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Office of the Assistant Secretary for Planning and Evaluation |
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Policy Information Center |
MISSION: To protect and promote public health through food, drug, medical device, and cosmetic regulation.
Evaluation Program
The Food and Drug Administration’s FY 2000 Evaluation Program ultimately reflected some of the goals established and promulgated by the Department of Health and Human Services (HHS) for which FDA has responsibility. HHS’s goals are products of its strategic performance planning process, and FDA uses its own strategic framework to accomplish these goals. This process also satisfies the implementation requirements of the Government Performance and Results Act (GPRA) and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The strategic and performance process is an evolving set of program directions for FDA as changes occur in FDA’s dynamic environment. FDA’s challenges, now and in the future, will rest on its ability to leverage its efforts in that environment, which grows increasingly complex and more institutionally networked. The Agency will strive to maintain the scientific knowledge base necessary to achieve greater effectiveness in assuring the quality and availability of the products it regulates.
One goal area within FDA’s strategic framework is Pre-Market Review, where the objective is to make timely and cost-effective pre-market review decisions, while assuring product safety and efficacy. The results achieved and reported in the Prescription Drug User Fee Act (PDUFA) FY 2000 Performance Report, are one indication of how well FDA is meeting its goal of making timely pre-market review decisions. The focus of performance goals under PDUFA is to expedite the entire drug development and review process, from research to approval, without compromising the safety or the quality expected from the Agency’s application review process.
Another goal area within FDA’s strategic framework is Internal Capacity, which focuses onFDA’s ability to make effective pre and post-market regulatory decisions. One strategy for accomplishing this goal is through the implementation of decision-supportive information systems where reporting burdens are being reduced for the regulated industry. For example, FDAMA has afforded FDA greater flexibility in the scope and amount of data collected and reported on medical devices than was possible under the previous mandate. The Agency has reevaluated the requirements already in place, removing those that no longer made sense from a public health perspective. As a result, hundreds of device tracking and post-market surveillance orders were rescinded for more than a dozen product types. FDAMA also enabled FDA to modify its user-facility reporting program for medical devices from a mandated universe of facilities to a representative sample of facilities.
External Leveraging, another element of FDA’s strategic framework, represents a significant shift in FDA’s direction for the twenty-first century as the Agency works to leverage a more technologically complex environment. One strategy involves fostering industry quality assurance programs, thereby capitalizing on the quality and safety control capabilities already resident in the regulated industry. HACCP (Hazard Analysis Critical Control Point) programs and the implementation of the Mammography Quality Standards Act (MQSA) are two examples of this approach that are underway.
The fourth and final goal area within FDA’s strategic framework is Post-Market Assurance, a goal that strives to strengthen the assurance that products on the market, or about to enter the market, are safe. One strategy of accomplishing this goal is by targeting high-risk products. The Tobacco Program illustrated one of the initiatives in this area. Prior to the court decision that ended this program, FDA planned to reduce access to tobacco products by youths under 18 through new FDA requirements for retailers.
On December 29, 1995, the FDA announced its plan to review its regulations pertaining to identity, quality and container fill for standardized foods, and its common or usual name regulations for non-standardized foods. The agency solicited comments from interested parties on whether these regulations should be retained, revised, or revoked. The FDA solicited comments on the benefits or lack of benefits of these regulations in facilitating domestic and international commerce. The FDA also asked for comments on the value of these regulations to consumers, and on alternative means of accomplishing the statutory objective of food standards. This was done in an effort to promote honesty and fairness in the interest of consumers. The FSIS published a similar announcement regarding its intent to consider whether to modify or eliminate specific Standards of Identity for meat and poultry products, or to modify its overall regulatory approach to standardized meat and poultry products. The FDA and the FSIS need information on how consumers would be affected by changes in Federal Standards of Identity for foods. Most importantly, the two agencies need information on whether consumers would prefer that particular standards be retained, modified, or eliminated for various types of food. (See PIC ID 6865.1, 6865.2)
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Clark Nardinelli, 202-205-8702
PIC ID: 6865
PERFORMER: Research Triangle Institute, Research Triangle Park, NC
FDA needs sales information on dietary supplements in order to perform its regulatory mission under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Provisions of DSHEA define dietary supplements and ingredients and set forth new labeling requirements whereby manufacturers must notify FDA of new dietary ingredients prior to marketing. Under the DSHEA, the Secretary of Health and Human Services is authorized to regulate dietary supplements and to prescribe good manufacturing practices (GMPs) for the industry. FDA contracted with RTI to conduct a survey on dietary supplement products according to a statistical sampling plan and to provide a database containing information on dietary supplement products. The report entitled Dietary Supplement Sales Information documents the procedures used to select a sample of approximately 3,000 dietary supplements sold in the United States through retail establishments, mail-order catalogs, and the Internet. It also describes the Dietary Supplement Product Database, which contains information collected for each of these products and provides a summary of the information in the database.
AGENCY SPONSOR: Food and Drug Administration
FEDERAL CONTACT: Clark Nardinelli, 202-205-8702
PIC ID: 7082
PERFORMER: Research Triangle Institute, Research Triangle Park, NC
This evaluation assessed the quality of written prescription information provided voluntarily to individuals receiving new prescription medicines in community pharmacies. The study tested whether fictitious patients as observers were given any written prescription information by pharmacists whom they asked for drugs prescribed (in addition to the labels and stickers on their medication containers). The quality of written information was also assessed. This pilot study produced encouraging results for consumers: (1) nearly 87% of new prescriptions were dispensed with some written prescription information in addition to the label and stickers on the medication container, suggesting that the provision of written prescription information is becoming a routine practice in community pharmacies; and (2) expert panelists found that most written information sheets were accurate and unbiased in content and tone. They included necessary details for monitoring and interpreting adverse reactions and appeared legible and comprehensible to consumers. The study raised several concerns: most patient information was rated low on identifying precautions, their significance, and how to avoid them, and storage instructions and general information. The study will be repeated nationally in 2001 and the results will be used to identify areas for improvement in consumer communication of prescription information.
AGENCY SPONSOR: Center for Drug Evaluation and Research
FEDERAL CONTACT: Mary Bender, 202-205-5592
PIC ID: 7496
PERFORMER: University of Wisconsin, Madison, WI
The Prescription Drug User Fee Act (PDUFA) authorized FDA to collect fees from companies that produce human drug and biological products. The PDUFA annual performance report to Congress for FY 2000 focuses on the Agency's performance toward the agreed-upon numeric goals for reviewing and acting on submissions and responding to sponsors' pre-submission requests. The major accomplishments to report are: (1) FDA continued to exceed nearly all the review performance goals in FY 2000— increasing numbers of applications filed; higher quality applications; quicker approvals for products with the requisite data; and outcomes that result in more quality products reaching American practitioners and consumers faster; (2) application filings and quality remain high by historic standards and approval times continue to drop; (3) compared to the approval rates for all new drug applications, there is a smaller increase in approval rates for new molecular entities (NMEs), unique new drugs that are approved for the first time by FDA; (4) median total approval time (i.e., time from the initial submission of a marketing application to the issuance of an approval letter) for priority applications submitted in FY 99 was 6 months, less than half the median approval times for priority applications submitted in the early PDUFA years. The FDA performance report states that since the passage of PDUFA there has been a shift in the pattern of NME introductions with more American patients now receiving the benefits of important new drugs before they are available to citizens of other countries. This shift requires that FDA be increasingly vigilant in its post- market surveillance efforts.
AGENCY SPONSOR: Food and Drug Administration
FEDERAL CONTACT: Dennis Hill, 301-827-5255
PIC ID: 6079.5
PERFORMER: Office of Planning, Policy Analysis and Legislation, Rockville MD
The objective of this study was to evaluate the safety of infant immunization with acellular pertussis vaccines in the U.S. The study consisted of reports of infant immunization against pertussis between January 1, 1995 (when whole-cell vaccine was in exclusive use) and June 30, 1998 (when acellular vaccine was in predominant use). The annual number of reported events categorized as non-fatal serious reported to the Vaccine Adverse Event Reporting System (VAERS) for all pertussis-containing vaccines declined between 1995 and 1998. It was concluded that VAERS data (although subject to the limitations of passive surveillance) support the prelicensure data with regard to the safety of the US licensed acellular pertussis vaccines that were evaluated.
AGENCY SPONSOR: Center for Biologics Evaluation and Research
FEDERAL CONTACT: Miles M. Braun, 301-827-3974
PIC ID: 7251
PERFORMER: Food & Drug Administration, Ctr. for Biologics Evaluation, Rockville, MD
The Food and Drug Administration (FDA) uses the Food Label and Package Survey (FLAPS) data to support policy, regulatory, food safety decisions, and economic impact assessments. FDA has used FLAPS data to gain information on nutrition labeling on product packages, the extent of labeling on various nutrients, the extent of use of specific product ingredients; the accuracy of product serving sizes, and the prevalence of various health claims on food products. In 1997, FDA conducted the eleventh FLAPS survey. Findings indicated that nutrition-labeled products accounted for an estimated 97% of the annual sales of processed, packaged foods. Nutrient content and health claims appeared on an estimated 39% and 4%, respectively, of the products sold.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Lori A. LeGault, 202-205-5269
PIC ID: 5711.2
PERFORMER: A.C. Nielsen Company
Schaumburg IL
The Food and Drug Administration contracted with the Research Triangle Institute (RTI) to conduct a survey of the dietary supplement industry to learn more about manufacturing practices in the industry and what constitutes good manufacturing practices (GMPs). This effort is part of the process of considering whether to institute rule making to develop GMP regulations. Information from this survey was to help the agency formulate a policy to ensure that dietary supplement products are produced under conditions that will result in a safe and properly labeled product without unnecessary costs to the industry. A sample of 966 dietary supplement establishments were selected from the Dietary Supplement Enhanced Establishment Database. A telephone/mail survey was used for data collection and a total of 238 completed questionnaires were received. This report describes the sample design and survey administration procedures and presents summary statistics for the survey questions.
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Clark Nardinelli, 202-205-8702
PIC ID: 7499
PERFORMER: Research Triangle Institute, Research Triangle Park, NC
This report published in Pharmaceutical Technology in January 2000. The article describes the Food and Drug Administration methods validation program for proposed regulatory methods submitted through the new abbreviated new drug application processes. The program is conducted by the Center for Drug Evaluation and Research (CDER) to ensure that scientifically well-founded regulatory methods are available to assess the quality of CDER-approved products. Industry, FDA, and the United States Pharmacopeia and the National Formulary have the common objective of ensuring that drugs in the US marketplace have consistent standards for drug substances and drug product regardless of the synthesis and manufacturing process. This is achieved by ensuring that the analytical methods used for new drug products are submitted for adoption as public standards soon after approval for marketing.
AGENCY SPONSOR: Center for Drug Evaluation and Research
FEDERAL CONTACT: Moheb Nagr, 314-589-2136
PIC ID: 7106
PERFORMER: Food and Drug Administration, St. Louis, MO
Recent examples of studies that have provided information to specific review decisions include: (1) interactions and metabolism studies of anti-cancer drugs such as paclitaxel, (2) anti-abuse drugs such as LAAM, (3) anti-HIV drugs such as the protease inhibitors, (4) anti-epileptic drugs, (5) cardiovascular drugs, and (6) anti-malarial drugs. In addition to the general technical expertise brought to bear on these problems, results from the program have been incorporated into final product labeling for some drugs, including paclitaxel and saquinavir. Labeling changes for other drugs are under discussion. Also, cutting- edge issues regarding cases of intermediate potency for cytochrome P450 pathways are under investigation.
EXPECTED DATE OF COMPLETION:10/01/2001
AGENCY SPONSOR: Center for Drug Evaluation and Research
FEDERAL CONTACT: Jerry Collins, 301-427-1065
PIC ID: 7103
PERFORMER: Food and Drug Administration, Rockville MD
This survey was implemented by the Food and Drug Administration (FDA) in 1977 with the purpose of producing a database containing label and package information obtained from a sample of processed food products. Food Labeling and Packaging (FLAPS) data enable FDA personnel to keep abreast of market responses to food labeling rules via changes in package labels.
EXPECTED DATE OF COMPLETION:09/30/2001
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Mary E Bender, 202-205-5592
PIC ID: 5711.3
PERFORMER: Food and Drug Administration, Rockville, MD
The Nationwide Evaluation of X-Ray Trends (NEXT) is a collaborative program conducted jointly between the Food and Drug Administration (FDA) and State radiation control agencies. The study estimates the radiation dosage from diagnostic x-ray examinations, using data collected from previous NEXT surveys of different types of x-ray examinations. The data are used by public health and professional organizations in setting policy.
EXPECTED DATE OF COMPLETION:09/30/2001
AGENCY SPONSOR: Center for Devices and Radiological Health
FEDERAL CONTACT: Orhan Suleiman, 301-594-3533
PIC ID: 4984
PERFORMER: Food and Drug Administration, Rockville MD
The Prescription Drug User Fee Act (PDUFA) of 1992 provided FDA with greater resources for the review of human drug and biologic applications. Fees that FDA collected from drug and biologics firms were used to reduce the time required to evaluate human drug applications without compromising review quality. FDA has submitted annual Performance and Financial Reports to Congress on progress in streamlining the drug review process and use of PDUFA fees. The original act expired September 30, 1997, but the FDA Modernization Act of 1997 amended and extended PDUFA through September 30, 2000. The amended act is now referred to as PDUFA II and its predecessor as PDUFA I.
EXPECTED DATE OF COMPLETION:09/30/2001
AGENCY SPONSOR: Food and Drug Administration
FEDERAL CONTACT: Dennis Hill, 301-827-5255
PIC ID: 6079.6
PERFORMER: Office of Policy, Planning, and Legislation, FDA, Rockville MD
Sepsis affects half a million people annually. Even though a large number of trials have been conducted, no therapeutic agent demonstrating clinical benefit or superiority to standard care has been identified. Designing clinical trials that have any probability of demonstrating efficacy is challenging, due to the heterogeneity of patient populations, poor understanding of the pathophysiology of acute sepsis, and lack of uniformly accepted standards of care in international trials. Intensive efforts have been undertaken by the Food and Drug Administration (FDA) to propose the optimal trial design and prospective analysis plans. Currently, an analysis of the failed sepsis trials is being initiated by the FDA with the hope of better clinical trials for the evaluation of the adjunctive therapy of sepsis in the future.
EXPECTED DATE OF COMPLETION:10/01/2001
AGENCY SPONSOR: Center for Biologics Evaluation and Research
FEDERAL CONTACT: Miles M. Braun, 301-827-3974
PIC ID: 6736
PERFORMER: Food and Drug Administration, Rockville MD
This project consists of a two-part survey of current hazard assessment quality control points (HACCP) that will: (1) yield information for the purposes of estimating the HACCP-related practices of the food industry (except seafood, meat and poultry), and (2) estimate the marginal costs to firms for compliance with HACCP.
EXPECTED DATE OF COMPLETION:03/02/2001
AGENCY SPONSOR: Center for Food Safety and Applied Nutrition
FEDERAL CONTACT: Clark Nardinelli, 202-205-8702
PIC ID: 6866
PERFORMER: Food and Drug Administration, Rockville MD