FDA's Woodcock points to science as reason for fewer drug approvals

WASHINGTON The Food and Drug Administration has been criticized recently by the pharmaceutical industry of rejecting or delaying new drug approvals because the agency was too risk-averse, partly in response to politicians and consumer groups who have attacked the FDA for approving medicines that have later proved to have dangerous side effects like the painkiller Vioxx and the diabetes medication Avandia.

The new head of the Center for Drug Evaluation and Research, Janet Woodcock, has come back, stating that science is the cause for the lack of new medicines, not pressure, according to an interview in the Financial Times. She said that when the FDA rejected new medicines, it did so based on an assessment of their safety and efficacy, not as a result of political pressure or greater conservatism.

Woodcock also stated that she was concerned about post-marketing surveillance studies on drugs because of the length of each study.

She also said the FDA would unveil new proposals in the fall on reducing drug developing costs by standardizing the format and content of clinical trial data. “We need to learn from Henry Ford. Companies collect too much information because they are worried that the FDA will ask for it.”