Cutting Red Tape to Save Lives

By Christine Gorman

Like the Internal Revenue Service, the U.S. Food and Drug Administration is one of those Government agencies that everyone loves to hate. Pharmaceutical companies lament the profits they might be making if only the drug-approval process did not take so long. Desperately ill people accuse the agency of denying them experimental drugs that might offer hope for survival.

Last week the FDA got a chance to play hero when it announced a streamlined procedure that could cut the time it takes to develop and market a new drug from eight to as little as three years. The new rules will affect only medications designed to treat seriously debilitating or life-threatening illnesses such as AIDS, some forms of cancer and Alzheimer's disease. Moreover, the regulations will probably disappoint many people because it will still take years for most drugs to pass through the agency's approval pipeline.

Greater cooperation between the FDA and pharmaceutical companies is the key to the new plan. Before a drug can be approved in the U.S., its manufacturer must guide it through a gauntlet of testing, moving from basic laboratory experiments through animal research to carefully controlled experimentation on people. Under the system in use until now, FDA investigators did not begin evaluating the evidence until the human trials were almost finished. If the research methods or the results did not meet FDA requirements, pharmaceutical companies had to perform more testing, sometimes starting all over again. Now manufacturers may ask for the FDA's guidance from the very beginning. "Up until this point, we've been the baseball umpire at the end of the process," explains FDA commissioner Frank Young. "What this new process offers is that we'll also be the catcher, giving early signals whether the research is leading to something or not."

The FDA move has met with mixed reviews. Critics charge that the announcement amounts to a political ploy by the Reagan Administration to make George Bush look good three weeks before the election. How? Bush chaired the Presidential Task Force on Regulatory Relief this summer, which suggested that the FDA could make the drug-approval process easier and faster. The Pharmaceutical Manufacturers Association, on the other hand, announced its support for the agency's plan, and industry analysts predicted that as many as twelve experimental drugs could be evaluated under the new schedule over the next year.

This is not the first time the FDA has unveiled a streamlined approval process. In 1982 the agency announced several timesaving steps, including a call for better communications between the FDA and manufacturers. Last year, after vociferous protests from people suffering from AIDS, the agency established a fast track for drugs that might help in the fight against the eight-year-old epidemic. So far, however, only one very expensive medication, which can cause severe anemia, has been approved -- Burroughs Wellcome's Zidovudine, or AZT.

Some of the delay can be blamed on a slow-moving bureaucracy, but not all. Uncovering a medication's side effects takes time. New drugs may promise hope in the lab, only to deliver pain -- perhaps even death -- in the real world. Early in the AIDS epidemic, for example, researchers tested a medication called suramin that worked well in a test tube. After administering it to dozens of people who had AIDS, doctors discovered that the drug killed the patients faster than the disease. Three years ago, cancer patients applauded the news that treatment with interleukin-2, a drug made from molecules in the body's own immune system, could fight off several kinds of malignancy. Then word came that it had killed four out of 157 patients. Against that backdrop, the FDA's efforts to expedite drug approval will be welcome -- as long as they do not put speed ahead of safety.

With reporting by Bernard Baumohl and Raji Samghabadi/New York