CDER Report to the Nation: 2003

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4 Communications

Index

• Public Participation
• Consumer and industry outreach
• Ombudsman activities
• Where to Find More Information

Highlights from 2003 include:

• Meeting almost weekly with outside experts on difficult scientific and public health issues.
• Receiving more than 12 million visits and more than 205 million hits on our Internet information site, which has 50,000 pages and documents, five databases and 250,000 hyperlinks.

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 analyze public comments on proposed new rules, and we seek and receive comments on our guidances to industry.

We held large public meetings and workshops to gather a wide variety of viewpoints on major scientific and regulatory issues, including:

• Risk management.
• Direct-to-consumer advertising .
• Evaluating drug names for similarities.
• Pharmaceutical good manufacturing practices initiative.
• Process analytical technologies.

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.

Consumer and industry outreach

• Regulations. We published four final regulations, and we sought public comment on another three proposed regulations.
• Guidances. We published 32 guidances for industry that explain our position on best practices in scientific and technical areas. We published another 24 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 23 documents last year.
• Drug reviews on Internet. Our Internet site now contains our reviews of more than 1,500 approved drugs or new uses for approved drugs.
• Trade press. We responded to about 2,200 telephone and e-mail requests from the specialized press covering the pharmaceutical industry.
• Exhibits. We exhibited at 31 conferences, reaching an estimated audience of more than 108,000 consumers, educators and health care professionals.
• Videoconferencing. We held 144 domestic and foreign videoconferences for academia, industry and associations.
• CDER Live! We produced one satellite television broadcasts 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.
• Freedom of Information requests. We responded to nearly 4,000 requests under the Freedom of Information Act.
• General information requests. We answered more than 36,000 telephone inquiries, 26,000 e-mails and 1,800 letters from consumers, health professionals and industry.

Public education programs

Our programs educate and empower consumers to make wise choices about their medications. Our messages, which reached many millions of Americans last year, include science-based information on:

• Antibiotic resistance
• Benefits vs. risks of medication use
• Buying drugs from outside the United States
• Buying prescription drugs online
• Counterfeit drugs
• Drug interactions
• Generic drug quality
• Misuse of prescription pain relievers
• Over-the-counter medicine labels
• Safe use of aspirin

These are available on the Internet at http://www.fda.gov/cder/consumerinfo/DPAdefaultht.htm.

Ombudsman activities

Our ombudsman’s office changed management; however, the overall tenor of the office did not change. Our ombudsman serves as a portal for consumers, regulated industry and small business for, among other things, comment on programs, drug development and FDA center jurisdictional advice, general information on drug regulation, and adverse drug experience reporting.

Several people contacted the office to report irregularities and possible fraud in conducting and reporting clinical trials, promotional activities and violations in pharmaceutical manufacturing. Several hundred people contacted the office to express their opinions on advisory committee members, on whether we should approve specific therapies and unwanted e-mail promotion by on-line pharmacies.

The ombudsman’s topic of the year was FDA’s enforcement against importing drugs from Canada.

The e-mail account ombudsman@cder.fda.gov has become a preferred method of contacting us with more than 1,500 contacts. Approximately 570 of these were forwarded to our druginfo@cder.fda.gov account. We received approximately 400 specific issue contacts by telephone. Examples of our cases were:

• Review/drug development delay.
• Freedom of Information Act access.
• Docket posting dispute.
• User fees dispute.
• Intellectual property dispute.
• Management/employee disagreement.
• NDA priority designation dispute.
• Perceived retaliation complaint.
• Repackaging/expiration dating dispute.
• Import/export issues.

Jurisdictional issues

Our ombudsman serves as our jurisdiction officer. Many times it is not readily apparent where proposed products will be reviewed and regulated either within the center or between FDA centers. Our ombudsman is a member of a steering committee that advises the congressionally created the FDA Office of Combination Products. The office, created in December 2002, has a mandate to define or clarify regulations in the area of combination products such as:

• Primary mode of action
• Single-separate applications
• User fees
• cGMPs

Our ombudsman is also a member of the working group for the FDA’s initiative in the area of novel drug delivery systems and in the agency’s dispute resolution processes.

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@cder.fda.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

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Date created: May 24, 2004