 |
 |
|
|
 |
|||||
|
|||||||||
 |
|||||||||
|
|
 |
|
|
CDER Report to the Nation: 2004 Print version
4 CommunicationsIndex
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 updatesWe 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 participationn 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, decisionsn 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. Consumer and industry outreachn 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 safetyWe work closely with many organizations on issues of public health and safety, including:
n
Consumers, patients and their organizations Public education programsOur 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 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. Ombudsman’s ActivitiesOur ombudsman serves as a portal for consumers, regulated industry and small business to, among other things:
n
Comment on our programs and actions. 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. Ombudsman's 2004 hot topicsn 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 issuesMany 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. Where to Find More InformationWe 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:
Date created: Aug. 22, 2005 |
|
 |
||
|
||