Performance Improvement 2003. Summary of Findings

CDER 2001 Report to the Nation: Improving Public Health Through Human Drugs

The Center promotes and protects public health by assuring safety and effectiveness of drugs used by Americans. The Food and Drug Administration (FDA) Modernization Act of 1997 affirmed the center’s public health protection role, clarified the FDA’s mission and called for the FDA to do the following: (1) promote public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of human drugs in a timely manner, (2) protect the public health by ensuring that human drugs are safe and effective, (3) participate through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements and achieve appropriate reciprocal arrangements, and (4) carry out its mission in consultation with experts in science, medicine and public health and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of human drugs. Among many findings, this report states that: (1) people with cancer, heart disease, HIV, AIDS, and other serious conditions have benefited from FDA approvals in 2001; FDA met its obligations to Congress for prompt and thorough review of drug applications supported by user fees; (2) with modern, state-of-the-art tools and techniques, FDA was  able to detect rare and unexpected risks more rapidly and take corrective action more quickly; and FDA augmented its risk assessment ability by gaining access to user fee data. http://www.fda.gov/cder/reports/rtn/2001/rtn2001.pdf

FEDERAL CONTACT: Debbie Henderson, 301-443-5281 PIC ID: 7890

PERFORMER: Food and Drug Administration, Rockville MD

Assessment of the Availability of Mammography Services

This analysis provided an overview of the availability of mammography services and of the changes in the demand for and supply of mammograms in recent years. It has been suggested that closures and  service curtailments by mammography providers have made it more difficult for women to schedule and obtain mammograms within a reasonable length of time. The possible shortage of mammography services has raised concerns that some women are not receiving needed mammograms due to limitations in access. The data from the FDA mammography database, in combination with population data, showed that the number of mammography facilities has declined in most states while the population of potential recipients of mammography services has increased. This suggested an increased demand relative to the supply of mammography services. The number of facilities did not capture the effective capacity of mammography providers. The CDC data failed to support claims that closures of mammography facilities or increased demand for mammography services have negatively affected the number of women obtaining mammograms. Data from CDC surveys, when combined with FDA data, show that providers conducted substantially more mammograms per facility in 2000 than they did in 1997. Other CDC survey data describing the prevalence of women who received clinical breast exams and mammograms showed that an increasing percentage of women in the 40 and older age group had recently obtained a mammogram. Furthermore, when only women receiving clinical breast exams were considered, an increased percentage received a mammogram in the same year. http://www.fda.gov/cdrh/mammography/mamavail01.pdf

FEDERAL CONTACT: Steve Tucker, (301) 827-5339

PIC ID: 6082.1

PERFORMER: Eastern Research Group, Lexington, MA

Cost Analysis of the Labeling and Related Testing Requirements for Medical Glove Manufacturers

The FDA is proposed regulations to reclassify surgeons’ and patient examination gloves as Class II medical devices, and placed controls and restrictions on the manufacturers and on some users of these products.  The reclassified gloves, including those made of natural rubber latex or synthetic material, were regulated in four categories: (1) powdered surgeons’ gloves, (2) powder-free surgeons’ gloves, (3) powdered patient examination gloves, and (4) powder-free patient examination gloves. This report showed that under the proposed regulation, the newly recommended protein and powder limits were lower than current average levels. In addition, the regulation required manufacturers to place expiration dates on glove labels to ensure adequate barrier protection (i.e., to prevent the transmission of pathogens to and from the patient). This report described the labeling requirements put forth by the FDA, the labeling cost model, and the various testing costs that determine total industry costs.

FEDERAL CONTACT: Steve Tucker, (301) 827-5339

PIC ID: 7889

PERFORMER: Eastern Research Group, Lexington, MA