About CDER - Report

CDER Report to the Nation: 2001

Table of Contents

Communications

Index

• Mission
• Highlights
• Public participation
• Consumer and industry outreach
• Where to Find More Information

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.

Highlights from 2001 include:

• Meeting almost weekly with outside experts on difficult scientific and public health issues.
• Responding to more than 52,000 individual requests for information.
• Launching twice-yearly, week-long introductory workshops for our stakeholders.
• Receiving nearly 6.6 million visitors and about 111 million hits on our Internet information site, which has 40,000 pages and documents, five databases and 175,000 hyperlinks.

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 40,000 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.

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 outside scientists, consumer and patient groups, professional and scientific societies, industry and trade associations about:

• Converting certain prescription antihistamines to over the counter sales.
• The effects of medication on vehicle operators. This was our first joint meeting with the National Transportation Safety Board. It was held in response to the board's request for warning labels on medicines that may impair a person's ability to drive, fly, sail or operate vehicles.

Workshops

• CDER 101. We inaugurated a workshop for external stakeholders including foreign regulators. Our cosponsors were two non-profit organizations and an academic institution. The workshop features many of our experts in a week-long introduction to our mission, organization and regulatory processes. We held two workshops in 2001 and will continue to offer them twice a year.
• Scientific workshops. We cosponsored one workshop addressing drug-induced liver damage and two addressing product quality issues in manufacturing.

Back to Index

Consumer and industry outreach

• Regulations. We published seven regulations, and we sought public comment on another five proposed regulations.
• Guidances. We published 15 guidances for industry that explain our position on best practices in scientific and technical areas. We published another 16 in draft form seeking public comment.
• Manual of Policies and Procedures. To foster transparency of our operations, we publish our internal operating policies and procedures on the Internet. We added 20 documents last year.
• Trade press. We responded to more than 2,340 telephone and e-mail requests from the specialized press covering the pharmaceutical industry.
• Exhibits. We exhibited at 23 conferences, reaching an estimated audience of over 100,000 consumers, educators and health care professionals.
• Videoconferencing. We held about 100 domestic and foreign videoconferences for academia, industry and associations.
• CDER Live! We conducted a satellite television broadcast and webcast for more than 5,000 industry employees in which we discussed our proposal to improve the format and content of the prescription drug label.
• Drug reviews on Internet. We posted on our Internet site our reviews of more than 200 approved new drugs or new uses for approved drugs.
• Information requests. We responded to 6,000 requests under the Freedom of Information Act and more than 16,500 e-mail requests from industry, consumers, patients and health care professionals.
• Other communications. We answered more than 34,000 telephone inquiries, 1,100 faxes and 8,800 written requests. We responded to nearly 6,000 requests for documents and guidance publications.

Partnering to reduce medical gas mix-ups

We developed an outreach plan to eliminate deaths and injuries occurring when incorrect medical gas tanks are connected to oxygen lines in hospitals and nursing homes. This involved more than two dozen health care organizations and several accreditation organizations.

Public education campaigns

In response to expressed need for information from the public and health care professionals, we developed 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
• The new over-the-counter medicine labels
• Misuse of prescription pain relievers
• Drug interactions

Ombudsman's activity

In its sixth year of operation, our ombudsman helped settle issues between us and industry, health professionals and consumers.

• The ombudsman handled about 100 disputes.
• He answered more than 1,300 e-mails, approximately 1,000 telephone calls and 20 letters.
• In addition, the ombudsman held about 20 meetings with external parties.

Back to Index

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-05
5600 Fishers Lane
Rockville, MD 20857

Back to Index

Back to Contents

Back to Top   Back to About CDER

FDA/Center for Drug Evaluation and Research
Last Updated: June 21, 2005
Originator: OTCOM/DCM
HTML by JO, PKS