Just a terrible run of bad luck or are there some serious problems with the way the Food and Drug Administration approves prescription drugs?
That question needs to be answered after almost as many of the drugs were yanked off the U.S. market in the past 10 months as were banned in the previous decade.The General Accounting Office has been called in to investigate whether the FDA is taking proper precautions to safeguard against risky medicines. The GAO needs to use the necessary resources to make a valid finding, and soon.
The concern now regarding FDA approval is just opposite what it was a couple of years ago when Congress pressured the FDA to speed the approval process. Critics even accused the FDA of being responsible for patients dying by delaying the potential live-saving therapies.
And that seemed to make sense. We backed efforts to speed up the process, noting in an editorial in September of last year that the average time from drug discovery to its arrival in the marketplace was 15 years. In the 1960s, the total drug development time averaged only eight years. If anything, scientific advances should have quickened the process.
The FDA hired hundreds more reviewers and approved a record 92 unique new drugs in 1996 and 1997, up from 50 the previous two years. One official left the agency claiming she was pressured to skim over safety concerns. The FDA's acting commissioner vehemently denied those charges.
Five drugs have been pulled off the market since September. In the previous 10 years the FDA had banned just six other drugs.
Unfortunately, either through neglect or bad luck, they resulted in a number of deaths and injuries before they were outlawed. The painkiller Duract caused liver damage, resulting in four deaths; the blood pressure drug Posicor resulted in 24 deaths and 400 injuries due to interactions with other medications; the diet drugs fenfluramine and Redux caused heart damage; and the antihistimine Seldane was lethal when combined with a number of other drugs.
The FDA claims the drugs were approved because the full scope of side effects did not show up at first. Certainly in those instances, better testing procedures would have helped.
Finding the balance that protects people and yet doesn't needlessly delay issuing drugs that may save many lives is something both the FDA and the GAO need to work together on immediately.