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FDA DEVICE PROGRAM FUNDING WOULD INCREASE 24% TO $153 MIL. IN FY 1994 UNDER CLINTON ADMINISTRATION BUDGET; $33 MIL. EARMARKED FOR SMDA, MAMMOGRAPHY LAW

This article was originally published in The Gray Sheet

Executive Summary

The Clinton Administration's budget for fiscal year 1994 proposes $153 mil. in funding for FDA medical device-related activities, up $30 mil. from FY 1993 revised estimated appropriations of $123 mil. The funding request does not represent the total budget for the Center for Devices and Radiological Health; for example, CDRH may also draw monies from the agency's program management budget. The administration's revised budget estimates include the effects of the President's pending economic stimulus package, certain re- estimates and supplemental budget requests for fiscal 1993. The funding boost for FDA device activities appears to be comprised entirely of appropriations targeted to implementation of two device-related laws, the Mammography Quality Standards Act of 1992 and the Safe Medical Devices Act of 1990. Clinton is asking Congress to approve $13 mil. for implementation of MQSA. Activities to be funded include "developing and publishing regulations on quality standards; designing and implementing a data processing system; and recruiting, training, and certifying inspectors," according to an HHS budget document. An "investment increment" of $20 mil. is sought to enable the agency to "increase monitoring and inspection coverage, to improve market surveillance, and to employ new enforcement authorities" under SMDA. The administration notes that SMDA "significantly expanded FDA's [medical device] responsibilities," and adds that, according to the Commerce Department, "the device industry is the fastest growing industrial sector." The budget does not earmark added funds for the device program's most visible trouble spot, device evaluation, but the additional funds for SMDA-related activities will free up resources that could be diverted to device review. The budget proposal also differs from that of prior years in that devices would receive the healthiest funding growth among FDA's programs. The drugs program, which in the Clinton budget includes biologics and veterinary medicine, would see a 11.7% increase to $428 mil. Foods program funding under the budget request is held to the 1993 level of $209 mil. The FY 1993 device activities budget of $123 mil. provided a 5.1% increase over FY 1992. In contrast, drug activities were funded with $340 mil. in FY 1993, up 3% from FY 1992. Foods funding grew 3% in FY 1993 to $209 mil. FDA's overall budget in FY 1994 would rise 12% ($98 mil.) to $929 mil. However, $259 mil. of the budget is slated to be derived from user fees (see following story). Funding for three additional budget categories remain level with the past two years: program management would be allotted $33 mil.; FDA buildings and facilities would receive $8 mil.; and a revolving fund would be provided with $5 mil. These figures may actually represent some belt-tightening in that no inflation update is provided. HHS is subject to the 2-3% government reduction in administrative costs that was proposed in the economic stimulus package. The agency's full-time equivalent staffing positions would be set at 8,834 in fiscal 1994, a reduction of 171, or about 2%, from the revised 1993 budget and 339, or 3.5%, from the current 1993 budget. The Clinton Administration is requesting $49 mil. in 1994 for FDA's expenses for office building rentals, up from $24 mil. in the two preceding years. In those years, rental payments actually exceeded $24 mil., but Congress capped FDA's portion at that figure, with the General Services Administration making up the difference. The Clinton Administration decided to place the full cost of FDA office building rentals within the agency's own budget. The budget request for the General Services Administration contains $73.9 mil. in FY 1994 for site acquisition and construction costs related to the project to consolidate all of FDA's Washington, D.C.-area buildings into a two-site campus. This adds to $200 mil. appropriated for the campus in FY 1992. Review of possible sites is expected to take at least the rest of the year. FDA's $929 mil. budget request represents roughly 4% of the total Public Health Service budget of $21.4 bil. The total HHS budget request for the year is $641 bil. PHS spending also includes $2.2 bil. for the Centers for Disease Control and Prevention, up $199 mil. (10%) from the FY 1993 revised estimate; and $10.7 bil. for the National Institutes of Health, an increase of $329 mil. (3.2%) over FY 1993 estimates. CDC's budget includes an increase of $40 mil. for women's health programs such as breast and cervical cancer screening for low income women. NIH projects include $1.3 bil. in AIDS research and an "additional $216 mil. for breast cancer research." The PHS budget also includes $158 mil. for the Agency for Health Care Policy and Research. Under the administration's budget request, AHCPR would spend $85 mil. "for continued support of outcomes research, clinical guidelines development, and information dissemination," a 16% increase over fiscal 1993. By the end of FY 1993, the agency expects to issue guidelines on early HIV infection, cancer pain management, sickle cell disease, benign prostatic hyperplasia, and depression. Eleven guidelines are slated for release in 1994, including recommendations on unstable angina, mammography, and cardiac rehabilitation, according to HHS. The AHCPR budget request for FY 1994 also includes $71 mil., a 34% increase from the previous year, for research on "health care costs, quality and access and technology assessment." Funds will support research and analysis in areas such as "utilization and cost of health care, improvements in health care delivery methods, ...and other special health services and technology research programs" including the HIV/AIDS program, the administration notes.

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