About CDER - Report

CDER Report to the Nation: 2000

Table of Contents

Communications

Highlights from 2000 include:

• Meeting almost weekly with outside experts on difficult scientific and public health issues.
• Responding to more than 58,000 individual requests for information.
• Receiving nearly 5 million visitors and about 80 million hits on our Internet information site, which has 30,000 pages and documents.

Mission

Carry out our mission in consultation with experts in science, medicine and public health and in cooperation with consumers, users, manufacturers, importers, packers, distributors and retailers of human drugs.

Public participation

We confer with panels of outside experts in science, medicine and public health in meetings open to the public. We assure that patient representatives are included on advisory committees considering medicines for HIV, AIDS, cancer and other serious disorders. We analyzed public comments on proposed new rules, and we sought and received comments on our guidances to industry.

In special public meetings, we received valuable input from consumer and patient groups, professional and scientific societies, industry and trade associations about:

• Ways to include consumer input in our evaluation of the usefulness of written information currently dispensed with prescription drugs.
• Reexamining a number of issues about over-the-counter drugs including prescription-to-OTC switches and classes of drugs available over the counter.
• Strengths and weaknesses of the Prescription Drug User Fee Act.

We cosponsored two public workshops on how consumers can make sure they use drug products safely and understand their role in improving the drug quality control system.

Consumer and industry outreach

We use a number of modern communication methods to reach our stakeholders. Highlights include:

• Responding to more than 1,680 telephone and e-mail requests from the specialized media that focus on the pharmaceutical industry. This compares with 1,250 in 1999 and about 1,000 in 1998.
• Completing successful showings of our exhibit and information program at 19 national health care conferences and meetings, reaching an estimated audience of over 100,000 health care professionals.
• Conducting about 70 domestic and foreign videoconferences for academia, industry and associations.

Educational campaigns

In response to the expressed need for additional information from the public and health care professionals, we developed public education campaigns about:

• Benefits vs. risks of medication use.
• Buying prescription medical products over the Internet.
• Aspirin therapy to reduce the risk of heart attacks and strokes.
• Pharmacy compounding.
• The new over-the-counter medicine labels.

Dissemination activities

• CDER Live! We conducted two satellite television broadcasts for industry in which our scientific and regulatory experts engaged in panel discussions about minimizing medical errors and direct-to-consumer advertising. About 5,000 industry executives, scientists and managers viewed the programs live, with additional viewers by webcast.
• E-mail information requests. We responded to more than 16,400 e-mail requests from industry, consumers, patients and health care professionals.
• Other communication. We answered more than 27,000 telephone inquiries, 4,000 faxes and nearly 7,000 written requests. We responded to more than 9,500 requests for documents and guidance publications.

Stakeholders in drug review, drug quality and safety

We work closely with many organizations on issues of public health and safety, including:

• Consumers, patients and their organizations
• Scientific and professional societies
• Industry and trade associations
• Universities, hospitals and health care professionals
• Federal, state and local government agencies
• Foreign governments

Internet updates

We have 33,000 subscribers to our service that provides daily and weekly e-mail updates of new content on our Web site.

To subscribe, visit http://www.fda.gov/cder/cdernew/listserv.html.

Ombudsman's activity

In its fifth year of operation, our ombudsman helped settle issues between the Center and industry, health professionals and consumers.

The ombudsman handled about 100 complaints. He answered more than 1,000 e-mails, approximately 1,000 telephone calls and 20 letters.

In addition, the ombudsman held about 50 meetings with external parties.

Reorganization of information activities

Our Office of Training and Communication created the Division of Drug Information and the Division of Public Affairs to improve information dissemination to our stakeholders and enhance consumer outreach and education.

Workshop on postapproval changes in analytical methods and packaging

We cosponsored a workshop to discuss scientific issues related to changes in analytical methodologies and packaging for pharmaceuticals.

Participants explored viable scientific approaches for predicting the potential impact of changes on drug substance and quality.

Packaging training

We cosponsored a training session for members of the pharmaceutical industry to discuss and clarify our guidance on container closure systems.

Where to Find More Information

We support multiple ways to obtain information about drug products and the laws, regulations and guidances concerning them.

Selected Internet sites

• FDA Internet home page: http://www.fda.gov/
• CDER Internet home page: http://www.fda.gov/cder/
• CDER's consumer drug information sheets for new medicines approved since January 1998:
  http://www.fda.gov/cder/consumerinfo/default.htm
• FDA Modernization Act of 1997 CDER-related documents:
  http://www.fda.gov/cder/fdama/default.htm
• From Test Tube to Patient: New Drug Development in the United States: http://www.fda.gov/fdac/special/newdrug/ndd_toc.html
• CDER Handbook: http:// www.fda.gov/cder/handbook/index.htm
• CDER organizational charts: http://www.fda.gov/cder/cderorg.htm
• CDER key officials: http://www.fda.gov/cder/directories/keyoffic.pdf

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
Drug Information Division
HFD-240, Room 12B-31
5600 Fishers Lane
Rockville, MD 20857

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