FDA TO MONITOR DRUG PROMOTIONS

By The Associated Press

WASHINGTON (AP) -- Concerned about possible misleading drug promotion, the
government moved on Monday to ensure that drug companies don't unfairly
promote their products through managed care.

At issue is how companies -- called pharmacy benefits managers -- influence
doctors, pharmacists and patients in choosing particular medicines. Often,
they persuade doctors to switch their patients from one drug to another by
arguing the cheaper drug is just as effective.

But the Food and Drug Administration says pharmacy benefits managers, known
as PBMs, sometimes give doctors and pharmacists false or biased
information. On Monday, the FDA proposed regulating PBMs that are owned by
drug manufacturers to ensure they provide accurate information.

Manufacturer-owned PBMs would have to submit promotional material to the
FDA for an accuracy review, just as drug manufacturers already submit their
own advertising. The new proposal means manufacturers can't illegally
promote their products under the guise of a managed-care company, explained
FDA's Laurie Burke, who helped write the proposal.

Drug manufacturers that don't own PBMs but have financial agreements with
them also could be responsible for illegal drug promotion, the proposal
says.

``We are particularly concerned about the health risks,'' said Burke,
saying the most common problem is PBMs declaring one drug as effective as
another without scientific evidence.

False information ``may result in inappropriate medical decisions,'' Burke said.

An estimated 115 million Americans are enrolled in prescription drug plans
administered by pharmacy benefit managers, companies hired to decide what
medicines insurance plans will pay for -- on a list called a formulary --
and encourage doctors to prescribe only those drugs.

Burke said the FDA is not ``against switching in general. Formularies are a
very important thing for controlling costs.''

Drug giants Merck, Eli Lilly and SmithKline Beecham own three of the
nation's largest PBMs, and numerous other drug manufacturers have signed
financial agreements with PBMs.

The FDA regulates drug companies, so it began investigating as
manufacturers entered the managed-care business. In March, the agency asked
doctors to report side effects from drug switching, and it now is looking
into whether illegal drug promotion caused some of the problem switches,
Burke said.

Because the FDA has never regulated managed-care companies, it did not
immediately crack down on drug-owned PBMs that it already has caught giving
false information, Burke said. Instead, the agency announced the change
Monday, giving companies until April 6 to comment on the proposal. A final
policy is expected later this year.

Merck-Medco Managed Care said in a statement Monday that its PBM program is
run independent of Merck's manufacturing divisions, ``and is based on the
recommendations of independent medical advisory boards.''

Lilly and the industry's Pharmaceutical Research and Manufacturers
Association declined comment.

There is no good evidence yet whether PBMs are controlling health care
costs or affecting disease outcomes, cautioned Thomas Moore of George
Washington University's Center for Health Policy Research.

But drug switching is getting attention:

- --New York City Public Advocate Mark Green recently reported that one woman
whose blood pressure medicine was switched came down with a respiratory
infection ``severe enough to almost cause death.'' He also cited an
aggressive Lilly plan to get its PBM patients switched from competing
antidepressants to Lilly's Prozac.

- --A 1996 Georgetown University study said Merck's product sales increased
10 percent after it bought Medco.

--The General Accounting Office, Congress' investigative and auditing arm,
said in 1995 that drug makers were buying PBMs to ``help maintain the
manufacturers' profits at a time when their drugs face increasing
competition.''

But Dr. Sidney Wolfe of the consumer advocacy group Public Citizen said the
FDA's new proposal has a problem: Congress last fall passed a law allowing
drug makers to tell managed-care companies certain cost-effectiveness
information about drugs even if the data is not FDA-approved.

``It is a huge loophole, and it will be very difficult for FDA to enforce
this,'' Wolfe said.