It's time to replace the FDA, says Newt Gingrich
The media attention to how first-grader Joshua Hardy from Fredericksburg, VA, won access to an investigational Chimerix drug to fight an infection after getting a bone-marrow transplant sheds light on the difficult and controversial process to allow compassionate use of unapproved drugs.
It also prompted former speaker of the House and presidential candidate Newt Gingrich to declare it's time to replace FDA because it is an “obsolete bureaucracy with obsolete rules that do more harm than good.”
The media attention in Hardy's case led FDA to work with Chimerix to allow a special pediatric trial where the company could enroll up to 20 patients and the data would then be used for seeking a pediatric-use indication. Maybe a new system is needed for those seeking a last-resort therapy because FDA won't have the resources to intervene in every media-driven compassionate-use case.
According to Gingrich, a “largely paper-based and slow moving FDA bureaucracy is simply incapable of this kind of modern, personalized model of developing new solutions in healthcare.”
Gingrich also tackles the cost dilemma small companies face when deciding whether to allow compassionate use. “We should redesign the system to lower the cost of approval so companies can afford to share breakthroughs even during the testing phase,” he writes. “A drug should not need to be worth billions to merit FDA approval.”