Pubdate: Sat, 9 Jan 1999 Source: San Jose Mercury News (CA) Copyright: 1999 Mercury Center Contact: http://www.sjmercury.com/ PRESSURED FDA SEEKS MORE FUNDS WASHINGTON (AP) -- The Clinton administration is seeking to infuse more cash into the agency that monitors the safety of food and drugs because of worries it's losing the ability to fully safeguard Americans' health. The Food and Drug Administration says it's $165 million in the hole because of six years of budgets that didn't keep up with inflation. It's short 500 employees, and needs more specialized scientists to evaluate increasingly complex therapies. Its inspectors can check the safety of only a fraction of medical and food factories every year. And its research, which helps ensure new products are safe, has been slashed. ``We cannot do everything that is expected of us,'' FDA Associate Commissioner Linda Suydam told industry lawyers recently, in an unusually stark admission. But it's unclear whether Congress, which has long battled the agency over issues such as tobacco, will go along. Clinton officials say more FDA money is a priority this year, but won't yet give a total. The first chunk: An extra $30 million that would increase food safety by hiring 60 more inspectors and better monitoring foods imported from abroad. The agency is responsible for $1 trillion in products -- from drugs, medical devices and donated blood to foods and cosmetics -- that Americans use daily. Even as it sounds an alarm, the agency insists consumers shouldn't panic. It has reshuffled enough resources to deal with serious health threats and properly approve new medicines, its two top jobs. But it has been under intense congressional pressure to approve new drugs faster. Consumer advocates charge that is dangerous and point to controversial drugs like the impotence pill Viagra, arguing it won approval with too little warning of deadly side effects. In a new report to Congress, the FDA details numerous gaps in other duties, including inspecting manufacturing plants and monitoring drug side effects. ``The Congress and the American public have said they want smaller, more efficient government. I think the FDA has certainly recognized and responded to that,'' said Deputy Commissioner Michael Friedman, who ran the agency the last two years. But with an increasing workload that demands ever more expertise, ``we face some really formidable challenges,'' he said. An influential Republican lawmaker was more blunt: ``Let's face it, the FDA is underfunded,'' Sen. Orrin Hatch, R-Utah, said in a recent speech. ``The administration and indeed the Congress is going to have to take a hard look at what we are asking the FDA to do, and with what resources.'' Every year, the number of new products the FDA evaluates rises by 12 percent. The products are getting more complex, including technologies like genetically engineered drugs. In recent years, threats such as new viruses and food poisonings have risen. The agency's budget is $1.1 billion, up from $800 million in 1993. Six years of inflation and the increased workload mean the FDA actually has a $165 million shortfall, Friedman estimates. Congress allows the agency to charge drug makers fees that hire reviewers of prescription medicines. Similar fees pay for quality inspections at mammography clinics. But money for other areas has lagged: There are delays in reviewing new foods and cheaper generic drugs. An aging population is using more powerful drugs and medical devices, yet the FDA estimates it detects only 10 percent of injuries caused by improper use or unexpected side effects. - --- MAP posted-by: Patrick Henry