
WASHINGTON — A former top official at the Food and Drug Administration and a longtime science journalist are suing the agency and the National Institutes of Health, saying they let clinical trial sponsors off the hook for reporting nearly a decade’s worth of important scientific data.
Under a law passed in 2007, researchers involved in many clinical trials must report their results to the federal government. But the NIH and FDA only finalized a rule to ensure compliance in 2016.
What is it?
STAT+ is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.
What's included?
- Daily reporting and analysis
- The most comprehensive industry coverage from a powerhouse team of reporters
- Subscriber-only newsletters
- Daily newsletters to brief you on the most important industry news of the day
- STAT+ Conversations
- Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
- Exclusive industry events
- Premium access to subscriber-only networking events around the country
- The best reporters in the industry
- The most trusted and well-connected newsroom in the health care industry
- And much more
- Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
This is what we get, when we allow a criminal to appoint industry insiders and people of low moral character to our federal agencies. These agencies are still understaffed, and key positions have been cut or left unfilled. These agencies have been undermined by design, in order to allow groups like PhRMA to continue their illegal activities.
All I am say that thanks for all you have done!
Comments received by the FDA on its plans show that patients, doctors and scientists overwlehmingly support the imposition of fines, across the board. Only PhRMA and AdvaMed are opposed:
https://www.transparimed.org/single-post/2018/12/07/Pharma-and-medical-device-lobbies-stonewall-on-transparency-as-doctors-and-patients-call-for-fines-on-companies-hiding-clinical-trial-results