Doctors to Pay Tab for New Drug Fight

The Bush administration plans to double licensing fees on doctors, pharmacies and drug makers to expand the government’s fight against prescription drug abuse, which is growing rapidly across the nation.

Officials said the fee increase will be disclosed in the next few days by the Drug Enforcement Administration, which polices the distribution of prescription drugs.

The illegal use of these drugs is growing by at least 27% each year, and represents as big an abuse problem as cocaine, at least in terms of the number of abusers, according to surveys by the federal Substance Abuse and Mental Health Services Administration and reports by the Drug Enforcement Administration.

An estimated 11 million Americans abused prescription drugs in 2000, principally opium-based painkillers, according to federal surveys and interviews with federal regulators. Tranquilizers, stimulants and sedatives are also widely abused, the surveys show.

The fee increase comes at a time when the DEA, which is part of the Department of Justice, is being criticized for not doing more to combat the illegal use of prescription drugs, and for putting a chill on the legitimate dispensing of painkillers.

Unlike the war on street drugs such as cocaine, heroin and marijuana, the control of legal pharmaceuticals requires a difficult balancing act involving substances that have legal and illegal uses. This effort also pits law enforcement against a highly educated, articulate and economically powerful medical community.

Under the DEA plan, doctors and pharmacies would pay $130 per year for a federal license to prescribe controlled drugs and drug makers $1,600 per year for a license to manufacture them -- about double the current levels. The White House Office of Management and Budget has reviewed and approved the increase, which will be published in coming days in the Federal Register, officials said.

Unlike other areas of drug enforcement and most operations in the federal government, the program to control pharmaceutical drugs is funded by fees imposed on the medical community, rather than appropriations from Congress.

The higher fees are projected to bring in $118 million annually, compared with $57 million under an increase approved in 1993. Most of the money is raised from licenses held by 980,000 doctors and other practitioners. Under the DEA rule, doctors must buy licenses for three years, so the actual outlay will be $390 when practitioners must renew their DEA license.

Although the dollar amount is not large, DEA officials are braced for a backlash from the medical sector, which has had an uneasy relationship with federal agents.

When licensing fees were last raised, the American Medical Assn. sued the DEA and tied up the increase in federal court for six years.

Although the DEA won the suit, it was not able to complete the increase until late last year. The AMA suit was based on allegations that the DEA violated technical federal rules in imposing the fee increase, but underlying that suit were the strained relations between the medical community and federal drug agents.

Doctors and federal investigators are at polar extremes in their view of the problem, according to David Brushwood, a professor of pharmacy administration at the University of Florida and an expert on the issue. Doctors believe “every patient who needs opioids should always get them,” Brushwood told a recent New York conference. But law enforcement officials believe “nobody who doesn’t need them should ever get them,” he said.

In the last decade, the medical community has come to believe pain is seriously under-treated and a phobia about opium has long prevented appropriate and legitimate use.

As a result, doctors have sharply increased their legitimate use of painkillers -- a trend in parallel with the growth of illegal use, said John Jenkins, director of the Food and Drug Administration’s Office of New Drugs. Jenkins said he and others are not sure how the two trends are linked.

Nobody knows for sure how many Americans legally take painkillers and use other controlled pharmaceuticals, but it is generally thought to be in the many millions. Medical experts estimate 75 million Americans suffer from acute or chronic pain. There are more than 15,000 controlled pharmaceuticals, up from 2,000 in 1973.

“We don’t want legitimate pharmaceuticals unfairly stigmatized,” said H. Wesley Clark, director of the Center for Substance Abuse Treatment, a federal office in the Department of Health and Human Services. Last month, Clark and officials from the FDA began a campaign to raise awareness of the growing danger of prescription drug abuse.

A recent case against a Harvard-educated doctor in Shasta County, for example, cast a chill on the medical community. The physician, Frank B. Fisher, was charged with murder in 1999 for prescribing painkillers for a cancer patient who later died. Those charges were dismissed last month.

Even while the DEA is criticized for sometimes going after doctors properly prescribing drugs, it also faces criticism for doing too little. Glenn A. Fine, the Justice Department’s inspector general, issued a report last fall questioning why the DEA was not doing more to combat prescription drug abuse when statistics show it has grown to be a problem equal to cocaine.

Federal studies suggest that 4.1 million Americans used cocaine in 2001, while 6.4 million illegally used opium-based painkillers. Such drugs account for 30% of emergency room deaths and injuries associated with drug abuse, according to federal figures cited by Fine.

“Only 10% of DEA’s agents are allocated to controlling prescription drugs,” Fine said in an interview. “But 30% of drug abuse deaths involve these substances.”

Arrests and convictions for prescription drug violations have been flat in recent years. In 2001, federal agents obtained 535 convictions, up from 513 the prior year. About 80 doctors are arrested each year, according to DEA officials.

Pat Good, a senior official at the DEA’s office of diversion control, said the cost of the control program exceeds the amount collected from existing fees.

The new fees will help the agency expand its efforts, including hiring dozens of additional personnel and improving its electronic tracking system for pharmaceuticals.

The drug diversion problem goes far beyond doctors willing to write illegal prescriptions, experts say. Trucks carrying drugs are hijacked, employees of drug-manufacturing plants steal pills and pharmacies sometimes dispense drugs without proper prescriptions.

Good said the DEA wants to find ways to fight abuse without interfering with doctors who legitimately prescribe the drugs for pain.

“It is not our role to eliminate drugs used for legitimate purposes,” she said.

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(BEGIN TEXT OF INFOBOX)

Illicit drug use

From 2000 to 2001, the number of users of illicit prescription psychotherapeutic drugs increased, as did the number of users of illicit drugs.

Estimated number of users of illicit drugs among people 12 and older

*--* (In millions) 2000 2001 Marijuana 18.59 21.09 Cocaine 3.33 4.19 Heroin 0.31 0.46 Hallucinogens 3.48 4.60 Psychotherapeutics* 8.76 11.10 Pain relievers 6.47 8.35 Tranquilizers 2.73 3.67 Stimulants 2.11 2.49 Sedatives 0.61 0.81

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*Nonmedical use of any prescription-type pain reliever, tranquilizer, stimulant or sedative; does not include over-the-counter drugs

Source: U.S. Department of Health and Human Services’ 2001 National Household Survey on Drug Abuse