htm.
Photocopies are available in the Medical Library (Parklawn Room
11B-40) and its branches (Corporate Boulevard Room S-121 and
Woodmont II Room 3001).
Views and opinions expressed are those of the authors and do not
necessarily reflect official FDA or CDER policies. All material in
the Pike is in the public domain and may be freely copied or
printed.
Pam Fagelson
Elaine Frost
Mary Jane Mathews
Edward Miracco
Melissa Moncavage
Ellen Shapiro
Ted Sherwood
Tony Sims
Nancy Smith
Wendy Stanfield
Marcia Trenter
Jennifer Wagner
Diane Walker
Grant Williams
Pamela Winbourne
Have ideas, news or comments to contribute? Please
contact a member
of the Editorial Board or:
News Along the Pike
CDER Office of Training and Communications (HFD-210)
Parklawn Building, Room 12B-31
Editor:
Norman "Joe" Oliver
(OLIVERN)
Associate Editors: Patrick Clarke, Sherunda Lister
Phone: (301) 827-1695
Fax: (301) 827-3055
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Date created: August 31, 2004
