US FDA Takes Star Turn In Recent Product Liability Lawsuits

Agency’s direct involvement in pharma product liability litigation is one of the most striking developments in the field over the past year. Chart of 16 cases in multidistrict litigation shows status of settlements and upcoming bellwether trials.

Pharma litigation
Zantac and Zofran are among 16 drugs in federal multidistrict litigation • Source: Alamy

A dispute over plaintiffs’ access to results of a Zantac (ranitidine) study sponsored by the US Food and Drug Administration illustrates how parties in multidistrict litigation are trying to get the agency to bolster their positions.

More from US FDA

More from Agency Leadership

US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By 

The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.

US FDA Commissioner’s Office Plans Involvement In Many Approvals In Potential Major Change

 

FDA Commissioner Martin Makary's remarks that his special assistant Tracy Beth Høeg will "be involved in other approval procedures" besides Novavax's COVID-19 vaccine application could be a dramatic change in operations, potentially making the approval system unpredictable.

US FDA Commissioner Rejected Some Proposed Reorg Plans

 
• By 

FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale.