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Dr. Woodcock provides highlights of her detail:
Implementing quality systems, collaboration with NIH top
list
By Janet Woodcock, M.D.
Over the past few months, I’ve been on detail to the
Office of the Commissioner, working on special projects.
My plan was to get these well underway and return to CDER
in late April. I’ve been enjoying working with many of
you to get these initiatives started.
As you know, I have been asked to extend my detail in
order to serve as the acting deputy commissioner for
operations. I will continue to work on the various
initiatives, and I will also be charged with managing a
number of day-to-day program operations. The length of
this detail is open-ended, but I will try to keep you well
informed of any plans for the future as they develop.
A number of the initiatives I have been working on,
such as quality systems and better collaboration with the
National Institutes of Health, will have a long-lasting
and far-reaching impact on the way we do our work.
Quality systems
We are starting down a long road to quality systems to
bring order and clarity to the Agency’s work. We already
have many quality systems and subsystems in place, so we
will build on those.
The basic concepts underlying quality systems are quite
simple: say what you do, do what you say, prove it and
improve it. We have been working on developing common
nomenclature and a jargon-free framework to help you
implement quality systems in your work.
The Senior Management Team
and I will be having a strategic planning retreat
in preparation for the quality systems program that will
have projects starting in the summer
Collaboration with NCI
We are exploring ways to facilitate interactions
between FDA and NCI in the development and review of drugs
and biologics to treat cancer.
As part of the FDA-NCI collaboration we will pull
together all that’s known about the use of imaging
agents in oncology drug development and make that
available to developers and reviewers. We have a large
steering committee that will invite speakers and likely
organize a workshop on imaging techniques. We are setting
up three subcommittees to draft papers for publication in
peer-reviewed journals on:
- Development of volumetric anatomical imaging for
oncology-revision of RECIST (Response Evaluation
Criteria in Solid Tumors).
- Validation of FDG-PET for oncologic drug development
and as a surrogate endpoint for drug approvals.
- Pathway for accelerating molecular imaging including
first-in-man studies in diagnosed cancer patients.
- We are also working on clarifying various regulatory
procedures.
NIH Roadmap
We are setting up other collaborations with the NIH on
their Roadmap initiative. Achieving some of their
objectives, especially in the clinical research area, will
require partnership with FDA. The NIH Roadmap sets forth
an ambitions vision for a more efficient and productive
system of medical research. It focuses on the most
compelling opportunities in three areas: new pathways to
discovery, research teams of the future and re-engineering
the clinical research enterprise. (More information is
available at http://nihroadmap.nih.gov/.)
Good Manufacturing Practices
I will continue to chair the GMP initiative. In
addition to moving this broad initiative forward, we also
are working on a multicenter draft guidance that will help
laboratory- and small-scale drug developers comply with
our cGMP regulations. This will help researchers, who only
make a batch or two of a drug for investigational use in
humans, understand what is required to reproducibly make a
good quality investigational product. The cGMP regulations
were writen primarily with large-scale production and
postmarketing manufacturing operations in mind.
Follow-on biologics
We are writing a scientific guidance that describes the
principles of determining the similarity of protein
molecules. CDER regulates proteins of many kinds under the
Food Drug and Cosmetic Act and also the Public Health
Service Act.
Cross-Agency guidances
We want to expedite publication of guidances on
pharmacogenomics and drug-eluting coronary artery stents.
The comment period on the pharmacogenomics guidance closed
on Feb. 2, and we are evaluating the comments. We have set
up a working group to begin drafting the drug-eluting
stent guidance.
Center Director Janet Woodcock is
currently on detail as the deputy FDA commissioner for
operations.
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Office of Testing & Research first to move to
White Oak
By Patrick E. Clarke
The Office of Testing and Research is the first CDER
group to make the long-awaited FDA consolidation move to
the White Oak facilities. While there were some glitches,
overall the move has been very positive for the office,
according to John M. Strong, Ph.D., deputy director
of the Laboratory of Clinical Pharmacology.
"The CDER laboratory component has been trying to
consolidate since I started with the Center in 1990,"
Dr. Strong said. "We’ve had laboratories located in
Gaithersburg, D.C. and Laurel. Now, we are consolidated
for the first time since I’ve been here."
He regards the consolidation of divisions as the
biggest asset of the move. "Now, we have direct
communication between all of our investigators, which
provides the opportunity for more collaboration and can be
more intellectually stimulating," Dr. Strong said.
In addition to the Laboratory of Clinical Pharmacology,
the 48-member office includes the Divisions Applied
Pharmacology Research, Product Quality Research and
Pharmaceutical Analysis. They moved into the first and
second floors of what is known as the Life Sciences
Building. OTR has some administrative offices on the third
floor, but the third and fourth floors are mainly occupied
by Center for Devices and Radiological Health. "CDER
and CDRH will share the animal facility in the basement,
which isn’t quite completed yet," Dr. Strong said.
Dr. Strong had high praise for the people who
coordinated the move. "Timothy Hinton was the
contractor who oversaw the move. He met with all the
scientists and researchers, was always available to us and
overall did a wonderful job."
He also singled out Patricia Long-Bradley, who
was the CDER contact for both the laboratory and office
moves. "She did an amazing job juggling all the
myriad details involved in making this move," Dr.
Strong said.
She also has contributed greatly to setting up the
animal facility and, after moving to the Center for
Veterinary Medicine, is presently the program officer for
the animal program at White Oak.
Dr. Strong also mentioned that Tammy Mueller should
be recognized for her efforts after becoming the OTR
contact for issues involving White Oak following the move.
Among other duties, she was the one who received all the
complaints from the end-users concerning modifications
that were required to their laboratories or offices.
Dr. Strong was one of the scientists on the design
committee for the Life Sciences building and served as a
CDER technical point of contact regarding the move. His
involvement with the White Oak consolidation goes back a
few years. In fact, he recalls representing CDER
approximately eight to nine years ago at a meeting between
FDA and military officials at the White Oak facility to
discuss the possible impact of ongoing armed forces’
initiatives on any future CDER laboratories.
Nine years later, he’s still working out details for
OTR. "Tammy and I went through all the labs and
offices and discussed with the laboratory personnel any
deficiencies requiring attentions. This information was
used to develop a punch list, or list of building
deficiencies, which was given to the facilities people to
work on," Dr. Strong said.
"I was impressed. My guess is that they got 90
percent of the building right, but there’s always that
10 percent," Dr. Strong said. Those for the most part
are minor things, according to Dr. Strong, such as power
outlets that aren’t the correct type or haven’t been
placed in the correct area and shelving that needs to be
added to the laboratories. "These things are to be
expected, but it can take up to a year to get everything
corrected," Dr. Strong said.
One area that was a rather large glitch was the
movement of chemicals to the White Oak facility. "The
movement of the lab equipment, glassware and so on,
wasn’t well-coordinated with the movement of
chemicals," Dr. Strong said. "We had all of our
equipment moved during the first and second weeks of
December, but we didn’t get all of our chemicals
delivered until around January 16."
He also pointed out that while they do have a nice
kitchen and canteens in the building, they lack a
cafeteria. Some of the support staff who depend on public
transportation are having some problems with the move.
"But, something that everyone appreciates is that
we all have our own offices," Dr. Strong said.
"Before, except for senior investigators, most of the
scientists just had desks located in their labs. Plus,
because the offices have been placed next to the outside
building wall, we even have windows. There’s a very
open, light feel to the whole work area."
Dr. Strong does have one bit of advice for other
offices planning their move to White Oak: "Don’t
ever plan to move in the month of December with the
holiday season coming on-it can be next to impossible to
contact people. There were some immediate things we needed
done and we just couldn’t reach people."
Dr. Strong acknowledged that people in OTR had
apprehensions about the move. "After all, we were the
first, the pioneers, so to speak. But now, I think by far
the majority of us are happy to be in such a spacious,
intellectually stimulating environment."
The Life Sciences Building
at the White Oak campus will be shared by CDER and CDRH
laboratory staff.
Dr. John Strong operates a
mass spectrometer. This $450,000 instrument is one of many
helping OTR stay on the cutting edge. (Photos by
Patrick Clarke)
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FDA issues draft guidances on direct-to-consumer
advertising
FDA issued three draft guidance documents designed to
improve communications to consumers and health care
practitioners about health conditions and medical products
on Feb. 4. The guidances are the result of FDA research
and policy development, and were influenced by public
participation at an open meeting on consumer-directed
advertising held by FDA in September (November
Pike).
The draft guidances provide advice on:
- Alternatives to the lengthy, detailed and
technically written "brief summary" of risk
information for consumer-directed print advertisements
for prescription drugs, with the goal of increasing
consumer understanding of the key risks of the
product.
- The use of disease awareness communications, which
are designed to educate patients or health care
practitioners about particular diseases or health
conditions and do not promote a particular medical
product, with the goal of getting more patients to
discuss under-treated conditions with their doctor.
- Compliance with federal risk disclosure rules for
consumer-directed broadcast advertising for certain
medical devices.
Brief summary
Typically, manufacturers fulfill the brief summary
requirement by including the complete risk-related
sections of the FDA-approved professional labeling in the
ad in small type. Risk information presented in this
manner is designed to satisfy applicable regulations but
is not user friendly.
While this risk information is technically in
compliance in that it contains important information on
benefits and risks, it does not convey key information
effectively to many consumers. This draft guidance is
designed to encourage manufacturers to deliver more
user-friendly information to the public so that they can
be better-informed partners in their own health care.
Help-seeking, disease awareness ads
This draft guidance clarifies the criteria that FDA
will use to distinguish manufacturer communications that
provide information about the importance of recognizing
that certain signs and symptoms may be evidence of a
treatable disease from manufacturer promotional messages
for particular treatments for a disease. The latter, but
not the former, are subject to FDA regulation as
advertising or promotional labeling.
FDA hopes that, by providing clarity, it will encourage
manufacturers to provide more educational messages to the
public. This draft guidance includes clarifications on
"bookend" advertisements in print or broadcast
formats. These advertisements or labeling pieces consist
of two parts:
First is either a "reminder" piece, which
includes the name of a drug or device but makes no safety
or effectiveness claims or a full product promotional
piece.
Second is a disease awareness message, which encourages
consumers to seek health care practitioner assistance or
practitioners to provide such assistance in identifying
and treating a particular health condition but does not
mention any product by name.
Disease awareness and reminder communications alone
would not be subject to FDA rules for requiring risk
disclosure. But, when reminder and disease awareness or
full product and disease awareness pieces that use similar
themes, story lines or other presentation elements are
taken together, FDA is concerned that they can be
understood as product claim pieces and the Agency will
regulate them as such.
The draft guidance provides advice to manufacturers on
the criteria FDA uses in determining whether such disease
awareness messages are subject to regulation as
advertisement or labeling. The criteria, in brief, are
whether the two components are perceptually distinct and
whether they are separated in space or time.
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Joe’s Notebook: Black History Month: Our scientists’
stories
For Black History Month, I usually tell the story of an
African-American pioneer in a particular field. This year,
however, given chemistry’s long-standing problem in
attracting blacks into the field, I thought you might like
to hear from some of CDER’s own black scientists.
National statistics outline the depth and structure of
the problem. There are about 1,200 to 1,300 doctorate
degrees in chemistry awarded each year in the United
States. As late as 1987, less than 1 percent in any year
were earned by African-Americans. The percentage has
increased to about 3 percent currently, but never more
than 50 a year. In 1997, blacks made up 11.4 percent of
the U.S. population, 10.3 percent of the workforce but
only 3.4 percent of the scientific, engineering and
technical workforce.
The disproportionately low numbers of African-American
students enrolled in and graduating from chemistry
graduate programs stems from influences in family, school,
neighborhood and American culture. Some of these
influences cause or result in race and gender bias in
education at all levels. Some limit the vision of young
African-American students.
I asked four black scientists in our Office of
Pharmaceutical Science about some of the influences and
challenges they faced in pursuing their dream of a career
in chemistry. It’s hardly a scientific survey, but a
persistent drive on the part of all to learn about science
appears to be an underlying theme. The scientists are:
from the Office of
Biotechnology Products.
Andre Jackson, Ph.D., from the Office of
Clinical Pharmacology and Biopharmaceutics.
Sherita McLamore, Ph.D., from the Office of New
Drug Chemistry.
Milton Sloan, Ph.D., also from the Office of New
Drug Chemistry.
Family support for educational and career choices is a
key, regardless of race or economic situation. For
example, despite a lack of family or friends who were
scientists, Dr. McLamore’s father pushed her to pursue
her Ph.D. Dr. Epps was the first in his family to graduate
in chemistry. His grandmother completed a nursing program
in the 1930s or 1940s but was unable to work as a nurse.
"Both family and friends were and continue to be
supportive," Dr. Epps said. "I am most proud to
have mentored many friends, students and associates over
years and it is a honor to continue to do so."
Dr. Sloan notes his family was delighted with his
choice. "I was always curious as to how things were
put together and came apart," he said.
"Although, they may have been surprised to learn that
I was curious even down to the molecular and atomic
level."
All had an early interest in science and benefited from
schools or programs that supported high school science.
"I liked science and math in high school. History
wasn’t exact enough for me," said Dr. Jackson, who
graduated in 1963 from Baltimore Polytechnic High School.
He recalls a geometry teacher who told him to "stop
fooling around" and set him on the
straight-and-narrow scholastic path.
Drs. Epps, McLamore and Sloan earned their
undergraduate degrees at one of the country’s
historically black colleges and universities. They report
supportive teachers and mentors at college and graduate
school. "I consider myself very fortunate in that my
mentors and preceptors were able to look beyond things
that made little difference," Dr. Sloan said. Dr.
Jackson reported that he painfully figured out on his own
how to pursue science despite discouragement and a lack of
role models.
You can find more information and statistics on blacks
in chemistry on a Web site maintained by Princeton
University librarian, Mitchell C. Brown, at http://www.princeton.edu/~mcbrown/display/faces.html.
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Organization Development Corner: First phase of CDER
culture survey completed, employees briefed
By Ken Wright
We are pleased that work on the first phase of the CDER
Culture Survey has been completed. The contractor held
briefings for the Center’s Senior Management Team and 10
all-employee sessions in six different locations,
including a video broadcast to employees in St. Louis.
An impressive survey response rate of 58.1 percent
exceeded any previous Centerwide survey by almost 30
percent. The survey results were highly favorabile when
compared to other government and corporate benchmarks.
Thank you for your participation!
Many of the questions during the survey briefings
centered on what CDER is planning to do with the survey
information. The SMT recognizes that, although the results
are positive, there are opportunities for moving the
Center to higher levels of quality performance and
continuous improvement. The SMT desires to open the lines
of communications in achieving this goal in strengthening
our corporate culture and involving all employees in the
process.
The SMT is planning a second round of follow-up
briefings and dialogue sessions with each major program
office by the contractor Herbert Wong, Ph.D., and myself.
First, copies of Dr. Wong’s briefing, including
Centerwide indices and organization specific indices will
be distributed to each CDER management officer. The
management officers have the responsibility for
distribution within each of their program offices as
appropriate.
In the near future, each program office will meet with
the management and employees for a session on their
organization’s findings to generate dialogue and ideas
to address the findings.
The contractor will also be conducting further
demographic analysis specific to each program office and
sharing the results during these sessions.
We want to assure you that the SMT is committed to
using the results of this comprehensive study and growing
our corporate culture to be a responsive, flexible, and an
even higher performing quality organization.
What can you do to help make this happen? By
participation in the future dialogue sessions in each of
your program offices.
Ken Wright heads the CDER
organizational development program in the Office of
Executive Programs and is project officer for the CDER
culture survey.
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FDA Library consolidation to preserve local user
services
By Karen Kapust
The new, consolidated FDA Library officially began
operations on Dec. 14. The consolidation, a result of a
competitive outsourcing known as the "A-76
process" (Oct. 2 Pike), will preserve effective local
user library services and save dollars by centralizing
behind-the-scene, backbone services.
What does this mean to you? Once we’re fully
implemented you should see more effective library
services. Also, you will soon have an online, merged
library catalog of all FDA Library holdings and an FDA
Library Web portal acting as a gateway to all our
electronic products, including virtual journals and
databases.
All direct user services will continue to be provided
at their current physical locations. The names of these
locations will be changed to identify them as FDA Library
branches and reading rooms. The FDA Medical Library
facility in Parklawn will be known as the Main Library
since most of the technical services functions will be
performed there.
The CDRH, CFSAN and NCTR Libraries are now the CDRH,
CFSAN and NCTR Branches. The former Corporate Boulevard,
MOD 1 and Woodmont II Branches are now reading rooms.
While technological enhancements and movement to a more
virtual environment provide opportunities for improved
services and eventual cost savings, implementing the new
FDA Library has brought its share of challenges. Quite a
few former staff members have chosen not to remain with
the Library and have accepted other positions. We are
currently recruiting to fill a number of reference
librarian and library technician vacancies.
In the meantime, we will make every effort to meet your
information needs; however, we ask for your patience and
understanding while we fill our vacacies.
All locations will remain open during their normal
hours, but to conserve staffing, we will temporarily
abbreviate Reference Desk staffing hours. Reference
librarians will still be available by phone or e-mail
during our normal hours. Check with the library you
regularly use for changes in desk staffing.
As we move into 2004, our staff will continue to
provide the very best service it can within our current
resources. Our commitment is to maintain the high level of
customer service you have come to expect. We look forward
to working with all of you in the year ahead.
Karen Kapust is the director of the FDA
Library.
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Draft guidance on access to investigational treatments
FDA on Jan. 27 issued a draft guidance designed to make
further information about the use of investigational drugs
more readily available.
The draft guidance is part of the Best Pharmaceuticals
for Children Act and is designed to augment information
available in the Clinical Trials Data Bank (http://www.ClinicalTrials.gov).
The new information required by the BPCA includes a
description of whether and through what procedure the
sponsor of the research will respond to requests for
access to the therapy outside of the clinical trial
setting, particularly in children. This draft guidance
explains how to provide that information in a
straightforward and efficient way.
Clinical Trials.gov was developed by the National
Library of Medicine following passage of the Food and Drug
Administration Modernization Act of 1997.
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Information Management Corner: CDER to develop
integrated system for regulatory documents
By Don Duggan
The Center has started work on a major information
management project to develop a single integrated system
that will eventually accommodate all of CDER’s
regulatory submissions, including new drug applications,
generic drug applications, biologics license applications
and investigational new drug applications.
The new system will be called the Document Archiving,
Reporting and Regulatory Tracking System, or DARRTS for
short. It will replace CDER’s current systems supporting
the receipt, management and reporting of information about
investigational and marketing submissions for human drugs
and therapeutics.
The systems being replaced include:
- Components of the Centerwide Oracle Management
Information System or COMIS.
- The Division Files System or DFS.
- CDER Standard Letters.
The DARRTS project is quite large in scope and a
complete rollout of all identified functionality is likely
to take a few years to complete. Therefore, the system
will be rolled out in phases. We are currently analyzing
the functionality that will be released with the first
phase.
The Office of Information Management and the Office of
Information Technology are working jointly to manage the
DARRTS project. We have contracted with ProObject, a
consulting firm specializing in advanced system design and
development, to assist us in the requirements and
development phases of the project.
Background
Several years ago, the Center had started separate
projects to upgrade the functionality of these three core
systems so that they would better meet CDER’s business
requirements. The new projects to redesign these systems
had been identified as STARS, E-Document Check-In and E
Document Generate, respectively.
We accomplished a great deal as a result of the
combined work of the project team and CDER business
community, including Office of Generic Drugs, the Office
of New Drugs and the Office of Pharmaceutical Science.
However, we became aware that the three applications had
significant interdependencies, and we would need to
revisit requirements based on an integrated vision.
We stopped work on the three projects and began DARRTS.
The new project will revisit the "big picture"
view of the integrated requirements for all of these
legacy systems to ensure that we deliver a system that
provides a comprehensive business solution to CDER’s
regulatory needs.
The good news is that much of the data and work
conducted during the earlier efforts will be used in the
DARRTS project.
For the past couple of months, we have been conducting
joint application development sessions with many of you
throughout the Center. You have been extremely valuable to
us in our efforts to understand fully the business needs
of the Center. With your help, we have wrapped up our
requirements gathering phase. We have begun working to
iron out the technical details of the system.
If you want more information about this project please
contact me.
Don Duggan is the OIM project manager
for DARRTS.
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Information Technology Corner: Your account to be
duplicated on new system, log-on to change
By Jim Marshall and Joe Neubauer
At the end of May, CDER will begin using a new system
to log into the FDA network and its resources. This will
begin the first of three phases of change for CDER related
to this new system.
Over the Memorial Day weekend (May 28 to May 31) all
CDER network accounts will move to this new system. Your
network accounts are what give you access to your PC, your
e-mail and other resources such as file shares and
printers.
Why this is taking place
FDA has transitioned to a shared services model for
certain support functions. As part of this transition, FDA
is consolidating the computing resources of individual
centers. This allows us to maximize our tax dollars by
eliminating redundant servers, maintenance and support
needs.
Consolidating computing resources gives us other
opportunities to improve and enhance the services and
applications that allow you to do your jobs more
effectively.
For example, the new system will eventually provide new
and enhanced ways for you to find network resources such
as file shares and printers by building, floor or office.
There may even be options for you to find a specific kind
of printer, such as one that can bind, as well as print, a
document.
What this mean for me
Starting on June 1, your FDACDER account will be
duplicated on this new system. The new account will be
used to log into resources. The goal is to make this
transition as transparent as possible, so every effort is
being made to minimize change.
As June 1 approaches, we will provide more details
about anything new or different you will have to do. Until
then, we want to give you an example of one of the changes
so you’ll have some feel for what will be different:
When you come to work on June 1, you’ll need to replace
FDACDER with the new system’s name-FDA-when logging on
to your PC.
Some things that will remain the same are:
- Your existing user name and password.
- All your desktop settings, shared drives, Outlook
profiles and printers.
As we get closer to the Memorial Day weekend
transition, look for more instructions and information on
the transition’s status via CDER OIT All Hands e-mails,
a Web page (to be announced) and future Pike
articles.
Jim Marshall and Joe Neubauer work in
OIT.
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Pike’s Puzzler: True or false test
By Tony Chite
Determine if each statement is true or false.
1. Of the 23 pairs of chromosomes normally present
in human cells, one pair (called the sex chromosomes)
determines the individual’s sex. The normal female
chromosome pattern is XY; the normal male pattern is XX.
2. Kepler’s First Law states: The orbit of a
planet or comet about the sun is an ellipse, with the sun’s
center of mass at one focus.
3. Moe’s Scale is used to grade the hardness of a
mineral. Talc scores the lowest with a score of 1; while
diamond scores the highest with a score of 10.
4. The pH scale ranges from 0 to 14. At the 0 end,
the concentration is increasingly acidic. Most biological
fluids are between pH 6 and pH 8.
5. On the aluminum cap atop the Washington Monument
in Washington are two words: Laus Deo, a Latin
phrase which means "Praise be to God."
Answer Key: 1.F; 2.T; 3.T; 4.T; 5.T.
Tony Chite is a pharmacist and CSO for
the Division of Information Disclosure Policy
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Drug OK’d for cancer linked to asbestos
On Feb. 5, FDA approved pemetrexed disodium (Alimta)
for use in combination with cisplatin for the treatment of
patients with malignant pleural mesothelioma. The drug
received a priority review and is designated as an orphan
drug. It is the first drug approved for this condition.
Cancer of the mesothelium, a membrane that covers and
protects most of the internal organs of the body is
rare-about 2,000 new cases are diagnosed in the United
States each year.
This form of cancer is usually associated with a
history of asbestos exposure. Asbestos fibers lodged in
the lung attach to the outer lung lining and chest wall,
causing tumors to grow. By the time symptoms appear, the
disease is usually advanced, and patients live, on
average, nine to thirteen months following diagnosis.
Up to now there has been no effective treatment for
treating mesothelioma. The effectiveness of pemetrexed was
established in one randomized clinical trial comparing the
effects of treatment with pemetrexed given with cisplatin
to treatment with cisplatin alone.
Patients receiving pemetrexed and cisplatin lived three
months longer after randomization than patients given
cisplatin alone (12 months vs. nine months). More
information is available on CDER’s Web site at http://www.fda.gov/cder/drug/infopage/alimta/default.htm.
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FDA launches consumer campaign on safe use of OTC pain
products
By Mandy Eisemann
On Jan. 22, FDA launched a national education campaign
to provide advice on the safe use of over-the-counter pain
and fever reducers. The campaign focuses on OTC drug
products that contain acetaminophen and non-steroidal
anti-inflammatory agents, which include products such as
aspirin, ibuprofen, naproxen sodium and ketaprofen.
Many OTC medicines sold for different uses have the
same active ingredient. To minimize the risks of an
accidental overdose, consumers should avoid taking
multiple medications that contain the same active
ingredient at the same time.
The campaign will include:
- An OTC pain reliever brochure to be distributed in
pharmacies and by health care providers.
- A newspaper article to be distributed to 10,000
community papers across the country.
- Two print public service ads that will be sent to
approximately 100 major magazines.
- A reprint of "Use Caution With Pain
Relievers", an FDA Consumer magazine
article that will be distributed at national
healthcare conferences and available for reprinting in
health-related publications.
All of these materials are available on CDER’s Web
site at http://www.fda.gov/cder/drug/analgesics/default.htm.
The campaign will provide advice on how to avoid
inadvertently taking more than the recommended doses of
these medicines.
For more information or copies of the campaign
products, please contact me.
Mandy Eisemann, a public affairs
specialist in DPA, is the project officer for this
campaign.
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FDA task force issues final report on counterfeit
drugs
FDA’s final report on counterfeit drugs highlights
specific steps the Agency is taking to keep the U.S. drug
supply secure against increasingly sophisticated criminal
efforts to introduce counterfeit drugs.
The report addresses growing concerns about the threat
to consumers posed by counterfeit drugs. Though
counterfeiting is not now widespread in the U.S. drug
market, FDA is investigating more cases of such activity,
often involving well-organized criminal operations working
to introduce finished drug products that resemble
legitimate drugs but may contain only inactive
ingredients, incorrect ingredients, improper doses or be
otherwise contaminated.
The comprehensive report highlights ways to assure that
the nation’s drug distribution system protects Americans
from counterfeit drugs. These measures address six
critical areas:
- Securing the actual drug product and its packaging.
- Securing the movement of the product as it travels
through the U.S. drug distribution chain.
- Enhancing regulatory oversight and enforcement.
- Increasing penalties for counterfeiters.
- Heightening vigilance and awareness of counterfeit
drugs.
- Increasing international collaboration.
The report was issued by an FDA task force, created in
July 2003, to identify steps that FDA, other government
agencies and the private sector could take to minimize the
risks to the public from counterfeit medications entering
the nation’s drug distribution system.
The task force met with and heard from security
experts, federal and state law enforcement officials,
technology developers, manufacturers, wholesalers,
retailers, consumer groups and the general public. In
October 2003, the task force issued an interim report that
was followed by a public meeting and technology forum
where 72 presentations were made.
The FDA report addresses the safety and security of the
legal U.S. drug supply, which the Agency regulates. The
FDA does not have the legal authority or resources to
assure the safety and efficacy of drugs purchased from
other countries outside this legal drug distribution
system, or from unregulated Internet sites that are not
run by pharmacies licensed and regulated by states.
The report describes specific steps that can be taken
now and in the future to protect consumers from
counterfeit drugs and to secure the U.S. drug distribution
system. These measures include:
- Implementation of new technologies to better protect
legitimate drugs against tampering or replacement with
counterfeits.
- Adoption of reliable modern track-and-trace
technology, which FDA has concluded is feasible by
2007, to accomplish and surpass the goals of the
Prescription Drug Marketing Act.
- Adoption and enforcement of stronger
anti-counterfeiting measures by the state regulators
of drug wholesalers and distributors.
- Increased criminal penalties to deter counterfeiting
and more adequately punish those convicted.
- Adoption of secure business practices by all
participants in the drug supply chain.
- Development of a system that helps ensure timely and
effective reporting of counterfeit drugs to the FDA
and that strengthens the ability of the FDA, other
regulatory agencies and the other participants in the
drug distribution system to respond rapidly to such
reports.
- Education of consumers and health professionals
about the risks of counterfeit drugs and about how to
respond if they encounter such products.
- Collaboration with foreign stakeholders to develop
strategies to deter and detect counterfeit drugs
globally.
Implementing these steps will:
- Help prevent the introduction of counterfeit drugs
into the U.S. drug distribution chain.
- Facilitate the identification of counterfeit drugs.
- Minimize the risk and exposure of consumers to
counterfeit drugs.
- Avoid unnecessary additional costs in the
prescription drug distribution system, and unnecessary
restrictions on lower-cost sources of drugs.
The FDA Counterfeit Drug Task Force Final Report is
available at http://www.fda.gov/oc/initiatives/counterfeit/.
Return to index
Import 'blitzes' reveal potentially dangerous imported
drug shipments
FDA and the Customs and Border Protection Agency
announced in January that their second series of import
blitz examinations found 1,728 unapproved drugs, including
so-called "foreign versions" of FDA-approved
drugs, recalled drugs, drugs requiring special storage
conditions, drugs requiring close physician monitoring and
drugs containing addictive controlled substances.
These findings provide additional evidence of the
serious risks posed by the illegal importation of
prescription drugs. Unapproved drugs lack assurances of
safety, effectiveness, quality and purity. Moreover, FDA
cannot assure the safety and efficacy of a drug product
the Agency has not reviewed and approved and when FDA has
not monitored the manufacturing and quality control
processes of the facility in which the product was
produced.
The blitz examinations were performed in November at
the Buffalo, Dallas, Chicago and Seattle mail facilities
and the Memphis and Cincinnati courier hubs In September,
FDA released the results of a similar study which had also
been conducted in collaboration with Customs at the Miami,
New York (JFK), San Francisco and Carson, Calif., mail
facilities in July and August.
The most recent blitz marked the first time that
imported drugs entering the country through courier hubs
were targeted in addition to those that pass through mail
facilities.
Details regarding the first joint FDA and Customs
import blitz, which occurred in July-August 2003, are
available online at http://www.fda.gov/bbs/topics/NEWS/2003/NEW00948.html.
Details on the most recent blitz are at http://www.fda.gov/bbs/topics/NEWS/2004/NEW01011.html.
Return to index
FDA approves monoclonal antibody cetuzimab to treat
colorectal cancer
FDA on Feb. 12 approved cetuximab (Erbitux) to treat
patients with advanced colorectal cancer that has spread
to other parts of the body. Cetuximab is the first
monoclonal antibody approved to treat this type of cancer
and is indicated as a combination treatment to be given
intravenously with irinotecan, another drug approved to
fight colorectal cancer, or alone if patients cannot
tolerate irinotecan.
Cetuximab was approved under FDA’s accelerated
approval program, which allows FDA to approve products for
cancer and other serious or life-threatening diseases
based on early evidence of a product’s effectiveness.
Although treatment with cetuximab has not been shown to
extend patients’ lives, it was shown to shrink tumors in
some patients and delay tumor growth, especially when used
as a combination treatment.
Cetuximab is a genetically engineered version of a
mouse antibody that contains both human and mouse
components. It can be produced in large quantities in the
laboratory. This new monoclonal antibody is believed to
work by targeting a natural protein called "epidermal
growth factor receptor" or EGFR on the surface of
cancer cells, interfering with their growth.
For patients with tumors that express EGFR and who no
longer responded to treatment with irinotecan alone or in
combination with other chemotherapy drugs, the combination
treatment of cetuximab and irinotecan shrank tumors in
22.9 percent of patients and delayed tumor growth by
approximately 4.1 months.
For patients who received cetuximab alone, the tumor
response rate was 10.8 percent and tumor growth was
delayed by 1.5 months.
Colorectal cancer-cancer of the colon or rectum-is the
third most common cancer affecting men and women in the
United States and is the second leading cause of
cancer-related death.
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 FDA Library (Parklawn
Room 11B-40) and its reading rooms (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
Pam Fagelson
Elaine Frost
Mary Jane Mathews
Edward Miracco
Melissa Moncavage
Ellen Shapiro
Ted Sherwood
Tony Sims
Nancy Smith
Wendy Stanfield
Gloria Sundaresan
Marcia Trenter
Jennifer Wagner
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: February 27, 2004
