US FDA Reform Plan To Give Govt Oversight Role

A comprehensive plan to reform the US Food and Drug Administration was unveiled last week by the Progress & Freedom Foundation, which would mandate non-governmental bodies to take on some FDA responsibilities and shift the government's role to oversight of the process, rather than operations per se. The report concludes a two-year Medical Innovation Project led by former Health and Human Services Secretary Louis Sullivan.

the PFF would retain current requirements that a drug be proved safe and effective before marketing, but would give new Drug Certification Bodies the FDA's oversight of companies' clinical testing and, after this is complete, of performing the primary review of the data that supports marketing. DCBs could be private or public-sector groups such as universities, profit-making or non-profit, and would be subject to FDA endorsement and auditing. As required by current FDA statute, they would be staffed by experts qualified by scientific training and experience.

A drug sponsor would submit its approval request to the DCB, which would then send its review, if favorable, to the FDA. The FDA Commissioner would have a set time in which to accept this or deny approval. A new Medical Review Board (an independent standing committee of 10-15 experts within the HHS) would advise the Secretary when the FDA disagrees with a DCB recommendation, and would hear appeals against such decisions. All parties, including the FDA, would be expected to accept the Secretary's decision.