FDA News

FDA Might Lack Balance Between Speed, Safety In Prescription Drug Reviews

 
(June 13, 2007)-- Several recent problems with prescription drug safety has "led many on Capitol Hill to question" whether FDA has "failed to strike the right balance between speed and safety" in reviews of medications, the New York Times reports. While "immediate access to breakthrough medicines" is important to patients, they "also want to believe the drugs are safe," according to the Times.

In 1992, when FDA began to accept user fees from pharmaceutical companies in exchange for expedited reviews of medications, the "culture at the FDA shifted toward valuing speed over safety," and agency managers "are now largely judged on how quickly their employees make a decision on new drug applications," the Times reports. According to the Times, as FDA "began to depend more and more on industry fees," efforts to monitor the safety of medications after approval -- which the pharmaceutical companies refused to fund -- "slowly withered," and questions about the safety of such treatments are "increasingly seen as sand in the gears." Part of the emphasis on speed also is to improve patients' access to breakthrough medicines, the Times reports.

In addition, an "increasing number of FDA drug safety officers ... say they have been punished or ignored after uncovering dangers of popular medicines," the Times reports. For example, Rosemary Johann-Liang, former deputy director of the Division of Drug Risk Evaluation in the Office of Surveillance and Epidemiology at FDA, lost the authority to approve strong safety recommendations after she agreed with a February 2006 review that recommended a black box warning for the type 2 diabetes medication Avandia.

Recommendations From FDA Safety Officials
Johann-Liang, David Ross -- a former FDA safety official who received resistance from agency Commissioner Andrew von Eschenbach in 2006 when he found evidence of increased risk for death and serious illness associated with the antibiotic Ketek -- and two other agency safety officials recommended that Congress require FDA to make regular public assessments of the safety of medications after approval; act on reports of prescription drug safety issues within one to two months; and provide regular reports on agency adherence to those requirements. The recommendations "would lead to the promotion of safety-conscious managers, not just speed-conscious ones," according to the FDA safety officials, the Times reports.

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