Index
·
Research on DTC ads
presented at public meeting: Influence of ads, ways to
improve brief summary aired
FDA proposes incentive to remove illegal Rx drugs By Amie
Braman,
Ph.D.,
and Kathryn
Aikin,
Ph.D.
·
FDA proposes
incentive to remove illegal Rx drugs By David J. Horowitz
·
Dr. Galson
promoted to rear admiral in Commissioned Corps
·
CDER
medical officer, Reservist makes a difference in
Afghanistan By Patrick E. Clarke
·
CDER
volunteer faculty for academic year 2002-2003 recognized
By Chris
Nguyen and
Jack
Morin
·
Training and
Development Corner Clinical update seminars bring latest
developments to reviewers By Dale Wilcox and Jack
Morin
·
IOM
elects McClellan, Crawford as members
·
CDER,
SAMHSA share communications award
·
Biologics
Corner: For biologics reviewers,
process defines the product
By Karen
Weiss, M.D.
·
Pediatrics
Corner: Pediatric Research Equity Act of 2003 passed by
Congress
·
Information
Technology Corner
o
New
version meeting tracking system on tap By Linda
Sigg,
Binh
Ta and Colleen
Ratliffe
o
10
Net conversions By Fred Goetze
·
FDA
issues guidance on how it will use pharmacogenomic
data
·
Pike’s
Puzzler: Know your definitions
By Tony Chite
·
NCI,
FDA to collaborate on speeding promising therapies to
clinical trials
·
Joe's
Notebook: Reflections on World Diabetes Day
Return to index
Research on DTC
ads presented at public meeting: Influence of ads, ways to
improve brief summary aired
By
Amie
Braman,
Ph.D.,
and Kathryn
Aikin,
Ph.D.
The Center’s Division of Drug Marketing, Advertising
and Communications sponsored an FDA public meeting on
direct-to-consumer advertising of prescription drugs on
Sept. 22 and 23. The purpose was to hear from researchers
who have investigated the promotion of prescription drugs
directed to consumers through print, broadcast and other
types of media.
FDA was especially interested in research on the impact
of DTC
advertising on the public health. During the two-day
event, a panel of FDA staffers and members of the public
listened to 29 presentations on issues such as the
influence of DTC
advertising on physician prescribing, the utilization and
demand for DTC-advertised
drugs, and ways to improve the communication of
information in the “brief summary” of print
advertising.
Firm conclusions from the public meeting cannot be made
at this time because the docket remained open until Dec.
1. However, a few ideas emerged from the meeting:
- It appears from the research
presented that there is no significant negative effect
of DTC
advertising, although areas of concern continue.
- DTC
advertising seems to inform patients about available
treatments and foster discussions between patients and
physicians.
- Patients who ask about a
specific drug are likely to be prescribed that drug.
- Patients do not comprehend the
risks and benefits in DTC
advertisements equally well.
- The brief summary in print
advertisements merits reevaluation. FDA is considering
ways to address this last concern.
Although DTC
advertising was never prohibited, its volume increased
dramatically after the issuance of FDA’s draft 1997
guidance clarifying how companies may advertise
prescription drugs on television and other broadcast media
without including detailed prescribing information. The
elements of the guidance, finalized in 1999, are
summarized in a previous issue of News
Along the Pike
(see “More Understandable TV Ads of Rx Drugs on Way,” August 27, 1997, pp. 1, 11).
At the time the guidance was issued, FDA reiterated its
plan to evaluate the effects of this guidance on the
public health. The recent public meeting, along with FDA’s
own research on the topic, is part of that evaluation.
Due in no small part to its high visibility, FDA has
received pressure on all sides regarding this issue.
Although FDA welcomes the input of various perspectives,
the Agency feels that empirical evidence is the best way
to investigate whether DTC
advertising has positive effects, negative effects or
both. FDA will consider the research to explore whether
its current regulatory approach should be modified and, if
so, how. Thus, the focus of the public meeting was on
information-seeking and not on policy decisions.
Presenters were organized by topic into seven panels.
Each speaker was allotted 15 minutes for his or her
presentation. The presenters on each panel then
collectively answered questions from the FDA panel, which
included representatives from DDMAC, the Office of the
Commissioner, Office of External Relations, Office of the
Chief Counsel, Office of Medical Policy, the
Center for Veterinary Medicine, the Center for Biologics
Evaluation and Research and the Center for Devices and
Radiological Health. Pending time constraints, audience
members asked questions as well.
The meeting began with an introduction by Thomas
Abrams, R.Ph.,
MBA, director of DDMAC, remarks by Janet
Woodcock, M.D.,
CDER director and a report of FDA research by one of
us (Kathryn
Aikin).
FDA presented the results of its three surveys--two
with patients and one with physicians--on
the impact of DTC
advertising on the doctor-patient relationship. Results of
the physician survey are summarized in a previous issue of
News
Along the Pike (“FDA’s
physician survey on DTC
Rx drug ads shows health benefits,” Feb.
21, 2003, p. 5).
The results of these surveys indicate the impact of DTC
advertising may be somewhat mixed. In the opinion of both
patients and physicians, DTC
advertising is very good at increasing awareness of
potential treatments and helps doctors and patients have
better discussions. Approximately 18 percent of patients
reported that a DTC
ad had caused them to talk to a doctor about a medical
condition they had not previously discussed.
More physicians report beneficial effects vs.
detrimental effects from their patient’s viewing of a DTC
advertisement. However, physicians feel these ads do not
convey information about the risks and benefits of the
product equally well. They believe their patients
understand the benefits much better than the risks.
General practitioners report feeling more pressured to
prescribe compared to specialists. Finally, physicians are
evenly divided in opinions about the overall impact of DTC
ads on their patients and practice--about
one-third believe it has a positive effect, one-third
believe it has a negative effect, and one-third believe it
has had no effect at all. More details about these three
surveys can be found online at http://www.fda.gov/cder/ddmac/presentations.htm.
Following the FDA presentation, researchers
representing diverse interests presented their findings. Thomas
Abrams moderated
the first day’s three panels and Melissa
Moncavage,
MPH., DTC
review group leader in DDMAC, moderated the second day’s
four panels.
The majority of presenters were affiliated with
academia, including representatives from Columbia,
Duke, Dartmouth,
and Harvard
universities and the Universities of British Columbia, California,
Michigan, Minnesota
and Texas.
Several representatives from the pharmaceutical industry
also participated, including representatives from Pfizer
Inc., Pharmaceutical Research and Manufacturers of America
and the Patient Marketing Group Inc. A number of consumer
groups were also represented, including the National
Consumers League.
Presenters covered a range of topics concerning DTC
advertising. Basic issues discussed included:
- Results of national surveys of
attitudes and health effects.
- Effects of DTC
advertising on prescribing behavior.
- DTC
advertising effectiveness.
- Utilization and demand for DTC-advertised
drugs.
- Usage and improvements of the
brief summary in DTC
print advertisements
- Patient/physician interactions
around the world.
- DTC
advertising effects on patient compliance.
Much of the research presented was consistent with the
findings of the FDA patient surveys of 1999 and 2002. For
example, Ed
Slaughter of Rodale
Inc., the publishers of Prevention magazine,
presented the results of six years of survey data. His
results reveal that 78 percent of respondents believe that DTC
advertisements allow people to become more involved in
their health care and that approximately one-third of the
respondents talked to a doctor as a result of DTC
advertising exposure.
Julie Donohue
of Harvard Medical
School and
others reported that DTC
advertising is only a small factor in determining health
outcomes when compared with other factors. For instance,
while DTC
advertising had no discernable effect on choice of
antidepressant medication, the practice of detailing in
physicians’ offices had a large effect. The FDA 2002
patient survey found that only 5 percent of patients who
visited their physician in the last three months did so
due to a DTC
advertisement.
One theme that arose repeatedly was the ineffectiveness
of the brief summary in DTC
print advertising in informing consumers about the
indications, contraindications and risks of prescription
medications.
According to the FDA survey, fewer than half of
consumers who are interested in the drug read either all
or almost all of the brief
summary, while only 16 percent
of consumers reported they typically read all or almost
all of the brief summary.
Michael Roberts
of Catalina Health Resource reported that more than 50
percent of research participants agreed that the brief
summary is somewhat hard or very hard to read and
understand. He presented a number of alternatives to the
presentation of the brief summary, including the OTC Drug
Facts labeling model adopted by FDA in 1999, a format also
endorsed by Linda
Golodner
of the National Consumers League.
For complete information about the public meeting,
including all presentation slides, please visit http://www.fda.gov/cder/ddmac/DTCmeeting2003.html.
Amie Braman
and Kathryn
Aikin
are social scientists in DDMAC.
Return to index
FDA proposes incentive to
remove illegal Rx drugs
By David
J. Horowitz
FDA issued a draft guidance
in October that describes how we intend to exercise our
enforcement discretion regarding new drugs marketed
without required FDA approval. Our policy provides an
incentive for manufacturers to have these products meet
modern standards. We estimate that there are several
thousand illegally marketed drug products in the United
States, comprising
several hundred unique molecules.
These include some formulations of therapeutically
important products such as morphine sulfate, hydromorphone,
phenobarbital, barium sulfate,
epinephrine, atropine sulfate and nitroglycerin
sublingual.
When final, our proposal, titled Marketed Unapproved
Drugs--Compliance Policy Guide, will:
- Clarify our interpretation
of a complex area of drug law, regulation and policy
that evolved over the last century.
- Specify a narrow reading of
clauses in the law regarding so-called “grandfathered”
drugs.
- Emphasize that illegally
marketed unapproved new drugs must obtain FDA
approval.
- Provide an incentive to be
the first manufacturer to obtain approval for one of
these drugs. After a grace period, FDA will consider
taking enforcement action against unapproved
competitors, which may result in de facto exclusivity.
- Avoid unnecessarily
restricting patient access to useful medicines.
- Reiterate our risk-based
criteria for enforcement action.
Our enforcement approach will give the highest priority
to those products which pose the most risk to public
health, either because they have inherent safety concerns
or because there are alternative, FDA-approved treatments
available. High-priority targets for enforcement will
include:
- Products with potential
safety risks.
- Products lacking any
evidence of efficacy.
- Products that
are clearly fraudulent.
Allowing continued marketing of unapproved drugs that
compete against approved counterparts challenges the
integrity of the drug approval system. Drugs that
challenge the approval system will automatically fall into
one of our high-priority enforcement categories. The
continued marketing of these unapproved drugs also
undermines the incentives needed to conduct the scientific
studies to determine the safety and effectiveness of
drugs.
Most of these drugs were first marketed before 1938,
when FDA approval was not required, or between 1938 and
1962, when approval was based on safety alone:
- Pre-1938 drugs. Many
pre-1938 drugs that are still marketed without FDA
approval purport to be “grandfathered.” Few of
these, if any, would meet the legal test for continued
marketing. FDA and the courts have taken a narrow
interpretation of the grandfathering clauses, and the
Agency has never formally recognized a drug as
grandfathered. A drug would be disqualified from
grandfathering if, after 1938, there were any changes
to the product in formulation, dosage form, potency,
route of administration, indication or intended
patient population.
- DESI
drugs. We initiated the Drug Efficacy Study
Implementation to evaluate the effectiveness of drugs
we had approved between 1938 and 1962 on safety
grounds alone. These drugs--and those identical,
related and similar to them--may continue to be
marketed until our administrative proceedings
evaluating their effectiveness have been concluded.
After that point continued marketing is only permitted
if an NDA is approved for each such drug. Under DESI,
we reviewed 3,443 prescription drugs with 16,000
claims. We removed 1,099 from the market for lack of
proven effectiveness. We currently permit continued
marketing of a few DESI
drugs whose proceedings are still pending.
At the request of Congress, we are examining whether
any class or classes of prescription drugs might be
regulated under a monograph system in lieu of requiring
individual applications. Although we have considered and
declined this approach on several past occasions, we will
consider whether new, relevant factors affect our analysis
as we re-visit the question.
Because the Office of Compliance doesn’t have
complete data on illegally marketed products and because
the market is constantly changing, we will need the
assistance of the Office of New Drugs and the Office of
Pharmacoepidemiology and Statistical Science in helping to
identify illegally marketed products for enforcement
action.
David Horowitz is
director of CDER’s Office of Compliance
Return to index
Dr. Galson promoted to rear
admiral in Commissioned Corps
Acting Center
Director Steven
K. Galson, M.D., MPH,
was promoted Nov. 1 to the rank of rear admiral in the
Commissioned Corps of the Public Health Service. He is one
of three officers promoted to that rank this year.
Dr. Galson
joined CDER in May 2001 as deputy center director and has
shared with the center director the executive direction of
the CDER’s scientific and regulatory activities. He also
serves as the lead for several high-profile FDA and HHS
initiatives such as patient safety.
He came to the Center with a background in emerging
health and science issues and regulatory reform at the
Environmental Protection Agency, the Department of Energy
and the National Institute of Occupational Safety and
Health.
Dr. Galson
received his medical degree from the Mount Sinai School of
Medicine in New York.
He earned his master’s in public health from Harvard
University. He
entered the Commissioned Corps in 1986 with the Centers
for Disease Control and Prevention.
Return to index
CDER medical officer, Reservist
makes a difference in Afghanistan
By Patrick
E. Clarke
David Gan, M.D., DrPH, MPH,
a medical officer in the Division of Scientific
Investigations in the Office of Medical Policy, is
testimony to the fact that one person--under the right
circumstances--can bring about change.
“I never thought I would be in a position where I was
actually influencing the health policies of a country,”
said Dr.
Gan, a major in the Army
Reserve. He recently returned from a year-long tour of
duty in Afghanistan,
where he served as the medical director of the Coalition
Joint Civil Military Operations Task Force. He was the
only HHS
official in the country and the only American doctor
tasked to work with the Afghan government and other
international agencies to reconstruct the country’s
health care system. Dr. Gan
was awarded the Bronze Star for outstanding service for
his efforts there.
Dr. Gan
holds both master’s and
doctorate degrees in public health with a specialization
in epidemiology from Tulane
University
in New Orleans.
With both his practical and educational experience, Dr. Gan
was involved in formulating major health care policy for Afghanistan.
“You must develop a very good working relationship with
people or you can’t help them influence policy,” Dr. Gan
said.
He had to cut through red tape and coordinate with both
internal and external organizations.
Dr. Gan
had only been working for CDER for 15 months when he got
his deployment orders. “I knew the deployment was coming
and could have gotten out of the Reserve, but I wanted to
serve my country,” Dr. Gan
said.
His deployment began with one month of mobilization
training at Fort Bragg, N.C.
In addition to physical, chemical warfare and weapons
training, he had classes on topics such as the Afghan
culture and language. “Plus, I was the battalion
surgeon, so I had to make sure there were medical supplies
for everyone,” Dr.
Gan said. Once in Afghanistan,
Dr. Gan
worked 12-hour days every day with no time off. The need
was there.
In Afghanistan,
Dr. Gan
was appointed as the principal coordinator for the
Department of Defense and HHS
efforts to establish maternal and child health projects in Afghanistan.
Currently, 40 percent of deaths among women of
childbearing age in Afghanistan
are caused by preventable complications related to
childbirth. The child mortality rate in Afghanistan
is the worst in the world. “Before a child there reaches
the age of 5, every fourth child will die,” Dr. Gan
said.
In addition to helping coordinate various U.S.
initiatives, Dr. Gan
was asked by the Afghan ministers of health and foreign
affairs to help reconstruct the Afghan pharmaceutical
industry. The Operations Task Force renovated the
government-owned pharmaceutical company, as Dr.
Gan worked with the
Afghan minister of health to privatize the company.
Dr. Gan
also led the effort to help the resume production at a
pharmaceutical plant owned by a German company that didn’t
want to return. Working with the ministers of health and
foreign affairs, among others, Dr.
Gan got a
commitment from another pharmaceutical company to invest
$20 million and reopen the site.
One of the key policies he helped institute was moving
the Afghan healthcare system to more of a cost-recovery
model. “Doctors in Afghanistan
only make $50 a month. They’ve had kind of a socialist
system,” Dr.
Gan said. “We
started a pilot study involving cost recovery--charging
just a small amount such as 5 cents a patient.”
Eventually, pilot cost-recovery programs were installed in
over 30 clinics throughout Afghanistan.
“As a result of the cost-recovery practices, the clinics
provide better quality health care to patients,” Dr. Gan
said.
He’s been told to expect a letter of appreciation
from Afghan President Harmid Karzai.
He was presented with a certificate of appreciation from
the Afghanistan
Minister of Health that states in part: “You have made
great contributions to reconstruct the healthcare system
in Afghanistan.”
Dr. Gan
was also pleasantly surprised to find that “99 percent
of the people there like us because they’ve just been
through 23 years of war.” Dr.
Gan spent hundreds
of dollars of his own money buying items for patients.
Although the majority of people liked Americans, it was
still a dangerous area. “Anywhere outside of our
compound you had to go as a team, with your weapons loaded
and ready to fire,” Dr. Gan
said. “There really was no protection--if someone wants
to kill you, they will. I prayed a lot.” He recalled a
group of German soldiers and medical personnel who were
attacked by a suicide bomber on the day they were
scheduled to leave the country. Four of the group
were killed. “I was very careful during my last
month there,” Dr.
Gan said.
One of the worst pressures Dr. Gan
had to face was concern for his family. “My wife is very
religious, and she got great support from our local
church,” Dr.
Gan said. His son
turned 17 while he was gone, and Dr. Gan
worried about not being home while his son was applying to
various colleges. “But, my son won about $75,000 in
scholarship money from Westinghouse, the Army and other
organizations and is going to Harvard, so he did OK
without me,” Dr. Gan said proudly. “My daughter, who
is 13 now, may have missed me the most. We used to jog
together every day. I know they prayed for me every day.”
Dr. Gan
is appreciative of how CDER helped him. “Dr.
Woodcock e-mailed
me several times, and I received hundreds of e-mails from
CDER employees,” Dr.
Gan said. “Especially
at holidays, the e-mails made my day. I read every single
one and tried to reply to them all.”
He’s also grateful to three people in his section who
stepped in and performed his job responsibilities while he
was gone. “Dr. Khin U, Carolanne
Currier, a consumer safety officer, and Michele
Lackner,
a consumer safety technician, really made sure my
duties were accomplished in an exemplary manner,” Dr. Gan
said.
Dr. Gan
has been asked by HHS
Secretary Tommy Thompson
and FDA Commissioner Mark
McClellan, M.D.,
Ph.D., to go back periodically to Afghanistan
as a civilian to continue to help accomplish some of the
department’s initiatives. Meanwhile, he is just grateful
to have made it back. “I appreciate our life here in America
so much more now,” Dr. Gan
said. “The experience changed me. I want a simple life
now.”
Return to index
CDER volunteer faculty for
academic year 2002-2003 recognized
By Chris
Nguyen and
Jack
Morin
CDER’s volunteer faculty provides invaluable
services. These dedicated volunteers share their time,
knowledge and experience with their colleagues. The Center’s
volunteer faculty number more
than 200, and they research, plan, develop and deliver
courses without additional compensation in addition to
their regular work.
The Division of Training and Development in the Office
of Training and Communications recognizes the hard work
and dedication of the following volunteer faculty during
the 2002-2003 academic year.
The course and faculty were:
An Introduction to the Center for Drug Evaluation
and Research: Susan Allen, M.D., MPH,
Joan Blair, Debra Boxwell,
Igor Cerny, Pharm.D., Antoine El-Hage, Ph.D., John Friel,
J.D., Kathleen Frost, Roger Goetsch, Pharm.D., David
Graham, M.D., MPH,
Roger Gregorio, Brian Hasselbach,
Deborah Henderson, R.N., MSN,
David Hilfiker, M.S., Carol Holquist, R.Ph., Carolyn
Hommel, John Jenkins, M.D., Jean-Ah Kang, David
Konigstein, R.Ph., Sandra Kweder, M.D., Denis Mackey,
Norman Marks, M.D., Andrea Masciale, Esq., Justina Molzon,
M.S., Pharm.D., Barry Poole, R.Ph., Terri Rumble, BSN,
R.N., Ellen Shapiro, Ted Sherwood, John Simmons, Ph.D.,
Nancy Smith, Ph.D., Karen Templeton-Somers, C.T.
Vishwanathan, Leslie Wheelock,
M.S., R.N., Sally Winthrop and Janet Woodcock, M.D.
Basic Statistical Methods: Ruthie
Davi,
M.S., Karen
Higgins,
Sc.D., Kate
Meaker,
M.S., and Dionne
Price, Ph.D.
New Reviewers’ Workshop: Fred Alavi, M.S.,
Ph.D., Aisar Atrakchi, Ph.D., Sammie Beam, Magdalene
Carolan, M.S., MSLS, Igor
Cerny, Pharm.D., Chris Cole, James Cross, Susan Cruzan,
Ruthie Davi, M.S., Gregg Davis, R.Ph., Jennifer DiGiacinto,
Antoine El-Hage, Ph.D., Amy Ellis, Ph.D., Harvey
Greenberg, Joe Hanig, Ph.D., Mark Hirsch, M.D., Dena
Hixon, M.D., Elaine Hu, R.Ph., Stephen Langille,
Randy Levin, M.D., Tim Mahoney, Sheldon Markofsky, Ph.D.,
Frederic Marsik, Ph.D., ABMM,
Iris Masucci, Melissa Maust,
Kathie McConnell, Kate Meaker, M.S., Joette
Meyer, Pharm.D., Catherine Miller, Judit
Milstein, James Morrison, Armando Oliva, M.D., Jacqueline
O’Shaughnessy, Lana Pauls, MPH,
Marilyn Pitts, Kathleen Quinn, Jerry Rachanow, P.D.,
J.D., Terri Rumble, BSN, R.N., Warren Rumble, John Senior,
M.D., Martin Shimer, Lisa
Stockbridge, Ph.D., Mike Verdi and Sarah Singer.
390 Retreat: Renata Albrecht, M.D., Robin
Anderson, R.N., MBA, Shukal Bala,
Ph.D., Sary Beidas,
M.D., Ellen Frank, R.Ph., Steven Gitterman,
M.D., Rita Hecker, Steve Kunder,
Ph.D., Kristen Miller, Pharm.D., Rigoberto Roca, M.D.,
and Diana Willard.
CASE 2002-2003: Hamid Amouzadeh,
Ph.D., Aisar Atrakchi, Ph.D., Shukal
Bala, Ph.D., Narayana Battula,
Ph.D., Lucinda Buhse, Ph.D.,
Mamta Gautam-Basak, Ph.D., Hanan Ghantous, Ph.D., Gurpreet
Gill-Sangha, Ph.D., Karen
Higgins, Sc.D., Len Kapcala, M.D., Markham Luke, M.D.,
Ph.D., Joette Meyer, Pharm.D.,
Patrick Nwakama, Pharm.D.,
John Quinn, R.Ph., M.S., William Rodriquez, M.D., Ph.D.,
Curtis Rosebraugh, M.D., MPH,
Arzu Selen, Ph.D., Philip Sheridan, M.D., Milton Sloan,
Ph.D., Rajeshwari Sridhara, Ph.D., Saleh
Turujman, Ph.D., and
Sue Jang Wang, Ph.D.
Videoconference Focal Points: James
Angel, James Black, Lisa Gilmer, Ayse Hisim, M.S., Merla
Matheny, Jamie Metz, Jody Moore, Paul Neff, Laura Riddle,
Joyce Routh, Ruth Warzala,
Kristen West and Donnie Wisner.
Liposomes--Scientific and Regulatory Challenges: Aisar
Atrakchi, Ph.D., Brian Booth, Ph.D., Mei-Ling
Chen, M.D., Mamta Gautam-Basak, Ph.D., Gene Holbert,
Ph.D., Kofi Kumi, R.Ph., Ph.D., Jeffrey Murray, M.D., MPH,
Eileen Navarro-Almario, M.D., Nam Atigur
Rahman, Ph.D., Arzu Selen, Ph.D., Grant Williams, M.D.,
and Lianh Zhou, Ph.D.
New Employee Orientation: Laura Bradbard,
Magdalene Carolan, M.S., MSLS,
Roy Castle, Heather Chafin, Nichelle
Cherry, MSLS, Lois Chester, MLS,
Davis Hilfiker, M.S., Michael Jones, Karen Kapust, MLS,
Lana Kostecka, Kathy Kruse, MLS,
Andrea Masciale, Esq., Judit
Milstein, Wayne Mitchell, Esq., Crystal Rice, Terri
Rumble, BSN, R.N., Ellen Shapiro, Ted Sherwood, John
Simmons, Ph.D., Michael Theodorakis, Kathleen Quinn, Mitch
Weitzman, Sally Winthrop and Robert Young, M.D.
Advisory Committee Meetings Workshop: Igor
Cerny, Pharm.D., Heather Chafin, Gemma Kuijpers, Ph.D.,
Marianne Mann, M.D., Andrea Masciale, Esq., Joy Mele,
M.S., Thomas Permutt, Ph.D., Kathleen Reedy, RDH,
M.S., Kimberly Topper, M.S., and John Treacy.
NDA Regulations and Policies: Barbara Chong,
Bronwyn Collier, BSN, Julieann
DuBeau, R.N., MSN,
Michael Folkendt, Ellen Frank, R.Ph., Melodi McNeil,
R.Ph., M.S., David Roeder, M.S., James Rogers, Robbin Nightswander,
R.Ph., M.S., Marianne Mann, M.D., and Terri Rumble,
BSN, R.N.
Successful Meetings and Minutes: Christy
Cottrell, Patrick Guinn, Alice Kacuba, Deborah Kallgren, Judit
Milstein, Raquel Peat and Maureen Pelosi.
IND
Regulations and Policies: Nancy
Derr, Jackie
Ware and
Cathie
Schumaker.
Topics in Clinical Trials: Susan
Ellenberg, Ph.D.,
Robert
Temple, M.D.,
and Judy
Racoosin, M.D.,
MPH
University
of North Carolina
Physician Fellows Visit with CDER: Kathleen
Frost, Susan
Honig,
M.D.,
Melodi
McNeil, R.Ph.,
and Robert
O’Neill, Ph.D.
Tools for Pre-Approval Drug Safety Evaluation: Steve
Gitterman, M.D., Shiew-Mei
Huang, Ph.D., Lawrence Lesko, Ph.D., Zilli
Li, M.D., Robert O’Neill, Ph.D., Judith Racoosin, M.D., MPH,
Victor Raczkowski, M.D., John Senior, M.D., Lee Simon,
M.D., and Douglas Throckmorton, M.D.
Toxicologic
Pathology II: Elizabeth
Hausner,
DVM.
Evaluating Human Pregnancy Outcome Data: Dianne
Kennedy, R.Ph.,
MPH, David
Morse, Ph.D.,
and Sandra
Kweder, M.D.
Survival Data Analysis: Kate
Meaker,
M.S.
Videoconferencing Skills Course: Pamela
Winbourne.
Clinical
update seminars
Endocrinology Update: Theresa
Kehoe, M.D.,
Robert
Perlstein,
M.D.,
and Anne
Pariser,
M.D.
Neurology Update: Leonard
Kapcala, M.D.
Chris
Nguyen is a training specialist in DTD and Jack
Morin is a writer and editor in DTD.
Return to index
Training and Development Corner
Clinical update seminars bring latest developments to
reviewers
By Dale
Wilcox and
Jack
Morin
The Clinical Reviewers Education Program is an ongoing,
monthly series of three-hour seminars designed to help
clinical reviewers keep up-to-date with the latest
developments in medical specialties and subspecialties
other than their own. Each clinical update seminar has a
maximum of three hours of Category 1 continuing medical
education credit.
For autumn 2003, two seminars have been completed and
one remains. The medical specialty covered, the dates and
the CDER faculty coordinator are:
- Cardiology, Sept. 10, Shari
Targum, M.D.
- Dentistry, Oct. 16, John
V.
“Jake”
Kelsey,
DDS,
MBA.
- Rheumatology, Dec. 5, Andrea
Leonard
Segal,
M.D.
Seventy-one FDA staff attended the cardiology update.
The guest speakers, all eminent cardiologists, spoke on a
variety of subjects including interventional cardiology,
the evolution of drug evaluation, atrial
fibrillation, non-pharmacologic treatment of arrhythmias
and acute coronary syndrome.
For next year, the medical specialties or topics
selected for updates so far, the month tentatively
scheduled and the CDER faculty coordinators are:
- Gastroenterology, January,
Mark
Avigan,
M.D.
- HIV, February, Jeffrey
Murray, M.D.,
MPH.
- Oncology, March, Ann
Farrell,
M.D.
- Dermatology, April,
Jill Lindstrom, M.D.
- Psychiatry, May, Karen
Brugge,
M.D.
- Hematology, June,
Dr.
Farrell.
- Ophthalmology, September,
Wiley Chambers, M.D. and Jennifer
Harris,
M.D.
These three-hour seminars were developed to meet a need
that clinical reviewers identified during their first
retreat held in November 2001. A working group was formed
to plan and develop a series of clinical updates.
The group included Leonard
Kapcala, M.D.,
Markham
Luke,
M.D.,
Ph.D.,
Anne
Pariser,
M.D.,
and Dr. Segal
from the Office of New Drugs and Dale F. Wilcox
from the Office of Training and Communications.
A survey was sent to all CDER clinical reviewers to
assess how best to meet this need. As a result of this
survey, the Division of Training and Development worked
with the clinical review staff to develop and deliver
pilot seminars on neurology and endocrinology for fall
2002. These two seminars received favorable comments from
the Center’s clinical reviewers.
Subsequently, the Clinical Reviewer Education Program
Workgroup was formed to identify appropriate scientific
topics, identify guest speakers and serve as CDER faculty
coordinators for these seminars.
In addition to the physicians already mentioned, the
group also includes Steven
Gitterman,
M.D.
and Philip
Sheridan, M.D.
Please register online for the seminars on DTD’s
CDERnet site at http://cdernet.cder.fda.gov/dtd/index.htm.
Your registration helps us plan for sufficient chairs,
handouts and an adequately sized conference room. E-mail
either of us if you have questions.
Dale Wilcox is a
supervisory training specialist in DTD,
and Jack
Morin is a writer and editor in DTD.
Return to index
IOM
elects McClellan, Crawford
as members
The Institute
of Medicine
announced its election of Mark
B. McClellan,
M.D.,
Ph.D., and Lester
M. Crawford,
DVM,
Ph.D.,
respectively the FDA’s commissioner and deputy
commissioner, as members of the institute.
The IOM is a
leading organization that advises the government on the
most critical issues in medicine and public health. The
institute is a non-profit component of the National
Academies of Sciences.
It has elected individual FDA scientists in the past,
but never both the commissioner and the deputy
commissioner. New IOM
members are chosen worldwide on the basis of their
distinguished professional achievement in a field related
to medicine and health, and on their involvement in health
care, disease prevention, education and research.
Return to index
CDER, SAMHSA share
communications award
The public education campaign on the misuse of
prescription pain relievers (http://www.fda.gov/cder/pike/JanFeb2003.htm#Abuse)
sponsored by CDER and the Substance Abuse and Mental
Health Services Administration won a communications award.
The Paul G. Rogers 2003 Medication Communicator Award
will be presented to the HHS
agencies by the National Council on Patient Information
and Education at its national conference to be held Dec.
9.
NCPIE is a diverse
nonprofit coalition of organizations committed to safer,
more effective medicine use through better communication. Ayse
Hisim,
a public affairs specialist in the Office of Training and
Communications, is the CDER project manger for the
campaign.
Return to index
Biologics Corner: For
biologics reviewers, process defines the product
By
Karen
Weiss,
M.D.
On Oct. 1, the clinical and pre-clinical review staff
and the project management staff for therapeutic biologicals
became official members of CDER’s Office of Drug
Evaluation VI, a part of the Office of New Drugs.
While the review of clinical safety and efficacy is
very similar for drugs and therapeutic biologicals,
fundamental differences exist between drugs and biologicals.
The classic dichotomy can be seen in the product labels.
For a small-molecule drug, a diagram depicting the
chemical structure usually appears in the description
section. That type of diagram is almost never present in
labels of biological products, which tend to be large and
complex proteins that do not readily lend themselves to
diagrams.
“Traditional” biologicals
were poorly characterized proteins. It was not possible to
characterize all the components of a biological product
sufficiently to make a generic version. In fact, it was
also difficult for the same manufacturer to characterize
its own product sufficiently to ensure lot-to-lot
consistency.
One way to minimize this problem was to institute a
system of controls over all aspects of the manufacturing
process (in-process controls). The old saying in biologics
was: “The process defines the product.” Process
changes could introduce changes to the molecule that might
not be detected by standard chemical and molecular biology
characterization techniques,
yet could profoundly alter the safety or efficacy profile.
There is more blurring of the lines between drugs and
some of the newer recombinant proteins. These biotech
products tend to be purer and better characterized than
traditional biologics. In addition, there has been a lot
of progress in analytical tools. Manufacturers can usually
introduce changes to improve aspects of the product or its
yield, and show the new product is the “same” as the
older product by analytical tests, rather than by
generating extensive clinical efficacy data.
Many therapeutic biologicals
are recombinant versions of endogenous proteins. Despite
their similarities to naturally occurring substances, the
body may consider them “foreign” proteins and an
immune response can occur in the recipient.
An important part of the review of any therapeutic
biological is evaluation of the immunogenicity
data. This is a multidisciplinary approach--product
experts evaluate the sensitivity and specificity of the
assay itself and the characterization of the immune
responses, such as whether they neutralize the activity of
the product. Clinical reviewers must consider whether
immune responses alter the serum levels of the product,
affect clinical safety and efficacy or both.
Pre-clinical safety assessments of the therapeutic biologicals
can be challenging. Many recombinant proteins are species
specific. Toxicology studies in small animals such as
rodents may not be relevant to humans. Also, animals may
rapidly develop an immune response to a recombinant human
protein product, which has implications for the ability to
conduct chronic toxicity studies.
Another large difference between drugs and biologicals
is the starting, or source, material. Biologicals
are derived from living sources, including cells, organs
and tissues. There is the potential for a biological
product to be contaminated with adventitious agents,
despite vigorous manufacturing steps designed to inactive
or eliminate such contaminants, should they be present.
Consent forms and product labels indicate this
possibility.
While the majority of drugs have orally administered
dosage forms, the majority of
therapeutic biologicals are
broken down in the digestive system and, therefore, must
be parenterally administered,
such as by intravenous or intramuscular injection. The
exceptions are a few topical products. Thus, we do not
have multiple dosage forms for biologicals,
such as capsules, tablets, patches and so on.
Some of the more frequently asked questions that we
have received from industry since we consolidated with
CDER are:
- Will
previous commitments between FDA and industry be
honored? Yes,
unless new scientific evidence causes need for change.
Remember, for the most part, our reviewers for
specific products are not changing.
- Will
Biological License Applications
going to CDER become NDAs; will new biotech
products be NDAs? No. The law defines the
regulatory mechanism for biologics. There is no plan
to convert existing BLAs to NDAs. Furthermore, there
is no plan to initiate an NDA mechanism for new
biologic products.
- Will
requirements for facilities and equipment remain the
same? Yes,
because the risks remain the same. However, there will
be a reassessment of need for reporting under the FDA
initiative: Pharmaceutical cGMPS for the 21st Century
(July
2002 Pike).
- Will
bi-annual inspections (Team Biologics) remain the
same? Yes,
for now. There will be a re-evaluation under the cGMP
initiative
- Will
there be generic biologicals?
The legislative history appears silent on whether a
regulatory scheme similar to that for generic drugs
could be applied to biologics. Biologics are licensed
under the PHS Act, which lacks provisions similar to
those in the FD&C Act for generic drugs. Also, the
Hatch-Waxman Act doesn’t apply to biologics. We are
exploring ways that a product comparable to a
well-characterized off-patent biologic could be
brought to market without unnecessary clinical
investigations.
When we consolidated with CDER, we brought with us 54
approved BLAs and about 1,500
INDs. ODE VI has three divisions. Our medical and
pharmacology/toxicology reviewers are either in the
Division of Therapeutic Biological Oncology Products or
the Division of Therapeutic Biological Internal Medicine
Products. Our project managers are in the Division of
Review Management and Policy (last
Pike).
The therapeutic biological products now under CDER’s
review include:
- Monoclonal antibodies for in-vivo
use.
- Cytokines, growth factors,
enzymes, immunomodulators
and thrombolytics.
- Proteins intended for therapeutic use that are
extracted from animals or microorganisms, including
recombinant versions of these products (except
clotting factors).
- Other non-vaccine therapeutic immunotherapies.
More information about biological therapeutic products,
including how to contact us, can be found on CDER’s Web
site at http://www.fda.gov/cder/biologics/default.htm.
Karen
Weiss is the director of ODE VI.
Return to index
Pediatrics Corner: Pediatric
Research Equity Act of 2003 passed by Congress
Congress passed the Pediatric Research Equity Act of
2003 on Nov. 19. This legislation, when signed into law,
will provide FDA with authority to require pediatric
studies of pharmaceutical products when such studies are
needed to ensure the safe and effective use of the
products in children.
“The public health of children will be best served by
enabling FDA to require testing of drugs for pediatric
use, when drug firms do not test them voluntarily,” said HHS
Secretary Tommy G. Thompson and FDA Commissioner Mark
B. McClellan, M.D., Ph.D., in a written statement.
For pharmaceutical companies that conduct FDA-requested
testing of drugs with existing patents or marketing
exclusivity, the Best Pharmaceuticals for Children Act,
which was signed into law in January 2002, allows FDA to
extend marketing exclusivity. This incentive has resulted
in a significant increase in the number of pediatric
studies performed and in important information to guide
safer and more effective use of medicines in children. So
far, 91 medicines have had studies completed.
In 1998, FDA had promulgated a final regulation known
as the Pediatric Rule in order to help assure that those
products that did not benefit from the exclusivity
incentive also had needed pediatric studies performed.
However, in October 2002, the U.S. District Court for the District
of Columbia held that FDA
lacked sufficient statutory authority to require pediatric
studies and prevented FDA from enforcing the requirements.
Instead of pursuing a time-consuming appeal of the
ruling, HHS
called on Congress to work with the department to write
legislation that would provide FDA with the authority to
require pediatric studies.
“We thank the members of Congress for their
determined efforts to secure enactment of legislation to
authorize FDA to require pharmaceutical manufacturers to
conduct appropriate pediatric clinical trials,” Thompson
and Dr. McClellan
said. “We look forward to the president signing this
legislation into law.”
A copy of the legislation can by found by typing the
bill number, S.650, into a THOMAS
search on the Library of Congress’ Web site at http://thomas.loc.gov/.
Return to index
Information Technology Corner: New
version meeting tracking system on tap; network upgrades
By Linda
Sigg,
Binh
Ta and Colleen
Ratliffe
The new version of the Industry Meeting Tracking System
will be available for use starting in December.
The Industry Meeting Tracking System supports the
tracking of scheduled meetings between Agency personnel
and the drug industry. IMTS
allows CDER management to monitor performance against
Prescription Drug User Fee Act goals for
industry-requested meetings and to track meeting workload.
In addition, the tracking system supports tracking
information for meetings that FDA requests with external
constituents and also within FDA internal organizations.
The new tracking system will provide users with:
- A Web-based interface.
- Data entry automation.
- Integration with DFS
to display meeting minutes.
- Better reporting
functionality via the Business Objects reporting tool
and other functional enhancements for tracking
meetings, such as data downloads to Microsoft Excel.
These enhancements will give CDER staff the tools
needed to better manage and meet performance goals as
required by PDUFA III.
Announcements for training sessions will be sent out
soon.
Linda
Sigg,
Binh
Ta
and Colleen
Ratliffe are IT specialists in the Office of Information Technology.
Return to index
10 Net conversions
By Fred
Goetze
After some initial delays, OIT will be updating all of
the CDER building locations to a newer IP address that
will provide communication for all PCs, printers and all
other network equipment. We are performing the necessary
changes during non-maintenance weekends and some federal
holidays during November and December.
As a result, all systems and applications, including
e-mail in these buildings will be unavailable during the
work time. A message for each of the building locations to
be changed will be sent out with about a week’s notice.
Fred
Goetze
is a acting director of OIT’s
Division of Infrastructure Management and Services.
Return to index
FDA issues guidance on how it
will use pharmacogenomic data
FDA issued a new document--Draft Guidance for
Industry: Pharmacogenomic Data
Submissions--that when final will encourage drug and
biologic developers to conduct pharmacogenomic
tests during drug development and clarifies how FDA will
evaluate the resulting data.
The guidance provides specific criteria and
recommendations on submission of pharmacogenomic
data to INDs, NDAs and BLAs.
This includes information on what data are needed and how
FDA will or will not use such data in regulatory
decisions.
Because there is a need for scientific exchange between
industry and FDA, the Agency is asking for voluntary
submissions of research information. This data will help
FDA gain experience as the field evolves. FDA advises
sponsors to label voluntary submissions clearly. FDA will
not use information from voluntary reports for regulatory
decisions.
If a sponsor subsequently develops additional data that
meet the criteria for submission for regulatory purposes,
the Agency advises sponsors that such data should be
submitted as explained in the guidance.
Pharmacogenomics deals with
the small genetic differences that help explain why some
people respond positively to a drug, while others don’t
respond, or may experience a side effect. Genetic
differences also can predict variations in drug
metabolism--how quickly or slowly a drug is eliminated
from the body.
In the draft guidance, FDA says that the promise of pharmacogenomics
lies in its potential to individualize therapy by
predicting which individuals have a greater chance of
benefit or risk--thus helping to maximize the
effectiveness and safety of drugs. FDA believes that pharmacogenomic
testing can be smoothly integrated into drug development
processes.
This is FDA’s first step toward integration of this
new field into the process of demonstrating that new drugs
are safe and effective. This guidance is intended to
ensure that evolving regulatory policies and study designs
are based on the best science; provide public confidence
in this new field where scientifically appropriate;
facilitate the use of such tests during drug development;
and clarify for industry what types of pharmacogenomic
data to submit to FDA.
“Using genomic testing to guide drug therapy will
constitute a significant shift from the current practice
of population-based treatment towards ‘fine-tuning’
individual therapy,” said Center Director Janet
Woodcock, M.D.
Currently, scientific understanding of phamacogenomics
is most advanced in the drug metabolism area, and early
results are expected in this field. However, FDA
anticipates rapid evolution of additional uses. For
example, pharmacogenomic
testing may help identify cancers that have a high
probability of responding to a particular medication or
regimen. Pharmacogenomics may
also be used to help track down the cause of certain rare,
serious drug side effects.
FDA’s Science Board at its April meeting endorsed
Agency proposals to move forward with this guidance. The
Agency also held public meetings and workshops in which
the key issues for drug development were identified.
Return to index
Pike’s Puzzler: Know your
definitions
By
Tony
Chite
1. The Saffir
Simpson
Scale:
a. measures the category
strength of a hurricane.
b. is a scale for weighing
premature neonates.
c. is the most common grocery
store produce scale.
d. converts human blood
pressure in outer space to earth.
2. The word “icteric”
is defined as:
a. a disease common to
tropical fish.
b. a sudden seizure or stroke.
c. pertaining to or affected
with jaundice.
d. a dermatitis with oozing
pustules.
3. The word “hypopyon”
is defined as:
a. spontaneous ignition of a
flammable substance.
b. impairment of digestion.
c. abnormal decrease in
production of saliva.
d. an accumulation of pus in
the anterior chamber of the eye.
4. The word “irides”
is defined as :
a. the plural of iris.
b. the ninth letter of the
Greek alphabet.
c. the inflammation of a
cuticle.
d. one of the smallest bones in
the human body.
Key: 1 a
; 2 c; 3 d; 4 a
Tony
Chite is a Pharmacist and CSO in the Division of
Information Disclosure Policy.
Return to index
NCI,
FDA to collaborate on speeding promising therapies to
clinical trials
National Cancer Institute Director Andrew C. von Eschenbach,
M.D., and FDA Commissioner Mark McClellan, M.D.,
Ph.D., announced on Nov. 12 two new collaborative
initiatives to facilitate the development and use of
better cancer treatments.
“We are working to get safe and effective cancer
therapies to patients as quickly and inexpensively as
possible,” McClellan said. “Using
modern information technologies to make our processes more
efficient is a key approach to achieving this goal.”
Specifically, the new initiatives will:
- Link cancer researchers around the nation
electronically to FDA, reducing the time it takes for
promising new drugs to enter clinical trials.
Electronic submission of data should allow patients
earlier access to experimental therapies as a result
of shorter FDA processing time of IND
applications.
- Initiate Cancer Fellowship Training Programs to
develop a corps of physicians and scientists
expert in clinical research, the regulatory approval
process and translation of research breakthroughs to
clinical practice.
These initiatives result from ongoing work from the
Interagency Oncology Task Force established in May 2003 to
improve the efficiency of all aspects of cancer drug
development and regulatory review.
Investigators submitting INDs electronically to CDER
will need to use the format for the electronic Common
Technical Document (August
27, Pike). The Center has posted
technical specifications for the eCTD at http://www.fda.gov/cder/regulatory/ersr/ectd.htm.
“However, before submitting an official IND
electronically to a review division, sponsors should send
a sample eCTD to the Center,” said Gary Gensinger
from CDER’s Office of Information Management.
“We will test the sample to ensure that in conforms
to our eCTD specifications. The content of the sample won’t
be reviewed by an FDA reviewer.”
Directions for submitting the sample eCTD were
announced Sept. 1 and are at http://www.fda.gov/ohrms/dockets/dockets/92s0251/92s-0251-m000027-vol1.pdf.
Return to index
Joe's
Notebook: Reflections on World Diabetes Day
World Diabetes Day, which
was Nov. 14, may have passed below most our radar screens,
but odds are it affects someone close to you--a
relative, friend, neighbor or co-worker. Watching the
progression of the disease in a neighbor has been
hearth-wrenching for me and my family.
HHS
used the occasion of World Diabetes Day to announce that,
sadly, the number of Americans with diabetes rose to an
all-time high. In 2003, an estimated 18.2 million fellow
citizens-that’s 6.3 percent of us-have diabetes.
The new diabetes estimates
are based on data from the Centers for Disease Control and
Prevention, the National Institutes of Health and the
Indian Health Service. Highlights of the updated data
include:
- Diabetes continues to be the nation’s sixth
leading cause of death.
- An estimated 13 million Americans have been
diagnosed with this disease, and about 5.2 million
more Americans have the disease but have not been
diagnosed.
- Diabetes is the leading cause of blindness among
adults between 20 and 74 years old.
- 14.9 percent of American Indians and Alaska Natives
who are at least 20 years old and receive care from
IHS have diabetes. American Indians and Alaska Natives
are 2.3 times more likely to have diabetes than
non-Hispanic whites of similar age.
- 11.4 percent of non-Hispanic blacks 20 years old or
older have diabetes. On average, non-Hispanic blacks
are 1.6 times more likely to have diabetes than
non-Hispanic whites of a similar age.
- 8.4 percent of non-Hispanic whites 20 years old or
older have diabetes.
- 8.2 percent of Hispanics 20 years old or older have
diabetes. On average, Hispanic Americans are 1.5 times
more likely to have diabetes than non-Hispanic whites
of similar age.
- Native Hawaiians and Japanese and Filipino residents
of Hawaii 20 years old or older are twice as likely to
have diabetes as white residents of Hawaii.
The data are included in a
new HHS
2003 National Diabetes Fact Sheet available at http://www.cdc.gov/diabetes/pubs/factsheet.htm.
The fact sheet
defines diabetes, describes treatments, identifies “prediabetes”
(a term used to describe people at increased risk of
developing diabetes), and briefly discusses the
control of glucose, blood pressure, blood lipids and
preventive care practices for the eyes, kidneys and
feet.
Diabetes is a group of
diseases characterized by high levels of blood glucose
resulting from defects in the body’s insulin
production, insulin action or both. Serious
complications and premature death are associated with
diabetes, but people with diabetes can take steps to
control their disease and lower the risk of
complications.
“Prevention is the
key to stemming this unfolding epidemic,” CDC
Director Julie
Gerberding,
M.D.,
said. “By
eating a healthy diet and engaging in regular physical
activity, individuals can greatly reduce their risk of
developing type 2 diabetes.”
Modern medicine is also
helping people control the disease. Among adults with
diagnosed diabetes, 12 percent take both insulin and
oral drugs, 19 percent take insulin only, 53 percent
take oral drugs only and 15 percent take neither
insulin nor oral drugs.
Many Americans are
unaware that they may be at risk for--or already
have--diabetes. Early diagnosis and proper treatment
of diabetes can delay, and even prevent, the
progression of serious health problems such as heart
disease and stroke, blindness, lower limb amputations
and kidney failure.
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
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
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Date created: December 3, 2003