CDER
Report to the Nation: 2005
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4 Communications
Index
In 2005, we met 27 times with outside expert advisors in
public discussions of difficult scientific and public health
issues. We received more than 17 million visits and nearly
417 million hits on our Internet information site, which has
nearly 115,000 files and about 700,000 hyperlinks. Our Web
site accounts for 28 percent of total FDA Web site use.
Drugs@FDA is the most visited content page on the FDA
Web site.
Internet use
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text.
Internet updates
We have more than 25,000
subscribers to our service that provides daily email
updates of new content on our Web site and more than 24,000
subscribers to our weekly email 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
Our risk management communications strategies.
n
The use of pharmacogenomics in drug
development.
n
Developing a scientifically sound, risk-based
system to assess drug quality.
n
Direct-to-consumer promotion.
Small business assistance workshop
Along with FDA's field operations, we co-sponsored a
workshop in Kansas City, Mo., for 125 representatives from
the small pharmaceutical business community. The meeting
gave small businesses the opportunity to consult with our
subject matter experts and those from FDA's Office of
Regulatory Affairs. The workshop provided an introduction to
the regulatory requirements for approval and marketing of
drug products.
Transparency of policies, decisions
n
Regulations. We issued a final rule
that will remove albuterol metered-dose inhalers containing
chloroflourocarbons or other ozone-depleting substances from
the market by Dec. 31, 2008. This is consistent with certain
treaty obligations and Clean Air Act requirements. We
published a proposed rule on current good manufacturing
practice regulations for positron emission tomography drugs.
We want to ensure that these drugs meet the requirements for
safety, identity, strength, quality and purity. In addition,
we continued work on a number of other regulatory
initiatives, including reviewing and considering comments on
more than 10 previously published proposed rules..
n
Guidances. We published 14 guidances
for industry that explain our position on best practices in
scientific and technical areas. We published another 29 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 17 documents last year.
n
Freedom of Information requests. We
responded to 4,876 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/drug/DrugSafety/drugSafetyConsumer.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.
Industry, drug and device consultants contacted
the office more often than consumers. About one-third of industry
contacts related to jurisdictional and drug development assistance.
Several people contacted the office to report irregularities and
possible fraud in conducting and reporting clinical trials, in
manufacture's promotional activities and violations in
pharmaceutical manufacturing. Several hundred people
contacted the office to express their opinions urging us to approve
some drug therapies and to disapprove or rescind the approval of
other drug therapies. Fewer consumers commented in 2005 than in 2004
on direct-to-consumer prescription drug advertising and on advisory
committee members.
Examples of cases and allegations our ombudsman handled in 2005
included:
n
Unethical conduct of clinical research
including institutional review board issues.
n
Whistle blowers' informing about
pharmaceutical companies in violation of FDA regulations.
n
Delay in review or drug development.
n
Unfair handling of an issue.
n
Backlog in processing Freedom of
Information requests.
n
Management and employee disagreements.
n
Citizen petition delays and advice.
n
Incorrect advice provided to industry
by our staff.
n
Import and export issues.
Ombudsman's 2005 hot topics
Two hot topics with consumers were the
same as in 2004:
n
Enforcement against importing
prescription medicines from Canada.
n
Our non-approval letter for
over-the-counter sales of emergency contraception.
Consumers have definitely made the Internet their
primary method of communication with us. We received many times more
e-mails than telephone contacts. Many consumers requested assistance
in reporting drug adverse events.
Others commented on:
n
The high cost of medicines.
n
Inconsistency in color and shape among
generic brands of prescription drugs.
n
The necessity to increase the size of
OTC labeling.
n
High profile market withdrawals.
n
Abuse of oxycodone.
n
Politicizing of FDA.
Internet, e-mail
n
More information and a full report on
2005 activities is at
http://www.fda.gov/cder/ombud/default.htm.
n
You can e-mail our ombudsman at
Warren.Rumble@fda.hhs.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 41 of these
requests in 2005, a large 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@fda.hhs.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
E-mail notification from us
At
http://www.fda.gov/cder/cdernew/listserv.html,
you can sign up for these updates from the Center for Drug
Evaluation and Research:
n
Website updates.
Daily and weekly lists of new postings.
n
MedWatch.
Immediate notification of new safety information on
human health-care products.
n
Drug shortages.
New, medically necessary drug shortages.
n
Consumer news.
New education materials.
n
Small business.
Information for small pharmaceutical companies.
n
Cancer Information. Information on new cancer drug and
therapeutic biological products
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Date created: August 18, 2006 |