Safety Concerns About New Drugs
The authors of a study published in the August 2014 issue of Health Affairs contend that when the FDA approval process for medications changed in 1992 with the Prescription Drug User Fee Act (PDUFA), which allowed the FDA to collect fees to expedite drug approvals, the new process may have led to the release of drugs before they could be adequately evaluated for safety issues.
Drugs recently approved by the U. S. Food and Drug Administration have a one in three chance of acquiring a black box warning or being withdrawn for safety reasons within 25 years of their approval, according to researcher done at Cambridge Health Alliance /Harvard Medical School, Boston Medical Center (BMC)/Boston University School of Medicine (BUSM), City University of New York School of Public Health, and Public Citizen. The study is the largest on this topic, encompassing all of the drugs approved by the FDA over a 35-year period.
A release from BUMC explains that black box warnings are part of the prescription medication label intended to alert consumers and health care professionals about important safety concerns, such as serious side effects or life-threatening risks. They are the most serious medication warnings required by the FDA.
The study compared warning and withdrawal rates for drugs released before and after 1992. The approval process for medications changed in 1992 with the Prescription Drug User Fee Act (PDUFA), which allowed the FDA to collect fees to expedite drug approvals. Congress passed PDUFA after heavy lobbying by the pharmaceutical industry, and PDUFA has been reauthorized by Congress several times. Since the law’s enactment, the average drug approval time for all drugs has fallen from 34 months to 16 months.
Very few of the 32 drugs withdrawn for safety reasons had clearly unique benefits at the time of approval, but all had unique risks that eventually led to their withdrawal.
The researchers discovered that drugs released after the PDUFA passed were more likely to be withdrawn or have a black box warning, with 26.7 percent of these drugs receiving such a warning compared to 21.2 percent in the pre-PDUFA drugs that underwent the longer approval process. Half of all black box warnings appeared after a drug had been on the market for 12 years, and safety withdrawals have occurred as late as 30 years after a drug’s initial release.