Product News and Recalls

Study Finds Change in Law Linked to More Unsafe Drugs

A new study found that prescription drug safety issues have increased with the passage of the Prescription Drug User Fee Act in 1992. The Act has allowed for an accelerated drug approval process. The law allows drug makers to pay to expedite the FDA approval of new prescription medications.

The report examined all of the drugs that were approved by the FDA from 1975 to 2009 and looked at the drugs that received black-box warnings for lethal side effects or were withdrawn from markets for safety issues. The researchers concluded that of the 748 new drugs approved by the FDA during that time period, about 15 percent were given one or more black box warnings and four percent were withdrawn from the market for safety concerns. The investigators found that since the passage of the Prescription Drug User Fee Act, 27%, or 208 of the 748 drugs, received black-box warnings or were taken off the market within 16 years. Before the law’s passage, the rate was 21%.

The law, designed to speed up the long approval process for prescription medication, has cut the median approval time in half. From 1997 to 2002, it took an average of 16.1 months for approval, compared with 1979 to 1986, when the average time to approval was 33.6 months. Also, between 1999 and 2009, 30 million prescriptions were written for each of nine drugs that were withdrawn from the market or were given black-box warnings. The researchers said that “the ultimate solution is stronger U.S. drug approval standards.”

You should consult your medical provider before making any changes in your medications. If you or a loved one has suffered an injury as a result of misleading drug information or incorrectly prescribed medication, you should contact a lawyer at Lopez McHugh for a consultation.