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Appraisal of FDA’s Drug Safety Proces

ded by the Institute of Medicine, to ensure we continue to fulfill our mission," said Dr. Andrew von Eschenbach, the FDA's acting commissioner. Others within FDA were quick to hype the steps the agency's already taken.

"We're simply saying we have been on a trajectory to address the issues," said Dr. Janet Woodcock, the FDA's deputy commissioner for operations.

Burke called much of the effort little more than "moving boxes" around on organizational charts. "They have not been an integrative solution. They have addressed pieces of it but not in a fulsome way," she said.

The institute recommended a series of steps to enhance safety review, like improving FDA's budget whether through an appropriation from Congress or taxes. It also advised to lift restrictions on how FDA can spend the charge collected from drug companies. Those fees now finance the cost of reviewing new drugs before approval.

The institute recommended the FDA to appraise the safety of all new drugs five years after their introduction, making their initial approval more or less speculative and subject to withdrawal.

A logo, probably a black triangle will be present on drugs for 2 years warning patients and doctors that doubts may remain about their risks and benefits. Advertising would be limited in that period, if officially acceptable.

A drug industry group responded unperturbedly to that proposal. "Drugs are approved as safe and effective by FDA under the conditions that are prescribed on the label. The label can highlight that there are issues with the drugs, with respect to how they are used. I don't think it's fair to characterize all new drugs as requiring heightened regulatory uncertainty," said Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America.

Some had expected the report to advise the introduction of a distinct center to supervise the safety of drugs, however, it did not. The report recommended t
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