More Prescription Drugs Withdrawn or Got Black-Box Warnings After Drug Law Passed

More prescription drugs have received black-box safety warnings since a law designed to speed the drug approval process was passed in 1992, according to a new study. An increasing number of drugs have also been withdrawn from the market because of safety concerns since the law was passed, CBS News reports.

Almost 27 percent of drugs approved after the Prescription Drug User Fee Act was implemented in 1992 received black-box warnings or were withdrawn from the market within 16 years, compared with about 21 percent before the law was passed. The law allows the Food and Drug Administration (FDA) to collect fees from pharmaceutical companies to speed the drug approval process.

“New drugs have a one-in-three chance of acquiring a new black-box warning or being withdrawn for safety reasons within twenty-five years of approval,” the researchers wrote in Health Affairs. “We believe that the ultimate solution is stronger U.S. drug approval standards.”

The researchers looked at all 748 drugs approved by the FDA between 1975 and 2009. They found 15 percent received one or more black-box warnings, and 4 percent were withdrawn from the market because of concerns over safety.

After the law was passed, median drug approval times were reduced from 33.6 months in 1979-1986, to 16.1 months in 1997-2002. Between 1999 and 2009, outpatient prescribers wrote 30 million prescriptions for each of the nine drugs that were later withdrawn due to safety concerns, or that received black-box safety warnings.

“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.