AGENCY OKS MORE PILLS IN CHASE

DEA, In Charge Of Fighting Drug Abuse, Authorizes Increases In Narcotics
Production

A federal agency that spends nearly $100 million dollars a year fighting
illegal prescription-drug use has also been contributing to the problem's
growth.

The Drug Enforcement Administration is best known for busting heroin gangs
and cocaine smugglers.

But in one of its lesser-known roles, the DEA has also authorized
narcotics-makers to increase their annual output sharply over the last 10
years. The result has been hundreds of millions more pain pills -- some of
which inevitably wind up in the hands of abusers and street dealers.

No one knows just how much of America's legal drug supply is used
illegally. But a rule of thumb is that as the availability increases,
illegal use grows proportionately, if not faster, according to many
physicians, regulators and law-enforcement officers.

"There's definitely a correlation. The very same drugs that show up in the
statistics are the ones we see when working cases," said Mark Caverly, a
supervisor in the DEA's Louisville office.

Under federal statutes, the DEA deals with both. It must decide how much of
the most abuse-prone painkillers, sedatives and other medications are
needed to meet bona fide needs.

It then must try to keep those same substances out of the wrong hands.

The agency controls total availability by setting annual manufacturing
quotas for scores of legitimate chemicals used in painkillers and other drugs.

The DEA must be careful to ensure an adequate, uninterrupted supply for
legitimate medicine while preventing oversupply that would feed abuse, said
Frank Sapienza, chief of the drug and chemical evaluation section.

"These substances are not marijuana or heroin. These are good medicines
when given to the right people for the right reasons," Sapienza said.

To arrive at volumes it thinks will meet domestic, export and inventory
needs, the DEA collects data on production, sales and inventory from
manufacturers. It also reviews information on new products, total U.S.
medical needs and prescription trends.

It divides the overall quota for each chemical among the companies that use
it in their products.

Most of the process is secret. The DEA says information that companies
provide is confidential under trade-secret laws. The same goes for their
allotments; only totals for each broad chemical category, expressed by
weight, are made public.

The DEA has a good relationship with drug-makers, Sapienza said. That helps
avoid surprises that could create shortages of important drugs. But the
companies don't get everything they want, he said.

Their market projections are viewed with caution because "companies are
generally optimistic," Sapienza said.

Drug-makers that don't like the DEA's quotas have the right to squawk.

For example, the DEA posted its first 2003 quotas in November. Ten
companies wanted more of 20 drugs, according to the Federal Register, the
daily record of government actions. In response, the DEA raised 11 quotas.

Twelve requests and five increases were for materials classified as narcotics.

The latest version of that list, issued last month, authorizes a total
narcotics output that is 27 percent higher than five years ago and 75
percent higher than a decade ago.

This year's quota for output of hydrocodone, which is used in many brands
of pain pills, is 14 percent higher than last year's and 79 percent higher
than five years ago.

The ceiling for oxycodone, the active ingredient in OxyContin, remains the
same as last year's, 26 percent below the record set in 2001. But it's
nearly triple 1998's level. Many doctors say adverse publicity in 2001
slowed their prescribing of OxyContin.

The DEA has made huge midstream adjustments in the past. In 2000, it raised
the oxycodone quota four times to nearly double the 1999 level.

In one round, Purdue Pharma, the maker of OxyContin, advised the DEA that
it would seek a formal hearing if the oxycodone quota and one other quota
weren't increased to meet its estimates of medical need. The oxycodone
quota rose 35 percent. Purdue said it didn't ask for a hearing.

In 2001, two DEA administrators told Congress, about six months apart, that
they might cut quotas to fight OxyContin abuse. The oxycodone limit fell in
2002, but by then demand was slowing, too.

Sapienza said that it is impractical to try to quell potential abuse just
by adjusting quotas. "If we cut a certain percentage, how do we know that's
the percentage going to the abusers?" he asked.

That's where the DEA's other job comes in. The agency has requested a $114
million budget this fiscal year -- an increase of $24.6 million -- for its
division that combats prescription-drug diversion. Much of that money would
pay 75 new investigators to help chase down illicit pill users and suppliers.