Clinton Announces US FDA Reform Proposals

Clinton Announces FDA Reform Proposals

The US Clinton Administration has announced proposals for changes in five areas of Food and Drug Administration responsibilities, under its Reinventing Government initiative. The aims of the reforms, which are entitled Reinventing Drug and Device Regulation, are "to protect people not bureaucracy, promote results not rules, get action not rhetoric, whenever possible to try to embrace common sense," according to President Clinton.

The Administration proposes that: - regulations covering reporting of changes to manufacturing of drugs and biologics should be eased, permitting companies to change the way they manufacture already-approved products without prior FDA approval if the risks are negligible. This would allow companies to modernize their facilities and practices more easily;