FDA INSPECTIONS
Records? What records?
As the incoming Trump administration weighs its approach to China and Congress considers an anti-China biotech bill, Ed implores us to consider the case of Tianjin Darentang Jingwanhong Pharmaceutical.
The company refused to hand over records to FDA inspectors, provide access to key production areas, or allow photography of machinery during an inspection of its facilities last March, according to an Oct. 30 warning letter that was posted on the agency web site this week.
The U.S. drug supply relies heavily on Chinese made ingredients, and many lawmakers in both political parties worry that reliance has become a national security risk. Tianjin Darentang Jingwanhong Pharmaceutical may not be an ingredients supplier, but its conduct is an example of why the U.S. government is worried about the pharmaceutical supply chain. More from Ed here.
FDA REGULATION
In the dark
The FDA’s regulation of medical devices can leave patients unaware of hazards lurking in their bodies, and my colleague Lizzy Lawrence has an example.
Data has surfaced on a blood-clot prevention device that shows it could break apart after being implanted and migrate to other parts of the body. The clinical trial required for getting the product on the market was designed in a way that might have caused researchers to miss adverse events. That aside, data from the trial wasn’t available to patients and their doctors anyway.
“Especially in this current moment where there’s so much concern about trust, medicine, and FDA transparency, this is a tangible example of where that lack of transparency really does cause harm,” said Kushal Kadakia, an author of a paper on the incident.
