| FY 01 | FY 00 | FY 99 | FY98 | |
|---|---|---|---|---|
| Total ($000) | 153,479 | 132,703 | 124,365 | 123,012 |
The mission of the Biologics program is to ensure the safety, purity, potency, and effectiveness of biological products (primarily vaccines, blood products, and therapeutics) for the prevention, diagnosis, and treatment of disease. The products that the Biologics Program regulates are on the leading edge of technology. Rapid scientific advances in biochemistry, molecular biology, cell biology, immunology, genetics, and information technology are transforming drug discovery and development, paving the way for unprecedented progress in developing new medicines to conquer disease.
The number of Investigational New Drug Applications (INDs) and Investigational Device Exemptions (IDEs) received by the Biologics Program has increased almost 40% from FY 96 to FY 99. INDs and IDEs are an indication of future workload. Sponsors submit INDs/IDEs prior to beginning clinical trials to determine the safety and efficacy of the product in humans.
While scientific advances of new biological products promise great health benefits for U. S. consumers, FDA must ensure that these products are safe. FDA is also responsible for ensuring the safety of the nation's blood supply by minimizing the risk of infectious disease transmission and other hazards, while maintaining an adequate supply of whole blood and blood products. These challenges are represented by the Program's two strategic goals for the 21st century:
FDA has the responsibility for ensuring that vaccines and related products (such as botulinum toxin, skin test reagents for tuberculosis, and allergenic products) are safe and effective and adequately labeled. Vaccines against diseases such as Hepatitis B, polio, Haemophilus influenzae type b, mumps, measles, rubella, diphtheria, tetanus, pertussis, and chicken pox are recommended for all U.S. children, and vaccines against influenza and pneumococcal infections are recommended for all adults more than 65 years of age. Periodic tetanus and diphtheria booster vaccinations are recommended for all adults. The use of influenza vaccine among adults has, in recent years, increased markedly (to a current use of about 80 million doses/year). Additional vaccines are recommended for special groups (for example, Hepatitis A) or for travelers to particular areas of the world (e.g., Salmonella typhi or Japanese encephalitis virus vaccines). Many additional vaccines are in various stages of investigation (e.g., HIV or Herpes simplex virus vaccines) and their INDs are being reviewed.
FY 99 Program Accomplishments
CBER is continually challenged by the need to regulate new products of increasing technological complexity while still making strides in improving the efficiency and speed of the review process.
In FY 99, CBER completed the following major approval actions: 8 PLA/BLAs (including the approval of 1 vaccine and 7 therapeutics), 10 PMA/510(k)s, and 1 NDA. Major supplement approval actions comprised: 9 PLA/BLA supplements and 2 PMA supplements. The total approval actions included: 91 PLA/BLA/ELAs; 1,275 PLA/BLA/ELA supplements; 2 PMA and 7 PMA supplements; and 48 510(k)s. The following were among the major FY 1999 approvals.
On November 2, 1998, Etanercept, trade name, Enbrel, was approved. Enbrel brings about a reduction in signs and symptoms of moderate-to-severe active rheumatoid arthritis (RA) in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDS). Of the approximately two million Americans with RA, as many as a third to a half are estimated to have moderate-to-severe RA. Enbrel is a product of Immunex Corporation of Seattle, Washington.
Enbrel is a new genetically-engineered protein called etanercept. It can also be used in combination with methotrexate if patients do not benefit enough from use of methotrexate alone.
On December 21, 1998, Lyme Disease Vaccine (Recombinant OspA) was approved. The vaccine, LYMErix is for active immunization against Lyme disease in individuals aged 15-to-70 years of age. LYMErix is a product of SmithKline Beecham Biologicals of Belgium.
LYMErix is the first vaccine to aid in the prevention of Lyme disease, which is transmitted to people through the bites of ticks infected with the bacterium Borrelia burgdorferi. Approximately 13,000 confirmed cases of Lyme disease were reported to the CDC in 1997. LYMErix is marketed by SmithKline Beecham Pharmaceuticals of Philadelphia, PA.
CBER approved a new indication for a plasma-derived product called Antihemophilic Factor/von Willebrand Factor Complex (Human), marketed as Humate-P, on April 1, 1999. The product is now approved to treat severe or hard-to-treat cases of von Willebrand's disease (vWD), a bleeding disorder. It was previously approved for adult patients with hemophilia A. vWD affects approximately 1% of the U.S. population.
Strategic Goal 1:
Ensure the expeditious availability of safe and effective human drugs, including biologics, for the prevention, diagnosis, and treatment of disease.
A. Strategic Goal Explanation
Approach
The FDA is responsible for reviewing and approving biologics covered under the Prescription Drug User Fee Act (PDUFA). These products are primarily vaccines and therapeutics. FDA also has responsibility for reviewing and approving biologic products not covered by PDUFA. The non-PDUFA biological products are primarily blood and blood products, biotechnology-derived hematologics, allergenic products, and devices associated with their manufacture.
To provide the U.S. public with quicker access to new biologics, FDA consults closely with product sponsors early in product development, and makes prompt decisions on important new biological product applications. FDA will continue to make timely decisions in reviewing PDUFA product license applications (PLAs), Biologic License Applications (BLAs), and New Drug Applications (NDAs) and their supplements (performance goals 13001-13004). FDA will also continue to make timely decisions in reviewing non-PDUFA biologics, primarily blood and plasma products (performance goal 13005).
PDUFA Products: The Food and Drug Administration Modernization Act of 1997 (FDAMA), Public Law 105-115, amended the Prescription Drug User Fee Act (PDUFA) of 1992, and extended PDUFA through September 30, 2002. The PDUFA authorized revenues from fees paid by the pharmaceutical industry to expedite review by the FDA of human drug applications, including biologics. These revenues were directed by section 101(4) of this Act toward accomplishment of goals identified in the letters of November 12, 1997 from the Secretary of Health and Human Services to the Chairman of the Energy and Commerce Committee of the House of Representatives, and the Chairman of the Labor and Human Resources Committee of the Senate.
Fees that FDA collected from drug and biologic firms are used to reduce the evaluation time for certain human drug, including biologics, applications without compromising review quality. FDA primarily spent these PDUFA funds to acquire personnel to review applications and update the information technology (IT) infrastructure supporting the review process. PDUFA II will provide FDA with the resources necessary to sustain the larger application review staff. It will also provide FDA with additional funds to acquire the resources needed to achieve the more stringent performance goals.
The PDUFA time frames and performance goals are the result of in-depth negotiations between the drug industry and FDA. Industry and FDA determined that both the time frames and the percentage goals are realistic, achievable with the additional user fee resources, and desirable. The PDUFA time frames for drug applications differ in some cases from the Food, Drug and Cosmetic Act (FD&C) statutory requirements. Biologics applications are covered by the Public Health Service Act, which does not have any statutory time frames. Industry is pleased with the certainty of a timely action and response from the FDA review process and the net result of a higher percentage of applications being approved faster. Patients benefit by having more therapies available more quickly. Performance goals for PDUFA applications are based on the PDUFA time frames. Some of the more stringent PDUFA II goals are phased in over several years.
Non-PDUFA Products: The Biologics Program also reviews and approves license applications for products not covered by PDUFA. The mission of the Blood Program is to ensure that blood, blood products, biotechnology-derived hematologics, and devices associated with their manufacture and use, are safe, effective, and adequately labeled.
The blood supply is critical to the nation's health care system, and the United States has the safest blood supply in the world. Each year approximately 14 million blood units are drawn from volunteer donors for use in more than 3.5 million Americans. FDA vigorously continues to strengthen its efforts to protect the nation's blood supply, and to minimize any risk to patients acquiring the human immunodeficiency virus (HIV), hepatitis, Creutzfeldt-Jakob disease (CJD), and other blood-borne diseases.
Factors which affect the Agency's ability to achieve the performance goals are: the quality and complexity of applications, the number of applications received, and commitments which take researchers/reviewers away from their assigned review work, such as regulation/guidance writing.
Research and Standard-Setting Contributions
To provide effective regulatory review of biological products, the Center conducts active mission-related research programs. The research expands the Agency's knowledge of fundamental biological processes and provides a strong scientific base for regulatory review. The functions of CBER's research are:
CBER researchers are fully integrated into the application review process. They participate in the following regulatory procedures: review of INDs, and license applications; development of policy and guidance documents; meetings with sponsors and advisory committees; pre-license and biennial inspections; and evaluation of adverse drug reactions and risk assessment.
CBER's research supports the application review process. Various types of research are performed by CBER scientists. Research is conducted on specific products including but not limited to mechanism of action, potential toxicity, and surrogate measures of efficacy. Research is also performed on specific policy issues related to product class, disease area and therapeutic modality. Research associated with the development of methods and standards is also conducted.
The standardization and testing of vaccines for lot release is also one of FDA's responsibilities, and this activity continues to be a major effort. Each year CBER is responsible for the development of the reassortant influenza viruses that are used by the manufacturers for vaccine production. FDA is also responsible for the development of the sera that is used for the assignment of vaccine potency. CBER tests many vaccines for potency and safety in its laboratories.
The Agency also conducts research of blood and blood products pertinent to FDA's regulatory mission. FDA will continue to develop regulations to screen and test donors for infectious diseases. The ability of FDA to protect the nation's blood supply is enhanced through scientific efforts to understand HIV, hepatitis, CJD, and other blood-borne diseases. The ability of CBER scientific reviewers to ensure the safety and efficacy of blood screening tests and other new technology is increased through applied regulatory research.
Leveraging/Communication
CBER's vision statement (CBER Vision: 2004) includes the following statement: "CBER demonstrates international leadership in regulation through development of innovative regulatory strategies and standards, a managed regulatory process, coordinated research, and use of partnerships." The efficient use of resources through leveraging is a CBER strategic goal. CBER will examine the feasibility of using external resources to perform some application review functions. CBER collaborates with other Department of Health and Human Services (DHHS) agencies (the Centers for Disease Control and Prevention [CDC], the National Institutes of Health [NIH], and the National Vaccine Program Office [NVPO]), the Department of Defense, and the Department of Veterans Affairs on issues relating to biological products. CBER actively participates in several staff fellow programs under the National Research Council (NRC), the NIH, and the Oak Ridge Institute for Science and Education (ORISE). Through these programs, CBER enhances the educational programs offered by academic institutions, strengthens its scientific and technical resource base, transfers its knowledge and technology to the academic community, and supports a growing national commitment to scientific education. Cooperative Research and Development Agreements (CRADAs), under the Federal Technology Transfer Act of 1986, are utilized by CBER.
FDA scientists continue to play an active role in many national and international groups and organizations involved in setting vaccine policy and utilization, including: the Interagency Group of the NVPO; the National Vaccine Advisory Committee; the Advisory Commission on Childhood Vaccines; the Advisory Committee on Immunization Practices; the Committee on Infectious Diseases of the American Academy of Pediatrics; the World Health Organization; the Children's Vaccine Initiative; and national vaccines control agencies such as the National Institute of Biological Standardization and Control (in the UK). For vaccine-related issues, FDA continues to work closely with the NIH (especially National Institute of Allergy and Infectious Diseases [NIAID]), and the CDC. The Office of Vaccines Research and Review continues to play an active role on committees related to AIDS, such as the NIH HIV Vaccine Selection Committee.
CBER personnel have played key roles in CISET, the PHS Interagency Working Group on Influenza Pandemic Preparedness, the Adult Immunization Plan, and the TB vaccine development plan.
Reinvention
The Biologic's Program implemented a Managed Review Process to ensure that the PDUFA performance goals are achieved. This process establishes timeframes for specific review events so that managers can obtain current status of application review and to ensure that goals are met. The current process covers licensing submissions and is initiated by a request from industry for a pre-pivotal trial meeting. The process ends with the licensure of the biological product. The process has been so successful that management has extended the Managed Review Process to include non-PDUFA applications. The full implementation of the Managed Review Process will make the application review process more efficient and speed the review of applications.
FDA will also extend its current blood oversight, and regulation revitalization and reinvention project. The major areas to be addressed include: development of the BLA as it applies to blood establishments; development of Agency-wide goals and direction; coordination of Agency-wide resources to protect the blood supply; and the revitalization and rewrite of blood regulations. The Blood Action Plan was initiated in July 1997, to increase the effectiveness of scientific and regulatory actions, and to ensure greater coordination among PHS agencies. The Action Plan addresses highly focused areas of concern such as emergency operations; response to emerging diseases; monitoring the blood supply; and updating blood regulations. Implementation of the Blood Action Plan has greatly improved the regulatory oversight and safety of the nation's blood supply.
FDA also continues to improve efficiency of its review process by its automation initiative. The Agency is in the process of transitioning from a largely paper-based regulatory submission and review environment to an electronic environment. This process is designed to meet the PDUFA IT goal that "the agency shall develop and update its information infrastructure to allow by FY 02, the paperless receipt and processing of INDs and human drug applications."
B. Summary of Performance Goals| Performance Goals | Targets | Actual Performance | Reference1 |
|---|---|---|---|
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1. Review and act on 90% of standard original NDA/PLA/BLA submissions within 12 months of receipt (70% within 10 months); and review and act on 90% of priority original NDA/PLA/BLA submissions within 6 months of receipt. (13001) |
Standard Applications within 12 months: FY 01: 90% FY 00: 90% FY 99: 90% Standard Applications within 10 months: FY 01: 70% FY 00: 50% FY 99: 30% Priority Applications within 6 months: FY 01: 90% FY 00: 90% FY 99: 90% |
Standard Applications within 12 months: FY 01: FY 00: FY 99: 11/00 FY 98: 100% FY 97: 100% FY 96: 100% Standard Applications within 10 months: FY 01: FY 00: FY 99: 09/00 FY 98: NA FY 97: NA Priority Applications within 6 months: FY 01: FY 00: FY 99: 05/00 FY 98: 100% FY 97: 100% |
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2. Review and act on 90% of standard efficacy supplements within 12 months of receipt (70% within 10 months); and review and act on 90% of priority efficacy supplements within 6 months of receipt. (13002) |
Standard Applications within 12 months: FY 01: 90% FY 00: 90% FY 99: 90% Standard Applications within 10 months: FY 01: 70% FY 00: 50% FY 99: 30% Priority Applications within 6 months: FY 01: 90% FY 00: 90% FY 99: 90% |
Standard Applications within 12 months: FY 01: FY 00: FY 99: 11/00 FY 98: 100% FY 97: 100% FY 96: 88% Standard Applications within 10 months: FY 01: FY 00: FY 99: 09/00 FY 98: NA FY 97: 44% Priority Applications within 6 months: FY 01: FY 00: FY 99: 05/00 FY 98: 100% FY 97: 100% |
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3. Review and act on 90% of manufacturing supplements within 6 months of receipt, and review and act on 70% within 4 months of receipt. (13003) |
Within 6 months: FY 01: 90% FY 00: 90% FY 99: 90% Within 4 months: FY 01: 70% FY 00: 50% FY 99: 30% |
Within 6 months: FY 01: FY 00: FY 99: 05/00 FY 98: 99% FY 97: 98% FY 96: 99% Within 4 months: FY 01: FY 00: FY 99: 03/00 FY 98: NA FY 97: 26% |
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4. Review and act on 90% of Class 1 resubmitted original applications within 2 months; and review and act on 90% of Class 2 resubmitted original applications within 6 months of receipt. (13004) |
Class 1 resubmissions within 2 months: FY 01: 90% FY 00: 70 % FY 99: 50% Class 1 resubmissions within 4 months: FY 01: NA FY 00: 90% FY 99: 90% Class 2 resubmissions within 6 months: FY 01: 90% FY 00: 90% FY 99: 90% |
Class 1 resubmissions within 6 months: FY 98: 100% Class 1 resubmissions within 2 months: FY 01: FY 00: FY 99: 100% FY 98: 100% Class 1 resubmissions within 4 months: FY 01: FY 00: FY 99: 100% FY 98: NA Class 2 resubmissions within 6 months: FY 01: FY 00: FY 99: 05/00 FY 98: 100% |
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5. Review and act on 85% of complete blood bank and source plasma PLA/BLA submissions, and 90 percent of PLA/BLA Major supplements within 12 months after submission date. (13005) |
Complete Submissions: FY 01: 85% FY 00: 85% FY 99: 60% Major Supplements FY 01: 90% FY 00: 90% FY 99: 90% |
Complete Submissions: FY 01: FY 00: FY 99: 11/00 FY 98: 85% FY 97: 83% FY 96: 95% Major Supplements FY 01: FY 00: FY 99: 11/00 FY 98: 97% FY 97: 98% |
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TOTAL FUNDING ($000) |
FY 01: $117,677 FY 00: $103,201 |
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1. Increase: Indicates achievement of the goal is dependent upon increased resources in FY 01. NPR: Goal supports an FDA National Partnership for Reinventing Government Goal |
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C. Goal-By-Goal Presentation of Performance
Note about Baseline Data: In several years of the program, performance (Baseline Data) exceeds the projected performance goals. The projected performance goals are as the Secretary committed to in her letters to Congress. "NA" means the goal is not applicable in that fiscal year.
1. Review and act on 90% of standard original NDA, PLA, and BLA submissions within 12 months of receipt (70% within 10 months); and review and act on 90% of priority original NDA/PLA/BLA submissions within 6 months of receipt. (13001)
2. Review and act on 90% of standard efficacy supplements within 12 months of receipt (70% within 10 months); and review and act on 90% of priority efficacy supplements within 6 months of receipt. (13002)
3. Review and act on 90% of manufacturing supplements within 6 months of receipt, and review act on 70% within 4 months of receipt. (13003)
4. Review and act on 90% of Class 1 resubmitted original applications within 2 months; and review and act on 90% of Class 2 resubmitted original applications within 6 months of receipt. (13004)
5. Review and act on 85% of complete blood bank and source PLA/BLA submissions, and 90% of PLA/BLA Major supplements within 12 months after submission date. (13005)
Strategic Goal 2:
Reduce the risk of biologics products on the market through assuring product quality and correcting problems associated with their production and use.
A. Strategic Goal Explanation
Approach
FDA is required by law to conduct biennial inspections of all licensed establishments to determine compliance with Current Good Manufacturing Practice (CGMP) regulations and to ensure compliance with applicable product and establishment standards and license commitments. In addition, FDA inspects all manufacturing facilities, which are unlicensed and/or under contract to a licensed establishment. FDA conducts biomedical research inspections to review pivotal clinical trial data, and in inspections of new tissue-cellular based products.
By accomplishing the performance goals 13007 and 13012, the Biologics Program will ensure that biologics establishments are in compliance with regulations and that the products produced in those establishments are safe and pure. The Biologics Program also ensures that high-risk plasma fractionator establishments are in compliance (performance goal 13008).
Factors which affect the FDA's ability to achieve the performance goals are unanticipated crises such as product tampering, which require immediate investigative and enforcement actions and take inspectors investigators away from their planned assignments.
The availability of qualified scientific personnel to review, evaluate and investigate postmarket adverse events affects the Agency's ability to make sound and timely decisions concerning recalls and withdrawals.
Research and Standard-Setting Contributions
The Center statistically evaluates clinical and pre-clinical studies of human products and vaccines, and epidemiologically evaluates post-marketing studies and adverse biologics events.
CBER researchers are fully integrated into the compliance process. They participate in pre-license and biennial inspections and the evaluation of adverse drug reactions and risk assessment. CBER research supports regulatory decisions to recall or withdraw products from the market.
Leveraging/Communication
FDA continues its efforts to leverage the Agency's enforcement capability internationally by working toward mutual recognition agreements (MRAs) with the European Community and other nations so imports entering the United States meet the same high quality and safety standards of U.S. produced products.
FDA will continue to collaborate closely with other government and non-government regulatory organizations such as the National Institute of Health, Centers for Disease Control and Prevention, state health agencies, the American Red Cross, and the American Association of Blood Banks to assure that all policies are mutually consistent in guarding the safety of the nation's blood supply.
Reinvention
In addition to enhancing quality assurance procedures in blood banks, FDA will be defining new strategies for blood bank inspections based on control processes for critical production points. The Agency will also provide training programs for inspectors to implement the new approaches; conduct workshops to clarify Agency expectations for industry; and evaluate the need for changes in the error and accident reporting requirements. Biologics is working towards the goal of an integrated Agency-wide Adverse Event Reporting Initiative.
FDA will continue to improve donor-eligibility criteria and deferral programs. It will also continue studies to assess the effectiveness of donor interview and education programs, and coordinate a national effort to address concerns regarding donor-deferral registries.
CBER's Managed Review Process is a system implemented to meet PDUFA performance goals. CBER's success with its Managed Review Process impressed upon CBER's senior managers the need to expand the principles of this process to CBER's entire regulatory process. Senior management incorporated the goal of "a managed and integrated regulatory process which is continuous from discovery through post marketing", into their strategic vision for the year 2004.
B. Summary of Performance Goals
| Performance Goals | Targets | Actual Performance | Reference1 |
|---|---|---|---|
| 6. Assure that FDA inspections of domestic biologics manufacturing, repacking and blood banks establishments result in a high rate of conformance (at least 90%) with FDA requirements (13007) |
FY 01: at least 90% FY 00: at least 90% FY 99: at least 90% |
FY 99: 98% FY 98: 98% FY 97: 98% |
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7. Maintain the percentage of plasma fractionator establishments in compliance with CGMPs at 80%. (13008) |
Currently 26 foreign and Domestic Plasma Fractionator establishments FY 01: 80% FY 00: 80% FY 99: 80% |
FY 01: FY 00: FY 99: 62%, 16 out of 26 in compliance FY 98: 54%, 13 out of 24 in compliance FY 97: 41%, 9 out of 22 in compliance FY 96: 75%, 9 out of 12 establishments inspected were in compliance |
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8. Meet the biennial inspection statutory requirement by inspecting 50% of registered blood banks, source plasma operations and biologics manufacturing establishments. (13012) |
FY 01: 50% FY 00: 50% FY 99: 43% |
FY 99: 64% FY 98: 46% FY 97: 46% of establishments inspected |
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TOTAL FUNDING ($000) |
FY 01: $35,802 FY 00: $29,502 |
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1. Increase: Indicates achievement of the goal is dependent upon increased resources in FY 01. NPR: Goal supports an FDA National Partnership for Reinventing Government Goal |
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C. Goal-By-Goal Presentation of Performance
6. Assure that FDA inspections of domestic biologics manufacturing, repacking and blood banks establishments, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high conformance rate with FDA requirements (at least 90%)
7. Maintain the percentage of plasma fractionator establishments in compliance with CGMPs at 80%. (13008)
8. Meet the biennial inspection statutory requirement by inspecting 50% of registered blood banks, source plasma operations and biologics manufacturing establishments.(13012)
The Biologics Program uses various databases to mange its diverse programs and to assess performance. The principal CBER database is the Biologics Regulatory Management System (BRMS). The BRMS is CBER's VAX-based, Oracle database that is used to track all PLA, BLA, and supplement submissions; provide information to facilitate the review process (product, application status, milestone tracking, facility, review committee, industry contacts, and other information); and produce a wide variety of management reports. The BRMS records application review information on each license application and supplement received and filed by the Center. The BRMS records information about PDUFA and non-PDUFA license applications. The milestone tracking module is used to track and report on CBER's PDUFA goals. Data entry is done in each of the offices' application review divisions. The Regulatory Information Management Staff (RIMS) monitors and is responsible for maintaining data quality and integrity in BRMS.
The Biologics Investigational New Drug (IND) Management System (BIMS) is CBER's VAX-based, Oracle database that is used to track all Investigational New Drug Applications (IND), Investigational Device Exemption (IDE), and Master Files (MF) submissions (over 12,000 in 1998); provide product, application status, and other information to facilitate the review process; and produce a wide variety of management reports. The system also stores summaries of telephone conversations and meetings related to the submissions, as well as actually generating some of the correspondence to sponsors. Most data entry is done by the Document Control Center (DCC) or the Consumer Safety Officers in each office's application review division. There are numerous mechanisms established for quality control in DCC, the application review offices, the Regulatory Information Management Staff, and several built into BIMS itself.
The Blood Logging and Tracking System (BLT) is under development by the Office of Blood Research and Review (OBRR) to record and track the various applications reviewed by that Office. The OBRR receives and reviews a wide variety of application types. PLAs, ELAs (Establishment License Applications) and BLAs are tracked by the BRMS, discussed above. INDs are tracked by the BIMS, also discussed above. The Office utilizes the BLT to record and track data concerning device premarket applications (PMAs) and PMA supplements, 510(k)s, and Abbreviated New Drug Application (ANDAs) and ANDA supplements. The Office also has an NDA tracking system.
The data retrieved from these systems are reviewed and validated by the RIMS and the application review offices. If errors are detected, they are corrected.
Federal regulations (21 CFR, Part 600.14) require reporting of errors and accidents in the manufacture of biological products that affect the safety, purity, or potency of the product. The error and accident reporting process enables the Agency to evaluate and monitor establishments, to provide field staff and establishments with trend analyses of the reported error and accident types, and to respond appropriately to reported errors and accidents to protect the pubic health. The regulation applies only to licensed manufacturers.
In May 1995, the DHHS Office of the Inspector General issued a report recommending that the reporting requirements be expanded to include unlicensed blood banks and transfusion services. A proposed rule was issued on September 23, 1997 that expands the reporting requirements to all biological product manufacturers regulated by FDA.
In the past five years, the Agency has received an average of 12,000 error and accident reports annually. FDA estimates that over 116,000 error and accident reports would be received under the proposed regulation. FDA does not have a computer system to permit the electronic submission of error and accident reports. If the Agency is to comply with the intended goals of the error and accident reporting regulation, it will need a system that would allow it to receive electronic submission of reports; and to review, process, and analyze more than 100,000 reports annually.
The Biologics Program relies in the Office of Regulatory Affairs' Field Accomplishments and Tracking System (FACTS) to register and record biologics manufacturing establishment inspection and compliance data. FACTS versions 1 and 2 together will replace the several dozen applications that comprise the current Field Information System (FIS). The software development contractor delivered FACTS version 1 to the FDA on September 30, 1997. Version 1 functionality includes all sample collections; all sample tracking, accountability, and dispositions; sample analysis of pesticides, additives, colors, elements, mycotoxins and radionuclides; firms inventory, maintenance and registration; work assignments and work management; and other features.
Meanwhile, the design and development of FACTS version 2 is underway. Major features of version 2 include replacing the remaining FIS functions: remainder of lab analyses; inspections; rest of investigations including records and tracking; compliance functions; other core items including personnel management (MUS); and miscellaneous operations including recalls and audit checks.
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