News
Along the Pike
October 2, 2003
Volume 9,
Issue 4
Center for Drug Evaluation and Research
Index
Return to Index
Center has big role in 5-part
strategic action plan: Plan builds on CDER efforts to
protect, advance public health
The FDA document, Protecting and Advancing America’s
Health: A Strategic Action Plan for the 21st Century,
establishes a framework for achieving five broad priority
goals.
“The strategic plan is very ambitious but very familiar
because it builds on what we in CDER were doing,” said Steve
Galson, M.D., the Center’s deputy director. During the
annual State of the Center address held Sept. 10, Dr. Galson
outlined how the Center’s strategic direction for 2004 is
based on the Agency plan’s five components:
- Efficient, science-based risk management.
- Patient and consumer safety.
- Better informed consumers.
- Counterterrorism.
- A strong FDA.
Efficient, science-based risk management
We have long led the world in applying the principles of
risk management-assessing public health risks, analyzing
methods for reducing them and taking appropriate action.
With the expanding complexity of the Agency’s medical
challenges and the need to reduce the health risks facing
the public at the lowest cost to society, efficient risk
management is more important than ever.
The Agency’s approach to efficient risk management
requires the use of the most current biomedical,
statistical, managerial, and economic science. The plan aims
to achieve quicker access to safe and effective new products
and reduce public health risks without unnecessary costs by:
- Employing principles and technologies that can reduce
avoidable delays and costs in product approvals.
- Overhauling and updating the way medical products are
manufactured.
- Implementing an enforcement strategy that combines
clear communications to industry backed up by effective
civil and criminal enforcement.
Patient and consumer safety
Too many American’s suffer from preventable adverse
events related to medical products resulting in human
suffering and avoidable medical costs.
Consequently, we are enhancing our post-market
monitoring, communication and regulatory activities. In
addition, one of the most promising new ways the FDA can
improve its system for reporting safety problems is to have
direct and secure access to relevant modern electronic
health information.
By supplementing the current passive reporting systems
and partnering with healthcare providers and other
government agencies, we will develop more innovative and
effective information on the risks associated with
FDA-regulated products.
We will help speed the implementation of safer systems
for medical care through steps such as:
- Bar coding medications in hospitals.
- Implementing 21st-century methods for communicating
with health professionals to reduce adverse events.
Better informed consumers
Informed consumers represent our nation’s greatest
public health asset, because the choices that people make
every day can have a great impact on their own health and
the health of the nation.
We are undertaking major new efforts to ensure consumers
have the most up-to-date, truthful information on the
benefits and risks of FDA regulated products. In this arena,
we fulfill two complementary roles:
- Ensuring the information that sponsors provide about
products is accurate and allows for their safe use.
- Communicating directly with the public concerning
benefits and risks of products we regulate.
The strategic plan calls for the Agency to learn more
about how to communicate with consumers more effectively
about risks and benefits.
The goal is a well-informed public, empowered to make
better choices to improve their health.
Counterterrorism
We are working harder and more creatively than ever to
speed the availability of the next generation of safer, more
effective countermeasures to protect Americans against
biological, chemical, nuclear and radiological agents of
terrorism. We have two complementary but necessarily
separate roles in this effort:
- We will help get products developed.
- We will then review marketing approval data on the
same products.
A strong FDA
Our continued ability to carry out our mission of
protecting and advancing America’s health rests squarely
on its most important resource: a talented and dedicated
staff. Unlike other HHS agencies that provide grants or fund
programs, our contribution to the public health is through
our professional services.
Additional information about FDA’s strategic plan,
including a list of key action items and objectives, is
available online at http://www.fda.gov/oc/mcclellan/strategic.html.
Slides from the State of the Center address are available
to FDA employees only on the Center’s intranet at http://cdernet.cder.fda.gov/dtd/SEMINARS/Fall03/State%20of%20CDER2003.ppt.
Return to Index
Outsourcing ends for library, underway
for clerical jobs
By Patrick E. Clarke
Competitive outsourcing under the Office of Management
and Budget Circular A-76 is continuing as planned at FDA. By
June 24, all phase-1 study employees were told they had won
their functional competitive bidding. Those functions were
graphic arts, visual information services and library
services. Since then FDA has won two more outsourcing
initiatives-real property management and biological lab
technicians.
“But, winning isn’t always ‘winning,’” said Maddy
Carolan, a senior medical librarian at CDER.
As a result of the competitive bidding process for the
library function, approximately 39 full-time employee slots
at CDER will be downsized to 26, a net loss of 11 government
and two contract library staff. In addition, positions will
be downgraded. However, FDA has guaranteed that anyone who
might lose a government job under this downsizing and who
decides not to transfer to a contractor will be offered
another job in the Agency and retrained if necessary at the
Agency’s expense.
Also as a result of the study, all FDA libraries will
consolidate into one system operated by CDER. This approach
ensures minimal customer impact because it allows all the
physical libraries, including those in other centers, to
stay open for research purposes while centralizing
behind-the-scenes technical processes such as procurement,
cataloging, periodical management and acquisitions.
The centralization should eliminate redundancy and make
the library system stronger and able to provide more
efficient service, Carolan said. But the A-76 effort has
taken its toll. “We’ve spent the last 18 months in
limbo. It’s been terrible for morale,” Carolan said. “Still,
we all pulled together and continued to provide excellent
service to all of FDA.”
By the time the library staff went through the bidding
process, they were emotionally drained, said Carol
Cavanaugh, the director of the Division of Library and
Information Services and the functional coordinator for the
library A-76 study. “It is difficult to keep up services
and motivation while the A-76 work and the transition is
going on,” she said. “I think we all went through stages
of grief. It was hard to manage a team. Some staff felt
threatened and became defensive.
“If I had to do it over again, I would have involved
our customers more and enlist their support,” Cavanaugh
said. “People who don’t use the libraries’ research
services frequently don’t understand the depth of
knowledge required to do our jobs and how specialized the
library profession has become. To be a librarian requires a
master’s degree in library and information science. In
addition, all FDA librarians have extensive knowledge and
expertise in specific scientific and medical areas. Some of
our staff have or are working on doctorates, a number are
credentialed medical librarians and a few are credentialed
in other scientific and medical areas, such as pharmacy.”
A-76 process path in libraries
At the beginning of the process, two groups were formed,
one to prepare a description of the work and another to
prepare the government’s proposal. In order for the
competition to be open and fair to all potential bidders,
people in one group could not speak to those from the other
group about the A-76 work they were doing.
The first group consisted of representative library
personnel, a union representative and the contractor hired
by FDA to help conduct the A-76 process-Management Analysis
Inc. This group created a performance work statement, which
included a description of the tasks, workload statistics,
turnaround timeframes required to complete tasks, quality
standards associated with the tasks, the volume and
frequency of the tasks and types of interactions with other
customers. The completed statement with supporting documents
and appendices was more than 400 pages long.
The second group created the “most efficient
organization” proposal-the government’s offer, minus the
costing. Known as the MEO, this is the government’s
proposal to perform a commercially defined activity. It may
include a mix of federal employees and contract support. It
is the basis for calculating the government’s cost bid.
The second group also had to try to factor in special
initiatives. “We may get FDA or Center requests for
extensive, long-term work on a particular project, such as
the tobacco initiative,” Cavanaugh explained. This type of
work outside the lines had to be accounted for in the
government’s proposal.
“Once the MEO was submitted, we went into a personnel
freeze, and attrition in a few of the Center libraries was
rather high,” Cavanaugh said. “People have retired or
gone on to other positions, and we have been unable to fill
the vacancies.”
The contractor worked extensively with both groups,
including interviewing each employee about his or her work.
The contractor has an 80 percent success rate in terms of
government employees winning their A-76 bids.
However, most of the contractor’s experience had been
working with the Department of Defense, Cavanaugh said. “The
contractor was used to working with DoD libraries where they
could do things like reduce the number of hours the library
is open or the number of books purchased to come up with a
lower-cost bid. A lot of what we do is used in Agency
decision-making, and it’s critical that we continue to
provide full research services.”
Based on the performance statement, a proposal request
was advertised, and Cavanaugh conducted site visits for
potential bidders. A project advisory committee evaluated
bidders’ proposals to see that minimum requirements were
met and that they had the ability to perform all the
required tasks. The advisory committee never saw prices,
just technical specifications. This committee, too, could
not discuss issues with members of the other two teams.
After the final decision, a transition team was formed to
transition to the government proposal. “We’ve requested
the use of early outs and buyouts, but haven’t gotten word
yet on approval,” Cavanaugh said. The library is scheduled
to operate with the new organization beginning Dec. 5.
That may not be the end. A-76 is a continual process with
all contracts and MEOs subject to renewal every five years.
Clerical positions face A-76 next
In fiscal years 2004 through 2006, all clerical jobs at
FDA will be competed. These positions are file clerk (305
job series), secretary (318 series) and office automation
clerk (326 series). This will affect about 156 CDER clerical
employees, including summer hires, according to Devota
Herbert, administrative assistant to the center director
and chairperson of the Support Staff Coordinating Committee.
A functional assessment of all CDER clerical staff
positions has already been completed, according to Herbert.
This is not a formal part of an A-76 study, but a precursor
to developing specific A-76 studies. “The contractor
worked closely with us to get the interviews completed in
time,” Herbert said. “They worked with our schedules and
agreed to interview in groups of up to six people at a time.”
The SSCC, along with selected members from the Office of
Management, Human Resource and the NTEU, sponsored a
workshop for CDER’s clerical staff to help prepare and
inform them of the functional assessment interviews and the
A-76 process. “Before the workshop, a template was sent to
employees to help them think about all the various functions
that make up their jobs,” Herbert said. We emphasized that
they think beyond the four functions targeted in the
assessment:
- Mail, correspondence and reports.
- Office automation.
- Travel.
- Office supplies and equipment.
The workshop, held June 18, drew approximately 135
members of the Center’s clerical staff. “It went very
well,” Herbert said, “and everyone seemed to leave with
a more positive attitude and a more confident feeling with
regard to the interview process.
“We were so very pleased with all the support
throughout the Center. Many supervisors we called offered
their assistance and expressed their concerns. Many even sat
in on the interviews. CDER management is very committed to
the clerical support.”
The workshop would not have been held without the support
of Center Director Janet Woodcock, M.D.
“Dr. Woodcock places a very high value on the support
staff at the Center,” said Doug Hamilton, deputy
director, Office of Management. “She is very committed to
lessening any negative impact of A-76 on the staff and the
Center.”
However, Rick Rohdenburg, A-76 coordinator for
FDA, sounded a cautionary note. “It’s not expected that
FDA will be able to guarantee jobs in the upcoming studies,”
he said of the process involving clerical jobs.
“In fiscal year 2004 through fiscal year 2006, FDA must
review more than 500 positions for possible outsourcing.
Contractor wins on these studies would make it extremely
difficult to place this number of employees in other FDA
jobs,” he said.
“Additionally, FDA has been directed to reduce
administrative positions by 15 percent-7.5 percent in fiscal
year 2004 and 7.5 percent in fiscal year 2005. Reductions
generated by A-76 initiatives would be credited toward
meeting the 15 percent reduction goal.”
For more detailed information on the A-76 initiative, go
to: http://intranet.fda.gov/oms/change/a76/.
Patrick Clarke is a public affairs specialist in OTCOM.
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153 volunteer
to help translate foreign e-mail inquiries
By Mary Kremzner, Pharm.D.
In CDER, we’ve always thought of ourselves as
cosmopolitan because of our cultural diversity. This was
recently confirmed when the Division of Drug Information in
the Office of Training and Communications sent out an e-mail
asking for help with the occasional translation of written
correspondence. Within minutes, we had an overwhelmingly
positive response.
Our division serves as the focal point for public
correspondence in the Center. We receive and respond to
thousands of inquiries each month in the form of letters,
e-mails and telephone calls. Most of the correspondence we
receive focuses on inquiries from the American public. The
questions we answer regarding drug products range from side
effects and shortages to hot topics.
Our division’s 12 consumer safety officers and two
consumer safety technicians make sure that everyone who
calls or writes to the Center receives an acknowledgement
and an answer to their question.
During the last two years, thanks to the Internet, we
have experienced a significant increase in e-mail from
abroad. These inquiries are often quite unlike those
originating from the United States. The foreign e-mails tend
to focus on drug development guidance, assistance with
regulations, expert advice and document retrieval.
The increase in foreign inquiries and our work with Justina
A. Molzon, M.S. Pharm., J.D., CDER’s associate
director for international programs, gave us a bright idea.
Why not look within the Center in a more organized manner
for folks who want to help? Not only do CDER staff have the
language skills, but they also understand the scientific and
regulatory issues involved in many of the inquiries.
At the same time, we understand that CDER staff are
certainly not in need for more tasks. As a matter of fact,
we were very concerned with being sensitive to the workload
and anticipated few responses to our e-mail. Nonetheless, we
heard from 153 Center employees who volunteered to assist us
when needed. The languages ranged from Arabic to Yoruba with
34 languages in between.
The languages or dialects and the CDER employees who have
generously offered to help with translations are:
Arabic: Sophia Abraham, Ph.D., Ali Al Hakim,
Ph.D., Suliman Al-Fayoumi, Ph.D., Aisar Atrakchi, Ph.D.,
Sary Beidas, M.D., Ramzi Dagher, Hanan Ghantous, Ph.D., Wafa
Harrouk, Ph.D., Khairy W. Malek, M.D., Ph.D., Moheb M. Nasr
Ph.D., Patrick J. Marroum, Ph.D.
Bengali: Aloka Chakravarty Ph.D., Badrul A.
Chowdhury, M.D., Ph.D., Swapan K. De, Ph.D., Mamta
Gautam-Basak Ph.D., M. Atiar Rahman, Ph.D., Nam Atiqur
Rahman, Ph.D.
Burmese: Khin Maung U, M.D.
Catalan: Xavier Ysern, Ph.D.
Chinese: Bing Cai Ph.D., Conrad H. Chen Ph.D.,
Shaw T. Chen, M.D., Ph.D., Xiao-Hong Chen Ph.D., Yeh-Fong
Chen, Ph.D., George Chi, Ph.D., Tony Cho, Jinhui Dou, Ph.D.,
Guodong Fang, M.D., John Gong, Ph.D., Zi-Qiang Gu, Ph.D.,
Huiqing Hao, M.D., Ph.D., Ruyi He, M.D., Liang-Lii Huang
Ph.D., Zei-Pao Huang, Hsien W. Ju, M.D., Sue-Chih Lee, Ning
Li, M.D., Ph.D., Zili Li, M.D., Lugi Pei, Ph.D., Maria Shih,
Guoping Sun, Ph.D., He Sun, Ph.D., Joseph Sun, Ph.D., Duu-Gong
Wu, Ph.D., Yvonne Yang, Ph.D., Dylan Yao, M.D., Ph.D., Betsy
C. Yeh, Ita Yuen, Ph.D., Jenny J. Zheng
Columbian: Edwin Ramos.
Cuban: Edwin Ramos.
Czech: Daniela Vanco, M.D.
Dutch: Elizabeth Chikhale, Ph.D., Gemma Kuijpers,
Ph.D.
Farsi: Jila H. Boal, Ph.D., Kooros Mahjoob Ph.D.
French: Dorrie Ballmann, Eric Bastings, M.D.,
Siham Biade Pharm.D., Ph.D., Jila H. Boal, Ph.D., Marc W.
Cavaille-Cole, M.D., Ph.D., Jennie Chang Pharm.D., Ramzi
Dagher, Roman Dragos, M.D., Wafa Harrouk, Ph.D., Patrick J.
Marroum, Ph.D., Owen McMaster, Ph.D., Sally Newman, Nakissa
Sadrieh Ph.D.
German: Dorrie Ballmann, Vispi Bhavnagri, Ph.D.,
Marc W. Cavaille-Cole, M.D., Ph.D., Nancy E. Derr, Mamata
Gokhale, Roswitha Kelly.
Hindi: Shukal Bala, Raj Bykadi, Ph.D., Aloka
Chakravarty Ph.D., Chandra S. Chaurasia R.Ph, Ph.D., Mamta
Gautam-Basak Ph.D., Mamata Gokhale, Pradeep M. Sathe,
Surendra P. Shrivastava, Jyoti Zalkikar Ph.D.
Indonesian: Christina H. Chi Ph.D., Steve Wilson.
Italian: Mary Richard.
Japanese: Conrad H. Chen, Ph.D.
Kannada: Raj Bykadi, Ph.D.
Korean: Sang Chung, Seong H. Jang, Ph.D., Shinja
Kim, Chan H. Park, Ph.D., Herman Rhee, Ph.D., Melaine Shin
R.Ph, Huijeong Ashley Hahm Pharm.D., Ph.D.
Lithuanian: Edvardas Kaminskas, M.D., Daiva
Shetty, M.D.
Madarin: Shiowjen Lee, Ph.D.
Marathi: Jyoti Zalkikar Ph.D.
Mexican: Edwin Ramos
Persian: Ladan Jafari, Sally Newman
Polish: Violetta Klimek, Ph.D., Dorota Matecka,
Ph.D., Jean Nashed, Ph.D., Joanna K. Zawadzki, M.D.
Portuguese: Albert DeFelice, Ph.D., Maria Elena
Ruiz, Ana Szarfman, M.D., Ph.D.
Romanian: Roman Dragos, M.D.
Russian: Valeria Freidlin, Ph.D., Elens Mishina
Ph.D., Tatiana Oussiva, M.D., Ph.D., Daiva Shetty, M.D.,
Lyudmila Soldatova Ph.D.
Serbian: Svetlana Stojisavljevic.
Slovak: Renata Albrecht, M.D., Daniela Vanco, M.D.
Spanish: Silvia N. Calderon, Ph.D., Doris Ford,
Marta E. Gonzalez-Pineiro, Josephine Jee, Damaris Maldonado,
Judit Milstein, Rosa Motta, Juan Pelayo, M.D., Rosa E.
Perez, Irene Piwowarskii, Joseph Porres, M.D., Edwin Ramos,
Archana Reddy M.P.H., Maria Rivera, Ph.D., Libaniel
Rodriquez, Ph.D., Lilliam Rosario, Ph.D., Maria Elena Ruiz,
Milagros Salazar-Driver, Ph.D., Aida Sanchez Parm.D.,
Alfredo R. Sancho Ph.D., Sandra Suarez, Ana Szarfman, M.D.,
Ph.D., Lydia V. Velazquez Pharm.D., M. Lourdes Villalba,
M.D., Maria Ysern, Xavier Ysern, Ph.D.
Taiwanese: Zei-Pao Huang, Betsy C. Yeh.
Thai: Brian Hasselbalch.
Urdu: Mamta Gautam-Basak Ph.D., Anwar Goheer,
Ph.D., Amna Ibrahim, M.D., Daniyal Syed.
Vietnamese: Tan Nguyen, M.D., Nhan Tran, Ph.D.
Yoruba: Abimbola Adebowale, Ph.D.
Thank you for your support.
DDI wants to remind everyone that receives letters,
e-mails or telephone calls from the public that we are here
to help. You can call us at x74570, or forward the e-mail
to: druginfo@cder.fda.gov.
Mary Kremzner is a team leader in DDI.
Return to Index
Joe’s Notebook: cGMP progress
report issued
On Sept. 3-the first anniversary of launching the
strategic initiative to modernize the regulation of
pharmaceutical manufacturing and product quality-FDA issued
a progress report (http://www.fda.gov/cder/gmp/2ndProgressRept_Plan.htm).
Highlights covered in the report include:
- A final guidance on the use of electronic records
and signatures. The guidance clarifies the scope and
application of Part 11 of the Code of Federal
Regulations and provides for FDA enforcement discretion
in certain areas while the Agency undertakes rulemaking
to revise Part 11.
- A draft guidance on a process for resolving
disputes arising over scientific and technical
issues related to pharmaceutical current good
manufacturing practices.
- A draft guidance on the aseptic processes used
in the manufacture of sterile drugs, emphasizing current
science and risk-based approaches.
- A draft guidance on preparation and use of a comparability
protocol for assessing chemistry, manufacturing and
control changes to protein drug products and biological
products.
- A draft guidance for process analytical technology,
a framework for allowing regulatory processes to adopt
more readily state-of-the-art technological advances in
drug development, production and quality assurance.
- A collaboration with two universities to
identify the factors that predict manufacturing
performance to further refine our pharmaceutical
manufacturing risk-based assessment.
- A collaboration with the National Science
Foundation’s Center for Pharmaceutical Processing
Research allowing FDA to expand its scientific
foundation in the area of innovative pharmaceutical
manufacturing technology.
- A cooperative research and development agreement with
Pfizer Inc. to research chemical imaging applications in
pharmaceutical manufacturing and quality assurance.
- A memorandum of understanding between the Office of
Regulatory Affairs and the Center to set up the Pharmaceutical
Inspectorate. The inspectorate will consist of a
staff of highly trained individuals from the field force
who will devote most of their time to conducting human
drug manufacturing quality inspections on the majority
of prescription drug manufacturers and other complex or
high-risk pharmaceutical operations. The inspectorate
will also conduct pre-approval inspections.
- An effort to improve international standards for
drug manufacturing through global harmonization. Several
scientific workshops are planned overseas later this
year and early next year.
The Agency has begun the complex process of designing an
integrated Agencywide, risk-based quality management system.
Six organizations with expertise in quality systems and risk
management approaches are providing a series of
videoconference presentations to share their lessons
learned. Speakers come from other government agencies,
academia and a private health care facility. Copies of most
of the seminars will be available in the FDA libraries;
exceptions are presentations that are copyrighted by the
speaker.
The seminar series is produced by Elaine Frost, one
of my colleagues in the Office of Training and
Communications. Two programs aired on Sept. 4 and 24. The
others will air Oct. 2 and 16, Nov. 20 and Dec. 11 from 1:30
p.m. to 4 p.m.
----------
Correction: In the last issue, I incorrectly
identified the position of contributor Wafa Harrouk,
Ph.D. He is a pharm/tox reviewer.
Return to Index
Organizational
Development: Our next task: A culture survey; responses due
Oct. 15
By Ken Wright
In my first column, I talked about how working with an
organizational development consultant can assist employees
to become more informed as well as higher performing, and
better prepared for future changes. Three questions were
asked: What can we do better? What is higher performance?
How would we know if we had attained a higher performance
level?
Here are additional questions that need to be asked:
- Why should we become higher performing?
- Are we doing the right “what?”
- How good are we in the work we do?
- How do we treat each other and our customers?
My work focuses on helping clients answer these
questions. I have found that sharing techniques and
approaches to solve problems is effective for a “learning
organization.” Problem-solving is achieved as we share an
ongoing dialogue with our colleagues. I approach my work as
an internal consultant for CDER. I do this by contracting
with each organization’s leadership and assessing how I
can assist the organization to become more reflectively and
developmentally focused.
Research shows that those leaders who were most effective
at creating effective organizational change were able to
integrate successfully a series of five personal leadership
strategies:
- Create a compelling future.
- Let every customer drive the organization.
- Involve every mind.
- Manage collaboratively across boundaries.
- Build personal credibility.
These strategies work when coupled with the employee’s
desire and capacity for change. Planned organizational
change is exciting when a realistic set of expectations are
achieved in a realistic period of time.
A survey with instructions is being distributed this
month to all employees. The survey will examine the CDER
culture. Take the time to fill it out and send it back by
the Oct. 15 deadline, which is a week later than listed in
your survey.
Questions will be asked regarding the following:
- Your career and work place experiences at CDER.
- Workforce diversity and diversity management.
- Communication and leadership.
- CDER as a place to work
- Feedback about the survey.
We stress that the survey will be handled with the
highest degree of confidentiality. The results will be
returned directly to the contractor for tabulation and
analysis. Once we receive the survey results, we will be
scheduling meetings to share the results.
By participating in the survey and through the proper use
of the results we will be ready to face the future. Call me
at 594-5487 for more information.
Ken Wright is director of the Center’s Organization
Development and Strategic Planning Staff in OEP.
Return to Index
Informational campaign on hormone
replacement therapy launched
By Deborah Kallgren
For a number of years women and health care professionals
alike felt confident that the use of hormone therapy was
appropriate treatment for symptoms of menopause and the
prevention of menopause related health concerns such as
cardiovascular disease and osteoporosis.
However, in July 2002 findings from the NIH Women’s
Health Initiative Study, brought clinical investigations to
a halt due to concerns about increased risks of heart
disease, stroke and breast cancer in postmenopausal women
using combination (estrogens with progestins) hormone
therapy. Unease about the wide use of hormone therapy in
general among menopausal women began to increase.
In January, FDA responded by revising estrogen-containing
product labeling to reflect the new found safety concerns.
Shortly after, House Agriculture Appropriations Subcommittee
Chairman, Henry Bonilla asked FDA Commissioner Mark
McClellan, M.D., Ph.D., to create an informational
campaign to raise awareness about the recent findings on the
risks and benefits of menopausal hormone therapy.
In this call for action, FDA’s Office of Women’s
Health and CDER were asked to partner with other HHS
agencies and women’s health and community-based
organizations to develop and disseminate targeted
information to women across the nation.
Over the months that followed, the groups worked toward
the development of campaign materials which included a fact
sheet describing menopause, its symptoms and answers to
hormone therapy treatment questions and a purse guide to
serve as a tool for discussion with a health professional.
Within this literature, three key messages emerged to be
communicated to women:
- Become informed about menopause and hormone therapy
for a better understanding of the issues.
- If currently using hormone therapy, or deciding to use
hormone therapy for treatment of menopausal symptoms,
make sure that it is used at the smallest dose for the
shortest time necessary.
- Discuss the risks and benefits with your health care
professional to make the best decision for you.
On Sept. 9, Reps. Bonilla and Rosa DeLauro and both
federal and outside partnering organizations joined Dr.
McClellan on Capitol Hill for a press event to roll out the
Menopause and Hormones Information Campaign.
Copies of the information materials were made available
in both English and Spanish translations. All materials can
be obtained from the National Women’s Health Information
Center at http://www.4woman.gov.
The bottom line message to women is that hormone therapy,
like all medications has risks and benefits.
Deborah Kallgren, a regulatory health project manager in
OTCOM, recently completed a detail in FDA’s OWH.
Return to Index
Information Technology Corner:
Enterprise Search full content searches; MyPortal replaces
OITWeb
By Helen Mitchell
Enterprise Search is the new search tool that will not
only allow you to do full content searches on DFS documents
if you have a DFS account, but will also allow you to search
many types of “digital assets” within the CDER network
including files in Word, PDF, XML, text, HTML and scanned
images.
The collections of documents-or libraries-currently
available include DFS, CDER guidances, Office of Generic
Drugs Division Files and several Web sites.
The new search tool will also replace the current E-DocQuery
search tool for access to:
- Drug Master File reviews.
- AERS reports (images only).
- Biopharm division files (prior to entry in DFS).
- Approved final printed labels (1994-2000).
Please note: Security has been put in place, so you
will only be able to search those libraries you’ve been
granted permission to access. Between the end of September
and October, you’ll receive an e-mail notifying you of:
- Your Enterprise Search account username (network
username) and a temporary password.
- Instructions how to log on to Enterprise Search and
how to change your password.
- The libraries you have been given permission to
search.
- The link to the end users training manual.
- Instructions how to request additional libraries to
search.
Training classes will begin in October and will be
offered on an office-by-office basis. Demonstrations on how
to use the tool along with highlights of new features will
also be offered in the majority of the CDER buildings.
We will continue to leave the current E-Doc
Query/RetrievalWare system available for your use until all
offices and divisions have had an opportunity to attend a
hands-on training class or demonstration of the new
Enterprise Search tool features and capabilities. Stay tuned
for announcements on training and demo dates.
MyPortal
By Jennifer Wagner and Kathy Bright
The information available on OITWeb is being migrated to
the CDER Web portal, MyPortal. Everything that was available
through OITWeb is now available on MyPortal.
You should have received a password to log onto MyPortal.
If you have not received a password or do not remember
your password, please e-mail the Help Desk for a new
password. For security reasons, we cannot give you a
password over the phone.
You will be able to browse 80 percent of MyPortal without
logging on, but you will need your password to:
- See the external applications and make use of the easy
sign-on feature.
- View the Discussion Forums on the Applications tab.
- Enter the Training Application, view classes offered
by OIT for CDER and register for them.
- Change your assigned password.
It is a good idea to change your portal password to your
network password; however, when you change your network
password, you will have to change your portal password also
for them to be the same.
OIT offered several demonstrations of MyPortal throughout
the buildings. We hope you had a chance to attend one.
If you didn’t, you can look at and print an in-depth
training manual by following these steps:
- Go to http://myportal
(if you are on the CBER network, you must type http://myportal.cder.fda.gov).
- Log in with your username and password.
- Click on the Training tab.
- Clicking on the link for Training Documentation.
- Scroll down to find the MyPortal link and click on
that.
- Click on the Personal Portal Training Guide link to
bring up a PDF version of the training manual that was
distributed at the demos.
Please take the time to explore MyPortal before calling
the Help Desk.
If you run into difficulty navigating the site, please
e-mail the Help Desk, and we will assist you.
Return to Index
Letter from Kuwait: CDER lawyer is
Army Reservist facilitating humanitarian aid to Iraq
By Maj. Ken Borgerding
Kuwait City (May 2003)--I am working as the legal
advisor in the Humanitarian Operations Center in Kuwait
City. The center was set up by the Kuwaitis and is run by a
small group of Americans and British soldiers. We are
responsible for facilitating the work of non-governmental
organizations, or NGOs, that are providing humanitarian aid
to the people of Iraq.
Essentially, what we do is act as a liaison between the
Coalition Forces and the NGOs. We provide security
information, border crossing paperwork and reports detailing
humanitarian needs in Iraq. The NGOs take the information we
provide and then acquire needed aid and expertise. They then
coordinate with us for transportation and security for their
convoys and shipments.
I work with the United Nations, Red Cross/Red Crescent,
Physicians without Borders, Save the Children-name a
humanitarian organization, and they are here. It has been
interesting watching the competition among the various
groups as they race to be the first one into Um Qusr, Basra,
Nassiriya, all the way up to the North. My work has been
about half legal and half diplomatic-dealing with other
countries, our embassies across the Middle East and NGOs
from every corner of the world.
There are South Koreans, Japanese, Czech, Italians and
others here everyday. Talk about language barriers, but we
manage to get by with hand gestures and such. I have met
some very interesting people from Sir Richard Branson, the
founder of Virgin records and Virgin Atlantic Airlines, to a
South African who works on a game preserve and went to
Baghdad to help at the zoo.
I sleep in an air-conditioned classroom with no furniture
except an Army cot and empty cardboard boxes stacked up as a
dresser and a nightstand. I really can’t complain given
what I’ve heard about the living condition of the folks in
Iraq and even the folks here in Kuwait that are substandard
to say the least.
There are an incredible number of people over here and
they have them crammed into any available space in Kuwait.
There are camps here with four times the number of people
they were designed to hold. Before I came here, I was
sleeping in a warehouse with hundreds of people. I then
moved to another camp where I was in a tent. I’ve been
slowly moving up in the world in terms of living conditions.
In May, I made a trip into Iraq escorting a humanitarian
convoy. It was an interesting experience. We left Kuwait
City before dawn and reached the border at sunrise. The
border with Iraq consists of two barbed wire fences and a
15-foot-tall pile of sand that stretches as far into the
desert as the eye can see.
As we drove through the border town, I saw graffiti
everywhere saying “Thank you US/UK” and “Mr. Bleer,
Mr. Bush Yes, Saddam, No.” Hopefully, as we get their
schools running again, their spelling will improve.
The southern part of the country is pretty barren. It
reminded me of southern Arizona without the cactuses. That
part of the country used to be one of the main agricultural
areas in Iraq until Saddam dammed the rivers and drained the
marshes in the area to punish the people for rising up
against him after Desert Storm. There is still some
agricultural activity in the area. In fact, as we drove by,
we saw workers bringing in the tomato harvest and saw
truckloads of tomatoes headed North to Baghdad.
I talked to some other lawyers who worked in the POW
camps doing screenings of the detainees before release, and
they told me that one day they released some tomato farmers
to return to their homes. Word soon reached the other
prisoners, and everyone started to claim that he was a
tomato farmer in order to be released. The week before
everyone was a police officer as we were releasing police
officers to return to work. I guess some of them were
actually tomato farmers as they were home and taking care of
business when I drove by.
Every few kilometers on the highway, we would see Iraqi
military installations that had seen better days. We saw
burned-out tanks and broken down-vehicles that were stripped
of everything except the frame. There were also trenches and
fighting positions all along the highway.
Our convoy was delivering our aid to the hospital in
Nassiriya, and as we entered the town. I was surprised to
see that there was economic activity everywhere, people
selling everything at the side of the road-produce, gas,
batteries, cigarettes and tires. I was also surprised to see
that the town was in good shape. It looked no better or no
worse than any town I had seen in Egypt, Jordan, Uzbekistan
or Kazakhstan. Without that perspective, I would have
thought: “What a mess!”
Our arrival at the hospital created quite a ruckus. I was
one of two people there in uniform and instantly had Iraqis
of all ages all around me. They were asking me all sorts of
questions. I have a friend up around Baghdad who told me
that he was questioned about drinking whiskey and Michael
Jackson. In Nassiriya, I only got questions about Michael
Jackson. There were about forty Iraqis around me as we
discussed Michael Jackson in what is best described as “Araglish”-part
Arabic and part English with plenty of hand gestures.
During the conversation about M.J., a man with a young
boy pushed his way to the front. The boy had a bandage on
his head covering what appeared to be a superficial wound.
The man began to yell at me: “Is this freedom?” and “If
this freedom, give us Saddam.”
It became rather uncomfortable for a minute with a
political agitator yelling in one ear and a pop music critic
in the other, so I put my hand on my holster flap and backed
away. The group followed me. But, as soon as the man and the
boy had come, they were gone; and the conversation returned
to music. It was my only unsettling moment in Iraq.
I don’t know how some of these young soldiers faced
with crowds carrying AK-47s do it. I kept seeing the boy
with the bandage on his head throughout the day, but his “father”
was nowhere to be seen. I eventually approached the boy and
asked a few Iraqis with the boy where his father was. They
said that the man with the boy was not his father, but
rather worked for Saddam Hussein.
Along with crime, members of the old regime who are
trying to stir up trouble seem to be the biggest problem
here. They are digging up highways to stop aid shipments and
trying to start riots around soldiers.
As they unloaded the convoy, I walked into the hospital
pharmacy and wandered among the shelves of drugs
manufactured in Iraq. I’m not sure how comfortable I would
be taking some of these products.
I talked with the pharmacist who spoke some English. When
I asked: “How are you,” he replied that he was tired. I
asked if he worked long hours. He said no and repeated that
he was tired. I said he should take a nap, and he said that
he was not sleepy rather that he was tired of Saddam. He
said he had lived for 25 of his 40 years under Saddam and
that he was tired.
I told him that I hoped his next 40 years would be
better, and he said that he hoped so too. It was a sad
moment as I thought of all the people who had lived in an
oil-rich nation like Iraq and had so little, not to mention
the lack of freedom and the threat that at any time you or a
family member could be taken away at any time never to
return. We heard some horrible stories from the Iraqis about
life under Saddam.
The rest of the day was pretty uneventful. Incidentally,
the hospital where we unloaded was the hospital where Pfc.
Jessica Lynch was held before being rescued. On the way back
to Kuwait, we saw an Army convoy of tractor trailers
carrying supplies north go by. I almost drove off the road
laughing (which would have been a bad thing given our
training on land mine awareness prior to leaving the States)
when I saw a truck with two soldiers wearing wrap-around
sunglasses and full Arab headdress drive by.
Ken Borgerding, a regulatory counsel in the Office of
Regulatory Policy, is an Army Reserve major on active duty.
Return to Index
Center refines organizational
structure as components move
The Center has refined its organizational structure to
provide a more effective and efficient approach to
information management and to integrate the review of
biological therapeutics. Also, a number of groups are
moving.
The Office of Information Management provides a focal
point for:
- Establishing standards for regulatory and health data
as well as standards for paper and electronic
submissions.
- Training for use of review tools.
- Coordination of systems development projects with the
Office of Information Technology.
- Reports and analysis of drug review information.
- Oversight of CDER databases.
Randy Levin, M.D., and Cathie Schumaker are
the director and deputy directory respectively of the new
office, which has three components: Business Information
Staff, Division of Records Management and Review Technology
Staff.
Although the laboratory and review elements of the old
Office of Therapeutics Research and Review in CBER are being
assigned to the appropriate major offices in CDER; the
integration will preserve most of the biologics structure
and practices. These will be exist as currently outlined for
at least a year an a half as the Center evaluates best
practices with a view to future rationalization of its
organizational structure. Sharon Risso, who had been
heading OTRR, will be a senior advisor to the Center
Director.
Within the Office of Pharmaceutical Science, the Office
of Biotechnology Products is home to the laboratory-based
divisions that are located on the NIH campus. That office,
with Yuan-yuan Chiu, Ph.D., as acting director,
consists of the Division of Monoclonal Antibodies and the
Division of Therapeutic Proteins. (Gene therapy, which had
been a part of OTRR, remains in CBER as its own office.)
Most of the non-laboratory elements form the Office of
Drug Evaluation VI in the Office of New Drugs with an
indication-based structure. ODE VI, with Karen Weiss,
M.D., as director, consists of the Division of
Therapeutic Biological Oncology Products, the Division of
Therapeutic Biological Internal Medicine Products and the
Division of Review Management and Policy. The biologics
statistical reviewers and advertising and marketing
reviewers are integrated into other existing offices.
A number of moves are taking place to accommodate our new
colleagues from CBER, our PDUFA expansion and the
availability of facilities at White Oak.
- ODE VI will relocate from Woodmont I into Woodmont II.
- The Office of the Center Director will move from
Woodmont II to Rockwall, across from White Flint.
- Tentatively, ODE V is slated to move from Corporate to
a nearby office building, and the Office of
Counter-Terrorism and Pediatric Drug Development will
backfill that space.
- The CDER laboratories, except for St. Louis and the
two biologics divisions on the NIH campus, are moving
into new lab buildings on the White Oak campus in
October.
Return to Index
Pike’s Puzzler: Famous pairs
By Tony Chite
1. The carapace and the plastron are the
names of the:
a. Upper and lower shells of a turtle
b. Dorsal and ventral sides of a shark
c. Posterior and anterior sides of the vena cava
d. Left and right side of an incisor
2. The obverse and reverse most commonly
refer to the:
a. Inside and outside of the ear
b. Heads or tails of a coin
c. Front and back of a fingernail
d. Top and bottom of a hair
3. Estrogen and progesterone are secreted
by the:
a. Leydig’s cells
b. Anterior pituitary
c. Ovary
d. Adrenal cortex
4. The two predominant proteins found in skeletal muscle
tissue are:
a. Fibrinogen and fibrillin
b. Lysine and choline
c. Guanine and cytosine
d. Actin and myosin
Key 1a; 2b; 3c; 4d
Tony Chite is a CSO and pharmacist in the Division of
Information Disclosure Policy.
Return to Index
Project Management Corner: Biologics
project managers adjust to new CDER family
By Deborah Kallgren
When CBER’s Office of Therapeutics Research and Review
staff became CDER’s newest ODE VI and Office of
Biotechnology Products this summer, they knew that there
would be significant challenges in making the changeover
between centers.
The task of sorting out organizational, procedural and
cultural differences while staying “on track” with
review timelines would not be easy. So how have they done so
far? To find out, I caught up with Wendy Aaronson, director
of ODE VI’s Division of Application Review . . .
“They haven’t missed a beat! These really are an
extraordinarily committed group-reviewers and project
managers alike,” says Wendy. Clearly there have been some
“bumps in the road” for all making the transition, but
for OTRR’s 14 project managers and two branch chiefs
(equivalent to CDER’s chief PMs), the biggest is the fact
that their product-based review structure will, by Oct. 1,
be restructured to mirror CDER’s indication-based model.
“Our PMs are assigned to work with a particular product
and they know the status of every IND, BLA or supplement for
that product, regardless of the clinical indication. Because
they consistently deal with the same regulatory affairs
industry contact, it is also very conducive to building
solid working relationships with Industry counterparts,”
says Wendy.
Biologics PMs are also responsible for assessing review
team comments and monitoring for overlaps or inconsistencies
in topic areas.
This organizational change from that of product-based to
indication-based strongly impacts another key PM
responsibility-communications. “Having the same PM for a
product ensures that the various review disciplines and
groups stay informed of new issues and changes for that
product,” Wendy said. She describes communications now as
appearing to have many added layers.
Because of the size of CDER vs. that of CBER, there are
many more people and expert groups in other areas of the
Center to keep in the loop such as pediatrics, labeling and
counterterrorism. She says that understanding when to get
them involved is still confusing, but that they have created
checklists of contacts to help them sort out the
uncertainty. Project managers are asked not to make any
assumptions, but always refer to these lists.
A compounding glitch in internal communications is the
fact that CDER and CBER have vastly different databases that
are on different platforms. These cannot “talk” to one
another and even accessing the database from another center
is an issue. Furthermore, there is no simple way to migrate
the data from the CBER databases to CDER’s COMIS.
This would not be a significant hurdle if the databases
just captured important information about submissions. The
issue is that these databases populate other databases,
document management systems and the electronic document
rooms.
“CDER enters all reviews, telecons, and letters into
DFS.” Wendy said. “The document room even prints and
then mails the letter that was entered in DFS, so DFS is
integral to the CDER review process. CBER cannot use DFS
because we are not using COMIS. CBER still has a paper
archive of internal communications; however, we are
beginning to use the CBER electronic document room as a
repository for all internal communications. After digital
signatures are rolled out, we intend to use the CBER EDR as
the archive for all internal communications in the same way
as CDER uses DFS. CDER is working hard to iron out the IT
issues that are causing access problems. In the interim, we
just do what we can to try and minimize the information
disconnect.”
She credits much of the positive progress to steps taken
by CBER and CDER senior managers to understand overall
similarities and differences between the groups. This
identification process has been particularly helpful because
people can vent their frustrations, but also focus on
problem solving and identifying best practices of OTRR and
CDER.
“It’s good to acknowledge that we use the same IND
regulations, that we must meet the same PDUFA goals, but
seeing the obstacles and getting stuck in frustration mode
is not productive. Staying focused on leveraging our
strengths is the best approach to go forward.” That is why
most OTRR staff consider the “Biologics Orientation to
CDER” provided in July by OTCOM to be a highly positive
experience.
“It really gave people here the opportunity to learn
about the organization and the various groups within the
Center. Acronyms like ODS and OPS meant nothing to us
before, but hearing a presentation and matching a face to a
name for these areas was a tremendous help-processing all
the new information and being able to remember how the
pieces fit together is the key and that may not happen until
you just jump in, network, and interact.”
Finally, she added: “It’s like getting married and
meeting the entire family from out of town for the first
time and then being quizzed a week later on relationships
four generations removed. It doesn’t sink in until you are
forced to spend a weekend together in a cabin without
running water or electricity!”
Deborah Kallgren is a regulatory health project manager
in OTCOM.
Return to Index
Return to index
Editorial Board
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.
Editorial Board
Rose Cunningham
Pam Fagelson
Elaine Frost
Mary Jane Mathews
Edward Miracco
Melissa Moncavage
Jim Morrison
Ellen Shapiro
Ted Sherwood
Tony Sims
Nancy Smith
Wendy Stanfield
Gloria Sundaresan
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,
Christine Parker
Phone: (301) 827-1695
Fax: (301) 827-3055
Return to index
