A few days ago this page criticized the U.S. Food and Drug Administration for chronically dragging its feet when it comes to approving or rejecting new medications.
So it's only fair to give the FDA a pat on the back now that the agency has taken an overdue step to make new drugs available more quickly to people with life-threatening diseases.The FDA says that it will short-circuit the lengthy drug-approval process in order to get promising new medications faster to patients suffering such deadly illnesses as AIDS and cancer.
Scripps Howard News Service reports that the new program will build on the FDA's speedy approval last year of AZT for persons stricken with the AIDS virus. Normally it would take several years of testing - sometimes as many as 10 - before such a drug would be allowed on the market. But the FDA approved AZT in about two years after a small initial study showed it was helpful in prolonging the lives of some AIDS victims.
Traditional procedures require that drugs go through three stages of human testing. Only a few volunteers are used in the first study to determine how well a drug is tolerated, used by the body and excreted. The second, using a larger number of volunteers, tests toxicity and efficacy. Then comes a much more extensive study that can take as long as four years.
Under the new program for drugs designed for life-threatening diseases, the first two studies would be broadened so as to collect more information in a shorter period of time, and the third phase would be eliminated. This could shorten by several years the period between the time a potentially beneficial drug is discovered and the time it is made generally available to patients.
But even with its speeded-up procedures, the FDA is still talking about years for testing and paperwork on drugs that responsible European governments take only 10 months to complete. Despite the new reforms, further improvements are clearly in order at the agency.