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CDER Report to the Nation: 2005 Print version
4 CommunicationsIndex
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
Click image for larger chart, click here for accessible text. Internet updatesWe 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 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 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 workshopAlong 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, decisionsn 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. 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:
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:
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Antibiotic resistance These are available on the Internet at http://www.fda.gov/cder/drug/DrugSafety/drugSafetyConsumer.htm. Ombudsman's ActivitiesOur ombudsman serves as a portal for consumers, regulated industry and small business to, among other things:
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Comment on our programs and actions. 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 topicsTwo 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-mailn 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 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 41 of these requests in 2005, a large 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@fda.hhs.gov. Regular mail:
E-mail notification from usAt 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
Date created: August 18, 2006 |
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