University Daily Kansan / Wednesday. December 6. 1989
9
Price of medical drugs increasing Longer testing periods, more paperwork included as factors
By Travis Butler Kansan staff writer
The costs of many of the new "wonder drugs" have been high. A year's dosage sometimes can run more than $10,000 and the rising costs are likely to continue, a drug company executive said.
Ralph Christoffersen, vice president for research at Smith, Kline Bioscience Laboratories in King of Oceans, addresses the price reasons for the price increases:
"It prudent to do as much characterization of a drug as we can," Christoffersen said. "That takes longer and costs more."
The time needed to develop a drug has lengthened in the last two to three decades. More research is needed to understand its characteristics and characteristics of new drugs.
> The regulatory requirements and the paperwork needed for approval of a drug by the Food and Drug Administration have increased, he said. This work also has increased costs.
The exclusivity period, when a drug company has exclusive rights to market a drug, has remained constant, but developmental times have increased, Christoffersen said. This
effectively gives a drug company less time to recover its investment before competition brings the market price down.
Cam Davis, a pharmacist at Lawrence Memorial Hospital, agreed with this analysis.
"If it's a new medication, a drug company will invest a lot of money in processing their application," he said.
Julia Hewgley, a consumer affairs officer at the FDA's Kansas City, Mo. office, said requirements had become more strict.
In 1987, the FDA reduced the time needed to get new drugs to patients whose life was threatened by a disease, Hewgley said. The program, "Treatment IND," allows companies to sell a new drug to treat these illnesses before the paperwork is completed. However, it does not eliminate the eventual need for paperwork.
"The standard for safety and effectiveness has increased since in the past," she said. "That's true of all scientific areas. It's certainly far more complicated now than it was before."
"It's still required as a matter of law," she said. "It just makes the drug available to patients with life-
threatening diseases as soon as possible."
The high costs generally are not a problem for poor patients, Davis said. Medicare usually will pay for such drug therapy.
"If there is actually a need, they are covered," he said. "Sometimes, a brand-new category of drugs will not be covered. For the most part, that's not a problem. Sometimes, a few silo through the cracks."
Christoffersen cited two ways to reduce the drug costs. First, he would reduce the time the FDA takes to review a new drug, which is about three years. This would increase the patent life, or the time a company has to recover its costs. Second, he would simplify or reduce the number of regulatory agreements needed to file.
Davis said, "As a whole, the best thing is still using generic drugs, once the drug comes off of its patents."
Generic drugs are drugs made with the same chemical formula as brand-name drugs, Davis said. This is only possible after a patent has expired. Since a company does not have to pay development costs on a generic drug, it can price the drug based only on production costs.
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