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CDER 2007 Update
Communications
Our present and future mission remains constant: to ensure that drug products available to the public are safe and effective. Our yardstick for success will always be protecting and promoting the health of Americans.
Protecting consumers means listening to them. We consult with the American public when making difficult decisions about the drugs that they use. We hold public meetings about once a week to get expert, patient and consumer input into our decisions. We also announce most of our policy and technical proposals in advance. This gives members of the public, academic experts, industry, trade associations, consumer groups and professional societies the opportunity to comment before we make a final decision. In addition, we take part in FDA-sponsored public meetings with consumer and patient groups, professional societies and pharmaceutical trade associations. These help us obtain enhanced public input into our planning and priority-setting practices.
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 public meetings and participated in scientific workshops to both present information and gather a wide variety of viewpoints on major scientific and regulatory issues, including:
- 23 advisory committee meetings.
- Three public workshops.
- Six public meetings.
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, industry outreach
- Trade press. We responded to over 1,700 telephone and e-mail requests from the specialized press for the pharmaceutical industry.
- General information requests. We answered nearly 40,000 telephone inquiries, about 67,017 e-mails and 789 letters from consumers, health professionals and industry. We responded to all phone calls and e-mails within 48 hours and letters within 30 days.
- Support to FDA field offices. We had over 800 requests from FDA field offices for information.
- Videoconferencing. We held 229 domestic and foreign videoconferences for academia, industry and associations.
- Compliance information requests. We responded to nearly 6,400 compliance inquiries and concerns from drug sponsors, clinical investigators, institutional review boards, industry, consumers, advocacy organizations and other government agencies.
Outreach for revised Rx drug labeling format
Our 2007 requirement provides that labels for new and recently approved prescription drugs and new uses be presented in a format that is better understood, more easily accessible and more memorable for physicians. Our communications efforts included:
- Produced and launched a web-based continuing educational module for health-care professionals.
- Published an article in Pharmacy Today, a publication of the American Pharmacists Association (APhA). APhA is the largest association of pharmacists in the United States. The Pharmacy Today publication is circulated to over 144,000 pharmacists.
Transparency of policies, decisions
- Regulations. We published one final regulation and we sought public comment on two proposed rules.
- Guidances. We published eight guidances for industry that explain our position on best practices in scientific and technical areas. We published another 21 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 32 new and revised documents in 2007.
- Freedom of Information requests. We responded to 3,498 requests under the Freedom of Information Act.
Public education programs
Our programs educate and empower consumers to make wise choices about their medications. Our messages, which reached 200 million Americans last year, include information on:
- Antibiotic resistance
- Benefits vs. risks of medication use
- Buying drugs from outside the United States
- Buying prescription drugs online
- Using medicines safely in children
- Counterfeit drugs
- Generic drug quality
- Medicines and the elderly
- Misuse of prescription pain relievers
- Over-the-counter medicine labels
- Sedating medicines and driving
These are available at http://www.fda.gov/cder/drug/DrugSafety/drugSafetyConsumer.htm.
Internet updates
We 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. In 2007, there were 24,913,978 sessions: 273,552,280 page views and 670,008,349 hits on the CDER Web site. To subscribe, visit http://www.fda.gov/cder/cdernew/listserv.html.
Ombudsman Activities
Our ombudsman office serves as a portal for consumers, regulated industry and small businesses to, among other things:
- Comment on our programs and actions.
- Obtain formal and informal dispute resolution.
- Seek general information on product development and regulation.
- Report adverse drug experiences.
Consumers, law firms, and the pharmaceutical industry can contact our ombudsman’s office by fax, phone, postal mail and electronic mail. Beginning in March, the ombudsman instituted a different tracking system for phone calls and electronic mail. Therefore, the phone and email data presented below reflect contacts and activities from March through December 2007 and the numbers for fax and regular mail encompass the full calendar year.
In total, the ombudsman received 660 communications, the vast majority (94%) of which came via electronic mail and phone. In many instances, several emails or phone calls were exchanged per case. Follow up correspondences were not counted for this report.
Examples of cases and allegations from the Pharmaceutical Industry, Law Firms, Consultants, and Public or Private Research Institutions our ombudsman handled included:
- Regulatory jurisdiction.
- Generic drug decisions.
- Review delays.
- Whistle blower’s informing about unethical clinical research conduct.
- Lengthy response times to Citizen Petitions and Suitability Petitions.
- Import/Export issues.
- Enforcement actions taken on marketed drugs that do not have FDA approval.
- Freedom of Information Act requests.
- New drug approval or nonapproval.
- Unlawful promotional activities by competitors.
Examples of cases and allegations from consumers and health care professionals our ombudsman handled included:
- Reporting of drug adverse events and medication errors.
- Drug costs and insurance problems.
- Drug shortages.
- Complaints from consumers about their doctors.
- Personal importation of drugs not lawfully marketed in the United States.
- Study protocol violations as reported by study participants.
- Generic drug does not seem to work the same as the brand drug.
- Oxycontin abuse and pleas to remove it from the market.
- Misleading product websites.
- Albuterol inhalers.
Jurisdictional Issues
Many times it is not readily apparent where in FDA a proposed product will be reviewed and regulated. Our ombudsman is our jurisdiction officer and a member of the steering committee that advises FDA’s Office of Combination Products that coordinates intracenter jurisdictional issues.
This calendar year, our ombudsman responded to hundreds of informal jurisdiction questions from within and outside FDA and put forth CDER’s position on 44 requests for designation. Most of the designations were drug/device combinations. More information about jurisdictional issues can be found at www.fda.gov/oc/combination/ .
Outreach Efforts
The CDER ombudsman’s office conducted outreach to explain its functions including product jurisdiction and dispute resolution at several internal and external venues. The office also created an informative website for use by CDER employees.
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Date created: July 31, 2008 |
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