Gottlieb anticipates extra resources for drug safety

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FDA deputy commissioner for medical and scientific affairs Scott Gottlieb says he is confident additional resources will be allocated for the agency's drug safety efforts in the FY 2008 budget and under its user fee renegotiation (PDUFA 4).

Commenting on a Los Angeles Times report, Gottlieb said some $10 million was added for drug safety last year with more likely to come in the future.

The newspaper reported from interviews and documents on an FDA-funded study meant to answer questions about the drugs for ADHD that may be halted in midstream because the agency lacks funds to finish it.

The threat to the study, the newspaper said, stems from shortchanging of the nation's drug safety program and is a symptom of an agency constrained by a budget that has failed to keep up with costs.

Even as concerns grow, the Times said, the agency has budgeted only $1.6 million for such safety studies of medications already on the market, and that number is scheduled to drop to $900,000 in the coming year.

“Clearly we need additional resources as the complexity of our mission, and the products we regulate, continues to increase,” Gottlieb said.

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