Role of FDA's Drug Information Centers
Role of FDA's Drug Information Centers
Q: What unique dimension does the federal government add to the role of a drug information center (DIC)?
A: The first formalized DIC, established in 1962 at the University of Kentucky, served as a prototype for other institutions. Since then, DICs have expanded outside academic settings to include hospitals, industry, the Internet, and the federal government. Currently, two DICs are funded by the Food and Drug Administration (FDA): one in the Center for Biologics Evaluation and Research (CBER) and the other in the Center for Drug Evaluation and Research (CDER). Each DIC provides product information and regulatory guidance. The scope and breadth of FDA's mission present unique challenges to these DICs. Representing a large federal agency, these DICs serve a broader range of constituents than do DICs in hospitals, universities, and the pharmaceutical industry. In essence, they serve as FDA's liaison to the public.
Q: Who are FDA's constituents?
A: Inquiries come from a broad range of sources, including consumers, patients, health care professionals, insurance companies, regulated industries (e.g., manufacturers), academia, law enforcement, FDA itself and other government agencies (nationally and internationally), investment brokers, attorneys, and others.
Q: What is the difference between CBER and CDER?
A: The mission of CBER is to protect and enhance the public's health through the regulation of biologics and related products, including blood and blood products, vaccines, allergenics, and emerging technologies such as human cells, tissues, and cellular and gene therapies. Biologics, in contrast to drugs that are synthetically derived, are from living sources (e.g., humans, animals, microorganisms) and not easily identified or characterized. Further, many biologics are manufactured using biotechnology.
CDER promotes and protects the public's health by ensuring that all prescription and nonprescription drugs marketed in the United States are safe and effective. CDER evaluates all new drugs before they are sold and monitors more than 10,000 drugs on the market to ensure that they continue to meet the standards of purity, potency, and quality.
Q: How does CBER contribute as a DIC?
A: CBER has divided the work of its DIC into two branches: the Consumer Affairs Branch (CAB) and the Manufacturers Assistance and Technical Training Branch (MATTB). Both branches are located within CBER's Office of Communication, Training, and Manufacturers Assistance. CAB serves as CBER's primary contact to nonregulated entities such as consumers, health care providers, and the trade press.
MATTB serves as the contact point for regulated entities such as manufacturers, sponsors, and trade associations. MATTB provides assistance to manufacturers for a variety of issues, including clinical investigator information, adverse-event-reporting procedures, electronic submissions guidance and requirements, and information on how to submit an investigational new drug (IND) application to administer an investigational product to humans.
The staff of CAB and MATTB comprises consumer safety officers (possessing a minimum of 30 hours of science-based college education), public affairs specialists, and an education specialist. Each branch has about six staff members, with a wide range of educational backgrounds (i.e., nursing, social work, animal science, journalism, and molecular genetics).
Q: What types of inquiries does CBER receive?
A: CAB responds to inquiries on topics such as blood and tissue donor eligibility criteria, product approval information, and tips for locating clinical trials. MATTB provides assistance and training through outreach to industry.
Q: How does CDER contribute as a DIC?
A: CDER's Division of Drug Information (DDI) serves as a focal point for public inquiries regarding human drug products. Inquiries include a broad range of topics related to the regulations of new, generic, and nonprescription drugs, as well as clinical aspects related to individual drug products and drug classes. DDI is staffed by 18 consumer safety officers, 12 of whom are pharmacists and 1 is a nurse.
Q: What are some of the most frequently asked questions that DDI receives?
A: The majority of inquiries are related to regulatory issues, such as the drug review process, and are classified as follows: investigational new drugs (16%), new drugs (13%), generic drugs (17%), over-the-counter drugs (7%), drug registration and listing (6%), import and export regulations (11%), patents and exclusivity (7%), adverse events (11%), recalls and shortages (5%), and drug identification (7%).
Q: What percentage of questions require an extensive literature search to answer?
A: The types of inquiries that CBER and CDER receive distinguish their DICs from traditional hospital and academic DICs. The primary distinction is that neither of FDA's DICs provides medical advice that deviates from FDA-approved prescribing information. As a result, these DICs do not necessarily conduct extensive literature searches to convey medical information regarding uses other than FDA-approved indications.
Both DICs provide extensive responses that may require the use of multiple resources within the respective center. For example, for complex issues, CBER DICs may leverage expertise from their product review offices and Office of Compliance and Biologics Quality. CDER has a similar knowledge base to respond to questions. When clarifying a guidance document of policy, DDI consults with the medical policy staff and the appropriate review divisions to formulate an appropriate response.
Q: How many inquiries are received?
A: CDER's DDI receives roughly 1000 telephone calls and 900 e-mails each week. The volume of inquiries is largely driven by FDA's webpages, which generate over 1 million hits each day.
From 2000 to 2007, the number of e-mail requests sent to DDI increased from 17,070 to 81,291, respectively, while the number of requests generated from letters decreased (from 8,419 to 914), and requests via telephone remained steady (from 29,487 to 34,114).
CAB devotes a considerable amount of resources to answer inquiries submitted by nonregulated entities through CBER's toll-free consumer line and consumer e-mail account. Combined, CAB and MATTB answer approximately 600 inquiries per month.
Q: What is the average turnaround time for each inquiry?
A: CDER's DDI typically provides a response to telephoned inquiries within the next business day and e-mail information requests within two business days. Responses may take longer if consultations with CDER experts are necessary.
CBER makes a point to respond to all telephone calls by the next business day and to e-mails within three days. Similar to CDER, questions submitted by regulated entities are complex and may require a significant amount of time to answer.
Q: What references are most commonly used by DDI to respond to its constituents?
A: Like all DICs, DDI uses traditional drug information resources. DDI also relies heavily on information posted to FDA's website. Individuals contacting DDI are often directed to additional information available to the public on the FDA website. One additional reference the staff relies on is an internal database that serves as a repository for previously researched and answered inquiries. A list of useful links to information found on the FDA website is provided in the table . DDI may be reached by telephone at (301) 796-3400 Monday through Friday or by e-mail at druginfo@fda.hhs.gov .
To contact CBER with general questions about biological products, e-mail the center at octma@fda.hhs.gov . For manufacturer assistance, e-mail matt@fda.hhs.gov or call (301) 827-1800. For general inquiries, call FDA at 1-888-INFO-FDA (1-888-463-6332).
Q: What unique dimension does the federal government add to the role of a drug information center (DIC)?
A: The first formalized DIC, established in 1962 at the University of Kentucky, served as a prototype for other institutions. Since then, DICs have expanded outside academic settings to include hospitals, industry, the Internet, and the federal government. Currently, two DICs are funded by the Food and Drug Administration (FDA): one in the Center for Biologics Evaluation and Research (CBER) and the other in the Center for Drug Evaluation and Research (CDER). Each DIC provides product information and regulatory guidance. The scope and breadth of FDA's mission present unique challenges to these DICs. Representing a large federal agency, these DICs serve a broader range of constituents than do DICs in hospitals, universities, and the pharmaceutical industry. In essence, they serve as FDA's liaison to the public.
Q: Who are FDA's constituents?
A: Inquiries come from a broad range of sources, including consumers, patients, health care professionals, insurance companies, regulated industries (e.g., manufacturers), academia, law enforcement, FDA itself and other government agencies (nationally and internationally), investment brokers, attorneys, and others.
Q: What is the difference between CBER and CDER?
A: The mission of CBER is to protect and enhance the public's health through the regulation of biologics and related products, including blood and blood products, vaccines, allergenics, and emerging technologies such as human cells, tissues, and cellular and gene therapies. Biologics, in contrast to drugs that are synthetically derived, are from living sources (e.g., humans, animals, microorganisms) and not easily identified or characterized. Further, many biologics are manufactured using biotechnology.
CDER promotes and protects the public's health by ensuring that all prescription and nonprescription drugs marketed in the United States are safe and effective. CDER evaluates all new drugs before they are sold and monitors more than 10,000 drugs on the market to ensure that they continue to meet the standards of purity, potency, and quality.
Q: How does CBER contribute as a DIC?
A: CBER has divided the work of its DIC into two branches: the Consumer Affairs Branch (CAB) and the Manufacturers Assistance and Technical Training Branch (MATTB). Both branches are located within CBER's Office of Communication, Training, and Manufacturers Assistance. CAB serves as CBER's primary contact to nonregulated entities such as consumers, health care providers, and the trade press.
MATTB serves as the contact point for regulated entities such as manufacturers, sponsors, and trade associations. MATTB provides assistance to manufacturers for a variety of issues, including clinical investigator information, adverse-event-reporting procedures, electronic submissions guidance and requirements, and information on how to submit an investigational new drug (IND) application to administer an investigational product to humans.
The staff of CAB and MATTB comprises consumer safety officers (possessing a minimum of 30 hours of science-based college education), public affairs specialists, and an education specialist. Each branch has about six staff members, with a wide range of educational backgrounds (i.e., nursing, social work, animal science, journalism, and molecular genetics).
Q: What types of inquiries does CBER receive?
A: CAB responds to inquiries on topics such as blood and tissue donor eligibility criteria, product approval information, and tips for locating clinical trials. MATTB provides assistance and training through outreach to industry.
Q: How does CDER contribute as a DIC?
A: CDER's Division of Drug Information (DDI) serves as a focal point for public inquiries regarding human drug products. Inquiries include a broad range of topics related to the regulations of new, generic, and nonprescription drugs, as well as clinical aspects related to individual drug products and drug classes. DDI is staffed by 18 consumer safety officers, 12 of whom are pharmacists and 1 is a nurse.
Q: What are some of the most frequently asked questions that DDI receives?
A: The majority of inquiries are related to regulatory issues, such as the drug review process, and are classified as follows: investigational new drugs (16%), new drugs (13%), generic drugs (17%), over-the-counter drugs (7%), drug registration and listing (6%), import and export regulations (11%), patents and exclusivity (7%), adverse events (11%), recalls and shortages (5%), and drug identification (7%).
Q: What percentage of questions require an extensive literature search to answer?
A: The types of inquiries that CBER and CDER receive distinguish their DICs from traditional hospital and academic DICs. The primary distinction is that neither of FDA's DICs provides medical advice that deviates from FDA-approved prescribing information. As a result, these DICs do not necessarily conduct extensive literature searches to convey medical information regarding uses other than FDA-approved indications.
Both DICs provide extensive responses that may require the use of multiple resources within the respective center. For example, for complex issues, CBER DICs may leverage expertise from their product review offices and Office of Compliance and Biologics Quality. CDER has a similar knowledge base to respond to questions. When clarifying a guidance document of policy, DDI consults with the medical policy staff and the appropriate review divisions to formulate an appropriate response.
Q: How many inquiries are received?
A: CDER's DDI receives roughly 1000 telephone calls and 900 e-mails each week. The volume of inquiries is largely driven by FDA's webpages, which generate over 1 million hits each day.
From 2000 to 2007, the number of e-mail requests sent to DDI increased from 17,070 to 81,291, respectively, while the number of requests generated from letters decreased (from 8,419 to 914), and requests via telephone remained steady (from 29,487 to 34,114).
CAB devotes a considerable amount of resources to answer inquiries submitted by nonregulated entities through CBER's toll-free consumer line and consumer e-mail account. Combined, CAB and MATTB answer approximately 600 inquiries per month.
Q: What is the average turnaround time for each inquiry?
A: CDER's DDI typically provides a response to telephoned inquiries within the next business day and e-mail information requests within two business days. Responses may take longer if consultations with CDER experts are necessary.
CBER makes a point to respond to all telephone calls by the next business day and to e-mails within three days. Similar to CDER, questions submitted by regulated entities are complex and may require a significant amount of time to answer.
Q: What references are most commonly used by DDI to respond to its constituents?
A: Like all DICs, DDI uses traditional drug information resources. DDI also relies heavily on information posted to FDA's website. Individuals contacting DDI are often directed to additional information available to the public on the FDA website. One additional reference the staff relies on is an internal database that serves as a repository for previously researched and answered inquiries. A list of useful links to information found on the FDA website is provided in the table . DDI may be reached by telephone at (301) 796-3400 Monday through Friday or by e-mail at druginfo@fda.hhs.gov .
To contact CBER with general questions about biological products, e-mail the center at octma@fda.hhs.gov . For manufacturer assistance, e-mail matt@fda.hhs.gov or call (301) 827-1800. For general inquiries, call FDA at 1-888-INFO-FDA (1-888-463-6332).
