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.