CDER
Report to the Nation: 2004
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4 Communications
Index
In 2004, we met 29 times with outside
expert advisors in public discussions of difficult
scientific and public health issues. We received more than
12 million visits and more than 205 million hits on our
Internet information site, which has nearly 100,000 pages
and documents, seven databases and 400,000 hyperlinks.
Drugs@FDA is the most visited content page on the FDA
Web site.
Internet use
Internet updates
We have more than 25,000
subscribers to our service that provides daily e‑mail
updates of new content on our Web site and more than 24,000
subscribers to our weekly e-mail updates.
To subscribe, visit
http://www.fda.gov/cder/cdernew/listserv.html.
Public participation
n
We confer with panels of outside experts in
science, medicine and public health in meetings open to the
public.
n
We assure that patient representatives are
included on advisory committees considering medicines for
HIV, AIDS, cancer and other serious disorders.
n
We analyze public comments on proposed new
rules, and we seek and receive comments on our guidances to
industry.
We held public meetings and workshops
to both present information and gather a wide variety of
viewpoints on major scientific and regulatory issues,
including:
n
Radioactive drugs for certain research uses.
n
Developing follow-on protein products.
n
Targeting safe and effective diabetes
prevention and treatment, a joint symposium with the
National Institutes of Health.
n
Structured product labeling.
n
Electronic Common Technical Document.
Transparency of policies, decisions
n
Regulations. We published five final
regulations, and we sought public comment on another four
proposed regulations.
n
Guidances. We published 25 guidances
for industry that explain our position on best practices in
scientific and technical areas. We published another 25 in
draft form seeking public comment.
n
Manual of Policies and Procedures. To
foster transparency of our operations, we publish our
internal operating policies and procedures on the Internet.
We added 22 documents last year.
n
Freedom of Information requests. We
responded to 6,807 requests under the Freedom of Information
Act.
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Consumer and industry outreach
n
Trade press. We responded to about
2,500 telephone and e-mail requests from the specialized
press covering the pharmaceutical industry.
n
Exhibits. We exhibited at 30
conferences, reaching an estimated audience of more than
100,000 consumers, educators and health care professionals.
n
Videoconferencing. We held about 150
domestic and foreign videoconferences for academia, industry
and associations.
n
General information requests. We
answered more than 32,000 telephone inquiries, 31,000
e-mails and 1,700 letters from consumers, health
professionals and industry. We respond to phone calls and
e-mail within 48 hours and letters within 30 days.
n
CDER Live! We produced one satellite
television broadcast and Web transmission for a largely
pharmaceutical audience estimated at about 5,000 viewers.
The first part of the program featured a discussion of the
broad science-based issues that form the basis of the
pharmaceutical cGMP initiative; the second part presented a
discussion of electronic signatures and records.
Stakeholders in drug review, drug quality and safety
We work closely with many
organizations on issues of public health and safety,
including:
n
Consumers, patients and their organizations
n Scientific and professional societies
n Industry and trade associations
n Universities, hospitals and health care
professionals
n Federal, state and local government agencies
n Foreign governments
Public education programs
Our programs educate and empower
consumers to make wise choices about their medications. Our
messages, which reached millions of Americans last year,
include science-based information on:
n
Antibiotic resistance
n Benefits vs. risks of medication use
n Buying drugs from outside the United States
n Buying prescription drugs online
n Using medicines safely in children
n Counterfeit drugs
n Generic drug quality
n Medicines and the elderly
n Misuse of prescription pain relievers
n Over-the-counter medicine labels
n Sedating medicines and driving
These are available on the
Internet at
http://www.fda.gov/cder/consumerinfo/DPAdefault.htm.
These are available on the Internet at http://www.fda.gov/cder/consumerinfo/DPAdefaultht.htm.
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Ombudsman’s Activities
Our ombudsman serves as a portal for
consumers, regulated industry and small business to, among
other things:
n
Comment on our programs and actions.
n
Obtain formal and informal dispute resolution.
n
Seek general information on product
development and regulation.
n
Report adverse drug experiences.
Several people reported irregularities and possible fraud in
conducting and reporting clinical trials, misleading or
false promotional activities and violations in
pharmaceutical manufacturing.
Several hundred people contacted the
office to express their opinions on advisory committee
members, direct-to-consumer prescription drug advertising,
pending decisions on specific therapies and unwanted e-mail
promotion by on-line pharmacies.
Further, numerous consumers have
commented on the association of certain antidepressants with
suicide, suicidal ideation and addiction.
Examples of cases and allegations our
ombudsman handles include:
n
Review and drug development delay.
n
Unfair handling of an issue.
n
Freedom of Information request backlog.
n
Docket posting dispute.
n
User-fee dispute.
Ombudsman's 2004 hot topics
n
Enforcement against importing prescription medicines from
Canada.
n
Our non-approval letter for over-the-counter sales of emergency
contraception.
n
Drug safety monitoring and related testimony before
Congress.
Of the approximately 1,950 people
who contacted us, more than half were by e‑mail.
Approximately 250 of these were forwarded to our “druginfo”
account (below). We received
approximately 800 specific issue contacts by telephone.
E-mail contact:
ombudsman@cder.fda.gov
Jurisdictional issues
Many times it is not readily
apparent where a proposed product will be reviewed and
regulated either within the center or between FDA centers.
Our ombudsman is our jurisdiction officer and a member of
the steering committee that advises FDA’s Office of
Combination Products, which coordinates intracenter
jurisdictional issues. Our ombudsman responded to more
than 200 informal jurisdiction questions that helped guide
product development. When regulatory assignment is not
readily apparent, a sponsor may submit a formal request for
designation. FDA received 67 of these requests in 2004, a
majority of which were combinations of drugs and devices.
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Where to Find More
Information
We support multiple ways to obtain information about drug
products and the laws, regulations and guidances concerning
them.
Internet site. CDER Internet home page: http://www.fda.gov/cder/.
Telephone. We respond to specific questions about
prescription, over-the-counter and generic drugs for human
use. You can telephone us toll free at 1-888-INFO FDA or
directly at 301-827-4573.
E-mail. We can be contacted at druginfo@cder.fda.gov.
Regular mail:
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Division of Drug Information
HFD-240, Room 12B-05
5600 Fishers Lane
Rockville, MD 20857
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Date created: Aug. 22, 2005