FDA Standards "Essential For US Competitiveness"

The US Food and Drug Administration's reputation for high standards are essential for the competitiveness of the US pharmaceutical industry, and they result in the fact that once a new drug has been approved in the USA, it becomes an international blockbuster, according to FDA Commissioner David Kessler.

Speaking before a hearing of the Senate Agriculture appropriations subcommittee this month, Dr Kessler revealed that the FDA is currently working with Vice President Al Gore on its own internal proposals for reform of the agency, and he asked the Congress to be patient while this procedure was underway. Over the last few months, he said, the agency has embarked on a very intensive review of how it can streamline its activities, and how it can reduce regulatory burden without lowering the agency's standards. He told the hearing he hoped that "within the next several months," he would be able to return to the subcommittee with concrete proposals for reducing unnecessary costs and burdens.

Concern Over Safety Issues However, asked if some of the FDA's current responsibilities could be shifted to other federal agencies, Dr Kessler replied: "it's hard to say that we're not going to focus on some area of safety."