WASHINGTON (CBS DC) – Ever since the law was changed to speed up the Food and Drug Administration’s approval process, more prescription medications have been taken off the market or given special warning labels because of potentially lethal side effects, says a new study.
The Prescription Drug User Fee Act of 1992 was designed to make it easier for life-saving drugs to make it to American pharmacies.
But the researchers found that safety issues have increased since then, with almost 27 percent of the drugs approved were given black-box warnings or pulled from the market within 16 years. The figure before 1992 was 21 percent.
The researchers said they were unable to find a direct link between the new law and the increase in safety issues.
“New drugs have a one-in-three chance of acquiring a new black-box warning or being withdrawn for safety reasons within twenty-five years of approval,” they wrote. “We believe that the ultimate solution is stronger U.S. drug approval standards.”
Since the Act went into effect, median drug approval times were cut in half, from 33.6 months in 1979-1986 to 16.1 months in 1997-2002
“Our findings suggest the need for reforms to reduce patients’ exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently,” the researchers wrote.
The study was published in the journal Health Affairs.
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