By Lisa Seachrist
WASHINGTON - The FDA and the National Institutes of Health (NIH) were winners in the fiscal year 2000 budget proposed Monday by President Clinton.
Affirming his commitment to promoting research, Clinton proposed an 18 percent increase in the FDA's appropriation for the year 2000, compared to 1999, and a 2 percent increase in NIH's FY99 windfall appropriation, raising it from $15.6 billion to $15.9 billion.
The president's budget calls for the FDA to receive $1.35 billion in FY2000, or $216 million more than was appropriated in FY1999. If enacted, it will be the largest increase in appropriations in the agency's history.
The additional funds would largely go toward increasing the FDA's scientific base and advancing key programs in food safety, prevention of tobacco use among youths, and defense against bioterrorism. In addition, the budget prioritizes three key areas of the FDA Modernization Act of 1997 (FDAMA): injury reporting, product safety assurance, and premarket application reviews for medical devices.
Even with the emphasis on some special programs, the agency, which has been chronically underfunded over the past decade, will have more financial flexibility, if Clinton's appropriations pass through Congress unscathed.
"It does look like the agency is on a little better financial footing than previous years," said Allan Goldhammer, director of technical affairs at the Biotechnology Industry Organization (BIO). "We still need to look at the individual programs to make sure that they have adequate funding, since that is one of our defined priorities."
The proposed budget includes $15.3 million earmarked for the injury-reporting program, highlighting the fact that errors in the use of drugs, biologics and devices (as well as adverse events of proper use of these medical products) cause death and injuries that could be prevented if the situation were well-documented. The money allocated for this program is to be used to develop a science-based system to improve the quality of information on adverse events, identify their causes, and implement strategies to prevent them.
In addition, the budget calls for 11 full-time employees to help the agency to move to a fully electronic, integrated procedure for adverse-event reporting.
The budget also calls for $13.4 million to be devoted to anti-bioterrorism activities. The FDA is part of an interagency group formed by the Office of Emergency preparedness of the Department of Health and Human Services. The group includes the Department of Defense, the Veterans Administration, the Centers for Disease Control and Prevention, and NIH. As part of the group, the FDA will use the funds to ensure expeditious development and licensure of new vaccines for anthrax, botulinum and other toxins; to train and equip investigators; and to develop a four-hour detection and decontamination methodology.
The president's budget wants new user fees for medical device applications. It provides for an $11 million appropriation to help the agency meet its statutory review deadlines established in FDAMA, but also calls for $17 million in user fees from manufacturers to improve the productivity of the agency's interactions with the manufacturers. These user fees would require that Congress pass a bill authorizing the agency to collect the fees.
The budget allocates $68 million for the Youth Tobacco Prevention program. Tobacco initiatives have proven very contentious in the past, Goldhammer noted, so appropriations for the FDA are likely to prove contentious when the House takes up the topic in late February.
"While the agency has fared better in this budget than in past years, you have to put that into perspective," Goldhammer said. "If you look at inflation and take away the money paid by industry in [Prescription Drug User Fee Act] user fees, this budget is actually lower than when [Jane Henney, FDA commissioner] left the agency in 1993."
The NIH budget proposed by the president would assign money for speeding up the rate of sequencing in the Human Genome Project to 190 million base pairs a year in 2000, in order to complete the sequencing of the human genome by 2003. It also provides for increasing the number of executed cooperative research and development agreements by 5 percent over 1998 levels.