IIn response to criticism, a senior Food and Drug Administration official said that creating a firewall among agency staff during the drug review process “would have significant negative repercussions for public health.”
The idea was raised two months ago by the Public Citizen advocacy group, shortly after an FDA advisory committee voted almost unanimously for not recommending a controversial Alzheimer’s drug for approval. At the same time, however, the panel of experts also took an unusual step of scolding the agency’s reviewers for the enthusiastic evaluation of the drug, which was developed by Biogen (BIIB). Public Citizen argued that the pharmaceutical industry and the agency collaborated so closely that the FDA’s independence and integrity were compromised.
Unlock this article by subscribing to STAT + and enjoy your first 30 days for free!
START
What is that?
STAT + is STAT’s premium subscription service for coverage and in-depth analysis of biotechnology, pharmaceutical industry, politics and life sciences. Our award-winning team covers news about Wall Street, policy developments in Washington, early scientific discoveries and results of clinical trials and health interruptions in Silicon Valley and beyond.
What’s included?
- Daily reporting and analysis
- The most comprehensive coverage in the industry by a powerful team of reporters
- Subscriber-only newsletters
- Daily newsletters to inform you of the most important industry news of the day
- STAT + conversations
- Weekly opportunities to interact with our reporters and industry-leading experts in live video chats
- Exclusive industry events
- Premium access to network events only for subscribers across the country
- The best reporters in the industry
- The most trusted and well-connected newsroom in the healthcare industry
- And much more
- Exclusive interviews with industry leaders, profiles and premium tools, such as our CRISPR Trackr.