STAT+: After a controversial Alzheimer’s drug review, FDA’s Woodcock rejects proposal to ‘firewall’ agency and drug companies
In response to criticism, a top Food and Drug Administration official maintained that creating a firewall between agency staff and drug company personnel during the process for reviewing medicines “would cause significant negative repercussions for public health.”
The notion was broached two months ago by the advocacy group Public Citizen shortly after an FDA advisory committee voted nearly unanimously not to recommend a controversial Alzheimer’s drug for approval. At the same time, however, the expert panel also took the unusual step of rebuking agency reviewers for glowing appraisal of the medicine, which was developed by Biogen (BIIB). Public Citizen argued the drug maker and agency collaborated so closely that the independence and integrity of the FDA was compromised.
